Cancer Policy Monitor: April 14, 2020
- AACR Sends Letter to Congress, President on COVID-19 Response
- AACR Annual Meeting 2020 Update: Decision to Hold A Virtual Format Only
- Appropriations Update from Capitol Hill
- Tobacco Use and COVID-19: Potential Health Implications
- FDA Responds to COVID-19 Pandemic
- FDA Requires New Cigarette Health Warnings on Cigarette Packages and in Cigarette Advertisements
- Low Cost HPV Tests and Treatments for Pre-Cancerous Cervical Lesions
- Dr. Brian Rivers Addresses Cancer Health Disparities
- AACR/AACI Hill Day Postponed
- AACR Holds 5th Annual Early-career Hill Day
- NIH-AACR Cancer, Autoimmunity, and Immunology Conference Ventures Intrepidly to Leverage Web-based Format
- FDA-AACR-IASLC Workshop Discussed the Need to Assess Tobacco Use During Clinical Trials
- Oncology Approval Recap
AACR SENDS LETTER TO CONGRESS, PRESIDENT ON COVID-19 RESPONSE
The AACR Board of Directors sent a letter to Congress and the president the week of March 30, urging federal leaders to take immediate action against COVID-19 and to protect patients with cancer during this pandemic.
The letter highlights recommendations for urgent action to alleviate the public health emergency caused by the spread of COVID-19, as well as to ensure that cancer patients receive the care that they need, and that scientific innovation can be sustained. The letters can be found at the following links:
You can contact your members of Congress and urge them to take immediate action through this campaign.TAKE ACTION
AACR Annual Meeting 2020 Update: Decision to Hold A Virtual Format Only
AACR has been closely monitoring the rapid escalation of the COVID-19 pandemic. The health and safety of all Annual Meeting attendees and the patients and communities they serve are the AACR’s highest priorities. Therefore, the AACR Board of Directors has made the decision to hold two AACR Virtual Annual Meetings.
APPROPRIATIONS UPDATE FROM CAPITOL HILL
-Brandon Leonard, MA
As the COVID-19 pandemic has grown spread throughout the United States, Congress has turned its full attention to this public health emergency, even as it attempts to stay on track with the regular appropriations process.
In March, Congress passed three large funding packages in response to the COVID-19 crisis. The first package, the Coronavirus Preparedness and Response Supplemental Appropriations Act, provided $8.3 for initial response measures and was signed by President Trump on March 6. The bill included funding for key federal agencies such as the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), as well as support for state and local governments and small businesses.
The second package, the Families First Coronavirus Response Act, was signed by the president on March 18. It provides $3.5 billion for paid sick leave for employees who did not previously have this benefit, coverage for COVID-19 testing, protections for public health workers, and additional assistance for children and families including nutrition programs.
The third package, the Coronavirus Aid, Relief, and Economic Security (CARES) Act, was signed by the president on March 27 and includes $2 trillion in additional funding. This package is intended to spread emergency relief throughout the American economy, with spending targeting individuals, small and large businesses, hospitals and other public health institutions, state and local governments, and the education system.
As of early April, congressional leaders and administration officials are discussing a fourth relief package, with others potentially to follow.
Prior to the coronavirus pandemic, appropriations leaders in Congress had been optimistic about moving spending bills for fiscal year 2021 (FY21) on a regular schedule despite falling behind in recent years. However, with Congress on an extended recess and staff working remotely due to COVID-19, appropriations hearings and markups have been canceled for the foreseeable future. Appropriators have indicated they are working on their bills remotely and still aim to have them completed, if not passed by their respective committees, by the summer.
TOBACCO USE AND COVID-19: POTENTIAL HEALTH IMPLICATIONS
-Carmine S. Leggett, PhD
Smoking remains the leading preventable cause of death and disease in the U.S. Although the percentage of adults who smoke is at an all-time low, approximately 40 million adults in the U.S. still smoke cigarettes, while nearly 4.7 million middle and high school students use at least one tobacco product, including e-cigarettes. The Center for Disease Control (CDC), reports that every day, about 1,600 U.S. youth younger than 18 years smoke their first cigarette. Each year, nearly half a million Americans die prematurely of smoking or exposure to secondhand smoke. Constituents in tobacco smoke and e-cigarette vapor harm the body, including damaging the lungs. As a result, smoking causes lung diseases and cancer, including most cases of chronic obstructive pulmonary disease (COPD); makes chronic lung diseases more severe; and increases the risk for respiratory infections. While additional research is warranted, the weight of the evidence suggests that smoking is also likely associated with the negative progression and adverse outcomes of the respiratory illness, Coronavirus disease 2019 (COVID-19).
Michael Felberbaum, a spokesman from the U.S. Food and Drug Administration (FDA), asserts that people with underlying health issues, such as heart or lung problems, may have increased risk for serious complications from COVID-19. This includes people who smoke and/or vape tobacco or nicotine-containing products. According to the World Health Organization (WHO), smokers are likely to be more vulnerable to COVID-19 as the act of smoking means that fingers (and possibly contaminated cigarettes) are in contact with lips which increases the possibility of transmission of virus from hand to mouth. Additionally, smokers may also already have lung disease or reduced lung capacity which would greatly increase risk of serious illness. Conditions that increase oxygen needs or reduce the ability of the body to use it properly will put patients at higher risk of serious lung conditions such as pneumonia. A systematic review of the evidence published by Constantine I. Vardavas and Katerina Nikitara identified five studies that reported data on the smoking status of patients infected with COVID-19. Notably, in the largest study that assessed severity, there were higher percentages of current and former smokers among patients that needed Intensive Care Unit support, mechanical ventilation or who had died, and a higher percentage of smokers among the severe cases.
Quitting smoking can be difficult, but now is a great time for smokers to quit all tobacco products, including vaping.
FDA RESPONDS TO COVID-19 PANDEMIC
-Trevan Locke, PhD
The U.S. Food and Drug Administration (FDA) has been an integral player in the nation’s response to the COVID-19 pandemic. The agency has worked swiftly to issue guidance to industry on clinical trials, diagnostic tests, and devices. The FDA Oncology Center of Excellence (OCE) has focused on providing information and resources to patients with cancer and their healthcare providers. It has also granted Emergency Use Authorizations (EUAs) to provide increased diagnostic testing capacity for COVID-19.
In March, the FDA issued COVID-19 related guidance on conducting clinical trials, developing diagnostic tests, leveraging remote patient monitoring devices (wearable, hand-held, stationary in-home monitoring, and digital interfaces), and producing ventilators, hand sanitizer, face masks, and sterilization devices among others. Most relevant to patients with cancer and their health care providers, the FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic provides guidance to sponsors and investigators on how to protect the safety of patients involved in ongoing clinical trials while minimizing risks to trial integrity. The guidance provides recommendations on informing trial participants about changes in study plans, working with Institutional Review Boards to determine the best course of action to protect patient safety, implementing alternative processes within trial protocols, and documenting the impact of protocol changes on data collection. FDA acknowledges that they are aware of the challenges that the pandemic presents and will work with stakeholders to maintain patient safety as this guidance is implemented.
The OCE recognized the impact COVID-19 will have on patients with cancer and their healthcare providers. While combatting the virus is a national priority, the OCE is committed to ensuring the cancer community has crucial resources for cancer treatment in this challenging time. On, March 23, 2020, the OCE shared their priorities for responding to critical issues for patients with cancer during the pandemic. These priorities include the OCE staff teleworking to sustain continuity of oncology product development, working with trial sponsors on any clinical trial modifications that may be needed in accordance with the FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, processing Expanded Access requests for investigational oncology drugs through Project Facilitate, and anticipating, preventing, and mitigating drug shortages. The OCE will also continue its efforts to improve education, outreach, and communication to the cancer community.
The FDA is responding to the pandemic in other critical ways as well. During this public health emergency, the FDA has been utilizing its EUA authority, which allows the agency to authorize unapproved uses of medical products to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate alternatives. At the end of March, the agency had issued 20 EUAs for COVID-19 diagnostic tests, 110 laboratories had begun offering tests under the guidelines outlined in FDA guidance, and a therapeutic EUA for hydroxychloroquine sulfate and chloroquine phosphate had been granted based on scientific and biological rationale but limited scientific evidence. To support clinical trials for these and other possible COVID-19 therapies, the agency has created the Coronavirus Treatment Acceleration Program (CTAP). According to the agency, CTAP utilizes all available tools to move COVID-19 treatments to patients as quickly as possible, while still evaluating treatment safety and efficacy. Meanwhile, working with the Federal Trade Commission, the agency has issued warnings to sellers that make false, unapproved claims of efficacy against COVID-19 about their products.
The COVID-19 pandemic is an evolving crisis and the FDA’s response will continue to evolve with it. For the latest updates from the agency, visit the FDA Newsroom.
FDA REQUIRES NEW CIGARETTE HEALTH WARNINGS ON CIGARETTE PACKAGES AND IN CIGARETTE ADVERTISEMENTS
-Carmine S. Leggett, PhD
On March 17, 2020 the U.S. Food and Drug Administration (FDA) issued a final rule to require new health warnings on cigarette packages and in cigarette advertisements. Beginning June 18, 2021, these new cigarette health warnings will be required to appear prominently on cigarette packages and in advertisements, occupying the top 50 percent of the area of the front and rear panels of cigarette packages and at least 20 percent of the area at the top of cigarette advertisements. Once implemented, the new warnings must be randomly and equally displayed and distributed on cigarette packages and rotated quarterly in cigarette advertisements. This action by the FDA is based on decades of science showing that large, graphic warnings are an effective way to increase awareness about the dangers of tobacco use, to dissuade nonsmokers from starting to smoke, and to motivate smokers to quit.
The American Association for Cancer Research (AACR), is committed to supporting many policy efforts, including the requiring of graphic warning labels to reduce the incidence of disease and mortality due to tobacco use. In 2019, the AACR submitted comments to the FDA that applauded the agency for its rigorous and science-based efforts to develop new graphic health warnings for cigarette packages and advertisements. In 2010, the AACR released a comprehensive policy statement on tobacco and cancer composed of numerous policy recommendations and a road map for future research to stem the tide of tobacco-related death and disease. The statement included, among other policy recommendations, that more stringent and effective warning labels based on scientific evidence were included on cigarette products and in cigarette advertising.
Tobacco use accounts for 30 percent of all cancer deaths and incidence and is causally associated with 18 different human cancers including, among other cancer types: lung, head and neck, stomach, pancreas, colon, and cervical cancers. Although cigarette smoking has declined significantly, tobacco use remains the leading cause of preventable disease, disability, and death in the United States. Scientific studies indicate that the U.S. public–including youth and adults, smokers and nonsmokers–holds misperceptions about the health risks caused by smoking. The new labels will be an invaluable tool to help communicate the many dangers of tobacco use to the public.
LOW COST HPV TESTS AND TREATMENTS FOR PRE-CANCEROUS CERVICAL LESIONS
-Nicholas Warren, PhD
Human Papilloma Virus (HPV) causes over 33,000 preventable cases of cancer in the US every year. Vaccination, screening, and early treatment can completely prevent cervical cancer. However, developing countries and high-poverty areas within the United States face significant barriers to access to cervical cancer screenings and treatments. For example, the Lower Rio Grande River Valley of Texas is home to 1.3 million people but has very few medical clinics and nearly half of all residents are uninsured. Cost and transportation burdens lead to poor HPV screening and treatment rates, and ultimately result in death rates from cervical cancer that are double the national average. In order to help reduce disparities like this one and improve healthcare access, several research groups are developing simple, low-cost screening tests and treatments.
Kathleen Schmeler, MD, from MD Anderson Cancer Center and Rebecca Richards-Kortum, PhD, from Rice University co-developed a low-cost “microendoscope” that allows physicians to diagnose pre-cancerous cervical lesions in real-time. This allows patients to be screened and treated in the same visit, saving them from traveling significant distances for a follow up visit. A randomized clinical trial of 200 women in Brazil found that the microendoscope identified early cervical cancer with similar sensitivity and specificity as standard colposcopy. They also found that screening in remote locations significantly improved follow up treatment rates versus medical center screenings. Dr. Schmeler is also helping train community health workers to surgically remove early cervical cancers both in Brazil and the United States.
A separate program aimed to address significant barriers to access to cervical cancer screenings in Honduras is being led by Gregory Tsongalis, PhD, from Dartmouth-Hitchcock Medical Center. For many women involved in the program, this was the first time they were ever screened for cervical cancer. The team found of the 1,732 women tested for the presence of HPV DNA, 28 percent were positive for a high-risk HPV strain, and of those, 26% had more than one HPV infection. They also found different high-risk HPV strains in Honduran women than are commonly found in United States; suggesting that vaccines developed in the United States may not be as effective in other countries.
The African Cancer Foundation in Kenya is also taking the charge to improve follow-up treatment rates by providing “thermo-coagulators” to health centers all over the country. In Kenya, providers use acetic acid (vinegar) to diagnose pre-cancerous cervical lesions, which turn white when exposed to acetic acid. These efforts follow successful clinical trials testing the feasibility and efficacy of thermo-coagulation that uses heat to kill pre-cancerous cells. A phase 1 feasibility study, led by Patrick Petignat, MD, from Geneva University, found that thermocoagulation resulted in very minor adverse effects. A single-arm phase 2 study, led by Heather Cubie, PhD, from the University of Edinburgh, found that 95.5 percent of 446 women were free of pre-cancerous lesions one year after thermo-coagulation treatment. Thermo-coagulators require less specialized training than surgical methods and do not need nitrogen gas like cryotherapy; these benefits allow nurses to perform the procedure in low-resource environments.
These advances in early cervical cancer detection and treatment hold great promise to address critical barriers to increased cervical cancer screening and treatment: cost and local availability. By making new tests and treatments that are portable, low-cost, and easy to use, these innovative researchers will help spare thousands of premature deaths each year. The AACR will continue to support research and policies to help eliminate all HPV-related cancers.
Dr. Brian Rivers Addresses Cancer Health Disparities
-Brian Rivers, PhD
Cancer research is fueling a record number of approvals for anticancer therapeutics. Overall cancer death rates are declining, and the number of cancer survivors has reached a record high. Despite this progress, cancer has a disproportionate impact on disadvantaged and minority groups.
The AACR has long recognized the need to address cancer health disparities through cancer research programs and initiatives. The AACR’s Conference on The Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved marked its 12th year in 2019. Developed in collaboration with the AACR’s Minorities in Cancer Research Council and Constituency Group, the conference strives to bring research on cancer health disparities to the scientific and advocacy communities. A critical tool to combat cancer health disparities is community engagement.
In 2018, the AACR formed a Cancer Health Disparities Task Force and hosted a think tank that included leading experts to chart the future direction of the AACR’s cancer health disparities programs. One of the products of the Task Force has been the AACR Cancer Disparities Progress Report 2020: Achieving the Bold Vision of Health Equity for Racial and Ethnic Minorities and Other Underserved Populations, which will be shared with members of Congress and their staff at a future Congressional Briefing and Hill Day.
A critical tool to combat cancer health disparities is community engagement. We welcome you to join the AACR in advocating for research and policies that address cancer health disparities. As a community of patient advocates, cancer survivors, researchers, and physician-scientists, we have a compelling and important story to tell.
To read the full article in AACR’s Cancer Today magazine, see Taking Steps to Address Cancer Health Disparities
AACR/AACI HILL DAY POSTPONED
The health and well-being of our Hill Day participants and cancer center patients is the top priority for AACR and AACI. With that in mind, we have been closely monitoring the coronavirus outbreak that has led to COVID-19 infection across the United States and throughout the world.
Due to mounting concerns related to COVID-19 transmission and travel restrictions in place at cancer centers, AACI and AACR’s annual Joint Hill Day, scheduled for Wednesday, May 13, has been postponed. Alternative dates and advocacy activities are currently being considered.
We will continue to monitor the COVID-19 emergency and will stay in touch about plans to reschedule. If you have any questions, please feel free to contact Brandon Leonard, AACR’s associate director of congressional relations, at firstname.lastname@example.org.
AACR HOLDS FIFTH ANNUAL EARLY-CAREER HILL DAY
-Brandon Leonard, MA
The Fifth Annual AACR Early-career Hill Day, held on February 27, brought 16 young researchers to Capitol Hill to advocate for continued, strong investments in cancer research through the National Institutes of Health (NIH) and the National Cancer Institute (NCI). Katerina Politi, PhD, associate professor of pathology and co-leader, cancer signaling networks at Yale Cancer Center, served as the scientist mentor for the Hill Day.
Participants held meetings with 57 congressional offices representing 18 states. In each case, they asked members of Congress to support an increase of $3 billion for the NIH in fiscal year 2021 (FY21), for a total budget of $44.7 billion. As part of this request, they also asked that Congress fund the National Cancer Institute at $6.9 billion in FY21.
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.
Three of the Hill Day participants shared their stories in blog posts for the Cancer Research Catalyst. Bianca N. Islam, MD, PhD, a returning Hill Day participant, shared her thoughts before returning to Capitol Hill in this post. First-time participants Henry Henderson, MS, PhD, and Emanuela Dylgjeri contributed to a post-event blog on their experiences.
NIH-AACR CANCER, AUTOIMMUNITY, AND IMMUNOLOGY CONFERENCE VENTURES INTREPIDLY TO LEVERAGE WEB-BASED FORMAT
-Elizabeth Barksdale, PhD
On March 23 and 24, the American Association for Cancer Research (AACR) together with the National Cancer Institute (NCI), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) hosted the NIH-AACR Cancer, Autoimmunity, and Immunology Conference. Although in its third year, this year’s conference was vastly different from its forebears, as the COVID-19 pandemic necessitated a late pivot to an entirely virtual format.
Undeterred, the invited speakers embraced the opportunity to convene via webcast, presenting their research and data on topics ranging from myositis associated with the use of immune-checkpoint inhibitors to differentiation of dermatologic immune-related adverse events seen in patients receiving combination therapies. Highly valued audience participation during the discussion panels was preserved by utilizing an online question submission tool.
A thorough recounting of the sessions and specific presentations is available on the AACR Cancer Research Catalyst. Recordings of the webcast will be made available in the coming weeks.
FDA-AACR-IASLC WORKSHOP DISCUSSED THE NEED TO ASSESS TOBACCO USE DURING CLINICAL TRIALS
-Nicholas Warren, PhD
On February 28, 2020, the American Association for Cancer Research ( AACR) partnered with the U.S. Food and Drug Administration (FDA) and the International Association for the Study of Lung Cancer (IASLC) to bring together leading academic, industry, and government scientists and physicians to discuss the importance of tobacco use assessments in oncology clinical trials. The workshop was led by cochairs: Matthew Steliga, MD; Michael Menefee, MD, and; Roy Herbst, MD, PhD, who also chairs the AACR’s Tobacco Products and Cancer Policy Subcommittee, and brought together stakeholders from academic cancer centers, industry scientists, government scientists, and patient advocates. Speakers and panelists discussed the importance and challenges of monitoring tobacco use of clinical trial participants.
In the first session, speakers Paul Bunn Jr, MD, and Carolyn Dresler, MD, highlighted preliminary evidence that smoking cessation due to the lack of tobacco assessments during clinical trials, the evidence of magnitude of benefit is quite poor, and interactions between smoking and specific cancer treatments are largely unknown. Panelists discussed the importance of better understanding which therapies work best for smokers and if dosing should be altered to improve efficacy or reduce toxicities.
Throughout the workshop panelists discussed many hurdles to assessing tobacco use during clinical trials. These include difficulties due to unstandardized categories and definitions to describe smoking status, collecting data at multiple time points, accounting for alternative tobacco products, and challenges associated with trial participation. Unfortunately, creating standardized definitions of smoking status has also been challenging because there is not enough data to conclusively determine what definition of “Former Smoker” is clinically meaningful. However, Stephanie Land, PhD, provided recommendations from the NIH-AACR Tobacco Use Assessment Task Force on optimal assessment time points. The workshop panelists discussed the need for more studies on these issues and leadership from regulatory agencies to help simplify and standardize terms.
Another significant issue discussed at the workshop was the stigma associated with smokers seeking cancer treatment. Laura Bierut, MD, described how providing advice for nurses to encourage patients to quit smoking helped patients feel like their concerns were being taken seriously. Matthew Steliga, MD, and Roy Herbst, MD, PhD, described how positive messaging campaigns dramatically increased smoking cessation success rates of patients with cancer compared to negative messaging campaigns at their institutions. These examples provide great hope to combat the stigma of smoking and treating lung cancer.
Quitting smoking is the single best thing you can do to improve your health. The AACR will continue to work with the FDA and other stakeholders to reduce the public health burden of tobacco. Workshop materials, including a recording and slides, can be found on the workshop webpage.
ONCOLOGY APPROVAL RECAP
In March, the U.S. Food and Drug Administration approved one novel therapy and two expanded indications for oncology drugs:
- Isatuximab-irfc was approved in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor,
- The combination of nivolumab and ipilimumab was granted accelerated approval for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
- Durvalumab was approved in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).
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.