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Cancer Policy Monitor: May 11, 2021

Appropriations Update from Capitol Hill

-Marc Johnson, MPP

The Biden administration released its FY 2022 Discretionary Funding Request, which provided top-line funding recommendations for federal programs and agencies, on April 9. The proposal would provide a total of $51 billion for the National Institutes of Health (NIH), an increase of $9 billion, of which $6.5 billion would be allocated to the establishment of an Advanced Research Projects Agency for Health (ARPA-H). On April 15, the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing on the FY 2022 budget request for the Department of Health and Human Services (HHS) with HHS Secretary Xavier Becerra. Secretary Becerra spoke to the intent of the ARPA-H proposal, which would have an initial focus on cancer and other diseases with a goal of increasing the speed of innovation in medical research to achieve faster results. The Biden administration is expected to release its full budget proposal later this spring, and more hearings will be held to discuss the details of the budget at that time. 

May is National Cancer Research Month

The AACR initiated and supports National Cancer Research Month to highlight the importance of lifesaving research to the millions of people affected by the collection of devastating diseases we call cancer. Please take a moment at this extraordinary time to show your support of pioneering cancer research that is saving lives. Learn more.

Anticancer Drugs Repurposed to Treat COVID-19

– Tod Guidry, PhD

The rapid pace and life-threatening consequences of the ongoing pandemic have pressed the need to test repurposed drugs as possible treatments for patients with COVID-19. Similarities between the pathogenesis of cancers and that of COVID-19 have led to investigations of anticancer drugs as potential COVID-19 therapeutics. An article recently published in Cancer Discovery discusses what is currently known about the efficacy of anticancer drugs in the treatment of patients with COVID-19.

Severe COVID-19 infections are primarily driven by immunopathological inflammatory pathways targeted by some anticancer therapeutics. Dexamethasone, a corticosteroid typically used to treat hematological malignancies, has been shown to improve the overall survival of patients with severe COVID-19. To alleviate COVID-19-related cytokine storm, some studies show a therapeutic effect of anti-cytokine therapeutics such as anti-IL6 receptor blockers. One example is tocilizumab which has been used to treat cytokine release syndrome (CRS), a frequent complication in cancer patients treated with certain treatments including chimeric antigen receptor-T (CAR-T) cell therapy. Observational studies have also suggested potential efficacy of Bruton tyrosine kinase (BTK) inhibitors approved to treat lymphoid blood disorders. Studies suggest that JAK inhibitors may restrict expression of the ACE2 receptor necessary for cellular entry of SARS-CoV-2 and improve outcomes of patients with severe COVID-19 by curbing inflammation.

Pro-angiogenic factors are implicated in the pulmonary edema and vascular permeability observed in patients with COVID-19. Treatment with antiangiogenic therapies such as bevacizumab may suppress pulmonary edema and promote vascular normalization, and has been associated with improvement in patients with severe COVID-19.

The authors also highlight anticancer drugs targeting host interacting proteins as potential COVID-19 therapies. The multiple myeloma treatment plitidepsin, an inhibitor of the host factor eEF1A observed to interact with SARS-CoV-2, has shown robust anti-SARS-CoV-2 activity in preclinical studies, particularly when compared to remdesivir. Silmitasertib, a casein kinase 2 (CK2) inhibitor currently being investigated in recurrent medulloblastoma, has shown potent anti-SARS-CoV-2 activity in vitro. Apilimid, a drug investigated in the treatment of non-Hodgkin lymphoma, was shown to inhibit viral replication. SARS-CoV-2 also interrupts the cell cycle, and several drugs targeting host cell cycle factors represent promising candidates for COVID-19 treatment as well.

The Cancer Discovery article highlights a variety of drugs originally developed as anticancer therapeutics with the potential to treat patients with COVID-19. However, strong clinical evidence for their efficacy remains lacking, and future studies carrying out longer follow-up of trial participants and enrolling more precise patient populations are needed. The article tabulates ongoing clinical trials investigating the efficacy of repurposed anticancer therapies.  Altogether, the findings outlined in the review suggest anticancer drugs could hold both direct antiviral effects and other indirect effects against COVID-19, and thus serve as a valuable tool in lessening the pandemic’s disease burden.

Congratulations to AACR Distinguished Public Service Award Recipients

The AACR presented Distinguished Public Service Awards to three individuals whose extraordinary work exemplifies the AACR’s mission to prevent and cure all cancers: Kathy Giusti, founder of the Multiple Myeloma Research Foundation; Nancy P. Pelosi (D-California), speaker of the U.S. House of Representatives; and Charles L. Sawyers, world-renowned cancer researcher and AACR past president. Learn more. 

Annual Meeting Panel Discussed Building Vaccine Confidence

-Nicholas Warren, PhD

Approximately half of all Americans have now received at least one dose of a COVID-19 vaccine. This is a spectacular development that provides light at the end of the tunnel for the COVID-19 pandemic. While demand for vaccines previously outweighed the supply, every American adult is now eligible for a COVID-19 vaccine, and public health officials have turned their attention to increasing vaccination rates in an effort to reach herd immunity. In order to help answer lingering questions and encourage greater vaccine uptake, the American Association for Cancer Research (AACR) hosted a panel discussion during the first week of the 2021 Annual Meeting on “Building Vaccine Confidence,” co-moderated by Gilbert S. Omenn, MD, PhD, chair of the AACR Health Policy Subcommittee, and AACR Immediate Past President, Antoni Ribas, MD, PhD, FAACR.

The session featured Francis Collins, MD, PhD, director of the National Institutes of Health (NIH) and Lisa Richardson, MD, MPH, director of the Division of Cancer Prevention and Control at the Centers for Disease Control and Prevention (CDC), who shared federal efforts to build vaccine confidence. Dr. Collins detailed the NIH’s role in vaccine development and encouraged attendees to join the COVID-19 Community Corps. Dr. Richardson described how the CDC partners with state and local public health officials to provide technical assistance and help with crafting effective messages. Dr. Richardson also expressed the importance of building trust and knowledge in science to combat misinformation and help address uncertainty.

Liz Hamel from the Kaiser Family Foundation (KFF), detailed KFF surveys tracking perceptions of the vaccines among various demographics. Ms. Hamel expressed optimism in the growing number of people who have been vaccinated or want to do so as soon as possible, which was 62 percent of American adults in the March 2021 KFF survey. While there is a consistent group of 13-15 percent of the population that has answered they definitely do not want to get vaccinated, Ms. Hamel noted most of the progress in building vaccine confidence has been among the group she termed “wait and see.”

Patient advocates on the panel provided perspectives from patients with cancer and shared efforts to build confidence in their communities. Mary Gullatte, PhD, RN, ANP-BC, AOCN, from Emory Healthcare Inc., shared her experience speaking virtually with her church community and organizing vaccination clinics through the church. Dr. Gullatte expressed the importance of utilizing trusted messengers that represent the audience and compassionately listen to and answer concerns. Grace Cordovano, PhD, BCPA, echoed Dr. Gullatte’s message of  compassionate listening and the importance of health care providers showing their humanity when talking with patients; it is rational for patients with cancer to have questions and they deserve honest answers.

Panelists also answered questions patients with cancer have about the efficacy and safety of COVID-19 vaccines. Lee Greenberger, PhD, from the Leukemia and Lymphoma Society (LLS), expressed concern that some patients with blood cancers are less likely to generate an antibody response due to treatments that suppress the immune system. In response, LLS opened a study to characterize immune responses in patients with cancer and hopes to publish the data in the coming months. E. John Wherry, PhD, from the University of Pennsylvania, acknowledge the concerns about reduced antibody responses in certain patients with cancer, but emphasized there are other parts of the immune system activated by the vaccines which could prevent severe symptoms. Dr. Ribas also shared there is no evidence of adverse interactions between COVID-19 vaccines and cancer treatments. Additionally, the original anticancer mRNA vaccines, which provide the basis for the mRNA COVID-19 vaccines, were all studied in clinical trials in combination with cancer immunotherapies and were found to be safe.

Ending the pandemic through vaccination and maintaining other precautions like wearing masks is the key to restoring momentum against cancer. To learn more about COVID-19 and cancer, visit the AACR COVID-19 and Cancer Resource Center and watch the “Building Vaccine Confidence” session recording.

AACR Annual Meeting Shares the Latest in Cancer Prevention Research

-Nicholas Warren, PhD

Cancer prevention is at the core of the American Association for Cancer Research’s (AACR) mission, because up to half of all cancers globally can be linked to preventable environmental or lifestyle factors. Prevention is also far less costly than treating cancer and eliminates the mental stress and morbidity of a cancer diagnosis. After tobacco use, excess body weight is the second leading preventable cause of cancer, associated with 630,000 cases of cancer per year in the United States. Infectious diseases are another major environmental cause of cancer, especially in low income countries, causing more than 2.2 million cases of cancer each year. Additionally, the World Health Organization’s (WHO) International Agency for Research on Caner (IARC) found air pollution caused more than 220,000 lung cancer deaths globally, and millions more deaths from other respiratory diseases in 2010. During week one of the 2021 AACR Annual Meeting numerous posters, on-demand presentations, and live sessions presented the latest advances in cancer prevention research.

During the National Cancer Institute (NCI) Director’s Address, Norman Sharpless, MD, called for national urgency to address the obesity epidemic, which he stated will overtake tobacco use as the leading modifiable cause of cancer. During the Opening Plenary Session, Karen Vousden, PhD, from the Francis Crick Institute, and Matthew Vander Heiden, MD, PhD, from the Massachusetts Institute of Technology, had a paired presentation and discussion about the role of diet in cancer. Drs. Vousden and Vander Heiden shared there is very little evidence about ideal diets to prevent cancer or what patients with cancer should eat after diagnosis, but they shared some basic evidence-based guidance: avoid red meats, processed foods, and simple carbohydrates, and; focus on eating fruits, vegetables, whole grains, and healthy sources of fat and protein, like fish, legumes, and nuts. During the on-demand session Diet, Clock, and Cancer, Satchidananda Panda, PhD, from the Salk Institute, shared his research showing restricting eating to a 10 hour window each day helped control body weight, insulin, glucose, and lipid levels in human volunteers without reducing calorie consumption nor leaving participants feeling hungry. Dr. Panda theorized the effect of time-restricted eating is due to effects of stabilizing the circadian rhythm and eating when the body is most ready for digestion.

The session titled “Carcinogenic Exposures and Global Cancer Prevention” included presentations on the impact of global air pollution and infectious diseases on cancer risk. Dean Hosgood, PhD, from the Albert Einstein College of Medicine, discussed how air pollution, an IARC group I carcinogen, has steadily increased over the past several decades; major contributors are fossil fuel combustion, forest fires, as well as cooking and household heating in low income countries. Philip Castle, PhD, MPH, described various pathogens known to cause cancer like the bacteria, H. pylori, and the Human Papilloma Virus (HPV). While there are several effective vaccines to prevent HPV infections and common antibiotics cure H. pylori infections, much of the developing world does not have access to these lifesaving interventions. Dr. Castle emphasized the role of global collaborations to help build access to therapies and screening with the hope of eradicating pathogen-related cancers.

The AACR will continue to advance cancer prevention research and policy so millions of people may be spared from the horrible set of diseases we call cancer. The sessions described in this article and many more are available on-demand through June 21, please be sure to register for the AACR Annual Meeting and check them out!

Tobacco Policy Discussed at the AACR Annual Meeting

-Nicholas Warren, PhD

Tobacco is the leading preventable cause of cancer, resulting in more than 660,000 cases of cancer per year in the United States. Effective tobacco control policies and education campaigns have drastically decreased the percentage of American adults who smoke. While nearly half of adults smoked in the 1960s, just 14 percent smoked in 2019. However, there are concerns the youth e-cigarette epidemic could reverse the progress made in tobacco cessation, with almost one quarter of high school students reporting past 30-day tobacco product use in 2020. To discuss what more can be done to eliminate tobacco-related illness, the American Association for Cancer Research (AACR) organized on-demand presentations and a panel discussion on “Issues Important to Tobacco Control,” moderated by Roy S. Herbst, MD, PhD, chair of the AACR Tobacco Products and Cancer Policy Subcommittee.

The panel discussion featured Mitch Zeller, JD, director of the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products, who discussed FDA’s actions on menthol flavored cigarettes, education campaigns, and premarket tobacco product applications (PMTAs). Mr. Zeller shared how menthol cigarettes contribute to tobacco-related health disparities by increasing the likelihood of starting smoking after trying a menthol cigarette and that menthol makes it harder to quit smoking. Mr. Zeller also outlined how “The Real Cost,” “Fresh Empire,” and “This is Free Life” education campaigns are targeted toward minority communities disproportionately impacted by tobacco-related illness. Furthermore, Mr. Zeller detailed how the FDA received almost 5 million PMTAs for e-cigarettes by the September 2020 deadline and spoke about the FDA’s scientific review of the applications.

The panel also included members of the AACR Tobacco Products and Cancer Policy Subcommittee who discussed flavored tobacco products, the impact of health disparities in tobacco use, and the need for greater cessation therapies. Be sure to tune in to a follow up panel discussion on tobacco policy issues during week two of the 2021 Annual Meeting Friday, May 21. The AACR is committed to eliminating all tobacco-related cancers and will continue to advocate for policies that reduce tobacco use.

FDA Special Session with Patient Advocates at the AACR Annual Meeting 2021

FDA Oncology Center of Excellence’s Richard Pazdur, Paul Kluetz, Harpreet Singh, and Rea Blakey joined Anna Barker and patient advocates at the Annual Meeting to discuss how OCE is working with the advocacy community to improve outcomes for patients with cancer. Thank you to everyone who attended and special thanks to OCE.

Watch now

Rally for Medical Research 2021 Virtual Hill Day   

Registration is now open for the ninth annual Rally for Medical Research, which will be held September 22-23, 2021, as an entirely virtual event. This format will allow as many people as possible to participate, and we look forward to making this the biggest Rally for Medical Research ever!

A virtual reception with exciting speakers is being planned for the evening of Wednesday, September 22, while the virtual Hill Day meetings on Thursday, September 23 will be held with congressional offices via video and phone conference. We will hold a training session for all participants the week prior to the Hill Day. As in previous years, there will also be an online Rally National Day of Action. Stay tuned to the Rally website for more information as it become available. We look forward to your (virtual) participation in September!

Oncology Approval Recap

Between March 22 and April 24, the U.S. Food and Drug Administration approved three novel oncology therapies and new indications for four oncology drugs.

  • Pembrolizumab in combination with platinum and fluoropyrimidine-based chemotherapy was approved for patients with metastatic or locally advanced esophageal or gastroesophageal (GEJ) (tumors with epicenter 1 to 5 centimeters above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or definitive chemoradiation
  • Idecabtagene vicleucel was approved for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. This is the first FDA-approved cell-based gene therapy for multiple myeloma
  • Isatuximab-irfc in combination with carfilzomib and dexamethasone was approved for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
  • A new dosage regimen of 500 mg/m2 as a 120-minute intravenous infusion every two weeks (Q2W) for cetuximab was approved for patients with K-Ras wild-type, EGFR-expressing colorectal cancer (mCRC) or squamous cell carcinoma of the head and neck (SCCHN)
  • Sacituzumab govitecan was granted:
    • Regular approval for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease
    • Accelerated approval for advanced urothelial cancer
  • Nivolumumab was approved in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
  • Dostarlimab-gxly was granted accelerated approval for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen
  • Loncastuximab tesirine-lpyl, a CD19-directed antibody and alkylating agent conjugate, was granted accelerated approval for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma

Read more about FDA approvals on the AACR webpage and on the AACR Cancer Research Catalyst. To learn more about the approval of other cancer therapies, you can find more information on the FDA’s website and an AACR journal, Clinical Cancer Research, regularly publishes FDA approval summaries.