Longer-term data of the Phase 1/2 MajesTEC-1 study showed a high rate of deep and durable response in triple-class exposed MM patients. At 22 median follow up; complete response or better = 43%; duration of response = 24 months (27 months for ≥CR); median PFS = 12.5 months (20 months for ≥CR); median OS = 21.9 months (not reached for ≥CR).
Adverse event profile for all patients (and grade 3/4) included: infections = 78% (52%); CRS = 72% (0.6%); neutropenia = 72% (65%); anemia = 54% (38%); thrombocytopenia = 42% (22%); and lymphopenia = 35% (33%). ICANS occurred in 3% of patients, all grade 1 or 2.
Reference: van de Donk NWCJ, et al. Long-term follow-up from MajesTEC-1 of teclistamab, a B-cell maturation antigen (BCMA) x CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma (RRMM). J Clin Oncol. 2023;41(suppl 16):8011. doi:10.1200/JCO.2023.41.16_suppl.8011
Two Phase 2 full dose cohorts (50 mg and 200 mg) in the LINKER-MM1 trial were studied to optimize dose selection. Linvoseltamab 200 mg showed better efficacy compared with 50 mg, including in patients with high disease burden. The 200 mg dose had consistent efficacy across high-risk subgroups and induced responses in pts who progressed on 50 mg. The recommended dose for further study is now 200mg.
ORR for 200 mg dose = 71%; CR = 30%; very good partial response = 59%. Median duration of response = not reached. The probability of maintaining response at 6 months was 84% and 79% at 12 months. Treatment-emergent adverse events were reported in 95% of patients (grade 3 or higher = 79%): CRS = 45% (1%); neutropenia = 33%; fatigue = 33%; anemia = 27% (24%). ICANS ≥grade 3 = 2%.
Lee HC, et al. LINKER-MM1 study: Linvoseltamab (REGN5458) in patients with relapsed/refractory multiple myeloma. J Clin Oncol. 2023;41(suppl 16):8006. doi:10.1200/JCO.2023.41.16_suppl.8006
Updated Linvoseltamab (BCMAxCD3) Data from pivotal trial demonstrates early, deep, and durable responses in patients with heavily pre-treated multiple myeloma. News release. Regeneron Pharmaceuticals, Inc; May 25, 2025. Accessed June 15, 2023. https://investor.regeneron.com/news-releases/news-release-details/updated-linvoseltamab-bcmaxcd3-data-pivotal-trial-demonstrates
Pooled data from the MagnetismMM studies were presented. In pts with RRMM and prior exposure to BCMA-directed therapies, elranatamab was efficacious and well tolerated; no new safety signals were observed vs the BCMA-naïve population. ORR = 45.3% (prior anti-BCMA therapy = 41%-53%); median time to OR = 1.9 months; complete response or better = 17.4%; duration of response at 9 months = 72% (prior anti-BCMA therapy = 67.3%-78%); median PFS = 4.8 months; median OS 10-month endpoint not reached, but = 60.1% at 9 months.
Treatment-emergent adverse events in all patients (and grade 3 or higher) included: CRS = 65% (1%); anemia = 59% (47%); neutropenia = 44% (41%); thrombocytopenia = 41% (29%); diarrhea = 34% (0%); lymphopenia = 33% (30%); and ICANS = 6% (2%).
Reference: Nooka AK, et al. Efficacy and safety of elranatamab in patients with relapsed/refractory multiple myeloma (RRMM) and prior B-cell maturation antigen (BCMA)-directed therapies: A pooled analysis from MagnetisMM studies. J Clin Oncol. 2023;41(16 suppl):8008. doi:10.1200/JCO.2023.41.16_suppl.8008