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Cancer Policy Monitor: May 12, 2020

COVID-19 Legislation and Appropriations Update

-Marc B. Johnson, MPP

As of April 30, there are over 1 million cases of COVID-19 in the United States, with a little over 60,000 deaths. As COVID-19 continues to spread across the United States without showing any signs of slowing down, legislative actions are continuing to be put forth in order to address and remedy this unparalleled public health emergency.

Starting in March, three Coronavirus relief packages have been passed and signed into law. Phase 1-Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020; Phase 2-Families First Coronavirus Response Act; and Phase 3–Coronavirus Aid, Relief, and Economic Security Act”(CARES Act), which at $2.2 trillion, is the largest relief package in U.S. History. The CARES Act, has become particularly known for initiating the Paycheck Protection Program (PPP), which appropriated $349 billion to support small businesses to maintain their payroll and some overhead expenses through the period of the emergency, with the goal of paying workers and keeping their businesses afloat. The program, administered through the Small Business Administration, was overwhelmed by the applications process, and funding for the program ran out in two weeks. Congress quickly sought more money to restart the PPP, and to address other issues, as more and more constituencies sought relief money.

On April 24, the Congress passed what is known as “Phase 3.5”, the Paycheck Protection Program and Health Care Enhancement Act. In this bill, a total of $484 billion was allocated to restart the Paycheck Protection Program, funding hospitals, among other programs. A total of $1.8 billion was appropriated for the National Institutes of Health (NIH), with the National Cancer Institute (NCI) receiving $306 million.

At this time, “Phase 4” legislation is now being proposed for an equally sized (possibly larger) stimulus package as the initial CARES Act stimulus package. This next package would provide funding to state and local governments, election security, infrastructure, hazard pay for essential workers (doctors, nurses, grocery store clerks, etc.), funding for the U.S. Postal Service, and other items to be determined. Reps. DeGette (D-CO) and Upton (R-MI) have also sent a “Dear Colleague” letter to their fellow House members, urging congressional leaders to support $26 billion in funding for medical and scientific research in this next package (which received wide, bipartisan support). Although democratic leadership in the House and Senate are pushing for a new stimulus package, some members of Congress are concerned about such spending and its effects on the national debt. Also, there are some members, primarily republican members of the Senate, who want to increase funding for some programs, and decrease funding for others, in order for a package to gain republican support and passage in the Senate. On April 28, Senate Majority Leader McConnell stated that infrastructure will not be part of a Phase 4 relief package, despite the insistence of the White House. Leader McConnell stated that there is “…an equal interest in doing an infrastructure bill…”, however, “We don’t have an equal interest in borrowing money from future generations to pay for it. In other words, its unrelated to the coronavirus pandemic.”

After attempting to come back into session on May 4, the House of Representatives decided not to come back into session until further notice, citing health concerns related to COVID-19. However, the Senate will come back into session next week. Regular congressional business, including the  FY 21 appropriations process will resume, once Congress comes back into session.

AACR Forms Task Force to Guide COVID-19 and Cancer Response

During the opening session of the AACR Virtual Annual Meeting I on March 27, then President-Elect Antoni Ribas, MD, PhD, FAACR, announced the formation of the AACR COVID-19 and Cancer Task Force. Charged with providing leadership and insight to the AACR on issues surrounding the COVID-19 pandemic, the task force will:

  • Recommend science and policy priorities for COVID-19 and cancer;
  • Consider and determine the AACR’s potential involvement in COVID-19 related projects and what resources, information, data aggregations, etc., should be disseminated or endorsed by the AACR;
  • Propose and act on AACR-led COVID-19 and cancer initiatives after consultation with the AACR Executive Committee; and
  • Address other issues that may arise with respect to this complex disease and its relationship to cancer.

The AACR COVID-19 and Cancer Task Force is composed of cancer researchers and physicians with expertise spanning many fields at the intersection of these two diseases, including pathology, epidemiology, immunology, drug and vaccine development, clinical trial design and implementation, public health, and cancer and health disparities. The task force convened virtually for the first time on April 14 and will serve for the duration of the COVID-19 pandemic.

Members of the AACR COVID-19 and Cancer Task Force are:

  • Antoni Ribas, MD, PhD, FAACR (Chair), UCLA Jonsson Comprehensive Cancer Center;
  • Dafna Bar-Sagi, PhD, FAACR, New York University Langone Medical Center;
  • John M. Carethers, MD, University of Michigan;
  • Melissa Cushing, MD, Weill Cornell Medicine;
  • Gypsyamber D’Souza, PhD, MPH, Johns Hopkins University School of Public Health;
  • Keith T. Flaherty, MD, Massachusetts General Hospital;
  • Susan M. Galbraith, MBBCh, PhD, AstraZeneca;
  • Elizabeth M. Jaffee, MD, FAACR, Sidney Kimmel Comprehensive Cancer Center;
  • David R. Kaufman, MD, PhD, Bill and Melinda Gates Foundation;
  • Karen E. Knudsen, MBA, PhD, Sidney Kimmel Cancer Center at Jefferson Health;
  • Jean-Charles Soria, MD, PhD, Institut Gustave Roussy;
  • Avrum Spira, MD, Johnson & Johnson and Boston University;
  • David A. Tuveson, MD, PhD, FAACR, Cold Spring Harbor Laboratory Cancer Center;
  • E. John Wherry, PhD, University of Pennsylvania;
  • Helen X. Chen, MD (ex officio), National Cancer Institute;
  • James H. Doroshow, MD (ex officio), National Cancer Institute;
  • Marc Theoret, MD (ex officio), U.S. Food and Drug Administration; and
  • Margaret Foti, PhD, MD (hc) (ex officio), American Association for Cancer Research.

Science Must Lead the Way During COVID-19

In April, a group of scientists drafted and circulated an open letter stressing the need for both an objective, data-driven public policy and a rigorous scientific approach for responding to COVID-19 and the SARS-CoV-2 virus. Understanding and implementing the insights revealed through science is vital as we evaluate molecular and antibody tests; therapies and vaccines; the need for social distancing policies; and numerous other challenges.

This open letter was considered by the AACR COVID-19 and Cancer Task Force and echoes the importance of relying on rigorous science that was also conveyed in the AACR Board of Directors’ letters to Congressional leaders and to President Trump, Vice President Pence, and the White House Coronavirus Task Force. The letters call on political leaders to ensure that health care workers have appropriate personal protective equipment, the U.S. Food and Drug Administration uphold its science-based approach, and that sustained support for medical research continues during and after this crisis.

You can add your name to the open letter by following this link.

Patient Advocacy Resources to Combat COVID-19

The global pandemic of COVID-19 is having a serious impact on patients with cancer. To help their community navigate treatment and cancer during the COVID-19 pandemic, patient advocacy organizations are creating a number of educational and support resources.

Melinda Bachini, an AACR Scientist↔Survivor Program advocate and cancer survivor shares, “We recognize the impacts that uncertainty and fear, social isolation, the flood of negative news, and dearth misinformation can have on the physical, emotional, mental, and spiritual wellness of our global community. This is even more troublesome for cancer patients who must navigate access and treatment issues. We have made a commitment to our community to provide the most updated resources to support them during this pandemic.” 

To help and inform our cancer community, we are sharing patient advocacy resources in one central list that can be accessed on the AACR patient advocacy webpages. Please contact us at [email protected] if you have any questions.

HPV-Related Research Shared Virtually Continues Important Discussions Regarding Risk

-Nicholas Warren, PhD

According to the Centers for Disease Control and Prevention, almost 80 million young adults in the United States are infected with Human Papilloma Virus (HPV). High-risk HPV strains cause most head and neck, cervical, anal, and genital cancers later in life, but vaccination prevents infection and related cancers. As the scientific community goes virtual, groundbreaking HPV-related research important to understanding risk is becoming more accessible to large audiences. For example, the Society of Gynecologic Oncology (SGO) hosted its annual meeting virtually in March and presented a wide array of research on HPV-related cancers.  

It is well-documented that HPV vaccinations are currently only indicated for use before exposure to HPV, but it is possible vaccinations could provide benefit after exposure as well. During the SGO virtual meeting, Danielle Krause, MD, presented a meta-analysis of studies investigating HPV vaccination at the time of surgical resection to prevent recurrent precancerous cervical lesions. Six clinical trials with a combined 2,984 patients demonstrated that HPV vaccination reduced the recurrence rate at 48 months from 4.7 percent in non-vaccinated groups to 1.7 percent in vaccinated groups on average. These results suggest vaccinations can provide benefit even when precancerous lesions are detected. However, larger prospective studies are required for widespread adoption of this treatment.

Vaccinations work best when a majority of the population is vaccinated to potentially eliminate a disease entirely. Understanding vaccination rates among different demographics will help develop strategies to improve vaccination rates. John Chan, MD, presented a virtual poster on disparities in HPV vaccination rates between genders and sexualities. Dr. Chan and colleagues analyzed data from the National Health and Nutritional Examination Survey that included 4,115 participants from 2007 to 2016. Notably, only 7.7 percent of heterosexual men received at least one HPV vaccination, while 15.5 percent of homosexual men had at least one HPV vaccination. In comparison, 23.5 percent of heterosexual women and 34.6 percent of homosexual women had at least one HPV vaccination. These data highlight the need to improve HPV vaccination rates in all demographics, but especially in men, in order to eliminate HPV-related cancers.

Multiple strains of HPV cause cancer, but the prevalence of high-risk strains not covered by current vaccines is unclear. To address this question, Giorgio Bogani, MD, presented a retrospective analysis of a clinical trial with 15,138 patients. Of the 6,373 participants positive for at least one high risk strain, 4,159 (76.5 percent) were positive for strains covered by the nonavalent HPV vaccine, Gardasil 9. HPV strains not covered by Gardasil 9 were found in 2,214 (34.6 percent) of participants; percentages add to over 100 percent, because some participants had multiple HPV infections. Over the course of the 20-year study, strains not covered by vaccines increased in prevalence from 4 percent of the total population to 16 percent. These findings suggest that further development of HPV vaccines to cover additional strains may be necessary to provide protection from HPV-related cancers.

Virtual scientific conferences are essential to the dissemination and discussion of science during these unprecedented times. Be sure to tune in to the AACR’s Virtual Annual Meeting II on June 22-24 for more on advances in HPV-related cancer research.

Microbiome Plays a Role in HPV-Related Cervical Cancer Progression

-Nicholas Warren, PhD

The microbiome consists of trillions of microorganisms that coexist within the human body. Microbiota play important roles in human health by stimulating the immune system, breaking down toxic food compounds, and synthesizing certain vitamins. There is also emerging evidence that the microbiome impacts cancer progression. For example, colorectal cancer and prostate cancer have well documented links between the microbiome and cancer risk. Studies suggest that diet greatly influences the availability of nutrients for intestinal bacteria; metabolites from different bacterial species promote or protect from colorectal cancer. Additionally, bacterial infections in the prostate are often influenced by the microbiome. Infections drive inflammatory responses that promote proliferation of potentially cancerous cells.

Researchers are evaluating the effect microbiota may have on other cancers, such as cervical cancer. A recent study published in PLOS Pathogens examined the impact of the cervicovaginal microbiome on Human Papilloma Virus (HPV) infections and incidence of precancerous cervical lesions. The study, nested into the placebo arm of a phase III clinical trial of 7,466 women in Costa Rica, tested the efficacy of the HPV vaccine, Cervarix, for the prevention of cervical cancer. The authors found participants were significantly more likely to clear HPV infections and less likely to develop precancerous cervical lesions when Lactobacillus bacteria species predominated over the cervicovaginal microenvironment. These results have important implications for understanding the progression of HPV infections that cause over 34,000 cancers each year in the United States. While the majority of adults are infected with HPV, only 6-27 percent of HPV infections progress to cancer. The authors hypothesized that the flagella and the high motility of Lactobacillus keep the immune system active and better able to clear HPV infections. However, the findings are correlative and further investigation is needed to understand if the microbiome is directly causing these effects or whether the presence of Lactobacillus is a by-product of other traits.

Correlation of Lactobacillus with positive health outcomes suggests that treatment with probiotic Lactobacilllus may help prevent cervical cancer. Indeed, a trial of 117 women found probiotic Lactobacillus helped clear HPV infections. Approximately 32 percent of participants treated with probiotics for six months tested negative for HPV DNA at the nine-month follow-up. In comparison, 11 percent of women who stopped treatment after two months tested negative. The largest limitations of this study were a lack of a control arm without probiotic treatment and composition of the microbiome was not investigated to demonstrate a causal link. Although these results must be validated in a larger trial, they provide hope for a preventative treatment for cervical cancer following a diagnosis of HPV infection.

Conversely, high bacterial diversity was correlated with increased risk of developing precancerous cervical lesions. The authors hypothesized this could be a side effect of genetic traits or some bacterial species suppressing the immune system. The presence of a high degree of bacterial diversity could help clinicians identify patients with high risk of developing cervical cancer. Further clinical trials to better characterize the role of the microbiome in the natural history of HPV infections could improve screening guidelines for cervical cancer. The understanding gained from this line of investigation could also help inform the role of the microbiome for other types of cancer, other sexually transmitted infections, and reproductive health.

In 2019, the American Association for Cancer Research (AACR) joined over 70 other organizations to call for the elimination of all HPV-related cancers by expanding vaccination, screening, and early treatment. The AACR will continue to support research and policies to meet this goal.

Oncology Approval Recap

In April, the U.S. Food and Drug Administration approved four novel cancer therapies and six expanded indications for oncology drugs:

  • Luspatercept-aamt was approved for the treatment of anemia failing an erythropoiesis stimulating agent and requiring two or more red blood cell (RBC) units over eight weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
  • Encorafenib was approved in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, detected by an FDA-approved test, after prior therapy.
  • Selumetinib was approved for pediatric patients, two years of age and older, with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
  • Mitomycin was approved for adult patients with low-grade upper tract urothelial cancer (LG-UTUC).
  • Tucatinib was approved in combination with trastuzumab and capecitabine, for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
  • Pemigatinib was granted accelerated approval for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
  • Ibrutinib to include its combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • Sacituzumab govitecan-hziy was granted accelerated approval for adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease.
  • A new dosing regimen of 400 mg every six weeks was granted accelerated approval for pembrolizumab across all currently approved adult indications, in addition to the current 200 mg every three weeks dosing regimen.
  • Niraparib was approved for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

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.