Regeneron Pharmaceuticals announced that the 14-month median follow-up data from the pivotal Phase 1/2 LINKER-MM1 trial of linvoseltamab in patients with relapsed/refractory (R/R) multiple myeloma (MM) were shared during an oral presentation at the European Hematology Association (EHA) Congress 2024 and published in the Journal of Clinical Oncology. These longer-term results show a deepening of responses following the 11-month median follow-up data presented at the American Association for Cancer Research Annual Meeting in April. Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.
“Previous results from LINKER-MM1 have demonstrated that linvoseltamab has compelling efficacy characterized by deep and durable responses. With 14 months of median follow-up, 50% of patients achieved a complete response or better, despite their cancer being refractory to or relapsing on standard therapies,” said Suzanne Lentzsch, MD, PhD, Director of the Multiple Myeloma and Amyloidosis Program at Columbia University. “Additionally, a study using US-based electronic health record data to indirectly compare linvoseltamab to real-world standard-of-care treatment also supports the overall body of evidence for this investigational medicine in heavily pretreated multiple myeloma. Collectively, these presentations underscore the exciting potential of linvoseltamab as we await decisions from regulatory authorities.”
The 14-month median follow-up LINKER-MM1 data for linvoseltamab among patients treated at the 200 mg dose (N=117) reinforces the durability and increasing depth of response shown in previous data cuts. Per the presentation and publication, results showed a 71% objective response rate (ORR), with 50% of patients achieving a complete response (CR) or better and 63% achieving a very good partial response (VGPR) or better, as determined by an independent review committee.
Linvoseltamab Shows Promising Long-Term Efficacy and Safety in Multiple Myeloma Trial
The median duration of response (DoR) was 29 months for all responders, while the median DoR was not reached for those who achieved a CR or better. In analyses that were not pre-specified, there was an 81% and 95% estimated probability of maintaining a response at 12 months after achieving a partial response or better among all patients and those who achieved a CR or better, respectively.
Median progression-free survival (PFS) was not reached, with a 70% estimated probability of being progression-free at 12 months among all patients and a 96% probability among those who achieved a CR or better. Median overall survival (OS) was 31 months for all patients. In analyses that were not pre-specified, the median OS was not reached for patients who achieved a CR or better, with a 75% and 100% estimated probability of survival at 12 months among all patients and those who achieved a CR or better, respectively.
High rates of CRs or better were observed in prespecified subgroups, including 55% among those aged 75 years or older, 48% among those with high cytogenetic risk, 45% among Black or African American patients, and 28% among those with plasmacytomas (including extramedullary and paramedullary). Safety data at the 14-month median follow-up were generally consistent with those at the 11-month median follow-up.
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