Why is BMS myeloma drug Abecma’s introduction delayed?

For Abecma (idecaptagene vicleucel or ide-cel), BMS’ CAR-T cell therapy for multiple myeloma, to survive in the Korean market, it must devise an approval strategy differentiated from its competitor, Janssen’s Carvykti (ciltacaptagene autoleucel, or cilta-cel).

Abecma’s globally approved indication as the fifth treatment for recurrent and refractory multiple myeloma is less competitive in Korea. So it will have a chance only as a fourth treatment, according to an expert.

However, that will postpone the drug’s introduction to Korea even further.

Professor Kim Ki-hyun of the Hemato-oncology Department at Samsung Medical Center said so, comparing the two drugs’ clinical data.

In March 2021, Abecma won fast-track approval from the U.S. Food and Drug Administration to treat adult patients with recurrent and refractory multiple myeloma who have previously received for or more treatments, including immunomodulators, proteasome inhibitors, and anti-CD 38 monoclonal antibodies.

About a year later, in February 2022, Carvykti won an FDA nod for the same indication and approval from the Korea Ministry of Food and Drug Safety this past March.

Unlike in America, Carvykti made its debut earlier in the Korean market, noticeably weakening the competition of the latecomer Abecma.

FDA approvals of Abecma and Carvykti were made on the KarMMA study and the XARTITUDE-1 study in recurrent and refractory multiple myeloma patients with four or more previous treatments. Based on these, they won the nod for the fifth treatment of recurrent and refractory patients.

However, Abecma’s overall response (OR) and the median progression-free survival (mPFS) value stood at 73 percent and 8.89 months in the KarMMa-2 study, while those for Carvykti were 97.9 percent and 22.8 months in the CARTITUDE-1 study.

It isn't easy to compare Abecma and Carvykti directly with these figures shown in different studies as these were not head-to-head research. However, their data as the fifth treatment showed visible differences.

“Carvykti showed mPFS of 22.8 months in the CARTITUDE-1 study. This marked an improved figure of six times compared to the mPFS of four months shown in previous fifth treatments,” Professor Kim said. “In contrast, according to the data released, Abecma’s mPFS was relatively shorter (than Carvykti), with 8.9 months in the fifth treatment.”

Kim noted that Carvikty’s introduction was significant as it offered a new option for Korean patients requiring fifth treatments, making Abecma’s introduction difficult as a fifth treatment, however.

For Abecma to be competitive in the Korean market, it must get approval as the fourth treatment based on the ongoing KarMMa-3 study,” he said.

BMS is conducting the KarMMa-3 study, a phase 3 clinical trial in recurrent and refractory multiple myeloma patients who have received three or more treatments before.

In the study, the Abecma group’s mPFS was 13.3 months at the 18.6th month, the median point of follow-up monitoring, showing 51 percent or more PFS or death risks compared with the standard therapy group’s 4.4 months. OS was 71 percent in the Abecma group, and 42 percent in the standard treatment group, and CR was 39 percent and 5 percent, respectively.

Based on these data, BMS is attempting to expand Abecma’s indication to a fourth treatment overseas. It registered an indication-expansion application with the FDA in April and submitted applications to the European Medicine Agency and the Japanese Minister of Health, Labor and Welfare.

Accordingly, industry insiders expect it will take a little more time for Abecma to debut as a fourth treatment in Korea.