© Reuters.
NEW YORK – Regeneron (NASDAQ:) Prescribed drugs has introduced encouraging outcomes from its part 1/2 LINKER-M1 trial for the remedy of relapsed or refractory a number of myeloma (R/R MM) with linvoseltamab, an experimental remedy.
The trial reported a strong goal response fee (ORR) of 71% and a whole response fee of 46% at a 200 mg dose over a mean follow-up interval of 11 months. These findings, launched Thursday, sign vital progress within the improvement of linvoseltamab, which has demonstrated superior early efficacy knowledge in comparison with different remedies like Tecvayli and Elrexfio.
The promising outcomes have set the stage for Regeneron to plan a regulatory submitting. The corporate goals to focus on sufferers who’ve undergone a median of 5 prior therapies, together with proteasome inhibitors and anti-CD38 monoclonal antibodies. Regardless of the excessive total adversarial occasion fee noticed within the trial, critical cytokine launch syndrome (CRS) was minimal, with just one grade 3 case reported amongst members.
Regeneron’s oncology pipeline isn’t restricted to linvoseltamab. It contains odronextamab in part 3 trials for non-Hodgkin lymphoma (NHL), ubamatamab in part 2 trials in opposition to ovarian most cancers, and Libtayo accredited for varied carcinomas. Moreover, fianlimab mixed with Libtayo has been granted Quick Observe standing for metastatic melanoma remedy and is awaiting an FDA resolution anticipated by March 31, 2024.
The corporate additionally revealed that linvoseltamab’s dosing routine might doubtlessly provide a bonus over rivals by proposing prolonged intervals between doses for sufferers who reply properly to the remedy. This could be a big enchancment over Tecvayli’s weekly administration schedule.
Additional medical investigations are underway with the continuing part 3 LINKER-MM3 trial assessing linvoseltamab mixed with different remedies in much less closely pretreated sufferers and the part 1/2 LINKER-MM4 trial concentrating on treatment-naïve people.
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