Linvoseltamab, previously known as REGN5458, it is an investigational bispecific antibody which is designed to bind to CD3 while also bridging and binding T cells to the B cell maturation antigen (BCMA) protein on multiple myeloma cells. Developed by Regeneron, the aim of Linvoseltamab is to help activate T cells by their CD3 surface antigen receptor and trigger targeted T cell mediated killing of multiple myeloma.BCMA (B cell maturation antigen) is an important surface receptor that is found in most of the multiple myeloma cases and its specific expression on tumor cells, makes it a key target for generating a potential therapeutic effect. Several clinical studies have been supported that targeting the B cell maturation antigen in the case of multiple myeloma may close the significant clinical gap left by existing therapies.
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With potential antineoplastic and immunostimulating properties, Linvoseltamab can target the human B cell maturation antigen (BCMA), a tumor associated antigen (TAA) and engage CD3 on T lymphocytes. After administration, Linvoseltamab is said to bind to CD3 surface antigen present on cytotoxic T lymphocytes (CTLs) and BCMA on BCMA – expressing cancer cells, This will activate and redirect the immune system to B cell maturation antigen expressing tumor cells, leading to their T cell mediated killing.,/p.
The phase I clinical trial was an open label, dose escalation study which was investigating Linvoseltamab (REGN5458) in patients with relapsed / refractory multiple myelomas that received minimum 3 prior lines of therapy or were double refractory. All the patients enrolled had earlier received prior treatment with proteasome inhibitors, immunomodulatory drugs and CD38 antibody treatments.
The main aim of the phase I part of the clinical study was to assess the tolerability, safety and dose limiting toxicities of Linvoseltamab with efficacy being the secondary outcome. The results of the phase I portion were observed to show an objective response rate (ORR) of 51% across all dose groups which even rose higher to around 75% for patients who received higher dose of the bispecific antibody. Most of the responses were observed during the initial start of the study which deepened over time.
Partial response was confirmed to be very good at 86%, 43% of the patients achieved a complete response (CR) and with the 8 months from the time of response, there was 90% probability of getting an event free survival. Responses took place rapidly and over the course of the phase I, they developed higher in higher dose groups with safety profile being consistent. The phase II portion of this phase I/II further assessed the anti-tumor activity and safety of Linvoseltamab.
At the recommended dose for Linvoseltamab, the pivotal phase II clinical trial showed deep, early and durable responses in patients with multiple myeloma who has been on at least three prior therapies including those with high risk and high disease burden. If was found that 81% of the patients were triple refractory to the available therapeutic options. Out of the 87 patients in the set dose cohort, more than half were evaluated for efficacy with the median follow up of 3 months.
The objective response rate was confirmed to be 64% with 45% of the patients achieving very good partial response and probability of maintain the response at 6 months was found to be 79%. The most common adverse event observed was cytokine release syndrome in less than 20% patients. The primary objective for the Phase II portion of the study was the objective response rate while the key secondary objectives were duration of response, rate of minimal residual disease negative status, progression free survival an overall survival.
Linvoseltamab is currently under further clinical development, supported by the positive results observed from the phase I/II clinical trials, however, it safety and efficacy has not been fully evaluated by any regulatory agency. Regeneron plans to initiate the phase III clinical study for Linvoseltamab in patients with multiple myeloma including earlier lines of therapy by the first half of 2023 while also planning to submit a Biologics License Application (BLA) for its multiple myeloma indication by the second half of 2023.
Contact:
Neeraj Chawla
Kuick Research
Research Head