DP111 | POSITRON EMISSION TOMOGRAPHY WITH COMPUTED TOMOGRAPHY AND MINIMAL RESIDUAL DISEASE FOR EFFICACY ASSESSMENT IN TRANSPLANT-INELIGIBLE NEWLY DIAGNOSED MYELOMA PATIENTS: IMROZ ANALYSIS
Bibliographic record
Abstract
Introduction: MRD is a measure of response in the bone marrow. Imaging-based response assessment, such as PET/CT may distinguish metabolically active MM from non-active. Isatuximab (Isa) is approved in combination with bortezomib, lenalidomide and dexamethasone (VRd) in Ti NDMM pts based on the Phase 3 IMROZ study. Here, we present an analysis of IMROZ, investigating PET/CT negativity (−) with MRD− in front line efficacy assessment. Methods: Pts were randomized 3:2 to receive Isa-VRd or VRd as initiation, then Isa-Rd or Rd as maintenance. MRD was assessed at baseline (BL), then in case of complete response (CR) or very good partial response at end of initiation, and every 6 months for 2 years, then once a year until disease progression (PD) by next generation sequencing at 10-5 sensitivity threshold. PET/CT scans were assessed by central review and performed at BL, then yearly until PD; if positive for soft tissue plasmacytoma, repeated at time of CR and/or end of induction, then following time points for MRD assessment. BL PET/CT positivity (+) was defined as FDG 5PS Score ≥4, and complete metabolic response (CMR) was a Deauville score of ≤3. Results: Across the global and China populations, 244 Isa-VRd and 162 VRd pts had PET/CT at BL, of which 153 (62.7%) and 101 (62.3%) were PET/CT+, respectively. Of these, 121 (41.6%) and 83 (43.0%) had a post-BL PET/CT assessment. 155 pts presented with plasmacytoma at BL (95 Isa-VRd, 60 VRd), with comparable BL characteristics to the global population. The double negativity rate (PET/CT FDG 5PS score ≤3 and MRD−) was significantly higher in Isa-VRd pts than VRd (odds ratio [OR] 1.54; 95% CI 1.04-2.29; p=0.0155), and similarly for double negativity + ≥CR (OR 1.60; 95% CI 1.07-2.38; p=0.0108). As shown in Table, more Isa-VRd than VRd pts with plasmacytoma reached PET/CT CMR and MRD−, and PET/CT CMR with MRD− + ≥CR. Progression-free survival (PFS) in pts PET/CT+ at BL was in favor of the Isa-VRd arm (median PFS [mPFS] not reached [NR; 95% CI 59.4-NR]) vs VRd (mPFS 49.1 [95% CI 39.1 -NR]) (hazard ratio [HR] 0.58; 95% CI 0.39-0.88; p=0.6303), and HR was comparable to the intent to treat population. PFS in pts with plasmacytoma at BL was similar to the global population (HR 0.685; 95% CI 0.40-1.18; p=0.5332). Conclusions: This analysis of IMROZ shows the prognostic value of BL PET/CT findings. More Isa-VRd pts reached double negativity than VRd, regardless of whether pts had plasmacytomas.
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| 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".