DP114 | ISATUXIMAB, BORTEZOMIB, LENALIDOMIDE, DEXAMETHASONE IN PATIENTS WITH TRANSPLANT-INELIGIBLE NEWLY DIAGNOSED MYELOMA AND PLASMACYTOMAS: IMROZ SUBGROUP ANALYSIS
Bibliographic record
Abstract
Introduction. Isatuximab (Isa) is approved with VRd in Ti NDMM patients (pts), based on the Phase 3 IMROZ study (NCT03319667). This subgroup analysis of IMROZ compares efficacy and safety of Isa-VRd vs VRd in pts with plasmacytoma, including paramedullary and extramedullary disease (EMD). Methods. In IMROZ, 484 pts were randomized 3:2 to receive Isa-VRd (n=291) or VRd (n=193). Then Isa-Rd or Rd maintenance after 24 weeks of induction. Positron emission tomography and computed tomography (PET/CT) scans were conducted at baseline and annually until PD. In pts with plasmacytoma, PET/CT scans were repeated at complete response (CR) and/or end of induction and during minimal residual disease (MRD) assessments (next generation sequencing 10-5). Responses were assessed per IMWG criteria; PFS by an independent response committee; safety using the NCI Common Terminology Criteria for Adverse Events v4.03. Results. Among IMROZ population, 95 (32.6%) Isa-VRd and 60 (31.1%) VRd pts had plasmacytoma; of these, 19 (20.0%) Isa-VRd and 9 (15.0%) VRd pts had EMD. At baseline, more VRd pts with plasmacytoma had estimated glomerular filtration rate of <60 mL/min/1.73 m² (38.3%) vs Isa-VRd (27.4%) and had high-risk cytogenetics, VRd (18.3%) vs Isa-VRd (12.6%). In pts with plasmacytoma, Isa-VRd led to a longer median PFS than VRd (not reached [NR] vs 47.0 months; HR 0.69 [95% CI 0.40-1.178]; p=0.5332). Similar results were observed in pts with EMD (NR vs 31.7 months; hazard ratio [HR] 0.24 [95% CI 0.07-0.81]; p=0.1980). The rate of ≥CR was 67.4% for Isa-VRd and 63.3% for VRd, and corresponding overall response rates were 82.1% and 86.7% (Table). 48 (50.5%) Isa-VRd and 24 (40.0%) VRd pts achieved MRD−, while 40 (42.1%) and 14 (23.3%) had sustained MRD− at 12 months. MRD− and CR was reached in 43 (45.3%) and 23 (38.3%) of Isa-VRd and VRd pts, respectively. Treatment discontinuation rates were similar (24.2% [Isa-VRd] vs 28.3% [VRd]). Isa-VRd pts had higher grade ≥3 upper respiratory infections (2.1% vs. 0%) and pneumonia (18.9% vs. 13.3%), similar to the overall IMROZ population. Neutropenia was more common in Isa-VRd pts (34.7% vs. 15.0%), with fewer cases of peripheral neuropathy (4.2% vs.13.3%). Conclusions. Isa-VRd led to improved efficacy in pts with plasmacytoma, including EMD, achieving greater responses and longer median PFS than VRd, showed a similar safety profile in pts to that of the overall IMROZ population. No new safety signals were observed.
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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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.006 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 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".