- Regeneron Pharmaceuticals Inc REGN announced updated data from two Phase 2 expansion dose cohorts of linvoseltamab (formerly REGN5458) in patients with heavily pre-treated, relapsed/refractory multiple myeloma.
- The LINKER-MM1 trial will form the basis of planned submissions to regulatory authorities, including the FDA, later this year.
- Among the 200 mg cohort, the median soluble BCMA (sBCMA) was 377 ng/mL, 22% had bone marrow plasma cells ≥50%, and 36% had high-risk cytogenetics.
- The objective response rate (ORR) was 71%. 59% achieved a very good partial response (VGPR) or better, with 30% achieving a complete response (CR) or stringent complete response (sCR).
- The median time to onset of response was less than one month.
- 84% and 79% probability of maintaining a response at 6 and 12 months.
- Median progression-free survival was not reached.
- Strong efficacy per ORR was consistently observed in the 200 mg cohort across multiple subgroups, even in high-risk patients.
- Additionally, among patients treated with 50 mg and 200 mg that achieved CR or sCR with available minimal residual disease (MRD) data, 54% were MRD negative.
- Regeneron also announced data from three independent cohorts of fianlimab and Libtayo (cemiplimab) in adults with advanced melanoma. The early clinical trial results demonstrated that the combination led to clinically meaningful and durable results across multiple clinical settings.
- Data demonstrated objective response rates from 56%- 63%, about double the rate historically seen with anti-PD-1 alone in similar settings.
- Price Action: REGN shares closed at $725.00 on Thursday.
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