Johnson & Johnson and Legend Biotech got a positive opinion from a European Medicines Agency panel for earlier lines of treatment, as they ready for a March FDA advisory committee meeting.
Pictured: J&J’s business center in Switzerland/iStock, yuelan
The European Medicines Agency has recommended expanding Johnson & Johnson and Legend Biotech’s CAR-T therapy Carvytki (ciltacabtagene autoleucel) for use as an earlier treatment in patients with relapsed or refractory multiple myeloma, Legend announced on Friday.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) supported moving Carvykti into the second-line setting, opening up its use in patients who had undergone at least one prior line of therapy, including a proteasome inhibitor and immunomodulatory agent. To be eligible, patients need to have shown disease progression on their last therapy and must be refractory to lenalidomide.
Currently, Carvykti is approved in the EU to treat patients with at least three prior lines of therapy, whose disease has worsened since the last treatment.
The CHMP recommendation will now be reviewed by the European Commission, which will hand out the final regulatory verdict.
The recommendation is backed by data from J&J and Legend’s Phase III CARTITUDE-4 study, a randomized trial that compared Carvykti against standard chemotherapy regimens, including pomalidomide-bortezomib-dexamethasone or daratumumab-pomalidomide-dexamethasone. Participants in the late-stage trial received one to three prior lines of treatment.
In January 2023, the partners released interim findings from CARTITUDE-4, showing that Carvykti met its primary endpoint and elicited a significant improvement in progression-free survival. The companies at the time did not reveal specific data but said that the study had been unblinded per the recommendation of an independent data monitoring committee.
Data from CARTITUDE-4 leaked in April 2023, demonstrating that treated patients saw a 74% reduction in the risk of disease progression versus standard treatment. Carvykti also decreased the risk of death by 22% compared with chemo, though this was not statistically significant.
Jesús San Miguel, professor and senior consultant at the Center Clinica Universidad de Navarra in Spain, said in a statement that CARTITUDE-4 “demonstrated significant clinical benefit for patients who experience a relapse early in the treatment of their disease.”
San Miguel also called the CHMP’s recommendation an “important step toward making Carvykti available to more patients in Europe.” He has served as a consultant and advisor to Legend but has not been paid for any media work, according to the announcement.
The CHMP’s positive opinion come as J&J and Legend prepare to face the FDA’s Oncologic Drugs Advisory Committee, which will discuss the partners’ application to push Carvykti into an earlier line of treatment in the U.S. The meeting is set for March 15, 2024.
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.
