The FDA’s Oncologic Drugs Advisory Committee will meet on March 15 to discuss BMS and J&J applications for their CAR T-cell therapies Abecma and Carvykti, respectively.
Pictured: FDA sign at its office in Washington, DC/iStock, JHVEPhoto
The FDA has scheduled its Oncologic Drugs Advisory Committee to meet on March 15, 2024 to discuss applications from Bristol Myers Squibb and Johnson & Johnson to move their respective CAR T-cell therapies, Abecma (idecabtagene vicleucel) and Carvykti (ciltacabtagene autoleucel), into earlier lines of treatment for multiple myeloma.
The adcomm meeting will take place as the industry continues to grapple with the regulator’s recent move to add a class-wide boxed warning to CAR T treatments, flagging their potential risk of secondary T-cell cancers.
According to Monday’s notice in the Federal Register, the day-long meeting on March 15 will first discuss J&J’s Phase III CARTITUDE-4 study, testing the Legend Biotech-partnered Carvykti in adult patients with relapsed ore refractory multiple myeloma who have undergone at least one previous line of therapy with an immunomodulatory agent or a proteasome inhibitor. CARTITUDE-4 also tested the CAR T therapy in patients refractory to lenalidomide.
During last year’s annual meeting of the American Society of Clinical Oncology, held June 2023, J&J and Legend reported that Carvykti cut the risk of disease progression or death by 74% versus standard care in this specific patient population.
However, the FDA’s Oncologic Drugs and Advisory Committee (ODAC) on March 15 will focus on CARTITUDE-4’s overall survival data as well as the risk-benefit profile of Carvykti as an earlier-line treatment option.
The ODAC’s afternoon session will address BMS and 2seventy bio’s Abecma, likewise zeroing in on the overall survival findings of the Phase III KarMMa-3 trial which enrolled patients who had been treated with a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
In December 2023, the pharma partners presented data from KarMMa-3 at the American Society of Hematology meeting, touting an adjusted 31% decrease in risk of death versus standard care. However, BMS and 2seventy bio obtained this estimate after it accounted for more than half of the patients who crossed over to Abecma from the standard care arm after disease progression.
Unadjusted analyses found that Abecma had no significant effect on prolonging patients’ lives, though the CAR T therapy did reduce the risk of disease progression or death by 51%.
Carvykti and Abecma will face the FDA’s ODAC as the regulator ramps up its scrutiny of the safety of CAR T therapies. The FDA first announced its investigation in November 2023, after it detected cases of T-cell malignancies arising in patients who had been treated with these products.
Last month, in a perspective piece published in The New England Journal of Medicine, the regulator unveiled more details from its investigation, revealing that it was looking into at least 22 cases of these secondary cancers, most of which developed within two years of CAR T treatment.
In three cases, the FDA noted that the CAR transgene was found in a malignant clone, indicating that the CAR-T therapy was most likely involved in the secondary malignancy.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
