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Cancer Policy Monitor: June 8, 2021

AACR President, Dr. David A. Tuveson, Testified Before Congress

On Wednesday, May 19, AACR President David A. Tuveson, MD, PhD, FAACR, testified before the House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies in support of at least $46.1 in Fiscal Year 2022 funding for the NIH and at least $7.6 billion for the NCI. 

Dr. Tuveson discussed the NCI’s 12.8% success rate for competing research project grants in Fiscal Year 2020, among the lowest success rates across NIH, and the impact a low success rate could have for early-stage researchers planning to enter the cancer research field. In addition, Dr. Tuveson expressed support for NCI Director Dr. Ned Sharpless’ 15-by-2025 milestone, an effort to increase the number of RO1 grants funded by NCI until it reaches the 15th percentile in 2025. The AACR strongly supports this important mission and will continue working with Congress to increase resources for the NCI to fund more meritorious research.

View Dr. Tuveson’s testimony.

Appropriations Update from Capitol Hill

The Biden Administration released its fiscal year (FY) 2022 budget, May 28. The proposal requests 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). The proposal also requests $8.7 billion in discretionary funding for the Centers for Disease Control and Prevention (CDC), an increase of $1.6 billion over the FY 2021 enacted level.   

Senators Recognize National Cancer Research Month

Senators Dianne Feinstein (D-CA) and Shelley Moore Capito (R-WV) introduced S. Res. *** to recognize May as National Cancer Research Month. Marking the 50th anniversary of the National Cancer Act, the resolution recognizes the importance of cancer research, the significant advances in cancer detection, treatment, and care thanks to cancer research, and the invaluable contributions of cancer researchers who are dedicated to the conquest of eliminating cancer. Senator Feinstein stated that [Add quote here], with Senator Capito saying [Add quote].  Read the full text of the resolution.

Recording Now Available: Virtual Patient Advocate Forum on Immuno-Oncology

Over 300 advocates representing 26 countries joined AACR May 4 for the virtual Patient Advocate Forum: The Promise of Immuno-Oncology. Moderated by Anna Barker, speakers Elizabeth Jaffee, Carl June, Suzanne Topalian, David Rimm, and patient advocate Melinda Bachini discussed the promise and challenges of immuno-oncology, Watch now 

June is National Cancer Survivor Month

Thanks to spectacular advances in cancer research, more than 16.9 million people in the United States are cancer survivors who are living with, through, and beyond their disease. Please join AACR in support of this awareness campaign celebrating those who have fought the disease and those who are currently in treatment. Learn more.

US FDA OCE Project Community Initiates National Black Family Cancer Awareness Week

The AACR is proud to support the FDA Oncology Center of Excellence’s new community-based initiative, National Black Family Cancer Awareness Week, scheduled for June 17 through June 23. The purpose is to increase awareness in one of the most vulnerable segments of the US population on clinical trial participation and specimen donations to genetic databases for cancer research. Learn more

AACR Subcommittee Members Discussed Advances in Tobacco Policy During Annual Meeting Week 2

-Nicholas Warren, PhD

People who smoke tobacco are 15-30 times more likely than non-smokers to be diagnosed with cancer, making tobacco the leading preventable cause of cancer. Effective policies and awareness campaigns have reduced U.S. adult smoking rates to record lows of 14 percent in 2019. However, the youth e-cigarette epidemic threatens to reverse this progress. The mission of the American Association for Cancer Research (AACR) is to prevent and cure all cancers, therefore, further regulation is crucial to eliminate tobacco-related illness. To discuss the AACR’s advocacy efforts and advances in tobacco policy, several members of the AACR Tobacco Products and Cancer Subcommittee participated in a panel discussion titled “Discussion on Issues Important to Tobacco Control,” during Week 2 of the 2021 AACR Annual Meeting. The session was moderated by Roy S. Herbst, MD, PhD, chair of the subcommittee and chief of Medical Oncology at Yale Cancer Center.

The Biden administration has recently indicated support for two impactful tobacco policy changes: banning menthol flavored cigarettes, and capping the amount of nicotine in tobacco products. Suchitra Krishnan-Sarin, PhD, from the Yale School of Medicine, expressed her concern that flavored tobacco products are the number one factor driving youth use. While Dr. Krishnan-Sarin thinks a menthol cigarette ban would be a welcome step, the U.S. Food and Drug Administration (FDA) should do more to limit flavored tobacco products. Regarding nicotine levels, Dorothy Hatsukami, PhD, from the University of Minnesota, described the scientific evidence showing the lower nicotine concentrations reduce the amount of smoking, increase quit attempts, and therefore reduce exposure to tobacco carcinogens.

In March 2021, the U.S. Preventive Services Task Force (USPSTF) updated its lung cancer screening guidelines that nearly doubled the number of people eligible for screening. Benjamin Toll, MD, from the Medical University of South Carolina, welcomed the expanded guidelines which will help address cancer disparities, because racial minorities and women at high risk of lung cancer on average have lower smoking histories than White men. However, Dr. Toll expressed concern about low uptake of lung cancer screening among smokers and called for more awareness campaigns. Timothy Rebbeck, PhD, and K. “Vish” Vishwanath, PhD, from the Dana Farber Cancer Institute also discussed how predatory advertising at the point of sale as well as coupons and discounts disproportionately impact disadvantaged communities. Drs. Rebbeck and Vishwanath also emphasized the importance of engaging with trusted community partners when designing tobacco cessation outreach strategies.

Fewer than one third of smokers who attempt to quit do so with evidence-based methods. Peter Shields, MD, from the Ohio State University emphasized the importance of oncologists in helping patients with cancer find evidence-based therapies like nicotine replacement, varenicline, and cessation counseling. He discussed the evidence that shows patients with cancer who smoke have significantly better outcomes if they are able to quit.

In a lightning round of questioning, panelists said they hoped to see the FDA prioritize: the ban on menthol cigarettes and other flavored products; lowering nicotine content of tobacco; predatory advertising, and; facilitating clinical trials to determine if e-cigarettes are effective cessation therapies. If you or a loved one need help quitting, visit SmokeFree.gov or call 1-800-QUIT-NOW for free resources.

ODAC Recommends Withdrawal of Two “Dangling Indications” for Immune Checkpoint Inhibitors

-Tod Guidry, PhD

The U.S. Food and Drug Administration (FDA)’s Oncologic Drug Advisory Committee (ODAC) met at the end of April to discuss the fate of six indications for PD-1/PD-L1 inhibitors previously granted accelerated approval, as the results of confirmatory trials have not confirmed clinical benefit. The ODAC voted to recommend withdrawal of two indications, while the other four may remain on the market as confirmatory trials continue.

The past six years have seen an unprecedented level of development of PD-1/PD-L1 checkpoint inhibitors, with more than 75 oncology indications approved, 35 of which were accelerated approvals. Confirmatory trials required to maintain the approvals for ten such indications, referred to as “dangling indications,” have not confirmed clinical benefit. The FDA has consulted with the drug sponsors, resulting in the voluntary withdrawal of four such indications:

  • Atezolizumab in prior-platinum-treated metastatic urothelial carcinoma
  • Pembrolizumab for the treatment of patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy
  • Durvalumab for previously treated adult patients with locally advanced or metastatic bladder cancer
  • Nivolumab for the treatment of patients with small cell lung cancer whose disease has progressed after platinum-based chemotherapy and at least one other line of therapy

The remaining six indications were put before ODAC on April 27, 28, and 29, during which the committee reviewed the original accelerated approvals, the completed and currently ongoing confirmatory trials, and the current treatment landscape for each indication, including whether the indications in question still fulfill an unmet medical need. The ODAC ultimately recommended withdrawal of the following indications:

  • Pembrolizumab for the treatment of patients with recurrent locally advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥ 1], as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy
  • Nivolumab for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib

Reasons for the withdrawal recommendations include not only inadequate evidence of clinical benefit but also the expansion of other approved therapies for each indication over time, which has helped to fulfill the unmet medical needs originally present at the time of initial accelerated approval. Because not all patients are good candidates for alternative therapies to drugs whose indications are pulled, they may remain available to patients though expanded access.

USPSTF Expands Colon Cancer Screening Eligibility

-Nicholas Warren, PhD

Every year approximately 150,000 Americans are diagnosed with colorectal cancer, and more than 50,000 die from the disease. Fortunately, colon cancer screening is extremely effective at finding cancers and colonoscopies are also capable of completely removing pre-cancerous or early-stage cancerous lesions. The previous guidelines of the U.S. Preventive Services Task Force (USPSTF) recommended screening for people age 50 to 75 years. However, the incidence in colon cancer before the age of 50 years has been increasing. It is now estimated that 10.5 percent of all new colorectal cancer cases occur before the age of 50 years, and disproportionately higher rates in Hispanic and African American patients.

To address the younger ages of colorectal cancer onset and racial and ethnic disparities, the USPSTF updated guidance to include adults aged 45 to 49 years old. This recommendation was given a “B” grade due to moderate certainty of benefit. The Affordable Care Act requires insurers to cover services granted A or B grades by the USPSTF, and as a result this new recommendation will allow earlier detection of colorectal cancer with little additional cost to patients.

Studies Find COVID-19 Vaccines Activate Immune Responses in Many Patients with Cancer

-Nicholas Warren, PhD

Survivors and patients with cancer are roughly twice as likely to experience severe COVID-19 symptoms or die compared to patients with COVID-19 and no cancer. Due to this increased risk, the American Association for Cancer Research (AACR) led more than 140 organizations in advocating for survivors, patients, and caregivers to be prioritized early in the vaccine roll out. Over the past month, supply of vaccines has outweighed the demand for getting vaccinated, partly due to lingering unanswered questions people have regarding the vaccines. During the AACR Annual Meeting 2021 session “Building Vaccine Confidence,” panelists discussed that many patients with cancer waiting to get vaccinated are concerned about limited efficacy data of the vaccines, specifically in patients with cancer. New evidence is now confirming that most patients with cancer receive at least partial protection from the vaccines that could prevent hospitalization and death.

Among the Phase III COVID-19 vaccine clinical trials, only Johnson and Johnson specified how well their vaccine performed in survivors and patients with cancer. The Johnson and Johnson trial included 226 survivors and patients with cancer, half of which received the vaccine. Fortunately, zero patients with cancer contracted COVID-19 following vaccination and zero experienced severe side effects during the trial. However, the details on the types of cancer and status of disease were not published, leaving unanswered questions regarding the impacts of immunosuppressive anti-cancer therapies.

Several recent studies have provided greater detail on vaccine efficacy with specific types of cancer and anticancer therapies. The first study, published in Blood, measured antibody responses following two doses of the Pfizer/BioNTech vaccine in 52 patients with chronic lymphocytic leukemia (CLL) compared with healthy matched controls. Approximately half of the patients with CLL generated antibody responses, but there were differences based on clinical status: 79 percent of patients who achieved clinical remission from CLL generated antibodies, compared to 16 percent on active treatment. Additionally, zero patients who received anti-CD20 therapy (e.g. rituximab) within the past year generated antibodies, likely due to B cell-depleting effects of the therapy.

While antibodies are important for preventing an infection from taking hold, other parts of the immune system, like T cells, can also prevent infections from getting out of control and prevent hospitalization. Another study in Lancet Oncology measured both antibody and T cell responses to the Pfizer/BioNTech vaccine in healthy controls and patients with solid tumors or blood cancers. All healthy controls developed antibody and T cell responses after two vaccine doses. In comparison, 95 percent of patients with solid tumors generated antibody responses and 88 percent developed T cell responses. While the sample size was small, 60 percent of patients with blood cancers developed antibody responses and 75 percent developed T cell responses. Additionally, patients with cancer experienced fewer vaccine side effects compared to healthy controls.

These data support the idea that most patients with cancer will benefit from COVID-19 vaccines, but some patients receiving highly immunosuppressive therapies may need to wait to get vaccinated when their immune systems recover. These findings are consistent with guidelines from the National Comprehensive Cancer Network. The data also highlight the importance of vaccinating family members and caregivers to protect loved ones who are unlikely to respond to vaccines. It is always a good idea to discuss your specific concerns about vaccines and other medical issues with your care team.

Oncology Approval Recap

Between April 25 and May 19, the U.S. Food and Drug Administration granted accelerated approval for one new indication for an oncology drug.

  • Pembrolizumab was granted accelerated approval in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

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 Researchregularly publishes FDA approval summaries.