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Considerations With Bispecific Antibodies in Development— Understanding Current Data in the Later-Line Relapsed/Refractory Multiple Myeloma Treatment Setting The EMPOWER Initiative

RELEASED DATE: January 05 , 2023
EXPIRATION DATE: January 05 , 2024

This enduring activity addresses the mechanisms of resistance and characteristics of refractory disease in patients with multiple myeloma; reviews the mechanisms of action of both current and emerging therapies in the treatment of patients with relapsing/refractory multiple myeloma; and lastly evaluates the clinical data for developing agents in the management of patients with late relapse/refractory multiple myeloma.

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Community Considerations in Relapsed/Refractory Multiple Myeloma: Current and Developing Anti-BCMA Therapies

RELEASED DATE: January 18, 2023
EXPIRATION DATE: January 27, 2024
 
This enduring activity has been designed for community-based hematology-oncologists, nurse practitioners, and physician assistants to ensure confidence in the management of relapsed/refractory multiple myeloma. It discusses the mechanisms of resistance and characteristics of refractory disease in patients with multiple myeloma; review the mechanisms of action of both current and emerging therapies in the treatment of patients with relapsing/refractory multiple myeloma; and lastly evaluates the clinical data for developing agents in the management of patients with late relapse/refractory multiple myeloma.

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This activity is provided by Med Learning Group.
This activity is supported by an independent medical education grant from Regeneron Pharmaceuticals, Inc.
Copyright © 2023 Med Learning Group. Built by Divigner. All Rights Reserved.

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Note: This CME program was recorded prior to the American Society of Clinical Oncology (ASCO) 2023 meeting in June 2023. Highlights of data released at ASCO include:

Teclistamab

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

Linvoseltamab (investigational)

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%.

References:

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

Elranatamab (investigational)

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

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