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This experimental drug could change the field of cancer research

Sacha Pfeiffer

Jonaki Mehta

The new treatment is categorized as immunotherapy. skaman306/Getty Images hide caption

The new treatment is categorized as immunotherapy.

A tiny group of people with rectal cancer just experienced something of a scientific miracle: their cancer simply vanished after an experimental treatment.

In a very small trial done by doctors at New York's Memorial Sloan Kettering Cancer Center, patients took a drug called dostarlimab for six months. The trial resulted in every single one of their tumors disappearing. The trial group included just 18 people, and there's still more to be learned about how the treatment worked. But some scientists say these kinds of results have never been seen in the history of cancer research.

Dr. Hanna Sanoff of the University of North Carolina's Lineberger Comprehensive Cancer Center joined NPR's All Things Considered to outline how this drug works and what it could mean for the future of cancer research. Although she was not involved with the study, Dr. Sanoff has written about the results.

This interview has been lightly edited

On her first reaction to the results: I mean, I am incredibly optimistic. Like you said in the introduction, we have never seen anything work in 100 percent of people in cancer medicine.

On how the drug works to treat cancer: This drug is one of a class of drugs called immune checkpoint inhibitors. These are immunotherapy medicines that work not by directly attacking the cancer itself, but actually getting a person's immune system to essentially do the work. These are drugs that have been around in melanoma and other cancers for quite a while, but really have not been part of the routine care of colorectal cancers until fairly recently.

On the kinds of side effects patients experienced: Very, very few in this study - in fact, surprisingly few. Most people had no severe adverse effects at all.

On how this study could be seen as 'practice-changing': Our hope would be that for this subgroup of people - which is only about five percent to 10 percent of people who have rectal cancer - if they can go on and just get six months of immunotherapy and not have any of the rest of this - I don't even know the word to use. Paradigm shift is often used, but this really absolutely is paradigm-shifting.

On why the idea of being able to skip surgery for cancer treatment is so revolutionary: In rectal cancer, this is part of the conversation we have with someone when they're diagnosed. We are very hopeful for being able to cure you, but unfortunately, we know our treatments are going to leave you with consequences that may, in fact, be life-changing. I have had patients who, after their rectal cancer, have barely left the house for years - and in a couple of cases, even decades - because of the consequences of incontinence and the shame that's associated with this.

On next steps for the drug: What I'd really like us to do is get a bigger trial where this drug is used in a much more diverse setting to understand what the real, true response rate is going to be. It's not going to end up being 100 percent. I hope I bite my tongue on that in the future, but I can't imagine it will be 100 percent. And so when we see what the true response rate is, that's when I think we can really do this all the time.

This piece was reported by Sacha Pfeiffer, produced by Jonaki Mehta and edited by Kathryn Fox. It was adapted for the web by Manuela Lopez Restrepo.

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New cancer treatment may reawaken the immune system

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Immunotherapy is a promising strategy to treat cancer by stimulating the body’s own immune system to destroy tumor cells, but it only works for a handful of cancers. MIT researchers have now discovered a new way to jump-start the immune system to attack tumors, which they hope could allow immunotherapy to be used against more types of cancer.

Their novel approach involves removing tumor cells from the body, treating them with chemotherapy drugs, and then placing them back in the tumor. When delivered along with drugs that activate T cells, these injured cancer cells appear to act as a distress signal that spurs the T cells into action.

“When you create cells that have DNA damage but are not killed, under certain conditions those live, injured cells can send a signal that awakens the immune system,” says Michael Yaffe, who is a David H. Koch Professor of Science, the director of the MIT Center for Precision Cancer Medicine, and a member of MIT’s Koch Institute for Integrative Cancer Research.

In mouse studies, the researchers found that this treatment could completely eliminate tumors in nearly half of the mice.

Yaffe and Darrell Irvine, who is the Underwood-Prescott Professor with appointments in MIT’s departments of Biological Engineering and Materials Science and Engineering, and an associate director of the Koch Institute, are the senior authors of the study, which appears today in Science Signaling . MIT postdoc Ganapathy Sriram and Lauren Milling PhD ’21 are the lead authors of the paper.

T cell activation

One class of drugs currently used for cancer immunotherapy is checkpoint blockade inhibitors, which take the brakes off of T cells that have become “exhausted” and unable to attack tumors. These drugs have shown success in treating a few types of cancer but do not work against many others.

Yaffe and his colleagues set out to try to improve the performance of these drugs by combining them with cytotoxic chemotherapy drugs, in hopes that the chemotherapy could help stimulate the immune system to kill tumor cells. This approach is based on a phenomenon known as immunogenic cell death, in which dead or dying tumor cells send signals that attract the immune system’s attention.

Several clinical trials combining chemotherapy and immunotherapy drugs are underway, but little is known so far about the best way to combine these two types of treatment.

The MIT team began by treating cancer cells with several different chemotherapy drugs, at different doses. Twenty-four hours after the treatment, the researchers added dendritic cells to each dish, followed 24 hours later by T cells. Then, they measured how well the T cells were able to kill the cancer cells. To their surprise, they found that most of the chemotherapy drugs didn’t help very much. And those that did help appeared to work best at low doses that didn’t kill many cells.

The researchers later realized why this was so: It wasn’t dead tumor cells that were stimulating the immune system; instead, the critical factor was cells that were injured by chemotherapy but still alive.

“This describes a new concept of immunogenic cell injury rather than immunogenic cell death for cancer treatment,” Yaffe says. “We showed that if you treated tumor cells in a dish, when you injected them back directly into the tumor and gave checkpoint blockade inhibitors, the live, injured cells were the ones that reawaken the immune system.”

The drugs that appear to work best with this approach are drugs that cause DNA damage. The researchers found that when DNA damage occurs in tumor cells, it activates cellular pathways that respond to stress. These pathways send out distress signals that provoke T cells to leap into action and destroy not only those injured cells but any tumor cells nearby.

“Our findings fit perfectly with the concept that ‘danger signals’ within cells can talk to the immune system, a theory pioneered by Polly Matzinger at NIH in the 1990s, though still not universally accepted,” Yaffe says.  

Tumor elimination

In studies of mice with melanoma and breast tumors, the researchers showed that this treatment eliminated tumors completely in 40 percent of the mice. Furthermore, when the researchers injected cancer cells into these same mice several months later, their T cells recognized them and destroyed them before they could form new tumors.

The researchers also tried injecting DNA-damaging drugs directly into the tumors, instead of treating cells outside the body, but they found this was not effective because the chemotherapy drugs also harmed T cells and other immune cells near the tumor. Also, injecting the injured cells without checkpoint blockade inhibitors had little effect.

“You have to present something that can act as an immunostimulant, but then you also have to release the preexisting block on the immune cells,” Yaffe says.

Yaffe hopes to test this approach in patients whose tumors have not responded to immunotherapy, but more study is needed first to determine which drugs, and at which doses, would be most beneficial for different types of tumors. The researchers are also further investigating the details of exactly how the injured tumor cells stimulate such a strong T cell response.

The research was funded, in part, by the National Institutes of Health, the Mazumdar-Shaw International Oncology Fellowship, the MIT Center for Precision Cancer Medicine, and the Charles and Marjorie Holloway Foundation.

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FDA approves groundbreaking treatment for advanced melanoma

The Food and Drug Administration on Friday approved a new cancer therapy that could one day transform the way a majority of aggressive and advanced tumors are treated.

The treatment, called Amtagvi, from Iovance Biotherapeutics , is for metastatic melanoma patients who have already tried and failed other drugs. It’s known as TIL therapy and involves boosting the number of immune cells inside tumors, harnessing their power to fight the cancer.

It’s the first time a cellular therapy has been approved to treat solid tumors. The drug was given a fast-track approval based on the results of a phase 2 clinical trial. The company is conducting a larger phase 3 trial to confirm the treatment’s benefits. The therapy’s list price — the price before insurance and other potential discounts — is $515,000 per patient. 

“This is going to be huge,” said Dr. Elizabeth Buchbinder, a senior physician at Dana-Farber Cancer Institute in Boston. Melanoma is “not one of those cancers where there’s like 20 different” possible treatments, she said. “You start running out of options fast.” 

Friday’s approval is only for melanoma, the deadliest form of skin cancer , but experts say it holds promise for treating other solid tumors, which account for 90% of all cancers. 

“It is our hope that future iterations of TIL therapy will be important for lung cancer, colon cancer , head and neck cancer, bladder cancer and many other cancer types,” said Dr. Patrick Hwu, chief executive of the Moffitt Cancer Center in Tampa, Florida. Moffitt has been involved with Iovance’s clinical trials of TIL therapy.

TIL stands for tumor-infiltrating lymphocytes, which are immune cells that exist within tumors . But there are nowhere nearly enough of those cells to effectively fight off cancer cells. TIL therapy involves, in part, extracting some of those immune cells from the patient’s tumor and replicating them billions of times in a lab, then reinfusing them back into the patient. 

It’s similar to CAR-T cell therapy, where healthy cells are taken out of a person’s body and then modified in a lab to fight cancers. That’s usually used for hard-to-treat blood cancers such as leukemia and lymphoma. With TIL therapy, the cells used are already programmed to recognize cancer — no lab modifications needed — they just need a boost in numbers to fight it. 

Like CAR-T, TIL therapy is a one-time treatment, though the entire process can take up to eight weeks. The TIL cells are first harvested from the tumor through a minimally invasive procedure and then grown and multiplied in the lab, a process that takes 22 days, according to Iovance. 

While that’s happening, patients are given chemotherapy to clear out their immune cells to make room for the billions of new melanoma-fighting TIL cells. Once the TIL cells are reinfused back into the body, patients get a drug called interleukin-2 to further stimulate those cells. 

Hwu said that most side effects in patients undergoing TIL therapy are not from the reinfusion of cells, but from the chemotherapy and the interleukin-2. These can include nausea and extreme fatigue, and patients are also vulnerable to other illnesses because the body is depleted of disease-fighting white blood cells. 

Putting billions of cells back into the body is not entirely risk-free, however, said Dr. William Dahut, chief scientific officer of the American Cancer Society. It’s possible that the body’s immune system could overreact in what’s known as a cytokine storm, which can cause flu-like symptoms, low blood pressure and organ damage.   “There are risks for immune-related side effects, which could be serious,” he said.

Common side effects associated with Amtagvi can include abnormally fast heart rate, fluid buildup, rash, hair loss and feeling short of breath, the FDA said.

Those side effects can be managed, said Dr. Steven Rosenberg, chief of the surgery branch at the National Cancer Institute. “They’re a small price to pay for a growing cancer that would otherwise be lethal.”

Overall, Dahut said the approval of TIL therapy is “meaningful.”

“What’s nice about this is that patients will receive a wide variety of tumor fighting lymphocytes that will be able to have the capacity to overcome resistance and actually be a living therapy over time, too, to target additional cancer cells should they develop,” Dahut said.

In addition to melanoma, Dahut said that TIL therapy is most likely to be useful in cancers that respond to drugs that “take the brakes off the immune system,” called checkpoint inhibitors .

“Those would be things like non-small cell lung cancer, kidney cancer, maybe bladder cancer, that we know are responsive to immune-based therapies to begin with,” he said. “Many of those patients relapse, so another immune-based therapy that works in a different way, seems to me, the most likely way for this to be effective.”

Much more research is needed, and it may be years before TIL therapy is approved for other types of cancer.

One of Iovance’s clinical trials investigating TIL therapy for non-small cell lung cancer was forced to pause when a participant died. While the death is under investigation, the company said it may have been the result of either chemotherapy or interleukin 2 — therapies meant to knock down each patients’ immune system before they can get the reinfusion of their TIL cells. 

The therapy is not expected to work for every metastatic melanoma patient. Clinical trial data that Iovance submitted to the FDA showed that tumors shrank in about a third of patients who received TIL therapy. 

Of those patients, about half saw their tumors shrink for at least one year, Dr. Friedrich Graf Finckenstein, chief medical officer of Iovance Biotherapeutics. “Some of these patients even had their tumor completely disappear,” he said. 

Another study, conducted in the Netherlands , did a head-to-head analysis of TIL therapy and another form of immunotherapy, called ipilimumab. Twenty percent of the patients who received TIL had complete remissions, compared with 7% of patients who got ipilimumab. Iovance was not involved with the Dutch trial.

The goal of the therapy, Hwu said, “is to get rid of the cancer and have it stay away. These immune cells stay in the body and live in the body for decades.”

The technology has been in development and studied for nearly 40 years. It was Rosenberg who pioneered TIL therapy — first describing how it could shrink melanoma tumors in the New England Journal of Medicine in 1988 .

“I’ve been waiting for a very long time to see this given to patients, because I know that it can cure some patients that have metastatic melanoma that cannot be affected by any other treatment,” Rosenberg said.

It’s worked so far for Dan Bennett, 59, of Clermont, Florida. Bennett was diagnosed with melanoma in 2011 after his daughter noticed a suspicious mole on his neck that had changed color. 

Despite surgery, chemotherapy and radiation, his cancer kept returning. In 2014, his doctors at Moffitt recommended he try TIL therapy.

“At first, we were pretty leery about it because it was unproven,” Bennett said. Ten years later, Bennett is convinced the TIL therapy is the reason he has survived so long with stage 4 melanoma, which usually has a five-year survival rate of 22.5% . 

“I would recommend any experimental drug if it’s your last opportunity,” he said. “You owe it to yourself and your family to do whatever you can to stay alive and to be a productive member of society.”

Buchbinder, the Dana-Faber doctor, was not involved with Iovance’s TIL therapy trial for melanoma, but she is scheduled to begin similar trials with other drugmakers. 

“We literally have patients right now waiting for approval because they are hoping they’ll be able to go on it,” Buchbinder said. “It is definitely a practice-changing therapy.”

Erika Edwards is a health and medical news writer and reporter for NBC News and "TODAY."

Anne Thompson is NBC News’ chief environmental affairs correspondent. 

Marina Kopf is an associate producer with the NBC News Health and Medical Unit.

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Cancer Research Catalyst The Official Blog of the American Association for Cancer Research

Home > Cancer Research Catalyst > Experts Forecast Cancer Research and Treatment Advances in 2023  

Experts Forecast Cancer Research and Treatment Advances in 2023  

The year 2022 will be remembered as the time when the emergency phase of the COVID-19 pandemic began to subside. Nearly 70 percent of the U.S. population has now completed the primary COVID-19 vaccination series; treatments are available to reduce the severity of the disease; and the highly contagious but less pathogenic Omicron variant seems to be driving the transition toward an endemic phase.  

Patients with blood cancers and some solid malignancies and those receiving certain types of cancer treatments remain at higher risk of infection and severe disease than the general population and display a reduced antibody response to vaccines. However, recent studies have shown robust T-cell responses to vaccines in patients with blood cancer, spurring research to develop vaccines that leverage the T-cell-mediated immunity. 

In the cancer research world, 2022 brought about some important developments. The U.S. Food and Drug Administration (FDA) issued 40 drug approvals for oncology indications, 12 of which were new, first-in-human molecules. A recent blog post summarizes the past year’s FDA approvals.

Among other promising news, the results of a groundbreaking and potentially practice-changing immunotherapy clinical trial showed that an immune checkpoint inhibitor given to patients with locally advanced rectal cancer with a certain defect in DNA repair led to a complete clinical response with no evidence of residual disease, sparing the patients from chemoradiotherapy and surgery. 

Thanks to the advances in cancer research and care in the past decades, in early 2022, the number of cancer survivors in the U.S. surpassed an estimated 18 million . Despite the progress we have made in detecting and treating the disease, much remains to be done to reduce the burden of preventable cancer.  

The American Association for Cancer Research (AACR) participated in the public debate on cancer risk factors, specifically smoking, with the release of a seminal  joint policy statement  with the American Society of Clinical Oncology, highlighting the latest research on the use of e-cigarettes and other electronic nicotine delivery systems (ENDS). The statement also called on policymakers and regulatory authorities to take action to limit ENDS use and support evidence-based smoking cessation therapies.  

In keeping with a new-year tradition on the AACR blog , we asked a group of experts to discuss the state of the art in their fields of research and to share their predictions for the next significant developments in the year 2023 in immunotherapy, precision medicine, prevention and early detection, patient advocacy, and cancer health disparities. 

Cancer Immunotherapy in 2023

• Precision Medicine in 2023
• Cancer Prevention and Early Detection in 2023
• Patient Advocacy in 2023
• Cancer Disparities Research in 2023

AACR President-Elect Philip D. Greenberg, MD, FAACR , editor-in-chief of the AACR journal Cancer Immunology Research , professor and head of the Program in Immunology, Clinical Research Division, and the Rona Jaffe Foundation Endowed Chair at the Fred Hutchinson Cancer Center, believes this is a time for optimism in cancer research. “I think the ability to create new therapies that benefit more patients is here right now,” he said.  

In addition to increasingly effective and broadly used immunotherapies, Greenberg expects that multiple areas of research will expand dramatically in the coming year, including gene editing, epigenetics, structural biology for protein design, and medicinal chemistry, which is allowing researchers to target cancer proteins once considered undruggable. 

Within the realm of cancer immunotherapy, Greenberg predicted an expansion in the use of combinations of agents that target independent cellular pathways and can work synergistically. 

The field of engineered cell therapies, he added, is progressing very rapidly. “This area of cancer therapies is still in its infancy, but the technologies are exploding, and the capacity to generate cells and give them to patients is expanding enormously,” he said. “We can now modify the cells to improve their function and survival after infusion into patients and their ability to target the cancer. The field is going to look very different in 2023 and 2024.”  

Adoptive cell therapies, Greenberg pointed out, provide important advantages over other approaches. “We can engineer very potent immune responses outside the body, expand the cells that mediate those responses to very large numbers, and infuse them into a patient to create a very potent, de novo immune response against a desired target,” he said. “Importantly, this strategy can be effective even in a body that has already encountered the target antigens and whose immune system is not responding to them.” 

“We can now better dissect the cell composition of the tumor microenvironment, identify the inhibitory signals that interfere with immune function, and engineer cells to overcome some of those obstacles,” Greenberg explained. “We can also turn those inhibitory signals into positive signals by rewiring how the cells perceive them, essentially taking advantage of how tumors evade immune responses.”  

Thanks to these advances, the adoptive cells are rendered able to thrive in a tumor environment where the natural immune response would not. Greenberg emphasized that these advances, coupled with improved selectivity toward tumor-specific targets, will have enormous impact on the development of effective adoptive cell therapies for solid tumors, which, so far, has been a challenge. 

According to Greenberg, the use of multi-omic strategies, including spatial transcriptomics that provides a snapshot of how the cells interact in communities and neighborhoods within the larger tumor microenvironments at the single-cell level, is very instructive for the development of increasingly effective cell therapies. 

“We already have clinical trials ongoing in pancreatic cancer , and multiple other groups are conducting trials targeting solid tumors ,” Greenberg said. “I am very optimistic that we will see enormous advances and increasing numbers of cell therapies brought into the clinic in 2023, and that this will lead to an expansion of the number of tumors that can be treated effectively in the coming years.” 

Another area that Greenberg expects will advance in the new year is the development of drugs targeting inhibitory molecules in the tumor microenvironment . “I think we will start seeing increasing numbers of those drugs tested in clinical trials, particularly as components of combination therapies, and we are going to learn how to use them more effectively,” he said. 

Greenberg is also looking forward to advances in cancer vaccines that will overcome some of the challenges that still impact this approach and will bring it closer to clinical use.  

“The mRNA vaccine technology that works so effectively against COVID-19 was developed years ago for cancer vaccines, though the initial efforts were minimally successful,” he said. “The success of the COVID-19 vaccines has highlighted the big difference between developing a vaccine against a tumor that already exists in the body and is not being effectively targeted by the immune system versus one that protects us from a pathogen that contains a genome completely different from the human genome. 

“However, from the initial lack of success of cancer vaccines has come a lot of information about why we were not obtaining stronger responses, and what can be done to overcome some of the hurdles to make increasingly effective vaccines,” Greenberg added. 

Thanks to deep sequencing, it is now possible to rapidly and efficiently identify what is unique in a patient’s cancer and to create personalized vaccines that incorporate those differences. 

Greenberg explained that getting the immune system to respond to these vaccines is challenging, because when they are given to patients, the tumor has already developed strategies to turn off or evade the immune response. “Researchers are investigating ways to reinvigorate and expand the immune responses,” he said, adding that different promising strategies are being pursued to make the vaccines more immunogenic, for example, using cytokines and blocking certain inhibitory pathways.  

“I think cancer vaccines will be an important part of cancer therapies in the future,” Greenberg concluded. 

Precision Medicine in 2023 

“There are many areas of excitement in cancer research and therapeutics,” began Lillian Siu, MD, FRCPC , who is a founding editor-in-chief of the newest AACR journal, Cancer Research Communications; senior medical oncologist at Princess Margaret Cancer Centre; and professor of medicine at the University of Toronto. “One area to watch for new developments in 2023 is the dynamic monitoring of the whole cancer journey, from detection to interception to monitoring of resistance in metastatic cancer, using new technologies, such as circulating tumor DNA (ctDNA) and other circulating biomarkers. 

“Molecular residual disease trials are coming of age, and I expect they will be game changers in oncology. We now have ultrasensitive technologies to detect and measure microscopic residual disease in patients who have undergone definitive treatment,” she said. “This will allow us to apply interception strategies to eradicate cancer in those high-risk patients.” 

In this type of trials, Siu explained, clearance of ctDNA can be used as a surrogate endpoint in addition to long-term, traditional endpoints such as relapse-free survival and overall survival. 

A second area experiencing rapid growth, Siu continued, is precision immuno-oncology. “All of us are now familiar with the term ‘precision medicine,’ referring to the use of targeted therapy,” she said. “Precision immune-oncology seeks to better understand the immune system, the complexity of the tumor microenvironment, and the tumor signaling pathways that affect the response to therapy, to allow us to use immunotherapy in the most precise way possible.” 

A session at the AACR Annual Meeting 2022 included several examples of the latest advances in precision immune-oncology. 

Siu is also excited about the new generation of immune checkpoint inhibitor molecules, for example, the novel CTLA4 inhibitors modified to better target the myeloid component, and the field of immune-oncology (IO) combinations. “We have been using immune checkpoint inhibitors as single agents for almost a decade now, and so far, IO therapy combinations have proven extremely challenging and have not been successful in overcoming primary and acquired resistance. This is partly due to the lack of appropriate preclinical models, as it is extremely hard to recapitulate the human immune system in a petri dish or even in animals,” she said. “However, the field is in constant development, and there are now new model systems that may allow us for better prediction of the response in humans before we give the combinations to patients.” 

To better characterize the effect of the IO combinations, researchers are using technologies such as single-cell sequencing to learn more on the responses at the singe-cell level, and spatial transcriptomics to analyze the geographical relationships between multiple biomarkers on the same tissue sample and monitor the immune responses over time. 

“With the novel technologies we can learn a lot more and we are going to see more strategic IO combinations,” she said.  

In Siu’s opinion, there are two drug classes of active interest in the modern era of precision medicine. The first one is represented by antibody drug conjugates (ADCs), which combine the target-specificity of monoclonal antibodies and the cancer-killing activity of cytotoxic drugs. “This is definitely a new pillar of therapeutics, where many pharmaceutical and biotechnology companies are actively developing a lot of novel tumor-specific targets, better linkers, and new payloads that have dramatic antitumor activity.” 

These developments, Siu clarified, are expected to improve the antibody/drug ratio, or the amount of drug that can be loaded into the molecules, making the ADCs more potent and resulting in superior therapeutic indexes. “There are going to be many early-phase clinical trials of these new ADCs,” Siu added. 

The next drug class on Siu’s list of exciting developments are mutant-specific molecules. “There are now strategies to sharpshoot and target very specific mutants in various oncogenes,” she said. 

By selectively inhibiting the mutant protein and sparing the wild type protein, such molecules may also avoid the side effects associated with systemic suppression of the protein’s function observed with some traditional molecularly targeted therapies, Siu explained. 

In addition to the first-in-class KRAS G12C mutant inhibitor sotorasib (Lumakras), which was approved in 2021 for advanced non–small cell lung cancer harboring the G12C mutation, more KRAS mutant-specific molecules are emerging.  

Other mutant-specific molecules are advancing in their development path, including those targeting the phosphatidylinositol-3 kinase , fibroblast growth factor receptor, p53 , and MYC pathways. According to Siu, we will likely see more emerge in the therapeutics arena. 

Lastly, Siu discussed the latest developments in clinical trial design, as well as the importance of patient engagement.  

“A very interesting space that we should watch for future advances in how we schedule the administration of systemic anticancer agents is the field of neoadjuvant therapy,” Siu said. “This area has attracted a lot of attention in lung cancer and melanoma, but it is going to be applied to other tumor types, where giving therapy, especially with immunotherapy combinations, before definitive treatment with surgery or radiation may have long-term clinical benefit.” 

The idea is to use immunotherapy to attack tumors when they are more likely to respond, Siu noted. 

“In 2022, we saw a great example of this strategy, with a clinical trial conducted in patients with rectal cancer with microsatellite instability, who experienced complete responses to immunotherapy and were therefore spared from having surgery. There is a lot of interest in applying that strategy for organ preservation, so that patients do not have to undergo disfiguring treatments, such as rectal surgery or head and neck surgery,” Siu said. “I don’t think we are ready yet to apply this approach broadly, but certainly the results from this small study were a wake-up call for a lot of us in the field, indicating that sometimes drugs could cure a cancer and that we may avoid putting patients through more invasive procedures.” 

Siu emphasized that randomized trials will be needed to test the neoadjuvant therapy against the standard of care in terms of survival outcomes. 

Another critical development in clinical trial design relates to increasing patient engagement in all phases of the process. “We need to engage our patients to understand, for example, if a biopsy is feasible, or if they prefer a liquid biopsy, or if going to the cancer center five times a month is acceptable. These are things that we have always assumed, but we need better protocols that ask these questions and obtain patients’ input,” she said. 

Siu added that, in support of this, several granting agencies now do not accept grant or trial applications that do not include patients’ voice.  

She highlighted the importance of including patient-reported outcomes in the trial endpoints. “In some pioneering studies in this area, patients are using their smartphone or tablet to report how they feel and how treatment is affecting their day-to-day life at home and at work, and not just on the days they visit the clinic. This allows us to assess tolerance to the treatment, not just toxicity.” 

Ensuring equity and diversity is a highly relevant aspect of clinical research. “Study results are much more likely to be applicable to the general population if they are mindful to include all patient groups who fulfill eligibility criteria regardless of race, ethnicity, and social background,” Siu stressed. “Every effort needs to be made to enable the enrollment of underserved and underrepresented patient populations in clinical trials.” 

Cancer Prevention and Early Detection in 2023 

We are in a decisive moment for cancer prevention, early detection, and interception, according to Timothy Rebbeck, PhD , member of the AACR Cancer Prevention Working Group Steering Committee, Vincent L. Gregory Jr. Professor of Cancer Prevention, and director of the Zhu Family Center for Global Cancer Prevention at Harvard T.H. Chan School of Public Health and Dana Farber Cancer Institute. “We have built a strong foundation in basic biology and understanding of the mechanisms of cancer progression from the earliest phases to invasive disease and metastasis,” Rebbeck said. “That basic biological information is now going to inform how we can predict the risk of cancer, intercept it, and detect it at an early stage.” 

One area that he expects will take off in the coming year is that of multicancer detection (MCD) assays, which aim to detect signals of more than one type of cancer in early, more treatable stages and from a single blood sample through liquid biopsies.  

Rebbeck foresees that early detection technologies are going to change the landscape of cancer as we know it. “This area is moving very quickly: There are at least two dozen companies developing MCD tests, and the National Cancer Institute will fund a research network to evaluate the use of these tests,” he said. 

Although the results from this research will not be available for a few years, he explained, some of these tests are already commercially available and are being used in the clinic.  

He cautioned that most of them don’t yet have the ability to detect cancers very early. “We are not quite there yet, but there is a great amount of promise in these technologies, and a lot of research is ongoing to increase the sensitivity of the tests to detect cancers early,” he said.  

Rebbeck added that the cancer community will have to catch up to these fast developments to understand the medical and social implications of these tests and establish the care pathways required to achieve equitable benefit from a screening test to a diagnosis and treatment for all people.  

Another exciting area of technological development for early cancer detection is molecular imaging, or the use of molecular biomarkers to visualize changes at the cellular level, such as metabolism or oxygen consumption by cells, before structural changes become apparent through more traditional imaging approaches.  

Using nanotechnology strategies reminiscent of science fiction, researchers are also developing nanoprobes that might be ingested, injected, or even tattooed into the skin, to sense and signal the presence of cancer. 

“These new technologies are still in their infancy, but such personalized approaches to prevention and early detection have the potential to enhance the more traditional, population-based strategies and to fill the gaps in cancers for which effective screening methods are currently not available, such as pancreatic and ovarian cancer,” said Rebbeck.  

He highlighted that risk stratification plays an important role in the success of the early detection strategies. “Some prevention approaches are applicable to the entire population—for example, everybody should stop smoking, regardless of their cancer risk,” Rebbeck said. “However, many technologies and interventions for early cancer detection will be expensive or difficult to implement, so their use has to be maximized in people who are at the highest risk and can really benefit from them. We also want to avoid over-diagnosis and over-intervention.”  

In the past decade, researchers have gained a vast amount of knowledge about the genes that are involved in cancer susceptibility and have now developed models to predict what combinations of gene alterations confer risk for certain cancers.  

“We are now studying how we can use genomic risk scores for risk stratification and to monitor cancer, but also to detect cancer early,” said Rebbeck. “These genomic risk scores are promising, but they haven’t yet been translated into prevention strategies. I hope that, too, is on the horizon.” 

One important caveat in the use of genomic risk scores is that they are not always transferable across populations and are often built based on data predominantly collected among people of European descent. Rebbeck stressed the importance of increasing diversity in the study populations so that the discoveries are applicable to all and are translated in the most accurate way. 

Overall, he added, many of the technologies and tools for cancer prevention, early detection, and even treatment can create or exacerbate disparities if they are not developed and implemented in a way that benefits everyone.  

One example is breast cancer. As Rebbeck pointed out, before the advent of mammography and adjuvant endocrine therapies, Black and white patients had comparable mortality rates. In the past 30-40 years, when these strategies became commonplace, breast cancer rates and mortality rates have dropped dramatically in white women but not in Black women. “In part, that is due to the fact that breast tumors have different features in Black and white women that impact the efficacy of screening and treatment. Also, mammography and the appropriate treatment strategies have not been applied equitably; therefore, not all groups have benefited equally from these strategies,” said Rebbeck. 

“As we develop new screening, early detection, and prevention strategies, we have to consider how they are going to be applied in all populations, and their implementation may have to be tailored to the different groups,” he emphasized. 

According to Rebbeck, that process should include education and cultural awareness about what different groups of people need, and what strategies they accept to lower their cancer risks. 

Patient Advocacy in 2023 

“The patient advocacy movement started with the goal of getting more resources into cancer research, but ‘resources’ means much more than money. It also means leveraging the intellectual resources of patient advocates, helping to identify the right patients for clinical trials, and making sure patients understand the new diagnostic technologies and therapies, so that they can receive the best care,” said Anna Barker, PhD, FAACR , chair of the AACR Scientist↔Survivor Program and chief strategy officer at the Lawrence J. Ellison Institute for Transformative Medicine, University of Southern California. For Barker, patient advocacy melds research with care. 

We asked her to discuss the main themes that will shape the landscape of patient advocacy in 2023. 

One area in which patients and advocates can make a difference for research, she explained, is in ensuring their tumor samples are collected, accurately characterized at the molecular level, and entered into an appropriate database. “Larger patient data sets support learning systems that will drive the development of more patient-centric targeted cancer therapeutics and diagnostics.”  

Another domain of critical patient advocate involvement, Barker indicated, will be clinical trials . “We are still under-enrolling patients in clinical trials, primarily because of a lack of education—people don’t fully understand the value of participating, and sometimes physicians don’t have time or resources to help them navigate the options,” she said. “I think this is going to be a big opportunity for patients and patient advocates to push the envelope for higher enrollment in trials that will allow us to identify more efficacious drugs, biologics, and combinations.”  

Barker emphasized the power of education and the importance of having a mutual learning system in place through which researchers and patient advocates can learn from each other.  

“AACR was one of the first organizations to enable patient advocates and survivors to contribute to and participate in research, and to empower them to become patient scientists,” Barker added. “Increasingly, patient advocates are extraordinarily well educated and are leveraging the power of cancer research. They do their homework, and many are incorporating sophisticated molecular information into their education programs.” 

In fact, many of the leaders of advocacy organizations, who often represent hundreds or even thousands of patient advocates, participate in scientific conferences and initiatives and bring the information they acquire back to their community.  

“I think it is going to be critical that patient advocates increasingly partner with scientists to ensure that the education they are receiving and delivering is on point and up to date,” Barker said. “On the other hand, scientists and physicians should take the time to discuss how to optimize the collection and use of patient samples, what that means to each patient in terms of treatment, and how research can inform every step of a patient’s cancer journey. This takes time, and the results may not be obvious right away, but when you empower patient advocates, they will work to inform both their constituencies and the research communities, which increases everyone’s understanding of cancer.” 

For example, the topic of cancer survivorship is now part of the research and patient advocacy agendas, and Barker hopes that scientists will do their part in educating patients about the importance of monitoring for secondary cancers and long-term toxicity from treatment. 

A larger cancer survivor population will also require some policy changes to ensure access to therapy for everyone and to lower the cost of treatment, especially for disadvantaged and underserved populations, including older patients who often have comorbidities. “Patient advocates are the most effective ambassadors for policy change,” Barker said. “I am looking forward to seeing what changes will happen in the next few years.” 

Engaging patients and patient advocates from these disadvantaged communities is another key priority for the near future. “Until we can equitably deliver the best cancer care to the communities that have been underserved so far, we are not going to achieve our goal of reducing the cancer burden in our lifetime,” Barker said.  

She also highlighted that it will be important to engage the patient advocacy communities in other countries. “Over the years, AACR has strived to expand our model of scientists and survivors working together, and this model has become of high interest to a lot of countries.”  

According to Barker, patient advocates will play a critical role in the relatively new area of multicancer early detection. “It is still very early, and it will take time to prove how valuable these assays are, but this is an active area of research that is developing quickly. In my opinion, if successful and managed appropriately, it could be transformative and will create a whole new approach to preventing and downstaging cancer, which offers opportunities to cure more patients in the future,” Barker said. 

She stressed that having patient advocates at the table is going to be important in determining how to best use the data obtained through these assays, how to integrate the information into a patient’s care, and how to educate people about this new approach. 

“We are at an inflection point in cancer research in which we really need participation of patients and patient advocates as we’ve never needed it before. I hope we have built relationships between scientists and patient advocates that will get stronger and stronger in years to come,” Barker concluded. 

Cancer Disparities Research in 2023 

Advances in immuno-oncology will likely dominate cancer disparities research next year, according to Melissa B. Davis, PhD , member of the AACR Minorities in Cancer Research Council, associate professor of cell and developmental biology research, and scientific director of the International Center for the Study of Breast Cancer Subtypes at Weill Cornell Medical College. “We are starting to uncover the population-level variation in the tumor immune landscapes across different cancer types,” she said. 

Similarly, the field is now delving into the role of ancestry in genomic diversity across populations. “I think that is going to be a hot topic, and we will see a vast amount of data coming out next year from population-level whole genome and whole exome sequencing projects, which will begin to address the broad diversity in patients,” Davis explained. “This will fuel our ability to identify genetic drivers that might have ancestry-specific functional consequences that impact a plethora of mechanisms, ranging from DNA repair to metabolism.” 

Artificial intelligence is also playing an increasingly important role, according to Davis, and will be applied to imaging, for histology and diagnostics, and to informatics data mining, related to the development of algorithms to identify genetic drivers of tumor biology. 

Dissecting the intricate contribution of intrinsic biologic factors and external socioeconomic and environmental factors on cancer health disparities is a big challenge of our time.  

Davis discussed the concept of oncologic anthropology, introduced by her research partner Lisa Newman, MD, MPH, which uses global approaches to understand how the ancestral origins of people, as well as their lived experience, significantly influence cancer incidence, severity, and mortality within a population.  

“We can measure the differences at a population level related to biology,” Davis said. For instance, research has shown that the aggressive triple-negative subtype of breast cancer has a disproportionately higher incidence in women of African descent compared to women of European descent. Similar differences, she added, are seen in other types of cancer, including liver, esophageal, and colorectal cancer. Disparities across populations also exist in therapy response and mortality rates. 

“But the reality is that on a global scale, some of the populations that experience a higher burden of certain cancers are also being marginalized due to structural racism and economic factors,” Davis said. 

As she pointed out, the key to addressing the interplay between ancestry-related biological factors and socioeconomic factors lies in multidisciplinary intersectionality, defined as a systematic and inclusive research approach that focuses on the whole spectrum of factors from multiple angles using appropriate tools.  

“Through the integrated work of different teams with relevant specialties, it may be possible to tease apart which components of disease biology are driven by an intrinsic predisposition based on evolutionary processes from ancient driver mutations and which are due to socio-cultural aspects, like the fact that marginalized groups are limited in their ability to live in a healthy environment,” Davis explained. 

“The issue of health equity is very complex and difficult to address. It encompasses where you live, the type of work you do, the type of insurance you have, whether you have the resources to afford a healthy diet and lifestyle, and preventative health care,” said Davis. “Maybe genetic predispositions interact with all these factors; then we thread into all of that the allostatic load, or the impact of the chronic stress associated with being who you are, where you are, and the discrimination you endure.” 

In addition, the effects of those environmental exposures accumulate over time. 

“I recognize that to cure a population of a disease that responds to how and where you live, we are limited by how much we can change patients’ environment,” Davis said. “That is why I think it takes a workforce of people coming together. It is going to be challenging, but maybe the evidence will allow us to affect policies that can start mitigating some of these factors.” 

Davis is hopeful that the scientific community is moving in the right direction. “In the last few years, we have seen much more attention and a new appreciation of the role that population variation can play in the mechanisms of malignancy and the differences that we can address on a biological level. I think that is really promising,” she said. 

Davis mentioned the importance of different cooperative team-based initiatives that target underserved populations, such as the Polyethnic-1000 Project from the New York Genome Center. 

“We don’t yet have the medicines that we need to cover all the types of biology in cancer, and we don’t have the best tools to screen a broad population,” Davis pointed out. “For example, polygenic risk scores are very promising, but if you are a descendant from the African diaspora, the current computations don’t work very well. However, I believe that having more information, more data, is going to be transformative, and provide the tools to build better clinical applications.”  

Davis stressed that training people of various backgrounds to become the scientists that drive research on health disparities is paramount. “It is very important that if you are studying a deprived population, you have stakeholders from that population on your team, and that they are involved in a very substantial way,” she said. “Their perspectives are going to be pivotal both for interpreting the results and for implementing any kind of intervention that is going to be sustainable in those communities.” 

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Thank you for pointing out that individuals with particular solid and blood tumors, as well as those undergoing certain cancer therapies, continue to be at higher risk of infection and serious illness than the general population and exhibit a lower antibody response to immunizations. My employee must obtain the immunization before going to the job site. He is cancerous. For his situation, I will consult with an oncology specialist.

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Review highlights advances in kidney cancer research and care

by University of North Carolina Health Care

New insights into the biology of kidney cancer, including those informed by scientific discoveries that earned a Nobel Prize, have led to advances in treatment and increased survival rates, according to a review by UNC Lineberger Comprehensive Cancer Center's William Kim, MD, and Tracy Rose, MD, MPH.

Their observations, drawn from a meta-analysis of 89 studies published between January 2013 and January 2024, were published in JAMA Aug. 28.

"The Nobel Prize in Medicine or Physiology in 2019 was awarded for the discovery of how mammalian cells sense oxygen," said Kim, the Rush S. Dickson Distinguished Professor of Medicine at UNC School of Medicine and co-leader of the UNC Lineberger Cancer Genetics Research Program.

"One of the key components of this oxygen sensing pathway is the von Hippel-Lindau tumor suppressor gene, which is mutated in approximately 90% of kidney cancers. This deep understanding of kidney cancer biology has led to several important therapeutic advances in recent years."

Kim trained as a post-doc with William G. Kaelin, Jr., MD, who was jointly awarded the 2019 Nobel Prize for demonstrating how the von Hippel-Lindau gene influences cellular responses to changing oxygen levels.

The American Cancer Society estimates that more than 81,500 people will be diagnosed with kidney cancer in the United States this year, and the disease will cause 14,300 deaths. While the incidence of kidney cancer has been increasing by approximately 1.5% annually in recent years, deaths have decreased by about 2% each year from 2016 to 2020.

This decline in deaths is largely due to improved treatments and early detection. "The majority of kidney cancer cases are now detected incidentally, often before symptoms appear," said Kim.

He noted that the widespread use of abdominal imaging for unrelated issues has led to the incidental diagnosis of kidney cancer. "More cases are being identified in earlier stages when the cancer is typically more responsive to treatment."

Cigarette smoking and being overweight are major risk factors for kidney cancer and are linked to nearly half of the cases in the United States. Other risk factors include high blood pressure, a family history of kidney cancer, workplace exposure to certain chemicals, and hereditary conditions, such as von Hippel-Lindau disease.

Current treatment approaches include surgery to remove part or all of the kidney, ablation using targeted heat or cold to destroy the tumor, or active surveillance with imaging technologies to monitor the tumor. For cancers that have metastasized, or spread beyond the kidney, newer treatment options include immune checkpoint inhibitors, tyrosine kinase inhibitors , or a combination of the two approaches.

"Advanced, metastatic kidney cancer is highly treatable with targeted therapy, immunotherapy or a combination of these newer therapies," said Rose, associate professor of medicine at UNC School of Medicine.

"Understanding the science underlying the disease has allowed for the rational development of therapies that have positively affected many patients the past two decades."

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One major challenge is the microenvironment surrounding the tumor. This environment is characterized by dense tissue creating a barrier around the tumor that inhibits blood vessel formation and blocks immune infiltration.  

“Drug delivery is a huge challenge due to the architecture of these difficult-to-treat tumors’ microenvironment,” says Prabhani Atukorale , assistant professor of biomedical engineering at UMass Amherst and one of the corresponding authors of the paper. She adds that the environment also blocks the activation of the body’s immune cells and their penetration into the tumor.  

“Pancreas cancer, unfortunately, doesn’t respond to most conventional therapies like chemotherapy, or even immunotherapy, which has revolutionized a lot of cancer therapy in the last 10 years,” says Marcus Ruscetti , assistant professor of molecular, cell and cancer biology at UMass Chan Medical School, and the other corresponding author.  

Ruscetti’s previous research demonstrated that two cancer drugs (MEK inhibitor trametinib and CDK4/6 inhibitor palbociclib, or T/P) can promote blood vessel development, enabling greater T cell (as well as chemotherapy) delivery into the tumor. However, the cancer “tricks” the immune system into thinking that the tumor is just a regular, healthy clump of cells. Since the T cells aren’t activated, simply having more of them present won’t clear the cancer. 

Here’s where the researchers want to implement a trick of their own. The first pathway is called the stimulator of interferon genes (STING) pathway. STING recognizes viral infections in the body. “If we can trick the immune system into thinking that there is a viral-type infection, then we harness a very robust anti-tumor immune response to bring in for tumor immunotherapy,” Atukorale explains. 

The researchers also wanted to activate the TRL4 pathway because it boosts the effects of STING activation. They use agonists, which are any chemicals that can trigger a biological response; in this case, in immune stimulatory pathways. But getting these immunity-triggering chemicals through the tumor’s microenvironment is still a challenge.  

The researchers’ solution: encapsulating the STING and TRL4 agonists in a novel design of lipid-based nanoparticles. The nanoparticles have several benefits. First, the research demonstrated that they are highly effective at delivering the agonists into the challenging tumor microenvironment.  

The design also allows both of the agonists to be packaged together — a challenge since these two mix as well as oil and water. “It ensures that they are carried within the blood circulation together, they reach the same target cell together and are taken up together by the same target cell,” says Atukorale. 

“We’re using biocompatible, lipid-based materials to encapsulate drugs that functionally work together, but don’t like to be next to each other, and then we are able to use engineering capabilities to build in various functionalities to direct them where they need to go,” she says. 

The synergistic effect of the two agonists plus the T/P therapy proved effective: eight out of nine of the mice saw tumor necrosis and shrinkage. “And we had two mice that had complete responses, meaning the tumors completely went away, which is pretty striking,” says Ruscetti. “We’ve never seen that in this model before.” 

There is still work to be done because the tumors returned after the mice were taken off of the treatment, but Ruscetti says it is still a very encouraging step toward a cure. 

“If you go beyond pancreas cancer to other cancer types, you need a combination therapy to target the tumor and to target the immune system,” he adds. “This is a strategy to be able to do that.” Treatments for cancers like PDAC that could be derived from this study include mutations of colon cancer, lung cancer, liver cancer and cholangiocarcinoma (cancer of the bile ducts). 

Prabhani adds that the modular nature of this design allows for therapies that can be easily personalized for patients. “It’s sort of plug and play,” she says. “We can tailor the agonist ratios, the drug combinations, the targeting molecules, but keeping essentially the same platform. This is what will make it hopefully translational, but also tunable on a per patient basis, because many of these cancer therapies need to be personalized.” 

Finally, she nods to the power of collaboration between the two UMass institutions, saying, “This type of system is easily built when you have complementary, but multidisciplinary and cross-disciplinary, expertise.”

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Further treatment option for triple-negative breast cancer recommended

NICE has today (8 November 2022) published final draft guidance which recommends pembrolizumab as an option for people with a type of breast cancer called triple-negative breast cancer.

The draft guidance recommends pembrolizumab (also called Keytruda and made by MSD ) as an option with chemotherapy to try to reduce the size of the tumour before surgery (neoadjuvant treatment), and on its own as treatment after surgery (adjuvant treatment), for adults with triple-negative early breast cancer at high risk of recurrence or locally advanced breast cancer.

Today’s draft guidance means NICE has produced 3 positive pieces of guidance for treating triple-negative breast cancer in little over 4 months, and 17 for breast cancer as a whole since 2018. 

Triple-negative breast cancer can be more aggressive than other types of breast cancer and accounts for a quarter of all deaths from breast cancer despite accounting for only 1 in 5 cases.

Clinical trial evidence shows that adding pembrolizumab to chemotherapy before surgery, then continuing with pembrolizumab alone after surgery increases the chance that the cancer will disappear. It also increases the time before any cancer recurs. However, it is not clear if pembrolizumab increases how long people live.

It is estimated there are around 3,200 people in England with triple- negative breast cancer, of whom approximately 1,600 will be eligible for treatment with pembrolizumab under this draft guidance.

The committee heard that there are relatively few effective treatment options for people with triple-negative breast cancer and that adding pembrolizumab to standard care would be welcomed and is seen as an additional lifeline. This is particularly because triple-negative breast has an increased risk of recurrence compared with other forms of breast cancer. It is also associated with younger people, who may have young families.

Triple negative breast cancer has a relatively poor prognosis and there are few effective treatments compared with other types of the disease. Today’s draft guidance means that we have now recommended 3 new treatments for routine use in the NHS since June, helping to address this unmet need and giving hope of a longer and a better quality of life to thousands of people.

NICE expects to publish its final guidance on pembrolizumab for treating early or locally advanced triple-negative breast cancer next month (December 2022).

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