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Updated Phase 1B Results from the TRIMM-2 Study Confirms Treatment with a Novel Immunotherapy-Based Approach May Yield Improved Clinical Efficacy

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Teclistamab is a B-cell maturation antigen x CD3 T-cell redirecting bispecific antibody being investigated in combination with daratumumab, a CD38-targeting monoclonal antibody, in patients with relapsed/refractory multiple myeloma in the TRIMM-2 study. At the 2022 American Society of Clinical Oncology annual meeting, Rodriguez-Otero and colleagues presented updated results from the TRIMM-2 study that included additional patients and a longer follow-up. Patients were aged >18 years with multiple myeloma who were previously treated with ≥3 lines of therapy (including a proteasome inhibitor and an immunomodulatory drug) or were double-refractory to a proteasome inhibitor and an immunomodulatory drug. The goals of the study were to identify the recommended phase 2 dose for the combination therapy and assess the safety profile of the 2 therapies.

Teclistamab was given in 3 dosing schedules, in combination with daratumumab, to a total of 65 patients. After a median follow-up of 8.6 months, it was shown that patients received an average of 5 prior lines of therapy. The updated safety results demonstrated that teclistamab plus daratumumab was well-tolerated and did not have overlapping toxicities. Cytokine release syndrome was found to be the most common adverse event in 67.7% of patients, all of which were grade 1 or 2. Other common adverse events included neutropenia (49.2%; 41.5% grade 3 or 4), anemia (41.5%; 27.7% grade 3 or 4), thrombocytopenia (32.3%; 24.6% grade 3 or 4), diarrhea (32.3%; 1.5% grade 3 or 4), and infections (67.7%; 27.7% grade 3 or 4). One patient experienced grade 1 immune effector cell–associated neurotoxicity syndrome, which fully resolved in a day.

In addition to updated safety results, response was evaluated in 51 patients from the 3 different dosing cohorts. Across cohorts, the overall response rate was 76.5%, while 70.6% of patients had a very good partial response or better. The overall response rate in patients with prior anti-CD38 exposure was 73.7%. The median time to first response across the 3 dosing cohorts was 1 month, and responses were durable and strengthened over time. Potential synergy of the combination in patients with prior anti-CD38 exposure was seen through upregulation of CD38+/CD8+ T-cells and proinflammatory cytokines.

Overall, these updated results from the phase 1b multicohort TRIMM-2 study demonstrated a novel immunotherapy approach that may be efficacious in patients with multiple lines of prior therapy.

Source

  • Rodriguez-Otero P, D’Souza A, Reece D, et al. A novel, immunotherapy-based approach for the treatment of relapsed/refractory multiple myeloma (RRMM): updated phase 1b results for daratumumab in combination with teclistamab (a BCMA x CD3 bispecific antibody). Presented at: American Society of Clinical Oncology Annual Meeting; June 3-7, 2022; Chicago, IL.

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