Cancer Policy Monitor: August 10, 2021
- Appropriations Update from Capitol Hill
- House Passes Bipartisan PFAS Action Act
- AACR President Dr. David Tuveson Discusses Opportunities in Cancer Research with the Biden Administration
- Pandemic-Induced Changes to Clinical Trial Conduct Recommended to Remain in Place
- Record Heat and Wildfires Strain Patients with Cancer and Health Systems
- FDA-AACR Oncology Educational Fellowship Application Period Open
- Register for the 2021 Rally for Medical Research Virtual Hill Day
- Register Now for the September 21 Virtual Patient Advocate Forum on Big Data and Machine Learning
- Cancer Research Leaders Share Insights from AACR/AACI Virtual Hill Day
- Oncology Approval Recap
APPROPRIATIONS UPDATE FROM CAPITOL HILL
–Marc B. Johnson, MPP
The House of Representatives passed a seven-bill appropriations “minibus” on July 29 which includes the Labor, Health and Human Services, Education, and Related Agencies (LHHS) spending bill. This includes an increase of approximately $3.5 billion in NIH base funding and $3 billion for the proposed Advanced Research Projects Agency for Health (ARPA-H). The National Cancer Institute (NCI) would receive approximately $7 billion, an increase of $432 million above FY 2021 levels. This includes $194 million for the Cancer Moonshot, $50 million for the Childhood Cancer Data Initiative, and $30 million for continued implementation of the Childhood Cancer STAR Act.
In addition, the bill would provide substantial increases for the Centers for Disease Control and Prevention (CDC), bringing its total funding to $10.6 billion, an increase of $2.7 billion.
House Passes Bipartisan PFAS Action Act
-Nicholas Warren, PhD
Poly- and Per- Fluorinated Alkyl Substances (PFAS) are human-made substances known for their ability to repel both grease and water, but are also potent carcinogens that can persist in the human body for decades. PFAS are used in a large number of consumer products such as non-stick cooking pans, microwave popcorn bags, stain-resistant coatings, carpet, firefighting foam, and cosmetics advertised as water-resistant or long-lasting. Additionally, more than 800,000 Americans are estimated to drink water contaminated with PFAS, concentrated near military bases or industrial areas. Concerns about the toxicity of PFAS in Congress led to the creation of H.R. 2467, the PFAS Action Act, which passed the U.S. House of Representatives this July with a bipartisan vote of 241 -183.
If signed into law, the PFAS Action Act would drastically increase federal regulation of PFAS. Provisions of the bill include designating the two most common PFAS molecules as hazardous substances, requiring the U.S. Environmental Protection Agency (EPA) to review all other PFAS molecules within five years, providing federal funds to help clean up heavily polluted sites, requiring water quality tests to include PFAS, and limiting industrial discharge of PFAS. The bill now heads to the Senate Committee on Environment and Public Works, which held a hearing on the dangers of PFAS pollution in June 2021. President Biden has voiced support for the bill, should it pass the Senate.
AACR President Dr. David Tuveson Discusses Opportunities in Cancer Research with the Biden Administration
On Wednesday, July 21, President David A. Tuveson, MD, PhD, FAACR, represented the AACR at a Listening Session held by the White House Office of Science and Technology Policy (OSTP) and the National Institutes of Health (NIH) to hear directly from patient advocacy and scientific research organizations on the potential for scientific opportunities and challenges that an Advanced Research Projects Agency for Health (ARPA-H) could consider addressing. Dr. Tuveson joined a small group of leading researchers and patient advocates who met virtually with NIH Director Dr. Francis Collins and leadership of the OSTP to discuss opportunities in medical research that could be achieved if ARPA-H is authorized, including opportunities in cancer research that could lead to improved health outcomes for cancer patients. The AACR continues to engage with Capitol Hill and the Biden Administration on the development of ARPA-H.
Pandemic-induced changes to clinical trial conduct recommended to remain in place
–Tod Guidry, PhD
The COVID-19 pandemic forced major adaptations in the conduct of clinical research, leading to a reevaluation of the aspects of clinical trials truly necessary to test efficacy of investigational products, and considerations for which adaptations to make more permanent. An article recently published in Cancer Discovery, authored in part by members of the AACR COVID-19 and Cancer Task Force, provides key insights into the impact of the pandemic on clinical trial conduct from the perspectives of academia, industry, and the federal government. The authors highlight adaptions made during the pandemic which they recommend become more permanent fixtures in future trials.
The COVID-19 pandemic brought on major disruptions to the clinical research enterprise. Clinic visits were frozen, travel restrictions were implemented, and clinical trials staff, considered non-essential health care personnel, were redeployed. The pandemic also had a crippling effect on accrual of clinical trial participants. Accrual to trials supported by the National Cancer Institute (NCI) suffered at 15 to 20 percent drop in the 2020 calendar year. Trials already in progress also experienced significant hurdles. Between 15 and 18 percent of AstraZeneca’s clinical trials were delayed by three or more months by late December 2020, with even higher percentages seen across industry.
The challenges posed by the pandemic necessitated changes to clinical trial conduct to provide patients continued access to investigational therapies and to allow investigators to continue collecting data on product safety and efficacy. The U.S. Food and Drug Administration (FDA) and NCI issued guidance on adaptations during the early stages of the pandemic. Such changes, outlined in the article, have included remote informed consent and outcome assessments, local or at-home administration of investigational products, and use of local laboratories and imaging centers, among others.
The changes necessitated by the COVID-19 pandemic created a more decentralized approach to clinical trial conduct. The clinical trial site has historically been at the center of trial conduct, serving as a central hub for consent, imaging and laboratory work, and investigational therapy administration. By allowing for remote informed consent and more localized therapy administration and data collection, the pandemic created a shift toward a more patient-centric paradigm of clinical trial conduct.
Many of the flexibilities implemented had long been recommended by the FDA. Since 2013, the agency has issued guidance documents to improve clinical trial efficiency through the use of electronic informed consent and data capture, electronic health record data, and remote monitoring. The FDA has also engaged stakeholders on aspects of decentralized clinical trial designs to facilitate trial access for underserved and rural patient populations.
The pandemic not only required substantial changes to aspects of clinical trial conduct that were in place for decades but has sparked interest in determining which of those changes should remain once the pandemic is over. The authors agree that flexibilities to clinical trial conduct that foster a more patient-centered approach to clinical research should remain in place.
In addition to flexibilities implemented during the COVID-19 pandemic, the authors also advocate for additional adaptations to improve access to clinical trials. Recommendations include expansion of eligibility criteria, incorporation of patient-reported outcomes in efficacy assessments, greater flexibility for protocol deviations, and increased funding for clinical trials conducted in underserved communities.
Record Heat and Wildfires Strain Patients with Cancer and Health Systems
-Nicholas Warren, PhD
This summer is on track to be the hottest on record for the Northern Hemisphere. The most extreme example is Lytton, British Columbia which broke Canada’s all-time temperature record on June 29 with a temperature of 121oF (49.5oC), and was consumed by wildfire the following day. Unfortunately, human-caused climate change has made these extreme temperatures and droughts far more likely. As a result, the past seven years have been the hottest seven years ever experienced by humans. Not only are extreme temperatures uncomfortable, they can be deadly to people with impaired ability to regulate body temperature and especially those without air conditioning. Furthermore, the large number of patients with heat-related illness is exacerbating the pandemic-related strain on health systems. Those most at risk of heat-related illness are older adults with chronic medical conditions and young children.
High temperatures are particularly concerning for patients with cancer due to the dehydrating effects of many cancer therapies and altered perceptions of body temperature. Additionally, patients with cancer are more susceptible to life-threatening infections; the U.S. Centers for Disease Control and Prevention (CDC) recommends patients with cancer seek urgent medical attention if their body temperature reaches 100.4oF (38 oC). To reduce the risks of dehydration, MD Anderson Cancer Center recommends tracking fluid intake; treating vomiting and diarrhea; discussing fluid and nutrition needs with a dietician; and attempting to consume fluids or moist foods like soup, jello, or yogurt. MD Anderson also recommends looking out for symptoms such as fever, dizziness, dry mouth, confusion, and skin that stays up when lightly pinched; caregivers should encourage fluid consumption throughout the day. The CDC also recommends people without air conditioning find local cooling centers, like libraries; avoid using fans when temperatures are higher than body temperature; taking cool showers or baths; and avoid sunburns by using sunscreen or staying out of the sun.
Wildfires brought on by extreme temperatures and drought pose additional challenges for patients. Wildfires have forced the evacuations of thousands of people already in 2021. Evacuations uproot the entire lives of those impacted, including regular health care access. Furthermore, wildfire smoke is a potent carcinogen, and outdoor air pollution causes more than four million deaths every year globally; wildfires in the Western United States this July impacted air quality as far as New York City. Acutely, exposure to wildfire smoke can worsen heart and lung disease symptoms, including from lung cancer, and shorten lives of vulnerable people by several years. To reduce risks from wildfires, the U.S. Environmental Protection Agency recommends discussing evacuation plans with a doctor before fire season; buying an indoor air cleaner; and using properly fitted N-95 face masks to filter out smoke. While urgent action to slow climate change is critically needed, adapting our behaviors can help mitigate the harmful effects of a warmer, less predictable world.
FDA-AACR ONCOLOGY EDUCATIONAL FELLOWSHIP Application Period open
The FDA-AACR Oncology Educational Fellowship was initiated in 2020 through a partnership between the AACR and the FDA Oncology Center of Excellence (OCE) to provide early-career cancer researchers and fellows with a unique opportunity to learn more about oncology drug development and the regulatory review process. Fellows will engage in targeted educational activities and interactions with experts from the AACR and the OCE. Applications for the fellowship are being accepted now until August 14, 2021.
Eligible candidates must have an advanced degree (DO, MD, PhD, or MD/PhD), be within five years of starting their current academic position, and be or have applied to become AACR members. Neither U.S. citizenship nor residency are required to apply, but candidates must be proficient in English.
Fellows will participate in educational events on topics such as investigational new drugs (INDs), expedited approval pathways, clinical pharmacology, clinical trial design, companion diagnostics, and animal studies. These sessions will be a mix of didactic content presented by FDA OCE experts and group discussions. Fellows will also have the opportunity to participate in several networking sessions with OCE and AACR experts.
Previous participants including basic researchers and clinical fellows have attested to the value of the FDA-AACR Oncology Educational Fellowship in improving their understanding of oncology drug development and review, cultivating professional relationships, and serving their careers.
Learn more on the fellowship webpage.
Register for the 2021 Rally for Medical Research Virtual Hill Day
Registration is 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 from Congress and the NIH is being planned for Wednesday, Sepember. 22, while the virtual Hill Day meetings on Thursday, September 23 will be held with members of Congress and their staff via video and phone conference. We will hold a training session for all participants the week prior to the Hill Day on Monday, Sepember. 20 (please note the date change from September. 17). Visit the Rally website for more information and to register!
Register Now for the September 21 Virtual Patient Advocate Forum on Big Data and Machine Learning
Data science and machine learning promise to revolutionize cancer treatments. But, the role of patients has yet to be clearly defined in this new world of large datasets and real-world evidence. Learn more on September 21 at a free virtual patient advocate forum moderated by Anna Barker.
Cancer Research Leaders Share Insights from AACR/AACI Virtual Hill Day
The AACR partnered with the Association of American Cancer Institutes (AACI) to host its annual Joint Hill Day on June 9. The event, which brings together patient advocates, researchers, physicians, and cancer center leaders in support of federal funding for cancer research, drew nearly 100 participants and was held in a virtual format due to the COVID-19 pandemic.
Following the Hill Day, three members of the AACR Science Policy and Government Affairs Committee who serve in leadership positions at their respective institutions provided their thoughts on the Hill Day and the importance of NIH and NCI funding: Douglas Yee, MD, director of the Masonic Cancer Center at the University of Minnesota; Ruben A. Mesa, MD, executive director of the Mays Cancer Center at UT Health San Antonio MD Anderson; and Sheila Stewart, PhD, associate director for basic sciences at the Siteman Cancer Center at Washington University of St. Louis. Read the blog post.
ONCOLOGY APPROVAL RECAP
Between June 25 and July 26, the U.S. Food and Drug Administration approved two novel oncology therapies and new indications for four oncology drugs.
- Asparaginase erwinia chrysanthemi was approved as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients one month or older who have developed hypersensitivity to E. coli-derived asparaginase.
- Enfortumab vedotin-ejfv, a Nectin-4-directed antibody and microtubule inhibitor conjugate, was approved for adult patients with locally advanced or metastatic urothelial cancer who
- Have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand (PD-L1) inhibitor and platinum-containing chemotherapy, or
- Are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.
- Daratumumab and hyaluronidase-fihj in combination with pomalidomide and dexamethasone were approved for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor.
- Belumosudil, a kinase inhibitor, was approved for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.
- Pembrolizumab in combination with lenvatinib was approved for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
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.