Bristol Myers, 2seventy roll out full Abecma data in earlier-stage cancer
2023-02-10
临床结果临床3期上市批准免疫疗法
Bristol Myers Squibb and 2seventy bio teased a top-line win for their BCMA-targeting CAR-T Abecma in earlier stages of multiple myeloma back in August. Now they’re offering a look at the full data.
The biotech and Big Pharma pair put out word
Friday
that relapsed or refractory patients on Abecma in the KarMMa-3 Phase III pivotal trial saw a median 13.3 months of progression-free survival (PFS), meeting the trial’s primary endpoint. That’s more than the amount of time experienced by patients on one of five “standard regimens,” who saw a median 4.4 months of PFS (p<0.0001). The median follow-up time was 18.6 months.
While Abecma is currently approved in the fifth-line and later setting, the KarMMa-3 study tested the drug in patients after just “two to four prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitorproteasome inhibitor, and an anti-CD38 monoclonal antibody, and who were refractory to their last regimen,” the companies said in their announcement.
In terms of safety, investigators said that adverse events grade 3 or 4 were observed in 93% of those on Abecma and 75% of those in the standard regimen group, according to an
NEJM
report.
Investigators reported six Abecma-related deaths. According to the report, two patients in the Abecma group died of cytokine release syndrome.
While PFS was the primary endpoint, Abecma also reached statistical significance in a secondary endpoint. The companies said that 71% of those treated with Abecma achieved a response — 39% seeing either a complete response or a “stringent complete response.” For the standard regimen group, only 41% achieved a response — and only 5% seeing a complete response or stringent complete response.
With all the data in hand, the partners said they plan to submit an sBLA filing later this year. The data were also presented at the European Hematology Association’s CAR T-cell meeting Friday.
The partners aren’t the only ones in the BCMA space. Carvykti, pushed by J&J and its partner Legend Biotech, is the second CAR-T to market that targets BCMA.
Carvykti got its start after a 2017 showdown at ASCO, where developer
Legend showed
a 100% ORR and 94% clinical remission in 35 relapsed, drug-resistant multiple myeloma patients. ASCO data in 2022 — after FDA approval as a fifth-line treatment —
reiterated
the drug’s effectiveness with a 98% ORR near the 28-month mark.
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