Adding Daratumumab to RVd Improves PFS in Transplant-Eligible MM

Adding daratumumab (D) to a lenalidomide, bortezomib, and dexamethasone (RVd) combination appears to improve depth of response and progression-free survival (PFS) among patients with newly diagnosed, transplant-eligible multiple myeloma (MM), according to research published in The Lancet Haematology.

While D, a monoclonal antibody targeting CD38, has previously been shown to be effective in treating relapsed or refractory MM, RVd induction followed by autologous hematopoietic stem cell transplantation (HSCT) and lenalidomide maintenance is the current standard of care among newly diagnosed patients who are considered eligible for transplant.

Researchers designed the phase 2 GRIFFIN study (ClinicalTrials.gov Identifier: NCT02874742) to determine whether adding D to RVd improved safety and efficacy compared with RVd alone in this patient population; initial results were, furthermore, positive. For the present paper, researchers completed a final analysis of data from the GRIFFIN trial.

Overall, 207 patients were enrolled, among whom 104 were randomly assigned to receive D-RVd, while 103 received RVd. At baseline, in the D-RVd and RVd groups, the median ages were 59 and 61 years, respectively, 56% and 58% of patients were male sex, and 84% and 86% had standard-risk cytogenetics.

The median follow-up was 49.6 months. Analysis showed that D-RVd improved the stringent complete response rate compared with RVd (67% vs 48%, respectively; odds ratio, 2.18; P =.0079). The 4-year progression free survival rates in the D-RVd and RVd groups were 87.2% and 70%, respectively (hazard ratio for disease progression or death, 0.45; P =.032). Median over survival was not reached for either group (P =.84).

Common grade 3 to 4 adverse events in the D-RVd vs RVd groups included neutropenia (46% vs 23%, respectively), lymphopenia (23% vs 23%), leukopenia (17% vs 8%), thrombocytopenia (16% vs 9%), pneumonia (12% vs 14%), and hypophosphatemia (10% vs 11%). In each group, 1 adverse event leading to death was noted, although neither were considered related to treatment.

“Although larger phase 3 trials powered for progression-free survival are needed to confirm these findings, these data nonetheless could provide a basis for translation of these results to real-world clinical practice,” the authors wrote in their report.

Disclosures: This research was supported by Janssen Oncology. Please see the original reference for a full list of disclosures.

Reference

Voorhees PM, Sborov DW, Laubach J, et al. Addition of daratumumab to lenalidomide, bortezomib, and dexamethasone for transplantation-eligible patients with newly diagnosed multiple myeloma (GRIFFIN): final analysis of an open-label, randomised, phase 2 trial. Lancet Haematol. 2023;10(10):e825-e837. doi:10.1016/S2352-3026(23)00217-X

This article originally appeared on Hematology Advisor