Cancer Policy Monitor: March 9, 2021
- Appropriations Update
- AACR Leads Over 130 Cancer Organizations on Prioritizing Vaccines for Patients with Cancer
- AACR Applauds Reintroduction of the RISE Act
- AACR Holds Sixth Annual Early-career Hill Day
- Recording Available! AACR Patient Advocate Forum: Precision Oncology Advances in 2020 – Looking Ahead to 2021!
- Second AACR COVID-19 and Cancer Conference Reviews Lessons from One Year of Pandemic
- Oncology Approval Recap
-Marc Johnson. MPP
Generally, an administration aims to submit a budget to Congress in early February. However, in the first year of a new administration that budget is almost always submitted late, and that will hold true for President Biden’s inaugural budget for Fiscal Year (FY) 2022. The FY 2022 budget is expected later this Spring. Until then, Congress is in the midst of formulating the next COVID-19 relief package under budget reconciliation.
President Biden’s proposed $1.9 trillion COVID-19 relief package has been the top legislative priority for Congress. With thin majorities in both chambers, especially in the Senate, Democrats are utilizing the budget reconciliation process to advance the package and avoid a Republican filibuster in the Senate. The current proposal does not explicitly include funds for the NIH, though it would include $5.2 billion in funds available to the Secretary of Health and Human Services for research and other purposes related to COVID-19 vaccines and therapeutics. March 14 is widely seen as the deadline to pass the package, as unemployment benefits for millions of Americans will otherwise expire on that date. A second large relief package, focused on infrastructure, is under discussion. This package could also be considered under budget reconciliation and may be an opportunity to include funding for NIH to support research impacted by the pandemic.
Senate Appropriations Committee leaders announced subcommittee rosters and leadership positions on February 12. Senator Patty Murray (D-WA) will serve as chair of the Senate Labor-HHS-Education Appropriations Subcommittee, which oversees funding for the National Institutes of Health (NIH) and other health agencies. Additionally, Senator Murray will serve as chair of the full Senate Health, Education, Labor and Pensions (HELP) Committee, which has authorizing jurisdiction over NIH.
AACR Leads Over 130 Cancer Organizations on Prioritizing Vaccines for Patients with Cancer
-Nicholas Warren, PhD
Patients with cancer are roughly twice as likely to experience severe symptoms and die from COVID-19, compared to patients of similar backgrounds who do not have cancer. Patients with blood cancers can also remain infectious for several months following SARS-CoV-2 infection. Due to these risk factors, and others, it is critical that patients with cancer, survivors of cancer, and their caregivers are prioritized for COVID-19 vaccines as supplies of the vaccine remain limited. Fortunately, 16 states are currently vaccinating patients with cancer. Unfortunately, the U.S. Centers for Disease Control and Prevention (CDC) and most states place many patients with cancer under 65 years old at low priority levels.
In order to raise awareness about the importance of vaccinating this vulnerable population, the AACR led a coalition of more than 130 organizations, cancer centers, and other institutions on a letter to the Biden Administration. Additionally, the letter was shared with health agencies and governors of all 56 U.S. states and territories. The letter has received broad media coverage, demonstrating the wide interest in this important issue. The AACR will continue to work with the broader cancer research and patient care community to advocate for policies that are vitally important for patients with cancer and survivors of cancer.
If your organization would like to sign on to the online version of the letter, please fill out this form.
AACR Applauds Reintroduction of the RISE Act
In an effort to strengthen investments in medical research, Congress has increased funding in the National Institutes of Health (NIH) by nearly 42% over the last six years. However, COVID-19 has threatened this progress by closing labs, delaying clinical trials, disrupting research, and jeopardizing the careers of trainees, early-stage researchers, and other professionals working toward a career in science and medical research. Without additional funding, much of this progress could be lost.
In February, Representatives DeGette, Upton, Johnson (TX), Eshoo, and Gonzalez (OH), as well as Senators Markey, Tillis, Peters, and Collins, reintroduced the Research Investment to Spark the Economy (RISE) Act, bipartisan, bicameral legislation which would authorize urgently needed supplemental funding to keep research institutions afloat during the COVID-19 pandemic. By authorizing $25 billion to support federal research agencies, including $10 billion for the NIH and $3 billion for the National Science Foundation, the RISE Act would support America’s research enterprise and ensure we do not lose a generation of researchers and years of biomedical research as yet another consequence of this pandemic.
As Congress debates emergency spending measures to combat COVID-19 and the economic toll of the pandemic, the AACR continues to support the RISE Act and applauds the sponsors for their bipartisan work to address this significant need.
AACR Holds sixth Annual Early-career Hill Day
The Sixth Annual AACR Early-career Hill Day, held February 25, brought together 22 early-career researchers to advocate for continued, strong investments in cancer research through the National Institutes of Health (NIH) and the National Cancer Institute (NCI).
Hill Day participants representing 17 states held nearly 60 meetings with their representatives and senators during the event. Meetings with congressional offices were held via video or phone conference because of the COVID-19 pandemic. In each case, participants asked members of Congress to support an increase of $3.2 billion for the NIH in fiscal year (FY) 2022 for a total budget of $46.1 billion. As part of this request, they also asked that Congress fund the National Cancer Institute at $7.6 billion in FY 2022. Due to the significant impact of the pandemic on the medical research enterprise – and particularly on early-career scientists – attendees also asked that Congress provide the NIH with at least $10 billion in supplemental funding to support disrupted research on cancer and other diseases.
In conjunction with the Hill Day, participants and the AACR encouraged early-career scientists and others around the country to join a National Day of Action by writing to their members of Congress or sending them messages on social media in support of NIH and NCI funding. Dozens of posts were shared on Twitter, Facebook, and other platforms using the hashtag #AACRontheHill.
Recording Available! AACR Patient Advocate Forum: Precision Oncology Advances in 2020 – Looking Ahead to 2021!
The recording is now available for the February 16 AACR Virtual Patient Advocate Forum. Moderated by Anna Barker, chief strategy officer at USC’s Ellison Institute for Transformative Medicine the Forum highlighted recent discoveries and advances in precision oncology and discussed how they have positioned the research community for 2021. Watch Video.
Second AACR COVID-19 and Cancer Conference Reviews Lessons from One Year of Pandemic
-Nicholas Warren, PhD
The first documented case of COVID-19 occurred December 1, 2019. Since then, SARS-CoV-2 has infected more than 110 million people worldwide and killed 2.5 million, including over 500,000 deaths in the U.S. alone. The pandemic has greatly impacted cancer research and care, by: halting clinical trials; closing laboratories; reducing cancer screenings; and drastically changing the way patients with cancer receive care. Fortunately, spectacularly efficacious and safe vaccines are now providing a light at the end of the tunnel and oncologists are learning how to adapt to care for patients during these challenging times. To help disseminate lessons learned during the first year of the pandemic, the AACR organized the second COVID-19 and Cancer Conference in early February 2021.
Several sessions at the conference highlighted the amazing progress on vaccine development and the cancer research that helped make them possible. Ugur Sahin, MD, PhD, CEO of BioNTech, delivered the opening keynote address to describe how BioNTech’s previous research on cancer mRNA vaccines helped prepare them to rapidly develop an effective mRNA vaccine for COVID-19. Another keynote presentation by Peter Marks, MD, PhD, director of the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research, discussed how the FDA ensured COVID vaccines and therapies were safe and effective.
Several other symposia and fora discussed research showing patients with cancer are at greater risk of severe COVID-19 symptoms, but are struggling to get vaccinated. Most notably, Laurence Zitvogel, MD, PhD, an oncologist at Goustave Roussy Cancer Center, presented new data during a keynote presentation on why patients with cancer are more likely to experience severe COVID-19 symptoms and prolonged infectious periods. These sessions highlighted the need to ensure patients with cancer are prioritized for COVID-19 vaccines.
Additional sessions detailed the impact of the pandemic on cancer research and treatment. A forum discussion on “Workforce Issues” discussed how the pandemic has posed enormous challenges to early-career scientists, especially women and under-represented racial and ethnic minorities. Other sessions described the benefits and challenges of telehealth, how to adapt cancer screenings to a socially-distant world, and the need to increase mental health care services for patients with cancer. The potential solutions to these challenges discussed during the conference show a path forward to move past the worst pandemic in modern history and rebuild cancer research and treatment to be better than ever.
Content from the second COVID-19 and Cancer Conference will remain available for on-demand viewing through April. There will also be new and impactful COVID-19 related content during the 2021 AACR Virtual Annual Meeting, April 10-15 and May 17-21.
Oncology Approval Recap
Between January 25 and February 21, the U.S. Food and Drug Administration approved three novel oncology therapies, including one new CAR-T cell therapy, and new indications for an oncology drug.
- Tepotinib was granted accelerated approval for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
- Umbralisib was granted accelerated approval for:
- Adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen;
- Adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.
- Lisocabtagene maraleucel was approved to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment.
- Cemiplimab-rwlc was granted:
- Regular approval for patients with locally advanced basal cell carcinoma (laBCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate;
- Accelerated approval for patients with metastatic BCC (mBCC) previously treated with a HHI or for whom a HHI is not appropriate.
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.