This week, the top managed care news included an FDA committee meeting on J&J's COVID-19 vaccine; cemiplimab approved for first-line advanced non–small cell lung cancer with PD-L1 expression; real-world outcomes contrast cancer clinical trial results in Medicare patients.
An FDA panel meets to discuss J&J's COVID-19 vaccine ahead of an expected emergency use authorization decision, cemiplimab approved for first-line advanced non–small cell lung cancer with PD-L1 expression, and real-world outcomes contrast cancer clinical trial results in Medicare patients.
Welcome to This Week in Managed Care, I’m Matthew Gavidia.
J&J Vaccine Will Go Before FDA; FDA Expedites Trial Process
Ahead of an expected emergency use authorization decision by the full FDA, Johnson & Johnson’s COVID-19 vaccine has demonstrated 86% and 82% effectiveness against severe COVID-19 cases in the United States and South Africa, respectively, with overall effectiveness rates of 72% and 64% reported in both countries.
Officials from Janssen, the Center for Biologics Evaluation and Research, and the CDC will present phase 3 trial data to the FDA’s Vaccines and Related Biological Products Advisory Committee on the single-dose vaccine’s effectiveness against both common strains and newly emerging variants.
Seeking to address the surge of such variants in the United States, the FDA announced this week it will expedite trials examining vaccine booster doses against variants of COVID-19, including those from South Africa and the United Kingdom, and will not require large clinical trials of the new shots’ efficacy compared with placebo.
The agency also provided new guidelines for makers of diagnostic tests and monoclonal-antibody drugs, which will focus on how those companies can best adapt their products to address virus mutations prominent in the United States.
Tennessee’s DOH Finds Wasted Vaccine Doses; Winter Weather Delays 6M Vaccine Doses
In other vaccine-related news, a recent investigation by Tennessee’s Department of Health, or DOH, found that more than 2400 COVID-19 vaccine doses had gone unused within the state’s largest county in February alone.
Local officials of Shelby County had reportedly sat on tens of thousands of additional shots, with recent winter storms leading to the tossing of 1000 of these doses, according to the DOH report.
White House officials confirmed last week that 6 million doses, equal to 3 days’ worth of doses, of COVID-19 vaccines were delayed due to the extreme winter weather conditions across the country.
FDA Approves Cemiplimab for First-line Advanced NSCLC With PD-L1 Expression
This week, Regeneron Pharmaceuticals and Sanofi announced that the PD-1 inhibitor cemiplimab, sold as Libtayo, received FDA approval as a monotherapy for patients with first-line advanced non–small cell lung cancer with PD-L1 expression of at least 50%.
The approval comes after a priority review by the FDA on data of 710 participants enrolled in the phase 3, open-label EMPOWER-Lung 1 trial, which randomized patients 1:1 to receive either cemiplimab or chemotherapy.
Patients were intended to have high PD-L1 expression, with the cemiplimab cohort exhibiting a 32% lower risk of death than the chemotherapy group in the overall population. Results, published recently in The Lancet, also indicated that a prespecified analysis on a cohort of 563 patients with confirmed PD-L1–high tumors showed a 43% lower risk of death compared with those treated with chemotherapy.
“This was achieved with a greater than 70% crossover rate to Libtayo following disease progression on chemotherapy, as well as the largest population of patients with pretreated and clinically stable brain metastases among advanced non–small cell lung cancer pivotal trials to date,” said study investigator Dr Ahmet Sezer, [MD] professor in the Department of Medical Oncology at Başkent University in Adana, Turkey, in a statement.
This now marks the third cemiplimab approval in the United States and the second in February 2021 alone.
For more, visit AJMC.com.
Real-World Outcomes Contrast Cancer Clinical Trial Results in Medicare Patients
According to study findings published this week in JAMA Network Open, pivotal cancer clinical trial data may lack generalizability in older adults with Medicare.
As an integral aspect of cancer drug development, clinical trials give researchers, regulatory bodies, and clinicians the safety and efficacy data necessary to make the best possible drugs available to patients. But it has long been known that disparities exist in cancer care overall and in clinical trial participation, including those related to racial, socioeconomic, and geographic factors.
Investigators aimed to determine whether overall survival, duration of treatment, and dose reduction trends in Medicare beneficiaries treated with FDA-approved oncology drugs for metastatic solid cancers aligned with the results seen in clinical trials.
Of the 29 total indications examined, 28 showed shorter overall survival in Medicare patients vs those in the intervention arms of clinical trials, with shorter median overall survival and median duration of therapy, as well as dose reductions found more prominently among Medicare beneficiaries in some of the indications than patients receiving the same treatment for the same indication in the trials.
Overall, the findings indicate that pivotal trial data may not reflect real-world clinical practice outcomes in Medicare patients who undergo cancer treatment, making it more difficult for oncologists to assess the risks and benefits of a particular cancer treatment or determine optimal dosing strategies for patients in this population.
“Pivotal trials can be improved, and regulatory requirements could emphasize the importance of generating data relevant to the older patients who constitute an increasing number of all patients with cancer in the United States,” concluded researchers.
For more, visit AJMC.com.
Outcomes Disparities Persist for Black Individuals Living With HIV
In the most recent Morbidity and Mortality Weekly Report from the CDC, findings spotlight a great unmet need for earlier intervention for and treatment of HIV among Black Americans living in rural areas.
Examining data from the National HIV Surveillance System on 14,502 Black Americans with HIV diagnosed in 2018, rural location was correlated with the highest rate of late-stage HIV diagnosis vs living in an urban or metropolitan area.
Overall, in 2018, the 62.9% of Black Americans 13 years or older who achieved viral suppression and 77.1% linked to care in the month after their diagnosis were far below the 95% goal of the government’s Ending the HIV Epidemic plan.
Addressing the results, researchers say “they likely underscore known differences in health-related behaviors, physical and sociocultural environments, and access to and use of health care systems among Black urban and rural HIV populations.”
Patient retention and re-engagement initiatives are especially important to help curb transmission, with top priorities being strategies that target injection drug users, sexually active older adults, geographic disparities, and social determinants of health.
For more, visit AJMC.com.
For all of us at AJMC®, I’m Matthew Gavidia. Thanks for joining us!