Submission of a supplemental BLA to the FDA seeking approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj)-based regimen for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma

This submission is supported by data from the Phase III PERSEUS (NCT03710603) study evaluating D-VRd induction and consolidation therapy, ASCT, and D-R maintenance therapy, compared to bortezomib, lenalidomide and dexamethasone (VRd), ASCT, and lenalidomide (R) maintenance.

Results from the primary analysis showed that the study met its primary endpoint of progression-free survival (PFS), reducing the risk of disease progression or death by 58 percent (Hazard Ratio [HR], 0.42; 95 percent Confidence Interval [CI] 0.30-0.59; P<0.0001). treatment with d-vrd and asct followed by d-r maintenance also increased the depth of response with higher rates of complete response (cr) or better, stringent complete response (scr) and minimal residual disease (mrd) negativity compared to treatment with vrd, asct and r maintenance.></0.0001).>

Overall, 64 percent of patients who entered the maintenance phase in the D-VRd arm were able to discontinue treatment with Darzalex Faspro after achieving a complete response or better and sustained MRD-negativity following at least two years of D-R maintenance in accordance with the protocol. The overall safety profile of D-VRd followed by D-R maintenance was consistent with the known safety profiles for Darzalex Faspro, VRd and R.

“We are committed to changing the course of multiple myeloma through building combination regimens such as D-VRd with complementary mechanisms of action. The Darzalex Faspro -based quadruplet therapy demonstrated a clinically significant reduction in the risk of progression or death for transplant-eligible, newly diagnosed patients with multiple myeloma,” said Craig Tendler, M.D., Vice President, Clinical Development, Diagnostics, and Global Medical Affairs, Johnson & Johnson Innovative Medicine. “Patients are most likely to experience their deepest and most durable responses during the first line of treatment with D-VRd. This regimen has the potential to improve long-term outcomes for newly diagnosed patients and we look forward to working with the FDA on the review of this application.”

Data from the PERSEUS study were presented as a late-breaking oral presentation (LBA–1) at the 2023 American Society of Hematology (ASH) Annual Meeting and simultaneously published in The New England Journal of Medicine.

See-"Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma"- Pieter Sonneveld, M.D., Ph.D., Meletios A. Dimopoulos, M.D., Mario Boccadoro, M.D., Hang Quach, M.B., B.S., M.D., P. Joy Ho, M.B., B.S., D.Phil., et al., for the PERSEUS Trial Investigators.-January 25, 2024 N Engl J Med 2024; 390:301-313. DOI: 10.1056/NEJMoa2312054.