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.
Bibliographic record
Abstract
8008 Background: Studies in the MagnetisMM program (MM-1, NCT03269136; MM-3, NCT04649359; MM-9, NCT05014412) enrolled pts treated with prior BCMA-directed therapies. A pooled analysis from these studies evaluated the efficacy and safety of elranatamab in pts with RRMM and prior exposure to BCMA-directed therapy. Methods: Eligible pts received at least 1 PI, 1 IMiD, 1 anti-CD38 antibody, and 1 BCMA-directed therapy (ADC and/or CAR-T cells). Pooled analysis included pts in MM-1 (n = 13) who received SC elranatamab 215−1000 µg/kg; MM-3 (n = 64) and MM-9 (n = 9) who received the RP2D, SC 76 mg QW. Efficacy endpoints were assessed by investigator per IMWG criteria. TEAEs were graded by CTCAE (MM-1, v4.03; MM-3 & MM-9, v5.0); CRS and ICANS were graded by ASTCT criteria. Results include data up through ~10 months after last pt initial dose in all pooled studies. Results: In total, 86 pts were included. Median age was 66.0 y (range, 40−84); 47.7% male. At baseline, 69.8% had an ECOG PS ≥1; 24.4% had high risk cytogenetics; 54.7% had extramedullary disease. Pts received a median of 7.0 (3−19) prior lines of therapy, including BCMA-directed ADC (67.4%), CAR T-cells (41.9%), 9.3% received both. 96.5% and 54.7% of pts were triple-class and penta-drug refractory, respectively; among pts who received ADC and CAR-T cells respectively, 79.3% and 27.8% were refractory to ADC and CAR-T cells. After a median follow-up of 10.3 mo (0.3−32.3), median duration of treatment was 3.3 mo (0.03−30.4). At data cut-off, 24.4% of pts remained on treatment; most common reason for permanent treatment discontinuation was progressive disease (44.2%). ORR was 45.3% (95% CI 34.6−56.5), with ≥CR achieved in 17.4% of pts. ORR for pts with prior BCMA-directed ADC and CAR-T cells was 41.4% (95% CI 28.6−55.1) and 52.8% (95% CI 35.5−69.6), respectively. Among responders, median time to objective response was 1.9 mo (0.3−9.3). Median DOR was not reached by 10 mo; the DOR rate at 9 mo was 72.4% (95% CI 54.7−84.2). DOR rate (95% CI) for pts with prior BCMA-directed ADC and CAR-T cells were 67.3% (43.1−83.0) and 78.9% (53.2−91.5) at 9 mo, respectively. Median PFS was 4.8 mo (95% CI 1.9−7.7), and median OS was not reached by 10 mo, with a rate of 60.1% (95% CI 48.9−69.6) at 9 mo. Most common (≥25% of pts) TEAEs were CRS (65.1% [G3 1.2%]), anemia (59.3% [G3/4, 46.5%]), neutropenia (44.2% [G3/4, 40.7%]), thrombocytopenia (40.7% [G3/4, 29.1%]), diarrhea (33.7% [G3/4, 0%], and lymphopenia (32.6% [G3/4, 30.2%]). ICANS was reported in 5.8% (G3, 2.3%) of pts. Conclusions: 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. Results support treatment with elranatamab in pts with RRMM post BCMA-directed therapy. Clinical trial information: NCT03269136 , NCT04649359 , NCT05014412 .
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.010 | 0.008 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.015 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".