Daratumumab plus bortezomib, lenalidomide, and dexamethasone (DVRd) in patients (pts) with newly diagnosed multiple myeloma (NDMM): Final analysis of transplant-ineligible (TIE) pts in the phase 3 CEPHEUS study.

7513 Background: The phase 3 CEPHEUS study established that DVRd improved overall minimal residual disease (MRD)-negativity (neg) rates and progression-free survival (PFS) vs VRd in pts with TIE or transplant-deferred (TD) NDMM. The first analysis of the DVRd TIE subpopulation at a median follow-up of 58.7 months (mo) showed a complete response or better (≥CR) rate of 80.6% and overall MRD neg rate of 60.4%, with ~70% of pts alive and progression free. This final analysis of the CEPHEUS TIE subpopulation describes a longer median follow-up of 76.0 mo. Methods: The primary endpoint of overall MRD neg rate (10 -5 and ≥CR), and secondary endpoints, including investigator-assessed PFS and ≥CR rate, and sustained MRD neg (confirmed MRD neg ≥12 months +/- 1 mo apart without MRD positivity in between and ≥CR) were assessed in the TIE population. The study was closed at the final analysis and pts were able to continue their study treatment via post-study access. Results: Of 395 pts enrolled, 289 pts with TIE NDMM received either DVRd (n=144) or VRd (n=145). The overall MRD neg rate at 10 -5 was 61.1% for DVRd and 40.0% for VRd (odds ratio [OR] 2.35; 95% CI 1.47–3.77; P =0.0004) and at 10 -6 was 46.5% for DVRd vs 27.6% for VRd (OR 2.27; 95% CI 1.39–3.71; P =0.0010). Sustained MRD neg rate at 10 -5 was 49.3% for DVRd and 29.0% for VRd (OR 2.40; 95% CI 1.47–3.91; P =0.0005) and at 10 -6 was 37.5% for DVRd and 16.6% for VRd (OR 3.01; 95% CI 1.73–5.24; P