Johnson & Johnson takes another step in CAR-T race with Bristol Myers in multiple myeloma

In a race with Bristol Myers Squibb to advance cell therapies to treat patients at an earlier stage of multiple myeloma, Johnson & Johnson has hit another milepost.

J&J and co-developer Legend Biotech have filed with the European Medicines Agency (EMA) for approval of Carvykti (cilta-cel) to treat patients with relapsed and lenalidomide-refractory multiple myeloma. The CAR-T drug, which was approved for fifth-line use in the United States and Europe last year, has shown promise as a second-line treatment.

An approval could catapult Carvykti past BMS’s CAR-T Abecma, which was approved by the FDA in March of 2021, also for fifth-line use.

“Today’s submission to the EMA is an important step towards helping patients benefit from this CAR-T therapy earlier in their treatment journey,” Edmond Chan, M.D., Janssen’s EMEA therapeutic area lead for haematology, said in a release. “If approved, this will be the first and only CAR-T therapy available to treat relapsed and refractory multiple myeloma patients as early as second line.”

J&J’s application is based on results from the phase 3 CARTITUDE-4 study, which will be released on June 5 at the American Society of Clinical Oncology (ASCO) meeting in Chicago.

Last month, a leaked abstract from the study indicated that one infusion of Carvykti slashed the risk of tumor progression or death by 74% over standard of care in multiple myeloma patients who had tried one to three therapy lines. Though the data were immature, it also showed Carvykti reduced the risk of death by 22%.

Despite the enthusiasm for these medicines, manufacturing capacity has weighed on uptake in the real world. For instance, J&J recently decided to postpone its Carvykti launch in the U.K. amid shortfalls in its production network.

For its part, BMS also has conducted a phase 3 trial of Abecma in attempting to expand its use. Five months ago, the company said that Abecma reduced the risk of tumor progression or death by 51% in patients who have undergone two to four stages of therapy.

While the trial was a success, its data was rejected by the American Society of Hematology (ASH) for presentation at its annual meeting.

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