AACR Presentation Confirms Linvoseltamab's Durable Response in Pre-Treated Multiple Myeloma

Regeneron Pharmaceuticals has reported impressive results from a Phase 1/2 clinical trial of linvoseltamab, a novel bispecific antibody, for patients with relapsed or refractory multiple myeloma (MM). The data were presented at the AACR Annual Meeting 2024, highlighting the drug's potential to significantly improve treatment options for this form of blood cancer. The drug works by linking BCMA on MM cells to CD3-expressing T cells, thus enhancing T-cell activation and the destruction of cancer cells.

Dr. Sundar Jagannath, a leading investigator and Director of the Multiple Myeloma Center at Mount Sinai, emphasized the significance of the findings, noting that linvoseltamab has shown early, durable responses that deepen over time, which is crucial for patients who have undergone extensive prior treatment. Notably, patients who received the drug for at least 24 weeks and achieved a very good partial response were able to modify their dosing schedule to every four weeks, which Dr. Jagannath witnessed firsthand and deemed a significant advancement.

The study involved 117 patients, with findings that included a 71% objective response rate, a median time to response of one month, and a median duration of response, progression-free survival, and overall survival that had not been reached at the time of the data cutoff. The 12-month estimates for maintaining a response, being progression-free, and survival were 78%, 69%, and 75%, respectively. Furthermore, 93% of patients with a complete response and evaluable minimal residual disease were found to be negative for MRD.

The clinical trial also incorporated a response-adapted dosing regimen, allowing patients who achieved a VGPR or better after 24 weeks to adjust to a less frequent dosing schedule. In the expanded dosing portion of the trial, 90% of patients who met these criteria were able to transition to the modified schedule, with nearly half of those who switched before achieving a complete response later attaining it.

The study also noted high objective response rates across various subgroups, including those at high risk or with high disease burden. Common treatment-related adverse events included cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, while infections were reported in 73% of patients, with a decrease in frequency and severity after six months.

Linvoseltamab has received Fast Track Designation and Priority Review from the FDA, with a decision expected in August 2024. The drug is also under review by the EMA. A Phase 3 confirmatory trial for linvoseltamab in R/R MM patients is currently in progress.

Multiple myeloma is the second most common blood cancer, with significant global and U.S. incidence rates. Despite treatment advancements, MM remains incurable, and patients often require additional therapies after initial treatments cease to be effective.

The Phase 1/2 trial of linvoseltamab is part of a broader clinical development program that includes trials in earlier lines of therapy and different stages of the disease. Regeneron, with over three decades of experience, is leveraging its VelociSuite® technologies to develop treatments for a range of blood cancers and disorders. The company's focus on bispecific antibodies and other therapeutic modalities aims to provide customized and synergistic cancer treatments.

Regeneron is a prominent biotechnology company known for its innovative medicines that transform the lives of patients with serious diseases. The company's proprietary technologies, such as VelocImmune®, have led to numerous FDA-approved treatments and candidates in development. Regeneron's commitment to improving the drug development process and its significant contributions to genetics research underscore its leadership in the field.