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Cancer Policy Monitor: February 11, 2020

Appropriations Update from Capitol Hill

-Brandon Leonard, MA

The appropriations process for fiscal year (FY21) begins in earnest with the release of the president’s budget proposal, scheduled for February 10. Because the budget deal reached by Congress and signed by the president last year set spending caps for both FY20 and FY21, the process could be smoother this year and Congress may forego drafting a budget resolution. However, with much smaller increases in the overall budget allocations and the election looming in November, many doubt that appropriations will be finalized by the end of the current fiscal year on September 30.

Congress has passed significant funding increases for the National Institutes of Health over the last five years, including an increase of $2.6 billion in FY20. This year, the AACR will continue to advocate for robust, sustained, and predictable funding increases for the NIH so that we can make new discoveries that will change the way we prevent, diagnose, and treat cancer, as well as many other diseases. The AACR will join other advocacy organizations in the biomedical sciences to ask Congress for a $44.7B funding allocation for the NIH, a $3 billion increase over the current fiscal year.

We will also join the cancer advocacy community in asking Congress to support a total budget of at least $6.928 billion for the National Cancer Institute (NCI), as included in the NCI Director’s FY21 Professional Judgement Budget Proposal. Additionally, the AACR will advocate for strong funding increases for the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).

Registration Now Open for FDA-AACR Workshop to Examine Under-representation of African Americans in Multiple Myeloma Clinical Trials

The American Association for Cancer Research (AACR) is partnering with the U.S. Food and Drug Administration (FDA) to present the FDA-AACR Workshop to Examine Under-representation of African Americans in Multiple Myeloma Clinical Trials on February 13, 2020, in Washington, D.C. The workshop is cochaired by:

  • Kenneth C. Anderson, MD, FAACR, Program Director, Jerome Lipper Multiple Myeloma Center and LeBow Institute for Myeloma Therapeutics and Chief, Division of Hematologic Neoplasia, Dana-Farber Cancer Institute; Chair, AACR Regulatory Science and Policy Subcommittee
  • ‘Lola A. Fashoyin-Aje, MD, MPH, Acting Deputy Director, Division of Oncology 3, Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
  • Nicole J. Gormley, MD, Acting Director, Division of Hematologic Malignancies 1, Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
  • Paul G. Kluetz, MD, Deputy Director, Oncology Center of Excellence, U.S. Food and Drug Administration

Registration for this one-day workshop is free and still open to the public for in-person and webcast attendees.

Make Your Voice Heard During the AACR Early-career National Day of Action 2020  

In conjunction with the AACR Early-career Hill Day, February 27, we invite early-career scientists anywhere in the U.S. to participate in the National Day of Action by contacting members of Congress and urging their support for robust, sustained and predictable funding increases for the National Institutes of Health. It only takes a few minutes to send an email and/or call your congressional representative and senators, and your voice can help amplify our message to Congress!

You can easily prepare a message for your members of Congress anytime in February by using our advocacy campaign. Just use our template message, or customize it based on your personal experience. On February 27, all messages will be approved and sent to congressional offices to magnify our impact in support of medical research funding.

Registration Available for FDA-AACR-IASLC Workshop to Address Tobacco Use Assessment in Oncology Therapeutic Trials

The American Association for Cancer Research (AACR) is partnering with the U.S. Food and Drug Administration and International Association for the Study of Lung Cancer (IASLC) to present the FDA-AACR-IASLC Workshop to Address the Criticality of Tobacco Use Assessment in Oncology Therapeutic Trials, February 28, 2020, at the U.S. FDA’s  White Oak campus in Silver Spring, Maryland. This workshop is co-chaired by:

  • Roy S. Herbst, MD, PhD, Ensign Professor of Medicine, Associate Director for Translational Research, Yale Cancer Center
  • Michael E. Menefee, MD, Oncologist, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
  • Matthew Steliga, MD, Surgical Oncologist, Winthrop P. Rockefeller Cancer Institute

Registration is free and open to the public.

Amid Epidemic Levels of Youth Use of E-Cigarettes, The FDA Finalizes Enforcement Policy on Flavors

-Carmine S. Leggett, PhD

Survey data from 2019 indicate that more that five million youth used e-cigarettes, and youth who use JUUL prefer mint- and fruit-flavored e-cigarettes. These alarming rates led the U.S. Food and Drug Administration (FDA) to issue final guidance outlining the agency’s enforcement priorities for electronic nicotine delivery systems (ENDS) January 2, 2020. 

Under this policy, companies must cease manufacture, distribution, and sale of unauthorized flavored cartridge-based e-cigarettes. More specifically, the policy prioritizes enforcement against ENDS products by focusing on any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product). Including all other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and any ENDS product that is targeted to minors or likely to promote use of ENDS by minors. 

The FDA asserts that by not prioritizing enforcement against other flavored ENDS products in the same way as flavored cartridge-based ENDS products, the agency attempted to balance the public health concerns related to youth use of ENDS products with considerations regarding addicted adult cigarette smokers who may try to use ENDS products to transition away from combustible tobacco products. 

However, many public health advocates criticized this final guidance, emphasizing that the policy allows menthol flavored e-cigarettes to remain on the market as well as all flavors for the refillable tank-style products that are commonly used and sold in vape shops located throughout the country. Public health advocates are particularly concerned that youth and young adult e-cigarettes users will switch to menthol flavored e-cigarettes and open-tank systems that remain on the market.  FDA officials stated that should the FDA become aware of an increase of youth using any other flavored products, the agency will take additional steps to address youth use of those products if necessary. 

Surgeon General Releases 2020 Report on Smoking Cessation

-Carmine S. Leggett, PhD

Smoking remains the leading preventable cause of death and disease. While smoking rates have declined in the U.S., 34 million adults still smoke. Smokers continue to be at risk of developing cancer and other smoking-related diseases. To emphasize the importance of quitting, the U.S. Surgeon General released Smoking Cessation: A Report of the Surgeon General. This report highlights the latest scientific evidence on the health benefits of cessation and proven treatments and strategies to help people successfully quit smoking. This report is notably the 34th tobacco-related Surgeon General’s report published since 1964.

Below are the 2020 Surgeon General’s Report Findings 

  1. Smoking cessation is beneficial at any age. Smoking cessation improves health status and enhances quality of life.
  2. Smoking cessation reduces the risk of premature death and can add as much as a decade to life expectancy.
  3. Smoking places a substantial financial burden on smokers, health care systems, and society. Smoking cessation reduces this burden, including smoking-attributable health care expenditures.
  4. Smoking cessation reduces risk for many adverse health effects, including reproductive health outcomes, cardiovascular diseases, chronic obstructive pulmonary disease (COPD), and cancer. Quitting smoking is also beneficial to those who have been diagnosed with heart disease and COPD.
  5. More than three out of five U.S. adults who have ever smoked cigarettes have quit. Although a majority of cigarette smokers make a quit attempt each year, less than one-third use cessation medications approved by the U.S. Food and Drug Administration (FDA) or behavioral counseling to support quit attempts.
  6. Considerable disparities exist in the prevalence of smoking across the U.S. population, with higher prevalence in some subgroups. Similarly, the prevalence of key indicators of smoking cessation—quit attempts, receiving advice to quit from a health professional, and using cessation therapies—also varies across the population, with lower prevalence in some subgroups.
  7. Smoking cessation medications approved by the U.S. Food and Drug Administration (FDA) and behavioral counseling are cost-effective cessation strategies. Cessation medications approved by the FDA and behavioral counseling increase the likelihood of successfully quitting smoking, particularly when used in combination. Using combinations of nicotine replacement therapies can further increase the likelihood of quitting.
  8. Insurance coverage for smoking cessation treatment that is comprehensive, barrier-free, and widely promoted increases the use of these treatment services, leads to higher rates of successful quitting, and is cost-effective.
  9. E-cigarettes, a continually changing and heterogeneous group of products, are used in a variety of ways. Consequently, it is difficult to make generalizations about efficacy for cessation based on clinical trials involving a particular e-cigarette, and there is presently inadequate evidence to conclude that e-cigarettes, in general, increase smoking cessation.
  10. Smoking cessation can be increased by raising the price of cigarettes, adopting comprehensive smoke free policies, implementing mass media campaigns, requiring pictorial health warnings, and maintaining comprehensive statewide tobacco control programs.  

Register Now for the 2020 NIH-AACR Cancer, Autoimmunity, and Immunology Conference  

– Meghali Goswami 

Meghali Goswami is a PhD candidate in the George Washington University – National Institutes of Health Graduate Partnerships Program and is currently serving a detail with the AACR. She is performing her dissertation research in the Laboratory of Myeloid Malignancies at the National Heart, Lung, and Blood Institute on immunotherapeutic strategies to treat relapsed and refractory acute myeloid leukemia. 

On March 23-24, 2020, the American Association for Cancer Research (AACR), in conjunction 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) will present the NIH-AACR Cancer, Autoimmunity, and Immunology Conference at the National Institutes of Health (NIH) in Bethesda, Maryland. 

Now in its third year, the purpose of this interdisciplinary conference is to bring together a diverse group across disciplines to promote an exchange of ideas around immune-related adverse events (irAEs) resulting from treatment with immunotherapies (such as immune checkpoint inhibitors), with the goal of improving both research and clinical care. This year the NIH-AACR Cancer, Autoimmunity, and Immunology Conference will feature sessions on the influence of microbiomes on treatment response and outcomes; irAEs resulting from combination therapies; multidisciplinary treatment models; and more. Leonard Calabrese, DO, FACR, of the Cleveland Clinic; Laurence Zitvogel, MD, PhD, of Institut Gustave Roussy; and Suzanne Topalian, MD, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, will provide keynote presentations. See the preliminary agenda.

The organizing committee for the 2020 NIH-AACR Cancer, Autoimmunity, and Immunology Conference includes:  

  • Julie R. Brahmer, MD, Director, Thoracic Oncology Program and Upper Aerodigestive Clinical Research Program, Sidney Kimmel Comprehensive Cancer Center
  • Elad Sharon, MD, MPH, Senior Investigator, NCI
  • Connie Sommers, PhD, Program Director, NCI
  • Howard Young, PhD, Senior Investigator, NCI
  • Ravi Madan, MD, Clinical Director, Genitourinary Malignancies Branch, NCI
  • Katarzyna (Kasia) Bourcier, PhD, Program Director, NCI 
  • Marie Mancini, PhD, Program Director, NIAMS
  • Annette Rothermel, PhD, Section Chief, NIAID
  • Lisa Spin, PhD, Program Director, NIDDK

Additionally, there will be a poster session and networking reception following the presentations on March 23; abstracts for the poster session will be accepted through February 28, 2020. Registration for this two-day conference is free for all NIH employees and trainees as well as non-NIH attendees. Those who cannot attend in-person are welcome to register to watch via webcast. 

AACR to Release Inaugural Cancer Disparities Progress Report on March 25

The AACR will release its inaugural Cancer Disparities Progress Report Wednesday, March 25, 2020, at a briefing on Capitol Hill. This report, the first of its kind, will feature the latest research on why disparities in cancer incidence, diagnosis, treatment, and survival exist, and what can be done to address them. The report has been developed by the preeminent cancer disparities researchers in the country and builds upon the AACR’s longstanding commitment to reducing cancer disparities through research, including our annual conference on the Science of Cancer Health Disparities.

The public is invited to attend the briefing, which will take place from noon – 1 p.m., March 25 in the Capitol Visitor Center, Room HVC 201AB. Please RSVP if you plan to attend.

The AACR will also host a “Hill Day” to increase awareness of cancer disparities and advocate for Congress to take action to eliminate these disparities. If you would like to participate in this Hill Day, please register.

Scientist↔Survivor Program at the AACR 2020 Annual Meeting

AACR received close to 100 applications from patient advocates who wish to participate in the Scientist↔Survivor Program® at the AACR 2020 Annual Meeting.  Reviewers now have the daunting task of selecting 40 attendees from this prestigious pool of applicants.

The AACR Scientist↔Survivor Program® is a unique educational program designed to build enduring partnerships among the leaders of the scientific, cancer survivor, and patient advocacy communities worldwide. The program provides patient advocates with special lectures using lay language, small group discussions, and other opportunities for the exchange of information on key aspects of cancer research, survivorship, advocacy, and public policy. Since its inception in 1998, more than 820 patient advocates have graduated from the program. The video shares more about the history of AACR’s Scientist↔Survivor Program® and what makes it so special. Watch Video

Save The Date for the 2020 AACR-AACI Hill Day

The AACR and the Association of American Cancer Institutes (AACI) invite you to Capitol Hill, Wednesday, May 13, 2020. This Hill Day will bring cancer center directors, researchers, physician-scientists, cancer survivors and other advocates to Capitol Hill to build support for a strong federal investment in biomedical research, and cancer research in particular, through the National Institutes of Health (NIH) and the National Cancer Institute (NCI).

Learn more information and register for the Hill Day.

Patient Advocate Perspective on Disparities in Therapeutic Outcomes

Comments from the 12th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and Medically Underserved

On Sunday, September 22, 2019, patient advocate and cancer survivor, Desiree A.H. Walker spoke at the 12th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and Medically Underserved. She represented the patient perspective on a panel discussing disparities in therapeutic outcomes and the prevalence of adverse effects. Desiree’s remarks, shared below, highlight the importance and value of including patient advocates in cancer research programs.

-Desiree A.H. Walker

Good afternoon,

I would like to thank the organizers for the opportunity to provide the patient advocate perspective on this panel.  I would also like to thank my fellow panelists for their efforts to increase our knowledge and their work in cancer research.

Over the past few years, I continue to hear at cancer research conferences that it is an exciting time in research. As a woman of color who identifies as a two-time breast cancer victor, initially diagnosed as a young woman, who has a daughter and a son and is the co-survivor to a sister with multiple myeloma, I am encouraged by the research discussed at this conference each year. Equally uplifting is the inclusion of the science of cancer health disparities in racial/ethnic minorities and the medically underserved at more scientific conferences. I join all the patients/survivors/those living with cancer, their co-survivors who are part of the populations at risk for cancer health inequities and research advocates in the desire to be exuberant that it is now out of the shadows! Addressing these inequities can be daunting but I share with you the words of Mother Teresa, “I alone cannot change the world, but I can cast a stone across the waters to create ripples.”

For those of you that have pioneering spirits, I say thank you. For those of you trying to decide if you want to be a pioneer, I would like to share the words of Gwendolyn Brooks, “Do not desire to fit in. Desire to oblige yourself to lead.”

Study #1 – Metformin use and pancreatic cancer survival: Are there racial differences?

Adetunji T. Toriola, Washington University School of Medicine, St. Louis, Missouri

I was excited to see the first study’s goal was to provide data on the association of metformin use with pancreatic ductal adenocarcinoma (PDAC) survival in African American patients. However, when I saw there was over 3800 participants but only 773 African American patients were enrolled, I wondered why so few. Were the rest of the participants non-Hispanic white? I also pondered why the VA system was selected and were there barriers to get more African American patients enrolled along with other underrepresented racial/ethnic groups. Is there a hypothesis as to why non-Hispanic whites responded to metformin while African Americans did not?

Study #2 – Breast tumor microenvironment in black women: A distinct signature of CD8+ T Cell exhaustion
Song Yao, Roswell Park Comprehensive Cancer Center, Buffalo, New York

The second study’s goal was to answer an important research question which is on the minds of many regarding why African American women have more aggressive breast cancer and a higher mortality rate. The study’s findings shed light on why breast cancer is more aggressive for African American women. It also stated there was a rational for the use of immune checkpoint inhibitors. However, we know that immunotherapy is currently not the panacea although it has promise. Having learned that remarkable responses occur in a subset of patients and most patients do no benefit raises questions – time, benefit vs. cost, toxicity, priorities? I also thought about how often eligibility requirements for studies are stringent and begs the question if all populations are not equitably represented in studies is the needle being moved towards treatments that increase progression-free survival (PFS), overall survival (OS), or quality of life (QoL) for all patients. Adverse effects are deal breakers! Also, where do patients who have comorbidities fit in?

Disparities in cardiovascular disease incidence in breast cancer survivors
Zaixing Shi, Fred Hutchinson Cancer Research Center, Seattle, Washington

The background for the third study was staggering for me and discouraging to learn that there’s little data on why the risk of cardiovascular disease (CVD) increases in African American women. However, I can appreciate the recent studies regarding modifiable risk factors of cardiovascular events for breast cancer survivors/those living with disease and the general population. I do believe patients should take an active role in their health and cancer experience. However, I would like to raise the question if all patients are not equal in health literacy or their respective disease what systems are in place or can be put in place to ensure they are taking the necessary measures to achieve and sustain good health. I believe an interdisciplinary team approach should be the standard of care. Recommendations without ensuring an individual has the wherewithal to comply can lead to frustration by all parties involved and poor outcomes. Taking into account whether an individual has a support system is key. It is critical that we have policy that ensure health care systems can offer health care providers the time to talk with patients to understand their lifestyle, cardiovascular risk factors and where they live and work and/or attend school. This information tells a story that’s just as significant as their disease. Navigating the health care system following a cancer diagnosis is a maze so having navigators and social workers as part of the team serving the patient is needed. I also think about the breast cancer survivors/those living with disease that I have met who have said they followed the suggested modifiable risk factors and still were diagnosed with CVD. Are they outliers or do we need to acknowledge that the chemotherapy trials testing efficacy of drugs and its dosing that are used today had and continue to have a low enrollment of African American women? I’ve heard oncologists say that African Americans appear to metabolize drugs differently which raises the question could the dosing of the chemotherapy especially the ones who are known to increase the risk of cardiotoxicity be a contributing factor. Novel therapeutic interventions are vital to reduce the late effects due to toxicity, relapses, and mortality. It’s clear there’s lots of questions to be asked and answered.

As you prepare to return to your respective positions, I implore you think about the cancer patient or the caregiver of a cancer patient who has just learned of their diagnosis or that their OS is poor. Time is relative! I encourage each of you regardless of which piece you are in the puzzle to get to know cancer patients/survivors/those living with disease. The real-world experience could change your approach and give you the fervor needed and a greater meaning to your work! It is important to keep in mind benefit must outweigh risk, patients want to live life fully and not just be alive! Also, I may be preaching to the choir, but research must include diverse populations because cancer does not discriminate!

I leave you with a quote from Margaret Mead, “Never doubt that a small group of thoughtful, committed citizens can change the world indeed, it is the only thing that ever has.”

Oncology Approval Recap

In January, the U.S. Food and Drug Administration granted two approvals to novel oncology drugs and one expanded indication:

  • Pembrolizumab was approved for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
  • Avapritinib was approved for adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including D842V mutations.
  • Tazemetostat was granted accelerated approval for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

Read more about these approvals 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.