Cancer Policy Monitor: July 14, 2020
- COVID-19 Legislation and Appropriations Update
- House Speaker Nancy Pelosi, Senator Roy Blunt and NCI Director Ned Sharpless Featured at AACR Virtual Annual Meeting II
- Special Session on “Racism and Racial Inequities in Cancer Research” During the AACR VAMII
- Regulatory Science and Policy at the AACR Virtual Annual Meeting II
- AACR FDA Advocate Listening Session on Cancer Clinical Trials During COVID-19
- AACR Honors Cancer Policy and Advocacy Leaders at the AACR Virtual Annual Meeting ll
- Underserved minorities are disproportionately impacted by the COVID-19 pandemic
- AACR to Hold COVID-19 and Cancer Conference in July
- NCI Study Reports Artificial Intelligence Dual-Stain Approach of Cervical Cancer Screening
- Carcinogens in the home increase cancer risk, but it is possible to reduce exposure
- NCSM NATIONAL CANCER SURVIVOR MONTH – Thank You!
- Register Today! Rally for Medical Research 2020 Virtual Hill Day
- Application Period Open for New FDA-AACR Oncology Educational Fellowship
- Oncology Approval Recap
COVID-19 Legislation and Appropriations Update
-Marc B. Johnson, MPP
Despite a recent uptick in diagnosed COVID-19 cases in several states after a period of some decline, many states are “reopening for business” in order to restart their economies and to return to some level of pre-COVID-19 normalcy. Still, the physical and financial health of this country continues to suffer in the wake of COVID-19, and the federal government is still struggling to come up with legislative remedies to mitigate the difficulties associated with the pandemic. Although the “Health and Economic Recovery Omnibus Emergency Solutions Act” (“HEROES Act”) passed in the House, the Senate is not in any rush to move on the legislation. Senate Majority Leader Mitch McConnell (R-KY) has expressed in the past that he wants to assess the impact of the other relief packages. It is not clear whether the Senate wants to move on the HEROES Act or develop their own version. If there is to be any movement in the Senate, it will be done after the July 4 recess, meaning the Senate will not act until at least July 20. At that point, the Senate would have three weeks to take action on legislation prior to the August recess, where the House and Senate will be out of session for the majority of August. It is unclear at this time how the Senate’s version of the HEROES Act would affect National Institutes of Health (NIH) funding. NIH would receive $4.7 billion to fund medical research efforts related to COVID-19 in the current version of the HEROES Act.
The House will begin to move on FY 2021 subcommittee appropriations bills on July 6. The Labor, Health and Human Services, and Education (Labor-HHS) Appropriations Subcommittee markup will occur on July 7. There has been no indication on when full committee consideration of the Labor-HHS appropriations will begin. As of right now, the Senate Labor-HHS Appropriations Subcommittee does not have a definitive date for their FY 2021 appropriations subcommittee markup. View House Committee Appropriations Chairwoman Nita Lowey’s (D-NY 17th) “Dear Colleague” letter detailing the subcommittee appropriations markup schedule.
On June 5, the AACR and the Association of American Cancer Institutes (AACI) held their annual Joint Hill Day. Due to COVID-19, this Hill Day was held virtually. Forty participants from 16 states held a total of 66 meetings with members of the House and Senate. Among the 40 participants were AACR’s President Antoni Ribas, MD, AACR’s Chief Executive Officer Margaret Foti, PhD, MD, and AACR’s President-Elect David A. Tuveson, MD, PhD., AACI’s President Roy A. Jensen, MD, AACI’s Executive Director Jennifer W. Pegher, MA, and AACI’s President-Elect Karen E. Knudsen, MBA, PhD. They held high level meetings with staff from House Speaker Nancy Pelosi’s (D-CA 12th) office, as well as staffers from the offices of House Minority Leader Kevin McCarthy (R-CA 23rd), House LHHS Appropriations Subcommittee Chairwoman Rosa DeLauro (D-CT 3rd), Senate Minority Leader Charles “Chuck” Schumer (D-NY), and Senate LHHS Appropriations Subcommittee Chairman Roy Blunt (R-MO). Both organizations continue to ask for robust funding for NIH. Specifically AACR/AACI asked for : (1) $10 billion for NIH in the next COVID-19 supplemental package; (2) Sustained funding for medical research for FY 2021 appropriations in the amount of $44.7 billion…an increase of $3 billion from FY 2020; and (3) $6.9 billion for the National Cancer Institute (NCI) in FY 2021…$500 million increase from FY 2020. This request is supported by the NCI’s Director’s Professional Judgement Budget.
On June 24, Congresswoman Diana DeGette (D-CO 1st), Congressman Fred Upton (R-MI 6th), and four other original co-sponsors introduced H.R. 7308, the Research Investment to Secure the Economy (RISE) Act. The bipartisan RISE Act would authorize billions in funding to U.S. researchers who have been impacted by the pandemic. Specifically, the bill would authorize $26 billion in emergency relief for federal science agencies (NIH being one of them) who would then award money to universities, institutions and laboratories in order for them to continue work on federally funded research projects. In a press release, Congresswoman DeGette stated that “…researchers are essential to our nation’s public health, national security, economic growth and international competitiveness. Preserving our scientific infrastructure and protecting our innovation pipeline will help ensure U.S. leadership in the world and help us better respond to future pandemics.” The genesis of the RISE Act began as an “ASK” by Congresswoman DeGette and Congressman Upton put forth in an April 29 Dear Colleague letter to House Speaker Nancy Pelosi and House Minority Leader Kevin McCarthy, which received wide bipartisan support. In the letter, they requested $26 billion to be included in the proposed “Phase 4” supplemental relief package to cover the costs associated with non-COVID-19 medical research.
House Speaker Nancy Pelosi, Senator Roy Blunt and NCI Director Ned Sharpless Featured at AACR Virtual Annual Meeting II
-Marc B. Johnson, MPP
The AACR held Part Two of its virtual annual meeting (“VAMII”) held from June 22 through June 24. The AACR was honored to have House Speaker Nancy Pelosi (D-CA 12th) and Senate Labor-HHS-Education Appropriations Subcommittee Chairman Roy Blunt (R-MO) provide remarks for the annual meeting’s opening ceremony. Speaker Pelosi started off by thanking “…the incredible researchers, doctors and advocates,” and acknowledging the “great work” of AACR President Antoni Ribas, MD, PhD, AACR Immediate Past President Elaine R. Mardis, PhD, and AACR Chief Executive Officer Margaret Foti, PhD, MD. In light of recent events, Speaker Pelosi touched on the topic of systemic racism and its effects on access to health care and cutting edge treatments for communities of color. Speaker Pelosi reaffirmed her support of medical research by stating that one of her proudest moments, while serving as a member of the House Appropriations Committee, was “helping to secure the doubling of the NIH budget to give researchers and scientists the tools to create modern medical miracles… .” Watch the entirety of Speaker Pelosi’s opening remarks. Chairman Blunt, in his opening remarks, immediately thanked the AACR for “…the life changing, and many times, life saving work…” that is done everyday in the fight against cancer. Senator Blunt, a renal and prostate cancer survivor, stated that in his five years as chairman of the Labor-HHS Appropriations Subcommittee, he has always made medical research a top priority and touted increased NIH funding under his leadership. Senator Blunt went on to acknowledge the role of medical researchers during the COVID-19 pandemic, advancements in cancer treatment such as immunotherapy, and spoke to the triumphs of pediatric cancer treatment. Watch the entirety of Senator Blunt’s opening remarks.
On the second day of the VAMII, the AACR was honored to have National Cancer Institute (NCI) Director Norman E. “Ned” Sharpless, MD, give the NCI Director’s Address. In his address titled, “Managing the Now, Focused on the Future,” Dr. Sharpless spoke of the impact that COVID-19 has had on society, citing the AACR having to change the annual conference to a virtual format as an example. He spoke about the disruptions that the pandemic has had on the cancer research community, and how the situation has become more complicated due to “profound upheaval in our nation.” Dr. Sharpless, in his nearly 25-minute address, discussed topics such as racial inequality in cancer research, NCI’s response to COVID-19, and sustaining and accelerating progress in cancer research. Regarding racial inequality in cancer research, Dr. Sharpless first acknowledged the death of George Floyd and the nationwide protests surrounding his death and the deaths of other African Americans at the hands of law enforcement. He stated that these events have “horrified the national conscience” and said “…as individuals these events have forced us to reckon with painful truths on many levels.” He also stated that the demonstrations highlighted racial inequality and how such inequality has trickled down into all aspects of our society, including the treatment of cancer. He emphasized that the cancer community has to commit itself to take appropriate actions in order to better society and promote change. He addressed other issues specifically related to racial inequality in cancer research, ranging from diversity in the workforce to funding disparities. Dr. Sharpless went on to speak about NCI’s “rapid, impressive, and nimble” response to the COVID-19 pandemic, emphasizing that NCI’s primary concern is the health and safety of cancer patients, health providers, and NCI grantees and staff. Dr. Sharpless explained numerous research activities that NCI is engaged in pertaining to COVID-19, which can be found at Cancer.Gov/Coronavirus-Researchers. Lastly, moving in a more positive direction, Dr. Sharpless spoke of advances in cancer research, including the recently FDA-approved medication selumetinib, used in the treatment of neurofibromatosis. He cited the development of this drug to illustrate the importance of investing in cancer research. Watch the entirety of Dr. Sharpless’ address.
Special Session on “Racism and Racial Inequities in Cancer Research” During the AACR VAMII
-Carmine S. Leggett, PhD
The recent tragic deaths of George Floyd, Breonna Taylor and Ahmaud Arbery, among others, have dramatically exposed the pervasive racism and social injustices towards Black Americans in our country and people of color around the world. This includes exposing significant racial discrimination and inequality in all areas of cancer research and treatment based on the color of their skin. In this special American Association for Cancer Research (AACR) session, the panel which represented academia, government, industry, and the patient advocacy community, talked openly about these problems and identified ways to achieve social justice and equality for all regardless of skin color, eliminate cancer health disparities among racial and ethnic minorities by increasing minority representation in clinical trials, and ensure diversity and recognition of the accomplishments of minority scientists and clinicians in the cancer workforce.
In his role as AACR President, Dr. Antoni Ribas, did a wonderful job moderating this panel of impressive leaders for an open and frank conversation about the pervasive racism and social injustices, including its occurrence in all areas of cancer research and treatment. The session was incredibly compelling and as one person remarked after the taping, “I was riveted to the conversation.” The link to the replay of the session that took place on Tuesday, June 23 at 12:45 p.m. (EDT)/9:45 a.m. (Pacific) is here:
Kenneth Frazier, CEO, Merck; Levi Garraway, CMO, Roche; AACR Board Member Marcia Cruz-Correa; and John Carpten, chair of the AACR’s Minorities in Cancer Research Council were among the nine panelists who participated. There were some strong emotions and passionate views expressed, which provided the audience with some important perspectives on the current situation. Their perspectives underscored the urgency of a collective commitment to working for positive change, and the panel members’ optimism about the future and their excellent suggestions and ideas provide us with a road map to move things forward. The AACR will continue the momentum from this special session, as the AACR will be sponsoring a virtual congressional briefing Wednesday, September 16, to formally release the “AACR Cancer Disparities Progress Report 2020: Achieving the Bold Vision of Health Equity for Racial and Ethnic Minorities and other Underserved Populations.”
Regulatory Science and Policy at the AACR Virtual Annual Meeting II
The AACR Virtual Annual Meeting II took place from June 22-24. Included among the meeting’s 125 sessions were five sessions devoted to regulatory science and policy issues. These sessions brought together experts from the FDA, academia, industry, and advocacy to cover a wide range of topics.
In Under-representation in Clinical Trials and the Implications for Drug Development, session participants expanded on discussions begun at the FDA-AACR Workshop to Examine Under-representation of African Americans in Multiple Myeloma Clinical Trials in February. Key themes that emerged from the session include the importance of curating clinical trial populations reflective of the demographics of those populations that will use the therapies in the real-world setting; designing enrollment and accrual plans to achieve that real-world representation; and strategies for engaging communities with low rates of clinical trial enrollment.
For COVID-19 and Cancer: Guidance for Clinical Trial Conduct and Considerations for RWE, FDA experts discussed strategies for adapting ongoing and new clinical trials in the midst of the COVID-19 pandemic as well as the potential for real-world evidence to help answer questions about cancer, COVID-19, and diagnostic tests. Representatives from Syapse and COTA Healthcare outlined practical challenges and opportunities in operationalizing real-world evidence to answer questions about cancer therapies or COVID-19.
Engaging the Oncology Community to Advance Regulatory Science: FDA’s Project Renewal and Project Socrates provided updates on these two FDA Oncology Center of Excellence (OCE) efforts, on which the AACR is collaborating. Project Renewal is an effort to update labels of generic cancer drugs with new indications or safety information. Project Socrates is an umbrella program for educational activities by the OCE. One of these, the newly announced FDA-AACR Oncology Educational Fellowship, will provide selected early career scientists with opportunities to learn about oncology drug development and regulatory concepts.
During Tumor Response Evaluation Criteria for Intratumoral Therapy, experts from academia and industry discussed existing response criteria for evaluating tumor responses to therapeutics and suggested a new approach for evaluating response to intratumoral therapies. Tumors treated with these therapies may progress (i.e., get bigger) before they shrink, and additional considerations make these therapies more difficult to evaluate under existing criteria. To facilitate the continued development of intratumoral therapies, it will be important to validate response evaluation criteria designed to measure their effects.
Hot Topics in Oncology Regulation featured several short presentations on topics of interest to the oncology drug development community. Speakers discussed current FDA thinking on tissue agnostic therapies, conducting clinical trials during the COVID-19 pandemic, neoantigen therapies, and the rationale and benefits of using patient-reported outcomes.
In addition to the Regulatory Science and Policy Track, FDA OCE Director, Richard Pazdur, MD, provided remarks during the meeting’s opening ceremony. He highlighted the center’s recent activities on drug approvals, Project Orbis, and announced the aforementioned FDA-AACR Oncology Educational Fellowship.
All of this content, and the entire meeting, is freely available for viewing on the Virtual Annual Meeting II webpage.
AACR FDA Advocate Listening Session on Cancer Clinical Trials During COVID-19
The American Association for Cancer Research (AACR) and the U.S. Food and Drug Administration (FDA) recorded a listening session on May 27, 2020, for patient advocates to learn more about cancer clinical trials during COVID-19 and the recently issued COVID-19 Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders.
The session was co-moderated by Marc R. Theoret, MD, deputy director (acting) of the FDA’s Office of Oncologic Diseases, with opening remarks from Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, and introductions by AACR’s Chief Policy Officer and Vice President of Science Policy and Government Affairs, Jon Retzlaff.
AACR’s patient advocacy community was surveyed for questions, which were then curated and posed by Scientist <-> Survivor patient advocates Roberta Albany (breast cancer survivor), Howard Brown (PALTOWN.org), Melinda Bacchini (Cholangiocarcinoma Foundation), and Vickie Buenger (Coalition Against Childhood Cancer). The session addressed protocol deviations, suspended trials, FDA’s Reauthorization Act (FDARA) and the RACE Act, disparities in enrollment, telehealth, and much more in terms of the short term and long term impact of COVID-19 on cancer clinical trials.
AACR Honors Cancer Policy and Advocacy Leaders at the AACR Virtual Annual Meeting II
The AACR presented Distinguished Public Service Awards to four people whose extraordinary work has exemplified the AACR’s mission to prevent and cure all cancers through research, education, communication, collaboration, science policy, advocacy, and funding for cancer research.
Roy S. Herbst, MD, PhD; Douglas R. Lowy, MD, FAACR; Yoshiyuki Majima, PhD, MPH; and Patricia Spears, BS, received awards recognizing their groundbreaking, innovative work in the cancer research community that reflected a wide range of contributions. This year’s award recipients were honored for their meritorious work in clinical research, scientific leadership, and cancer policy and advocacy, respectively.
Learn more about the 2020 Distinguished Public Service Awardees.
The AACR also recognized the founding members and the current project team associated with The Cancer Genome Atlas (TCGA) with 2020 AACR Team Science Awards.
The Cancer Genome Atlas Project began in 2006 as a joint effort between the National Cancer Institute (NCI) and the National Human Genome Research Institute, bringing together researchers from diverse disciplines and multiple institutions to create a detailed catalog of genomic changes associated with specific types of cancer. TCGA has since opened new avenues of research to improve the prevention, diagnosis, and treatment of numerous cancers. The TCGA founders and current project team members are being recognized for their extensive collaborations and ongoing efforts to generate one of the largest-ever sets of tumor characterization data.
The AACR honored the seminal contributions of Anna D. Barker, PhD, and Francis S. Collins, MD, PhD, who were directly responsible for the project’s inception and establishment.
Also recognized with this award were past NCI Directors Andrew C. von Eschenbach, MD, and John E. Niederhuber, MD, whose leadership throughout the years of the TCGA pilot project were vital to the financial stability of the project and its continued success. Eric S. Lander, PhD, and Leland H. Hartwell, PhD, were recognized for their efforts associated with the establishment of the initial TCGA pilot project, specifically their contributions as cochairs of the National Cancer Advisory Board’s Working Group on Biomedical Technology.
Also recognized with this prestigious award were 34 other individuals who contributed to the success of TCGA, including those who were, and some of whom continue to be, involved with various facets of the TCGA network including the TCGA Project Management Team, TCGA Advisory Committee, Cancer Genome Characterization Centers, Genome Sequencing Centers, Biospecimen Core Resource Center, and the Data Coordinating Center.
Learn more about the 2020 Team Science Awards.
Underserved Minorities are Disproportionately Impacted by the COVID-19 Pandemic
-Nicholas Warren, PhD
The COVID-19 pandemic has disproportionately impacted racial and ethnic minorities in the United States and United Kingdom. Of the confirmed COVID cases with racial and ethnicity data reported to the Centers for Disease Control and Prevention by May 30, 33 percent were Hispanic, 22 percent were African Americans, and 1.7 percent were Native Americans. This is despite only 18 percent of the U.S. population identifying as Hispanic, 13 percent as African American, and 0.7 percent as Native American. In the U.K., even after controlling for age, education, and income, Black residents are 1.9 times more likely to die from COVID than White residents. During the AACR’s Virtual Annual Meeting II, the AACR’s Minorities in Cancer Research Council hosted a session titled “Health Inequities and Disparities in the COVID-19 Pandemic and Impact on Cancer Care Among Racial and Ethnic Minorities and the Medically Underserved” to discuss the impact on these vulnerable populations. The session was chaired by Robert A. Winn, MD, director of the Virginia Commonwealth University Massey Cancer Center.
Health disparities among racial and ethnic minorities are not new concepts. Two speakers, Lisa Newman, MD, MPH, a surgical oncologist at New York-Presbyterian Hospital, and Francis Chinegwundoh, MBE, MD, consultant urological surgeon in the U.K. National Health Service, detailed that many comorbidities conferring higher risk for severe COVID-19 symptoms have disproportionately affected minorities for decades, including: diabetes; hypertension; asthma; obesity, and; cardiovascular disease. The root causes of these disparities are related to social determinants of health, like: lack of health coverage and poor access to care in the U.S.; unequal access to education; food deserts; higher unemployment and economic inequality; systemic racism in housing, and; police brutality. Dense housing, public transportation, and essential work also disproportionately increase risk of infection. Dr. Newman called for statistically powered representation of minorities in COVID-19 clinical trials and more support for hospitals that focus on underserved minorities. Dr. Chinegwundoh said the key to addressing disparities with both COVID-19 and cancer is to improve the comorbidities facing disadvantaged minorities.
Culturally relevant and understandable science communication is critical to supporting underserved minorities during the pandemic. Amelie Ramirez, DrPH, MPH, is the Director of Cancer Prevention and Health Disparities at the Cancer Center at UT Health Science Center and Director of Salud America!, a public health communication organization focused on the Hispanic and Latino community. In response to the COVID-19 pandemic, Salud America! Quickly developed Spanish language communications to help educate over 400,000 Hispanic people about risks associated with the virus and how to protect themselves. Dr. Ramirez recommended several policies to help improve COVID-19 disparities, such as: increasing SNAP benefits; providing paid sick leave and alternative housing for isolation; expanding health coverage, and; ensuring equal access to testing, treatments, and vaccines.
The AACR is committed to eliminating health disparities affecting underserved minorities and will continue to advocate for policies to address this important issue.
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 and the AACR Virtual Annual Meeting II in June, scientists from across the world shared data on the effects of COVID-19 on patients with cancer. The AACR will continue highlighting COVID-19 and cancer research later this month 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 featuring both invited presentations and proffered abstracts will cover topics including cancer drug repurposing to treat COVID-19; COVID-19 diagnostics development, vaccine development, and epidemiology; and the intersection of cancer and SARS-CoV-2 biology.
Headlining the conference as keynote speakers:
- Anthony Fauci, National Institute of Allergy and Infectious Diseases, Rockville, Maryland;
- Solange Peters, CHU Vaudois, Lausanne, Switzerland; and
- Trevor Bedford, Fred Hutchinson Cancer Research Center, Seattle, Washington.
The conference will also feature forum sessions to discuss various aspects of responding and adapting to the pandemic. In these forums, leaders from the FDA, NCI, academia, industry, and patient advocacy will consider regulatory implications of pandemic-necessitated changes to the conduct of clinical trials, the current and future role of telehealth, bringing patients back to the clinic, cancer researchers’ efforts to tackle COVID-19 issues, and addressing health disparities in COVID-19 and cancer.
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.
NCI Study Reports Artificial Intelligence Dual-stain Approach of Cervical Cancer Screening
-Carmine Leggett, PhD
The National Cancer Institute (NCI) leads the National Cancer Program and National Institutes of Health’s (NIH) efforts to dramatically reduce the prevalence of cancer and improve the lives of cancer patients and their families, through research into prevention and cancer biology, the development of new interventions, and the training and mentoring of new researchers. The NCI recently reported a new study that uses artificial intelligence (AI) to automate dual-stain evaluation and has clear implications for clinical care. Findings from the study show the algorithm developed by investigators at the NCI improved the accuracy and efficiency of cervical cancer screening compared with cytology (Pap test), the current standard for follow-up of women who test positive with primary human papillomavirus (HPV) screening. According to the investigators, dual-stain testing is more accurate in predicting the chance that a woman with a positive HPV test has precancerous cervical changes. The test measures the presence of two proteins, p16 and Ki-67, in cervical samples. The researchers found that the AI-based dual-stain test had a lower rate of positive tests than both Pap cytology and manual dual-stain, with better sensitivity and substantially higher specificity than Pap cytology. AI-based dual-stain reduced referral to colposcopy by about a third compared with Pap (approximately 42 percent vs. 60 percent). The testing method was also robust, showing comparable performance in anal cytology. Read more about this important study.
Carcinogens in the Home Increase Cancer Risk, but it is Possible to Reduce Exposure
-Nicholas Warren, PhD
Exposure to carcinogens from the environment or in your home can greatly increase your risk of a cancer diagnosis. A 2016 report by the World Health Organization (WHO) found that environmental factors were responsible for 20 percent of all cancer-related deaths. Carcinogens are also ubiquitous in consumer products, like: food packaging; cookware; furniture; clothing; pesticides, and; building materials. Additionally, manufacturing processes and agricultural pesticide use release billions of pounds of carcinogens into the air and drinking water every year, which disproportionately affects minority communities. The AACR’s Virtual Annual Meeting II educational session titled “Carcinogens at Home: Science and Pathways to Prevention,” chaired by Polly Hoppin, ScD, program director of the Environmental Health Initiative at the University of Massachusetts brought together leaders from academia, government agencies, and industry to discuss this important issue.
Evidence of risk and benefits of chemicals must be carefully analyzed in order to determine whether regulation is needed to improve public health. During the session, Kathryn Guyton, PhD, acting head of the WHO’s International Agency for Research on Cancer (IARC) Monographs Group, detailed how IARC coordinates independent scientists to review specific chemicals and classify their carcinogenicity. IARC working groups assesses human, animal, and mechanistic data and publish their findings in Monographs. Thus far, the IARC has classified 120 chemicals in Group 1 (carcinogenic to humans); 83 in Group 2A (probably carcinogenic); 314 in Group 2B (possibly carcinogenic), and; 500 in Group 3 (not classifiable). The limiting factors for the IARC to produce more Monographs are a lack of scientific data on new chemicals and availability of volunteer scientific experts. If you are interested in supporting this important work, you can nominate yourself or a colleague during an IARC call for experts.
Residential and agricultural pesticides are also significant sources of carcinogen exposure. Mary Ward, PhD, senior investigator at the National Cancer Institute, reported that 80-90 percent of U.S. households use pesticides in their homes and 14 percent of households are at risk from agricultural pesticides. Young children are most affected by home pesticide exposure, because they have higher respiration rates and pesticides fall to the floor where they breathe and put things in their mouths. Dr. Ward provided resources to reduce exposure to harmful pesticides through the Environmental Working Group, and Environmental Protection Agency.
The Silent Spring Institute has studied the impacts of environmental carcinogens and educated consumers since 1994. Julia Brody, PhD, executive director at the Silent Spring Institute shared their ongoing initiatives, including a crowd sourced study on carcinogen exposure in the home, that has recruited 800 participants. The study is still open to participation. Dr. Brody’s top recommendations to reduce your carcinogen exposure are to: test your home for radon; do not store gasoline in the home or attached garage; avoid furniture with added flame retardants, and; download the Detox Me smartphone app.
Building materials are also a significant source of carcinogen exposure in homes and workplaces. Bill Walsh, JD, founder of the Healthy Building Network, discussed how his organization helps architects and construction companies build with less toxic materials. Mr. Walsh collaborated with the American Cancer Society to design hotels near cancer centers for patients actively being treated. They found minimally toxic materials did not sacrifice building design nor strain the budget. The Pharos Project is now available to help all companies choose less toxic building materials. Mr. Walsh also described other industry-led initiatives that eliminated formaldehyde from particle board and home insulation in the U.S., as well as Home Depot’s efforts in 2017 to remove 30 toxic chemicals from all products they sell.
There were numerous recommendations for individuals to reduce their exposure to carcinogens throughout the session. However, the speakers emphasized that systemic policy changes are needed for the greatest impact on public health and to make safe products and materials the default versus the exception.
National Cancer Survivor Month – Thank You!
Thank you to everyone who joined the American Association for Cancer Research (AACR) to support the National Cancer Survivor Month 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.
Throughout the month cancer survivors and patient advocates shared their stories, taught us more about cancer survivorship, sent letters to Congress advocating for lifesaving cancer research, attended survivorship sessions at the AACR Virtual Annual Meeting II, raised funds for cancer research, and honored patients with cancer. The hope is that increasing awareness and support of survivorship will promote research and policies that control, treat, and prevent the late and long-term effects of cancer and cancer treatments.
Special thanks to SSP advocates Howard Brown, Christine Hodgdon, Sheila McGlown, Kimberly Richardson, and Congresswoman Deborah Wasserman Schultz (FL-23) for sharing your inspirational stories of cancer survivorship.Take Action: Contact a Member of Congress
Register Today! Rally for Medical Research 2020 Virtual Hill Day
Registration is now open for the eighth annual Rally for Medical Research, which will be held September 16-17, 2020, as an entirely virtual event. The health and safety of all Rally participants is the top priority in organizing this event, and due to the COVID-19 pandemic, we are unable to gather in person on Capitol Hill this year. However, it is as important as ever that we all join together in urging Congress to prioritize medical research funding.
Therefore, this year’s Rally events will all be held virtually. 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 is being planned for the evening of Wednesday, September 16, while the virtual Hill Day meetings on September 17 will be held with congressional offices via phone and webinar. We will hold a training session for all participants the week prior to the Hill Day. As in previous years, there will also be an online Rally National Day of Action. Stay tuned to the Rally website for more information as it become available. We look forward to your (virtual) participation in September!
Application Period Open for New FDA-AACR Oncology Educational Fellowship
During his remarks at the AACR Virtual Annual Meeting II Opening Ceremony, Richard Pazdur, MD, director of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE), announced that the AACR and OCE have partnered on a new initiative to provide early-career cancer researchers and fellows with a unique opportunity to learn more about oncology drug development and the regulatory review process. The FDA-AACR Oncology Educational Fellowship offers targeted educational activities and interactions with experts from the AACR and the OCE. Applications are being accepted until August 15, 2020.
Eligible candidates must have an advanced degree (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. It is anticipated that 10-15 fellows will be selected.
Fellows will participate—remotely, for now—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 virtual sessions will be a mix of didactic content presented by FDA OCE experts and group discussions. There will be additional activities for fellows related to the 2021 AACR Annual Meeting and the 2021 Accelerating Anticancer Agent Development and Validation Workshop.
Oncology Approval Recap
Between May 29 and June 26, the U.S. Food and Drug Administration approved seven new and expanded indications for oncology drugs:
- Atezolizumab was approved in combination with bevacizumab for patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
- Ramucirumab was approved in combination with erlotinib for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
- Nivolumab was approved for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
- Lurbinectedin was granted accelerated approval for adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
- Gemtuzunab ozogamicin’s indication for newly-diagnosed CD33-positive acute myeloid leukemia (AML) was extended to include pediatric patients 1 month and older.
- Pembrolizumab was granted accelerated approval for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
- Tazemetostat, an EZH2 inhibitor, was granted accelerated approval for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies, and for adult patients with R/R FL who have no satisfactory alternative treatment options.
- Selinexor was granted accelerated approval for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.
- Pembrolizumab was approved or patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by 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.