In a late-stage study, Johnson & Johnson and Legend Biotech’s CAR-T therapy Carvykti improved survival in multiple myeloma patients who had received one to three prior lines of therapy compared to treatments typically used for the disease, the companies said Tuesday.
Carvykti’s expanded approval in April was based on the same study that showed the treatment staved off disease progression in multiple myeloma patients who received at least one prior line of therapy. But survival benefit is a gold standard result for physicians, and the new data could help solidify Carvykti’s place in earlier lines of treatment.
But J&J and Legend did not disclose the overall survival numbers in their respective press releases, stating that more details would be shared at a future medical meeting. The 419-patient CARTITUDE-4 study pitted Carvykti against a cocktail of either Pomalyst, bortezomib, dexamethasone or Pomalyst, dexamethasone and J&J’s Darzalex.
Previously, patients were only eligible for Carvykti after four previous lines of therapy — meaning they had exhausted many of their other treatment options. Carvykti generated $500 million in revenue last year.
The therapy is one of a host of multiple myeloma treatments that have been approved in recent years, including Bristol Myers Squibb and 2seventy bio’s multiple myeloma cell therapy Abecma. In the pivotal study that led to its expanded approval to third-line patients, Abecma offered a survival benefit when results were adjusted for crossover, but showed no benefit when they were not adjusted.
Carvykti sales eclipsed Abecma sales in the third quarter of 2023, and have remained higher since.
But the pressing question for J&J and Legend remains whether they can keep up with demand for the cell therapy, which is not simple to make: Each dose requires a patient’s own immune cells.
Aside from its own manufacturing, J&J is partnered with Novartis to make commercial Carvykti. A J&J supply chain executive told Endpoints News in April that the company, alongside Legend, hopes to double Carvykti production capacity by the end of 2024.