Final analysis of Phase II GRIFFIN study presented for Darzalex (daratumumab)-based Investigational Quadruplet Regimen in patients with newly diagnosed, transplant-eligible multiple myeloma

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). Higher minimal residual disease (MRD) negativity rates were observed for Darzalex-RVd vs. RVd (64 percent vs. 30 percent). No new safety concerns were observed with longer-term follow-up.

“The final analysis of the GRIFFIN trial highlights the potential benefit of adding daratumumab to RVd for the treatment of newly diagnosed, transplant-eligible patients,” said Douglas W. Sborov†, M.D., M.S., Director of the Multiple Myeloma Program at the Huntsman Cancer Institute at the University of Utah and GRIFFIN study investigator. “We are constantly investigating the role of new regimens and combinations to improve outcomes in our patients and GRIFFIN is another important step forward in this research.”

Final Analysis from GRIFFIN: After two years of maintenance therapy, the MRD negativity rate continued to favor Darzalex-RVd versus RVd (64 percent vs. 30 percent; P=<0.0001). additionally, 44 percent of patients who received darzalex-rvd achieved sustained mrd negativity lasting 12 months or more, compared to 14 percent of patients in the rvd arm. treatment with darzalex-rvd also resulted in higher scr rates at all time points in the study, with the highest rates occurring following two years of maintenance therapy (67 percent vs. 48 percent; p="0.0079," respectively). cr or better rate was 83 percent in the darzalex-rvd arm vs. 60 percent in the rvd arm (p="0.005). At" the conclusion of the final analysis, after a median follow-up of 49.6 months, a 55 percent reduction in the risk of disease progression or death was observed in patients in the darzalex-rvd arm; an estimated 48-month pfs rate of 87.2 percent was observed in the darzalex-rvd arm, compared to 70 percent in the rvd arm. median pfs was not reached in either treatment arm. in addition, after extended follow-up, no new safety concerns were observed.

“The Phase II GRIFFIN study showed important results with the investigational Darzalex quadruplet regimen in the treatment of newly diagnosed, transplant-eligible multiple myeloma,” said Imran Khan, M.D., Ph.D., U.S. Vice President, Medical Affairs, Hematology at Janssen Scientific Affairs, LLC. “The evaluation of this treatment regimen will continue as part of the registrational, Phase III PERSEUS study. These studies represent our ongoing focus in multiple myeloma and our commitment to advance research and new therapeutic combinations for patients at each stage of their treatment journey.”