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MM-1021: Efficacy and Safety of Less Frequent Dosing With Elranatamab (ELRA) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM): A US Subgroup Analysis From MagnetisMM-3
Abstract   Peer reviewed

MM-1021: Efficacy and Safety of Less Frequent Dosing With Elranatamab (ELRA) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM): A US Subgroup Analysis From MagnetisMM-3

Ajay Nooka, Christopher Strouse, Sarah Larson, Alexander Lesokhin, Asya Varshavsky-Yanovsky, David Vesole, Guenther Koehne, Elpitha Soussou, Sharon Sullivan, Eric Leip, …
Clinical lymphoma, myeloma and leukemia, Vol.25(Suppl 1), pp.S954-S954
09/2025
DOI: 10.1016/S2152-2650(25)02667-9

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Abstract

ELRA has shown deep and durable responses in BCMA-naïve patients (Cohort A; n = 123) with RRMM in MagnetisMM-3 (NCT04649359). With a median follow‐up of 33.9 mo, ORR was 61.0%, mPFS was 17.2 mo, and mOS was 24.6 mo. Here we report the results of the US subgroup analysis (n = 47). Eligible patients had RRMM refractory to ≥1 IMiD, ≥1 PI, and ≥1 anti-CD38 mAb. Patients were given SC ELRA as step-up doses followed by 76 mg QW for 6 cycles. Patients who achieved ≥PR lasting ≥2 mo transitioned to Q2W dosing and to Q4W after ≥6 cycles of Q2W dosing. At the data cutoff date, September 10, 2024, the median (95% CI) follow‐up was 33.9 mo (32.9–35.7 mo) (estimated by reverse Kaplan-Meier). Patients in the US subgroup received a median of 5 prior lines of therapy (range, 2–22); 93.6% were triple-class refractory, and 46.8% were penta-drug refractory. Seventeen percent of patients were Black or African American. ORR (95% CI) by BICR was 66.0% (50.7%–79.1%); 42.6% had ≥CR (CR+stringent CR). Median (95% CI) DOR was not reached (NR) (24.0 mo–not estimable [NE]); the probability of maintaining response at 30 mo (95% CI) was 65.7% (43.3%–81.0%). Median (95% CI) PFS was 27.3 mo (4.3 mo–NE). Median (95% CI) OS was NR (14.9 mo–NE); the probability of survival at 30 mo (95% CI) was 55.8% (40.1%–68.9%). Any grade (G) and G3/4 TEAEs were reported in 100% and 78.7% of patients, respectively. Infections (any G, G3/4, G5) were reported in 70.2%, 40.4%, and 0.0%, respectively; 51.1% received Ig replacement. Anti-viral, anti-Pneumocystis jirovecii pneumonia, anti-bacterial, and anti-fungal prophylaxis were received by 80.9%, 21.3%, 14.9%, and 8.5% of patients, respectively. The rate of CRS was 61.7% (G1, 34.0%; G2, 27.7%; G ≥ 3, 0.0%). ICANS was reported in 8.5% of patients (G1, 4.3%; G2, 4.3%; G ≥ 3, 0.0%). Twenty-two patients switched from QW to Q2W, and eight further switched from Q2W to Q4W dosing. Consistent with overall Cohort A data, ELRA was associated with deep, durable responses in the US subgroup. CRS was G1/G2 only. Infections were consistent with those observed in the overall study population; infection prophylaxis including Ig replacement is recommended.
elranatamab phase 2 RRMM US subgroup analysis

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