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CANCER POLICY MONITOR: August 13, 2024

Congressional Update

-Benjamin Krinsky, PhD, and Matt Gontarchick

The House and Senate have both adjourned for summer recess having made incremental progress on fiscal year (FY) 2025 appropriations. On July 24, the House passed the FY 2025 Interior-Environment spending bill by a vote of 210-205. Despite having an ambitious plan to pass all twelve appropriations bills by the start of the August recess, the House gaveled out having completed five of the bills. The Labor, Health and Human Services, Education and Related Agencies (Labor-HHS) bill, which funds the National Institutes of Health (NIH) and the National Cancer Institute (NCI), has not yet passed on the House floor. The proposed House Labor-HHS bill, which includes controversial proposals to restructure NIH, was previously approved by the House Appropriations Committee on a party-line vote.

Meanwhile, after a prolonged set of negotiations, the Senate Appropriations Committee has begun to consider spending bills. In July, Senate Appropriations Committee Chair Patty Murray (D-WA) and Vice Chair Susan Collins (R-ME) agreed to provide $34.5 billion in FY 2025 emergency spending in addition to the budget caps imposed by the Fiscal Responsibility Act. Of this total, $21 billion is allocated for defense programs and $13.5 billion is allocated for non-defense programs. With an agreement reached on these overall levels, the Senate has begun marking up spending measures. The Senate Labor-H bill was approved by the Senate Appropriations Committee on August 1. The bill would provide $48.85 billion for the NIH base budget and $7.49 billion for NCI. The bill also retains the existing set of 27 NIH Institutes and Centers.

Congress may resume consideration of appropriations measures this fall, but with a busy election season ahead, it is increasingly unlikely that they will finish FY 2025 appropriations before the end of the fiscal year on September 30. It is therefore probable that Congress will have to pass a temporary funding measure (a continuing resolution) to fund the government at the start of the fiscal year. The AACR will continue to advocate for the highest possible funding levels for medical research programs.

New Perspective Article on Improving Overall Survival

-Nicholas Warren, PhD

Improved screening and cancer therapy breakthroughs have more than tripled the percentage of Americans who are cancer survivors, from 1.4% to 5.4% since 1971. These spectacular advances should be celebrated, and at the same time increase the challenge of making further progress.

The increasing challenges with timely drug development were highlighted in a new Clinical Cancer Research article, which focused on the gold standard endpoint, overall survival (OS). How long patients with cancer survive is directly related to the efficacy and safety of the therapies they take, which is why OS is considered the gold standard metric for clinical benefit. However, OS data take longer to collect and interpret as patients live longer. To continue the rapid pace of drug development, earlier efficacy endpoints are becoming more common but do not always correlate with OS.

In 2022, the U.S. Food and Drug Administration launched Project Endpoint to address these issues around determining if new drugs are safe and effective in a timely manner. This led to a workshop in July 2023, co-hosted by the FDA, the American Association for Cancer Research (AACR), and American Statistical Association (ASA) to discuss the future role of OS data in benefit-risk analyses. Key considerations from the workshop for trial designs and analyses were summarized in the recent Clinical Cancer Research article along with new statistical methodologies to support evaluating limited OS data from a safety perspective. Most importantly, the article encourages all late-phase trials to prospectively plan to collect and analyze OS data, because it remains a critical component of benefit-risk analyses in the new era of early efficacy endpoints.

The new article provides clarity on evaluating OS for safety, but more work is needed to further develop and increase confidence in emerging early endpoints, like ctDNA. FDA, AACR, and ASA are committed to continuing conversations with a broad range of stakeholders to improve how the benefits and risks of new cancer therapies are measured.

Register Now: 12th Annual Rally for Medical Research

The 12th Annual Rally for Medical Research will be held September 18-19, 2024, in Washington, D.C. The Rally brings together advocates from around the country to call upon the nation’s policymakers to make funding for the National Institutes of Health a national priority and bring attention to the importance of stable and robust investments in medical research. Both a participant training and a reception for advocates will be held on September 18, followed by the Rally Hill Day on September 19, in which participants will meet with congressional offices.

Register for the lobby day and book your room in the hotel block today. Please contact Rally organizers with any questions.

AACR VIRTUAL PATIENT ADVOCATE FORUM: ACTIVATING ARTIFICIAL INTELLIGENCE (AI) IN CANCER SCIENCE AND MEDICINE

Artificial Intelligence (AI) is promising to revolutionize cancer diagnosis, treatment, and patient care. But will it live up to the hype? Join us on Tuesday, August 20, for the next Patient Advocate Forum that will explore how AI is reshaping oncology and share insights into strategies to navigate the opportunity and uncertainty. Learn more about the AACR Virtual Patient Advocate Forum: Activating Artificial Intelligence in Cancer Science and Medicine.

Registration Open: 17th AACR Conference on The Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved

September 21-24, 2024
The Westin Bonaventure Hotel & Suites
Los Angeles, California

Discover breakthroughs in cancer health disparities research at the 17th AACR Conference on The Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved. This conference is dedicated to advancing the understanding of cancer disparities that pose significant public health challenges. Join experts from academia, industry, government, and the community as we facilitate the exchange of innovative ideas, delve into the latest findings, and catalyze the development of new research initiatives in the field of cancer health disparities. Your participation will contribute to the collective effort in eliminating these disparities and fostering a healthier future for all. Learn more on the AACR website.