Cancer Policy Monitor: December 8, 2020
- AACR President Discusses Positive Effects of Biden-Harris Administration for Cancer Research
- Appropriations Update from Capitol Hill
- 2020 Election Recap
- Californian Voters Approve $5.5 Billion for Medical Research
- Vaping, Tobacco, and Nicotine Issues on 2020 Election State-Level Ballots Across the United States
- Apply for The AACR Annual Meeting 2021 Scientist↔Survivor Program®
- FDA and AACR Unveil New Educational Series on Drug Labels
- The NCI Cancer Moonshot Seminar Series Features Engagement of American Indians in Cancer Genome Sequencing
- Addressing Adverse Consequences of Cancer Treatment
- 2020 Regulatory Recap: A Year-in-Review of FDA’s Progress Against Cancer
- Oncology Approval Recap
AACR President Discusses Positive Effects of Biden-Harris Administration for Cancer Research
In an op-ed article published in The Cancer Letter, AACR President Antoni Ribas discusses the election of Joe Biden and Kamala Harris, as it provides an excellent opportunity for cancer research to dramatically improve the health of our nation and the world. Read article.
Appropriations Update from Capitol Hill
-Marc Johnson, MPP
As the American public focused primarily on the presidential and congressional elections, diagnosed cases and deaths due to COVID-19 continued to rise at an alarming rate. Although there have been some discussions of an agreement, negotiations between House Democrats and Senate Republicans regarding a COVID-19 relief package still appear to be at a standstill, and a post-election White House seems to be disengaged from the process.
On November 19, Senate Minority Leader Chuck Schumer (D-NY) intimated that negotiations on another COVID-19 relief package are underway with Senate Majority Leader Mitch McConnell (R-KY): “They’ve agreed to sit down, and the staffs are going to sit down today or tomorrow to try to begin to see if we can get a real good COVID relief bill. So there’s been a little bit of a breakthrough in that McConnell’s folks are finally sitting down and talking to us.” Republican aides dispute Schumer’s statement. Despite passage of an updated $2.2. trillion HEROES Act in the House in early October, Senate Republicans still take issue with the price tag of any COVID relief legislation put forth by House Democrats. The White House, whose earlier negotiations with House Democrats were promising, appears to be in a state of inertia since the result of the presidential election. It is likely that there will not be another relief package before the end of the year.
Negotiations regarding Fiscal Year 2021 (FY 2021) appropriations appear to be more promising, as leaders from both parties and both houses of Congress hope to reach an agreement on funding totals for a substantial spending package which would avert a government shutdown before the December 11 deadline, when the current continuing resolution expires. The Senate Appropriations Committee released their FY 21 funding measures, on November 10, in an “…effort to advance [the] process…” and “…produce bipartisan results.”
In the Labor-HHS-Education (LHHS) bill, funding for the National Institutes of Health (NIH) was set at $43.68 billion, a $2 billion increase from FY 2020, and a total increase of $13.6 billion over the past six years. Out of the $43.68 billion, $6.72 billion would be allocated to the National Cancer Institute (NCI), a $282 million increase from FY 2020 funding levels. Within the NCI funding for FY 2021: $300 million will be provided “…to prioritize competing grants and to sustain commitments to continuing grants” regarding cancer research. Fifty million dollars will be provided for the second year of the Childhood Cancer Data Initiative, “…which will facilitate a connected data infrastructure and integrate multiple data sources to make data work better for patients, clinicians, and researchers.” Lastly, $30 million will be provided for the implementation of the STAR Act, which will be used in part to “…expand existing biorepositories for childhood cancer patients enrolled in NCI-sponsored clinical trials to collect and maintain relevant clinical, biological, and demographic information on all children, adolescents, and young adults with cancer.” If an agreement on FY 2021 appropriations cannot be reached by December 11, Congress will need to pass another continuing resolution to avoid a government shutdown.
2020 elections recap
-Brandon Leonard, MA
Former Vice President Joe Biden is the president-elect of the United States, and Senator Kamala Harris is vice president-elect, following their victory in the November general election. A record number of Americans cast ballots for president, and the voter turnout rate of over 65% was the highest in over a century. Biden and Harris will be inaugurated on January 20, 2020, and they will immediately face a plethora of critical priorities, including management of the worsening coronavirus epidemic.
The AACR looks forward to working with the new administration toward our mission of preventing and curing cancer. In a press release issued on November 13, the AACR congratulated Biden and Harris on their victory and highlighted Biden’s leadership of the Cancer Moonshot and his remarks at the 2016 and 2017 AACR Annual Meetings.
Following the election, Republicans hold 50 seats in the Senate for the session beginning January 3, and Democrats (including independents who caucus with them) hold 48. In notable races with a change of party, former astronaut Mark Kelly defeated incumbent Senator Martha McSally in an Arizona special election to complete the term of deceased Senator John McCain, flipping that seat to Democrats. Former Colorado governor John Hickenlooper also defeated incumbent Republican Senator Cory Gardner in Colorado. In Alabama, former college football coach Tommy Tuberville defeated incumbent Senator Doug Jones to return that seat to Republicans.
Control of the Senate will depend on two runoff elections in Georgia to be held January 5. One of those races is between incumbent Republican Senator David Perdue and investigative journalist Jon Ossoff. The second is a special election between incumbent Senator Kelly Loeffler, also a Republican, and Rev. Raphael Warnock, senior pastor at Ebenezer Baptist Church in Atlanta. If the Democratic candidates win both seats, the Senate will be evenly split, and Kamala Harris would cast tie-breaking votes as vice president. If Republicans win one or both of those races, they will retain control of the Senate.
In the House, Democrats will maintain control but with a slimmer majority after losing several seats. Democrats had hoped to expand their majority after making significant gains and winning the House in 2018, but Republicans instead won many of those seats back. With both chambers being tightly divided, bipartisan compromise will be essential to enact new legislation in the next Congress.
Californian Voters Approve $5.5 Billion for Medical Research
-Nicholas Warren, PhD
While the federal government funds the majority of research in the United States, there is an emerging role for states to help supplement research efforts. In 2004, nearly 60 percent of California voters passed Proposition 71, which included $3 billion in funding to establish the California Institute for Regenerative Medicine (CIRM) and support medical research focused on unmet clinical needs. However, the funds from Proposition 71 were nearly depleted, down to about $30 million. This November, Californians again voted to support medical research and CIRM by narrowly passing Proposition 14, which includes an additional $5.5 billion in funding.
CIRM’s external competitive grant program has sponsored over $2.6 billion in translational research and clinical trials for many different diseases. Since 2007, CIRM has sponsored 92 external grants for cancer research totaling over $370 million. Of the 92 cancer-related initiatives, 21 were clinical trials for promising therapies that were unlikely to find alternative funding. So far, two novel anti-cancer therapies studied in CIRM-sponsored trials have been approved by the U.S. Food and Drug Administration (FDA), including: glasdegib, used in combination with cytarabine to treat myelogenous leukemia, and; fedratinib, approved to treat myelofibrosis and polycythemia vera. Additionally, magrolimab, was recently granted a Breakthrough Therapy designation from the FDA, which will significantly aide further development. Magrolimab is currently in a phase III trial to investigate its use to treat myelodysplastic syndrome and acute myeloid leukemia in combination with azacytidine. The progress made by CIRM-sponsored therapies to treat rare cancers brings hope to patients without effective options.
In addition to providing treatment options for patients, research sponsored by CIRM has also resulted in significant economic benefits. A 2019 economic impact analysis by Dan Wei, PhD, and Adam Rose, PhD, from the University of Southern California found the original $3 billion investment from Proposition 71 generated $15.4 billion in economic activity, $10.7 billion of which was in California. Furthermore, this investment created over 80,000 high-quality jobs, including 56,000 new jobs in California. This economic activity generated an additional $641 million in California state tax revenue and $726 million in federal tax revenue. The success of CIRM highlights the vital role investment in research plays in driving local and national economies. By passing Proposition 14, Californians have ensured that CIRM can continue to support development of critical new therapies.
The American Association for Cancer Research (AACR) advocates for robust, sustainable, and predictable increases to research funding. To advocate for Proposition 14, AACR President Antoni Ribas, MD, PhD, sent an email to all AACR members living in California ahead of the vote asking for members to support the initiative. The AACR will continue to advocate for research funding at all levels of government.
Vaping, Tobacco, and Nicotine Issues on 2020 Election State-Level Ballots Across the United States
-Carmine Leggett, PhD
During the November 2020 election, there were nine states with election ballot measures related to health care, with two measures raising taxes on tobacco to fund health care programs. Several of the down-ballot issues dramatically impacted the tobacco and vaping industries. The local ballot measures to change the state-to-state makeup of vaping and nicotine regulation included measures that would increase taxes on tobacco and nicotine products, including e-cigarettes. These revenues would support state health and education programs used to help limit teenage vaping and fund needed programs. Opponents of these measures assert that there will be a financial impact on low-income tobacco users and argue that e-cigarettes should not be taxed the same because some people use them as cessation aids. Below are a few of the major state’s ballot measures including results:
Oregon Measure 108 (passed)
Oregon’s ballot measure 108 sought to increase the state’s tobacco tax levy further to fund health management policy and prevention education. This measure supports increased taxes on tobacco products and “inhalant delivery systems” to cover e-cigarettes in the state law to fund the state’s various public assistance and safety-net programs for medical and healthcare-related matters. Measure 108 will increase taxes on tobacco products’ distributors and other nicotine delivery products like e-cigarettes. The cigarette tax will increase from $1.33 to $3.33 per 20-pack of cigarettes under the measure. Nicotine inhalant systems and electronic cigarettes will be charged at a 65 percent rate for these products’ wholesale sales price. The cigar tax cap will be set at the wholesale sales price of 65 percent and will not exceed $1.00 per cigar. That’s an increase from 50 cents.
Oklahoma State Question 814 (did not pass)
State Question 814 would decrease the total amount of funds paid from the state’s tobacco settlement endowment trust fund to the Medicaid and health safety-net programs. This ballot measure focuses on whether the Oklahoma state government should continue taking money from the Master Settlement. Question 814 supports decreasing the percentage of the money, from 75 percent to 25 percent, that is deposited in the state’s tobacco settlement endowment trust fund. The ballot question also permits the state to shift these funds to receive federal matching grants to fund the Oklahoma Medicaid program.
Apply for the AACR Annual Meeting 2021 scientist↔Survivor Program®
The AACR is accepting applications for cancer survivors and patient advocates to enroll in the 2021 AACR Annual Meeting Scientist↔Survivor Program®. This unique educational program provides an opportunity to discuss the latest findings in cancer research, regulatory science, and health science policy. Please note that the 2021 program will be virtual. Learn More:
FDA and AACR Unveil New Educational Series on Drug Labels
In November, the American Association for Cancer Research, in collaboration with the U.S. Food and Drug Administration released the first episode of Project Livin’ Label, a new educational initiative that aims to foster broad understanding of specific oncology product labels and increase awareness of recent oncology drug FDA approvals among physicians, cancer patients and survivors, industry representatives, and others.
For each oncology product to be featured as part of this initiative, the FDA’s Oncology Center of Excellence (OCE) will moderate a panel discussion to include the FDA reviewer(s), a clinical trial investigator from academia, a patient who has benefitted from the therapy, and a representative from the company that developed the drug. This interaction about the product’s development and FDA’s review process will provide essential information for the safe and effective use of the product.
Tune into the first episode, moderated by Richard Pazdur, MD, director, FDA’s OCE, which discusses the story behind the April 17, 2020, approval of tucatinib. The OCE will select the oncology products featured in future episodes based on certain attributes that illustrate key issues in the development and review of each oncology product.
Learn more about Project Livin’ Label.
The NCI Cancer Moonshot Seminar Series Features Engagement of American Indians in Cancer Genome Sequencing
-Carrie Treadwell, MBA
The seminar series showcases research from different National Cancer Institute’s Cancer Moonshot initiatives that support the 10 recommendations of the Blue Ribbon Panel report. The recent seminar Engagement of American Indians of Southwestern Tribal Nations in Cancer Genome Sequencing, featured research that falls under the Participant Engagement and Cancer Genome Sequencing Network initiative. The study is being led by Cheryl Willman, MD, from the University of New Mexico Comprehensive Cancer Center and Jeffrey Trent, PhD, FACMG, from the Translational Genomics Research Institute (TGen) and addresses the recommendation to establish a network for direct patient engagement.
NCI’s Leah Mechanic elaborated that the purpose of the initiative is to promote and support direct engagement of cancer patients and post-tx cancer survivors as participants in cancer research for rigorous cancer genome sequencing programs addressing knowledge gaps in the genomic characterizations of rare cancers, highly lethal cancers, cancers with high disparities in incidence and/or mortality, cancers in understudies population, and cancers with early age of onset. Mechanic shared that the race distribution of participants in The Cancer Genome Atlas (TCGA) is 0.2% American Indian of Alaskan Native and 0.1% Native Hawaiian or Other Pacific Islander.
Moderated by AACR Minorities in Cancer Research Council Chair John D. Carpten, the seminar provided an overview of the American Indian Nations which are highly diverse in genetic ancestry, culture, language, and beliefs. The cancer health disparities data revealed that American Indians and Alaskan Natives are diagnosed at later stages of disease and have the poorest outcomes for all cancers combined and for the most common cancers compared to all other US racial ethnic groups. There are a number of contextual factors that contribute to these cancer disparities including lower rate of cancer screening, environmental exposures, access to care, among others. The Moonshot project aims to study 1,000 American Indian patients and survivors with disparities cancers over a five-year period and a matched cohort of 1,000 Hispanic patients with cancer.
Importantly, the study will build on the PIs history of deep engagement with southwest tribal nations in research which helped establish clear guidelines for this partnership. The guidelines establish that the tribal council approves the IRB and all processes. There will be joint monitoring of biospecimen collection and use, and participants may consent to not store residual biospecimens and request to re-consent for any future use. Data will be held until tribal review is completed for development of interpretative data narratives and publication. And, future use of data and any ancestry studies requires Tribal Review. It was also noted, that individual participants who consent to the study, will receive their own data through reports and genetic counseling. Oversight of these guidelines, and others, will be supported by the project’s Participant Engagement Unit based out of the University of New Mexico.
Addressing Adverse Consequences of Cancer Treatment
-Nicholas Warren, PhD
Progress on cancer screening and treatment has greatly improved the chances that patients will survive long-term following a cancer diagnosis. This success has led to a record 16.9 million cancer survivors living in the United States. However, there is a growing need to address the long-term side effects from toxic cancer treatments. These challenges are particularly prominent with survivors of pediatric cancer. While over 80 percent of pediatric patients in the United States with cancer survive long-term, more than 95 percent of survivors experience at least one severe or disabling chronic condition by the age of 50 years; survivors of pediatric cancer also have a significantly higher risk of being diagnosed with a second cancer than the general population. This November, the National Cancer Policy Forum organized a workshop titled, “Addressing the Adverse Consequences of Cancer Treatment,” which brought experts together to discuss how to improve the quality of life for cancer survivors.
Managing adverse events from cancer treatment not only improves quality of life, but also improves survival. A common theme from the workshop was oncologists need to “treat the whole patient.” Numerous speakers asserted that symptoms patients experience should be treated just as aggressively as the cancer. For example, Javid Moleshi, MD, from Vanderbilt University, and Kevin Oeffinger, MD, from Duke University discussed how many patients with cancer also have risk factors for heart disease. Many patients with cancer who have effective treatment options are more likely to die from a heart attack than cancer. Dr. Moleshi developed a heart disease prevention guide for oncologists treating patients with cancer, which was ultimately adopted by the National Comprehensive Cancer Network in their official clinical guidelines. Key hurdles to treating the whole patient are a lack of coordination of care between specialists and failure to ask patients about their non-cancer related health. Many workshop speakers suggested payment reform to incentivize coordinated care and making it easier to share electronic health records could help address these issues.
Another common theme of the workshop was the increased burden and worse outcomes from cancer treatment that underserved racial and ethnic minorities experience. Mary Scroggins, a patient advocate from the International Gynecological Cancer Society, and a member of the American Association for Cancer Research’s (AACR) Scientist↔Survivor Program, discussed the concept of health equity vs health equality: health equality means giving every patient the same care, while health equity means giving all patients the care they need to be healthy. Health equity entails: treating co-morbidities; meeting the nutritional needs of patients; addressing pollution in their communities, and; providing health information in easily digestible and culturally sensitive language. Many underserved minorities also face greater challenges to receiving cancer treatment and participating in clinical trials. Workshop participants suggested health disparities could be improved by: researchers and clinicians developing meaningful relationships with respected community organizations; increasing diversity of the health care and research workforce; including measures of health disparities in quality metrics for payment; paying patient navigators to help patients find resources, and; expanding health insurance coverage and sick leave.
The AACR is committed to curing all forms of cancer through research, education, and policy. This mission includes eliminating health disparities. The AACR is proud to sponsor forums like this one that bring experts and patient advocates together to discuss important issues affecting cancer survivors.
2020 Regulatory Recap: A Year-in-Review of FDA’s Progress Against Cancer
-Tod Guidry, PhD
Over the course of the calendar year, the U.S. Food and Drug Administration (FDA) granted approvals to over a dozen novel cancer therapies and three dozen new or expanded indications for cancer drugs. A large portion of these were granted accelerated approval, a designation reserved for treatments intended for serious or life-threatening diseases and that provide a significant benefit compared to existing therapies. In addition to ushering cancer therapies to market, the agency has continued its efforts to increase the availability of cancer drugs to certain populations and improve the efficiency of the drug review process, particularly in response to COVID-19.
The FDA recognized early the impact of the COVID-19 public health emergency on the cancer community. In March, the FDA Oncology Center of Excellence (OCE) outlined their priorities in responding to the impact of COVID-19 on cancer patients, including expediting oncology drug development while teleworking full time and mitigating anticipated cancer drug shortages. The OCE has also established collaborations with data and analytics experts to investigate clinical outcomes of cancer patients with COVID-19. In response to the challenges (e.g., trial site closures, travel restrictions) the pandemic has posed to the conduct of clinical trials, the FDA issued a guidance detailing flexibilities clinical investigators may take to maintain progress. Flexibilities include: virtual assessment of safety and outcomes in participants; home delivery and self-administration of investigational products, and; obtaining remote informed consent, among others.
This year the agency also addressed a more long-standing issue in clinical trials: under-representation of certain populations. In November the agency finalized a guidance providing recommendations to enhance diversity in trial populations. Issued in compliance with the FDA Reauthorization Act of 2017, the guidance describes situations in which eligibility criteria may be expanded and how to do so; recommends strategies to minimize challenges faced by trial enrollees and improve retention, and; encourages specific efforts to improve enrollment in trials for treatments of rare diseases. The agency also finalized a series of guidances over the summer on the inclusion in oncology trials of populations with specific conditions, specifically: brain metastases; HIV, hepatitis B virus, or hepatitis C virus infections, and; organ dysfunction or prior/concurrent malignancies. Another guidance offered minimum age considerations for inclusion of pediatric patients in clinical trials.
The FDA also took steps to increase the number of therapies available for certain cancer patient populations this year. In August the FDA finalized a guidance recommending steps to improve inclusion of men in breast cancer clinical trials from which they historically have been excluded given the rarity of male breast cancer incidence. That month, the agency also initiated enforcement of key provisions in the Research to Accelerate Cures and Equity (RACE) for Children Act requiring certain targeted cancer therapies developed for adult patients to be studied in pediatric patients. The move aims to increase the number of available therapies for childhood cancer patients.
The FDA has recognized an increase in applications requesting cross labeling of drugs used in combination therapies. Cross labeling involves the inclusion of relevant information in drug labeling that provides clear, complementary, and consistent guidance for each drug’s safe and effective use in a combined regimen. In November the agency issued a draft guidance on cross labeling of oncology drugs in combination regimens, which is open for comment until January 19, 2021.
June 2020 marked the anniversary of the OCE’s launch of Project Orbis, a collaborative global review program that provides a framework for the concurrent submission, review, and regulatory action on oncology products across international partners. Over Project Orbis’ first year, 60 marketing applications were received, of which 38 were approved. Median time-to-approval across the partners was 4.2-4.4 months. The OCE also provided an update on the Real-Time Oncology Review Program (RTOR), an initiative aimed at facilitating earlier submission of data to jumpstart the review process of oncology products. From February 2018 to April 2020, RTOR supported the application submission and review of 20 oncology products, of which nine received breakthrough therapy designation and all received priority review. The median time from application submission to FDA approval was 3.3 months.
Throughout 2020, the FDA has continued its vital work in not only getting safe and effective cancer treatments onto the market, but improving the regulatory processes by which it does so as well. The agency’s guidances issued, policies enforced, and initiatives advanced this year are critical to getting cancer treatments into the hands of a larger, more diverse patient population in a shorter amount of time.
Oncology Approval Recap
Between October 27 and November 23, the U.S. Food and Drug Administration granted one accelerated approval for an existing therapy and approved new companion diagnostic indications.
- The FoundationOne Liquid CDx test was approved as a companion diagnostic device to identify mutations in BRCA1, BRCA2 and ATM genes in patients with metastatic castration resistance prostate cancer (mCRPC) eligible for treatment with Olaparib.
- Pembrolizumab was granted accelerated approval in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test.
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.