IMS 2025 | Daratumumab and bortezomib maintenance in transplant-ineligible NDMM following DVMP induction

Daratumumab has changed a paradigm shift on transplant-ineligible multiple myeloma, as shown in the data of the ALCYONE and the MAIA trials. Although no head-to-head comparisons between Dara-VMP and Dara-RD exist, both regimens achieve comparable minimal residual disease negativity. However, there is a gap between the progression-free survival of the ALCYONE trial, three years, and the five years of the MAIA trial. And a possibility could be at the different maintenance strategies of both trials. ALCYONE, daratumumab immunotherapy after induction, and MAIA, Dara-RD, anti-progressive disease. And with this gap of knowledge, the Spanish Myeloma Group developed a study in which Dara, in combination with bortezomib, dara [inaudible], and bortezomib every other week, was a continuous maintenance after Dara-VMP induction with the aim to improve the data of the ALCYONE. In this trial, the OPTIMAL trial, 118 patients were included. The median age of the inclusion was 77 years. Nearly 80% of the patients had more than 75 years. And it’s important to mention that 30% of the patients did not meet the inclusion criteria of the ALCYONE, mainly due to kidney failure. Regarding to the primary endpoint of the study, the two years progression-free survival after the start of the maintenance was 73%, with no significant difference among the cytogenetic groups or international staging status, at least at the data cutoff. Following with the secondary endpoints, near to 80% of the patients achieve VGPR or better. And in the minimal residual disease evaluable populations, 45% achieved minimal residual disease negativity. In addition, the two years overall survival was 90%. Regarding to the safety profile, the most common adverse event reported was infections, especially viral respiratory tract infections, a total of 25% of the adverse event reported. No cardiac, neurologic, or hematological adverse event were uncommon, less than 5%, and no treatment-related death was reported. And to summarize, the combination of daratumumab and bortezomib as maintenance after dara-VMP inductions showed a sustained response with acceptable safety profile even in older and challenging populations compared to the ALCYONE trial. While longer follow-up is needed, this could be a valuable option for patients ineligible to quadruplets and intolerance to lenalidomide.

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