Final Analysis of Phase 2 GRIFFIN Study Presented for DARZALEX ® (daratumumab)-based Investigational Quadruplet Regimen in Patients with Newly Diagnosed, Transplant-Eligible Multiple Myeloma
LOS ANGELES, August 27, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the final results from the randomized Phase 2 GRIFFIN study evaluating the investigational use of DARZALEX® (daratumumab) in combination with lenalidomide (Revlimid®), bortezomib (VELCADE®) and dexamethasone (DARZALEX®-RVd), followed by maintenance therapy with DARZALEX®-lenalidomide (R), compared to RVd followed by maintenance therapy with R alone, in patients with newly diagnosed, transplant-eligible multiple myeloma. Data were presented in the plenary session at the 19th International Myeloma Society (IMS) Annual Meeting.In the primary analysis (median follow-up of 13.5 months), the GRIFFIN study met its primary endpoint, resulting in a higher stringent complete response (sCR) rate for DARZALEX®-RVd compared with RVd alone by the end of post-autologous stem cell transplant (ASCT) consolidation therapy (42.4 percent vs. 32 percent; 1-sided P=0.0680) meeting the prespecified 1-sided alpha of 0.1. At IMS, the predefined final analysis for GRIFFIN (median follow-up of 49.6 months), which occurred after all patients had completed at least one year of follow-up after end of study therapy or withdrew, showed that longer progression-free survival (PFS) was observed in patients who received DARZALEX®-RVd/DARZALEX®-R compared to those who received RVd/R (hazard ratio = 0.45; 95 percent confidence interval, 0.21-0.95; P=0.0324).[1] Higher minimal residual disease (MR...
Source: Johnson and Johnson - Category: Pharmaceuticals Source Type: news
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