P957: AN INDIRECT COMPARISON OF ELRANATAMAB’S (ELRA) OBJECTIVE RESPONSE RATE (ORR) FROM MAGNETISMM-3 (MM-3) VERSUS REAL-WORLD EXTERNAL CONTROL ARMS IN TRIPLE-CLASS REFRACTORY (TCR) MULTIPLE MYELOMA (MM)
Bibliographic record
Abstract
Topic: 14. Myeloma and other monoclonal gammopathies - Clinical Background: ELRA is a BCMAxCD3 bispecific antibody being investigated for the treatment of R/R MM. Aims: The phase 2 MM-3 trial was single-armed; the aim of this study (NCT05565391) was to contextualize the efficacy data from MM-3 with two real-world (RW) external control arms. Methods: A retrospective cohort study was conducted to indirectly compare the efficacy observed in MM-3 Cohort A (BCMA-naïve; N=123) from the 9-month data cut with two US-based oncology electronic health record databases, Flatiron Health (FH) and COTA, as external controls. MM-3 inclusion (eg, prior MM diagnosis, ECOG≤2, refractory to ≥1 PI, ≥1 IMiD, and ≥1 anti-CD38) and exclusion (I/E) criteria (eg, plasma cell leukemia, smoldering MM) were applied to each RW database to obtain comparable patient populations across sources. After imposing MM-3 I/E criteria, comparisons between data sources on ORR were conducted by estimating rate ratios (RRs) using log-binomial regression models (unweighted analysis). RRs were also estimated using both inverse probability treatment weighting (IPTW) and augmented IPTW (doubly robust) analyses to account for key covariates (eg, age, comorbidities, ECOG, ISS, prior lines/refractoriness, cytogenetic risk, extramedullary disease, lab values). Results: The 123 patients from MM-3 Cohort A were compared with the 152 and 233 patients identified from the FH and COTA databases, respectively. Treatment regimens in the RWD sources included various combinations of PIs, IMiDs, and mAbs, among other agents (eg, selinexor). Across unweighted, IPTW, and doubly robust analyses, the ORR for ELRA was significantly higher than treatments used for TCR MM patients from RWD sources (Table 1; all p<.05). Summary/Conclusion: Among TCR MM patients who resemble those of the MM-3 trial, ELRA showed improved ORR compared with treatments currently used in clinical practice.Keywords: Multiple myeloma, Myeloma, Real world data
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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 | 0.019 | 0.024 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
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".