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Cancer Policy Monitor: June 9, 2020

COVID-19 Legislation and Appropriations Update

-Marc B. Johnson, MPP

In the United States, cases of COVID-19 are approaching 2 million people and have surpassed 100,000 deaths. Despite multiple, groundbreaking relief packages passed by Congress and signed into law, the human costs continue to climb, and the damage to the economy will not be easily rectified. “Phase 4” legislation was introduced in the House to address further issues caused by the COVID-19 pandemic.

H.R. 6800, the “Health and Economic Recovery Omnibus Emergency Solutions Act”, or the “HEROES Act”, was introduced by House Committee Appropriations Chairwoman Nita Lowey (D-NY 17th) and announced by House Speaker Nancy Pelosi (D-CA 12th) on May 12, 2020. The emergency supplemental bill calls for $3 trillion to be appropriated to address several issues relating to COVID-19 relief, and if signed into law, would be the largest relief package in U.S. history. On May 15, the House passed the bill, largely along party lines. The 1,815 page, largely House democratic leadership-written bill, in its current form, will not receive any action in the Senate. House and Senate republicans feel that the bill appropriated money for programs that are irrelevant to COVID-19 relief, and feel that the other relief packages need to run their course, and be assessed before another large relief package moves forward. Senate Majority Leader McConnell is not adverse to another stimulus package, and believes one is likely. Currently there are negotiations between the House and Senate on a modified version of the bill.

Health sciences appropriations are proposed in the HEROES Act, but are not as pronounced as they were in the CARES Act. The National Institutes of Health (NIH) would receive $4.7 billion to fund medical research efforts related to COVID-19. Three billion dollars of that amount would be allocated to the Office of the Director to offset the “…costs related to reductions in lab productivity resulting from the coronavirus pandemic or public health measures related to the coronavirus pandemic.” The AACR and its partner organizations in the medical research community are advocating for at least $10 billion in the next supplemental package, which would reopen labs and restart research that have been put on hold due to coronavirus. In addition to NIH, the Centers for Disease Control and Prevention (CDC) would receive $2.1 billion to support federal, state, and local public health agencies. 

The House and Senate are back in session, with remote committee hearings occurring. The House adjusted its rules in order to allow remote voting and proxy voting in the Committee of the Whole. Proxy voting would allow a group of House members to select one member to vote on their behalf. Despite congressional activities returning to semi-regular order, FY ’21 appropriations are still in a state of ambiguity. Although no House and Senate hearings have been scheduled, discussions on the staff level are continuing, and there is talk that FY ’21 hearings may commence in June or July.

AACR to Hold COVID-19 and Cancer Conference in July

The COVID-19 pandemic has had far reaching effects on cancer care and research. At the AACR Virtual Annual Meeting I in April, scientists from across the world shared early data on the impact on COVID-19 on patients with cancer. The AACR will continue highlighting COVID-19 and cancer research at the AACR Virtual Annual Meeting II later this month and at the AACR Virtual Meeting: COVID-19 and Cancer on July 20-22.

The AACR Virtual Meeting: COVID-19 and Cancer will focus on emerging data related to COVID-19 and cancer while also exploring contributions of cancer researchers to address the pandemic. Symposia will cover topics including cancer drug repurposing to treat COVID-19, COVID-19 diagnostics development, COVID-19 vaccine development, epidemiology, and the intersection of cancer and SARS-CoV-2 biology. Conference forum sessions will consider regulatory implications of pandemic-necessitated changes to the conduct of clinical trials, the current and future role of telehealth, restarting the cancer research enterprise, and the impact of health disparities on COVID-19 and cancer.

Headlining the conference will be three keynote speakers:

  • Anthony Fauci, National Institute of Allergy and Infectious Diseases, Rockville, Maryland
  • Solange Peters, CHU Vaudois, Lausanne, Switzerland
  • Trevor Bedford, Fred Hutchinson Cancer Research Center, Seattle, Washington

Abstract categories range from basic research topics and drug development to cancer survivorship and science policy. Through this wide range of categories, the AACR hopes to highlight both the myriad ways in which cancer research expertise is informing efforts against COVID-19 as well as the impact of COVID-19 on cancer research and patients with cancer. Abstract submission for the AACR Virtual Meeting: COVID-19 and Cancer closes June 9, at 11:59 p.m. ET.

The AACR has designated this internet live activity for a maximum of 16.5 AMA PRA Category 1 Credit(s)™. More information on CME for this conference is available online.

AACR Virtual Annual Meeting II – Regulatory Science and Policy Sessions

The AACR Virtual Annual Meeting II will take place June 22-24, 2020. Access to this virtual meeting is free to everyone, and while access will be free, attendees are required to register. In addition to opening and clinical plenary sessions, a Presidential Select Symposium, Methods Workshops, and numerous Educational sessions, the virtual meeting will feature five Regulatory Science and Policy sessions developed in collaboration with the U.S. Food and Drug Administration Oncology Center of Excellence. These informative sessions are designed to highlight recent regulatory developments and provide a forum to hear discussion of cutting-edge issues in cancer drug, biologic, and diagnostic regulation. Learn more about these Regulatory Science and Policy sessions featured during the Virtual Annual Meeting II below.

Under-representation in Clinical Trials and the Implications for Drug Development | Monday, June 22, 1:30 – 3:30 PM (ET)

  • Kenneth C. Anderson (Cochair) – Dana-Farber Cancer Institute, Boston, Massachusetts
    Nicole J. Gormley (Cochair) – FDA, Silver Spring, Maryland
  • Daniel J. George – Duke University Medical Center, Durham, North Carolina
  • Ruben Mesa – Mays Cancer Center at UT Health San Antonio, San Antonio, Texas
  • Ajay K. Nooka – Winship Cancer Institute at Emory University, Atlanta, Georgia
  • Richardae Araojo – FDA, Silver Spring, Maryland
  • Yelak Biru – Patient Advocate, Bentonville, Arkansas
  • Lola A. Fashoyin-Aje – FDA, Silver Spring, Maryland

COVID-19 and Cancer: Guidance for Clinical Trial Conduct and Considerations for RWE | Monday, June 22, 3:45 – 5:45 p.m. (ET)

  • Harpreet Singh (Chair) – FDA, Silver Spring, Maryland
  • Amy Abernethy – FDA, Silver Spring, Maryland
  • Paul G. Kluetz – FDA, Silver Spring, Maryland
  • Wendy Rubinstein – FDA, Silver Spring, Maryland
  • Jonathan Hirsch – Syapse, San Francisco, California

Engaging the Oncology Community to Advance Regulatory Science: FDA’s Project Renewal and Project Socrates  | Tuesday, June 23, 12:45 – 2:45 p.m. (ET)

  • Jennifer Gao (Cochair) – FDA, Silver Spring, Maryland
  • Patricia Keegan (Cochair) – FDA, Silver Spring, Maryland
  • Paul G. Kluetz (Cochair) – FDA, Silver Spring, Maryland
  • R. Donald Harvey – Emory University School of Medicine, Atlanta, Georgia
  • George Demetri – Dana-Farber Cancer Institute, Boston, Massachusetts
  • Justin N. Malinou – University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland

Tumor Response Evaluation Criteria for Intratumoral Therapy | Wednesday, June 24, 1:45 – 3:45 p.m. (ET)

  • Ke Liu (Chair) – FDA, Silver Spring, Maryland
  • Sanjay Goel – Montefiore Medical Center, Bronx, New York
  • Gregory Goldmacher – Merck, West Point, Pennsylvania
  • Howard L. Kaufman – Immuneering Corporation, Boston, Massachusetts
  • Aurelian Marabelle – Institute Gustave Roussy, Villejuif, France
  • Lawrence H. Schwartz – Columbia University Medical Center, New York, New York

Hot Topics in Oncology Regulation | Wednesday, June 24, 4 – 6 p.m. (ET)

  • Lola A. Fashoyin-Aje (Chair) – FDA, Silver Spring, Maryland
  • Soma Ghosh – FDA, Silver Spring, Maryland
  • Nicole J. Gormley – FDA, Silver Spring, Maryland
  • Paul G. Kluetz – FDA, Silver Spring, Maryland
  • Steven J. Lemery – FDA, Silver Spring, Maryland
  • Ke Liu – FDA, Silver Spring, Maryland
  • Marc Theoret – FDA, Silver Spring, Maryland
  • Jeanne Fourie Zirkelbach – FDA, Silver Spring, Maryland

June is National Cancer Survivor Month

Please join the American Association for Cancer Research (AACR) in support of this awareness campaign celebrating those who have fought the disease and those who are currently in treatment. 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.

Who is a cancer survivor? According to the National Cancer Institute, an individual is considered a cancer survivor from the time of diagnosis, through the balance of his or her life. Every survivorship experience is unique as patients with cancer may face challenges during and after treatments. The hope is that increasing awareness and support of survivorship research will enable adverse effects to be controlled, treated, and prevented.

What will you do to support cancer survivors?

You Can Raise Awareness About Survivorship.

  • Tell a family member, friend, or stranger that June is National Cancer Survivor Month. Take a selfie, write a blog, or share social media post about your survivorsip story and how you have benefited from cancer research. Tag AACR and use the hashtags #SurvivorsAdvocate and #CelebrateSurvivorship.
  • Take the patient advocacy and survivorship survey. AACR is interested in hearing from patients, survivors, caregivers, and advocates as we are developing programs and initiatives to support the advocacy community. Your voice matters. Take this opportunity to share insights from your journey.
  • Use the Facebook profile frame. Support National Cancer Survivor Month by adding a frame to your Facebook profile picture.

You Can Learn More About Cancer Research.

You Can Contact A Member of Congress.

  • Share your concerns about funding, clinical trials barriers, and better treatments with your member of Congress. Reach out to your representative to make cancer research and survivorship research a national priority.

You Can Donate to Lifesaving Cancer Research.

  • The AACR is committed to helping prevent and cure all cancers. Your donation to lifesaving research propels the important work of the 47,000+ AACR scientific members worldwide who are leading the global effort to defeat cancer. With every donation, 88 cents of every dollar raised goes to cancer research.

You Can Join the AACR Advocacy Community.

  • Become a AACR Affiliate Advocate Member and join the 47,000+ cancer research professionals from around the world who are driving the conquest against cancer.
  • Engage on social media.  Like the AACR Facebook page, follow the AACR on Twitter, and join the Advocate Facebook group. Join the conversation and share the patient/survivor perspective.
  • Sign up for the AACR Advocacy Alerts. Receive quarterly emails that keep you in the know about AACR programs, events, and fellow advocates.
  • Subscribe to Cancer Today, the AACR publication for cancer patients, survivors, and their family members and friends.

Woodcock Temporarily Steps Aside at CDER

-Elizabeth Barksdale, PhD

The U.S. Food and Drug Administration (FDA) announced on May 22 that Janet Woodcock, MD, would step aside as director of the Center for Drug Evaluation and Research (CDER) in order to devote her full attention to Operation Warp Speed, the White House initiative to accelerate the development of medical products for the treatment and prevention of COVID-19. The move is temporary, and Woodcock is not leaving agency; she will be detailed to the Office of the Commissioner while overseeing therapeutics development for Warp Speed. Patrizia Cavazzoni, MD, presently CDER deputy director for operations, will serve as acting director.

The announcement shocked many in the drug development community as Woodcock has been a fixture at FDA since the 1980s and has led CDER since 2008. She is widely regarded as an experienced and steadying presence at an agency where top leadership often enjoys brief tenures. However, news of Woodcock’s inclusion in Operation Warp Speed raised concerns for watchdog groups like Public Citizen and Center for Science in the Public Interest that the dual role of overseeing the development and approval of new therapeutics to treat COVID-19 presented a conflict of interest.

Even reports that Woodcock would recuse herself “from the supervisory chain of command in matters related to product review decisions for applications related to” COVID-19, obtained from an email to FDA staff from Commissioner Stephen Hahn, MD, did not appease the concerned parties, thus the May 22 statement.

Woodcock’s FDA colleague, Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research (CBER), had been tapped to oversee vaccine development for Warp Speed but instead will remain at the helm of CBER and forego a role in the administration’s initiative.

Operation Warp Speed, formally introduced by President Trump on May 15, is an ambitious program with the goal of moving vaccines and other treatments for COVID-19 from R&D to mass production by early 2021. The U.S. government will invest billions of dollars and massive amounts of manpower into testing and manufacturing promising COVID-19 vaccines. The administration has identified 14 potential candidates from among the 100-plus COVID-19 vaccines currently in development and plans to pare those 14 down to eight to begin preclinical and clinical testing for safety and efficacy in early summer. The effort has drawn criticism for refusing to consider vaccines being developed in China, prioritizing U.S. citizens as first recipients of the final product(s), and competing with other ongoing vaccine initiatives.  

Smoking Impacts Cancer Treatment Outcomes

-Nicholas Warren, PhD

There is a large body of evidence demonstrating that smoking tobacco causes at least 12 different forms cancer and nearly 30 percent of all cancer deaths in the United States. Additionally, the Surgeon General’s 2020 Smoking Cessation Report strongly concluded that quitting tobacco helps reduce the risk of: cancer; heart disease; COPD; reproductive issues, and; many other health problems. Unfortunately, very few studies have investigated how smoking impacts treatment outcomes for patients with cancer. This has important considerations for patients who smoke while undergoing cancer treatment, because only 39 percent of medical oncologists provide support for smoking cessation and approximately half of smokers continue to smoke following a cancer diagnosis.

Gaining a better understanding of the interactions between smoking and cancer therapies could improve cancer treatment for smokers by identifying more effective dosing schedules or alternative therapies. For example, two clinical trials found that smoking reduces the therapeutic dose of erlotinib and irinotecan by upregulating metabolic enzymes; reduced drug availability likely leads to lower efficacy. The erlotinib study led to a new warning on the prescribing information for providers but did not specify how treatment should be altered. Erlotinib, gefitinib, and irinotecan are the only cancer therapies with known pharmacokinetic interactions with smoking.

A new phase III trial investigating the impact of smoking status on treatment outcomes with the anti-PD-L1 antibody, durvalumab, was presented as a virtual poster at the American Association for Cancer Research’s (AACR) Virtual Annual Meeting I on April 27th by David Planchard, MD, PhD of the Gustave Roussy Department of Medical Oncology, Thoracic Unit. Despite smokers having slightly higher tumor PD-L1 expression, they saw worse outcomes than never smokers. Progression-free survival at 18 months was 57.8 percent for never smokers and 43.1 percent for current and former smokers. Additionally, 33.6 percent of current and former smokers experienced a grade 3/4 adverse event while only 23.3 percent of never smokers had a serious adverse event; smokers discontinued treatment due to adverse events at almost double the rate of never smokers. A major limitation of this study was that smoking status was only assessed during trial enrollment and was not followed throughout the study. These results highlight the potential for interactions with smoking in oncology clinical trials, and the need to study the impact of smoking on treatment outcomes for more therapies.

Be sure to tune in to the AACR’s Virtual Annual Meeting II on June 22-24 to learn about more cutting-edge cancer research. Registration is free and open to all!

Oncology Approval Recap

In May, the U.S. Food and Drug Administration approved three novel cancer therapies and nine new and expanded indications for oncology drugs:

  • Daratumumab and hyaluronidase-fihj was approved for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab.
  • Capmatinib was granted accelerated approval for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
  • Selpercatinib was granted accelerated approval for the following indications:
    • Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC);
    • Adult and pediatric patients ≥12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy;
    • Adult and pediatric patients ≥12 years of age with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
  • Olaparib’s indication was expanded to include its combination with bevacizumab for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability.
  • Pomalidomide’s indication was expanded to include treating adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy and Kaposi sarcoma in adult patients who are HIV-negative.
  • The combination of nivolumab plus ipilimumab was approved as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
  • Rucaparib was granted accelerated approval for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.
  • Ripretinib was approved for adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
  • Atezolizumab was approved for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), with no EGFR or ALK genomic tumor aberrations.
  • Olaparib was approved for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone.
  • Brigatinib was approved for adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
  • The combination of nivolumab plus ipilimumab and 2 cycles of platinum-doublet chemotherapy was approved as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

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.