Dr Jagannath on the Potential Role for Linvoseltamab in R/R Multiple Myeloma

Sundar Jagannath, MBBS, director, Center of Excellence for Multiple Myeloma, professor of medicine (hematology and medical oncology), The Tisch Cancer Institute, Mount Sinai, discusses the potential role for linvoseltamab (REGN5458) in relapsed/refractory multiple myeloma, as well as the agent's continued investigation in this space.

In the latest analysis of the ongoing, open-label, multicenter, dose-escalation and -expansion phase 1/2 LINKER-MM1 trial (NCT03761108), treatment with 200 mg of linvoseltamab resulted in a 71% independent review committee–assessed objective response rate, which included a 46% rate of complete response (CR) or better. The median follow-up was 11.1 months.

Based on these data, investigators are hoping for the early approval of linvoseltamab in this population, Jagannath confirms. On February 21, 2024, the FDA granted priority review to linvoseltamab (REGN5458) for the treatment of adult patients with relapsed/refractory multiple myeloma who have progressed after 3 or more prior lines of therapy.

Jagannath emphasizes his confidence in these phase 1/2 findings. When looking at data from phase 3 studies supporting recent approvals of other CAR T-cell products in multiple myeloma, the median progression-free survival was often not reached, whereas the median PFS was approximately 3 months with standard chemotherapy, he states. Accordingly, efficacy outcomes with linvoseltamab are similar to that of other CAR T-cell products, further supporting its approval, he explains.

Equally significant is linvoseltamab's safety profile, Jagannath continues. The regimen's design, necessitating only 2 24-hour hospitalization sessions, aims to minimize treatment-related adverse effects. Importantly, this approach has resulted in a low infection rate of 5% after 6 months, positioning linvoseltamab favorably in terms of safety considerations compared to other intensive CAR T-cell therapies, Jagannath says.

The ongoing phase 3 LINKER-MM3 trial (NCT05730036) will further evaluate the efficacy and safety of linvoseltamab in this patient population, Jagannath adds. These forthcoming phase 3 trial results will be pivotal in confirming linvoseltamab's role in the evolving treatment landscape for this challenging disease setting, he concludes.