The MAA was submitted based on the data from the P-I/II (LINKER-MM1) trial evaluating Linvoseltamab (200mg) in patients (n=282) with r/r MM. The 1EPs were safety, tolerability & dose-limiting toxicities across 9 dose levels & 2EPs were DoR, PFS & OS
At a median follow-up of 11mos, the study depicted an ORR of 71% & CR in 46% of patients whereas following 24wks. of treatment, patients who achieved VGPR or better, shifted from a Q2W dosing to a Q4W dosing. The data were presented at the ASH 2023
Earlier in Dec 2023, the company submitted a BLA to the US FDA for Linvoseltamab, a bispecific Ab that integrates BCMA (on multiple myeloma cells) with CD3-expressing T cells causing T-cell activation & cancer-cell killing
Ref: Regeneron | Image: Regeneron
Related News:- Regeneron to Present Updated Results of Linvoseltamab for Patients with Heavily Pre-treated Multiple Myeloma at ASCO 2023
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
