OCEAN (OP-103): Melflufen/Dexamethasone (Dex) Compared with Pomalidomide (Pom)/Dex in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM) - Safety and Tolerability Analyses

Background: Most pts with MM are older (median age at diagnosis: 69 y), have comorbidities (Engelhardt, et al. Haematologica. 2017;102:910), and often relapse. Thus, there is a high unmet need for novel, tolerable agents to treat RRMM. Melphalan flufenamide (melflufen)-a first-in-class alkylating peptide-drug conjugate targeting aminopeptidases-and dex received accelerated approval for use in RRMM in the United States based on the phase 2 HORIZON study results (Richardson, et al. J Clin Oncol. 2021;39:757). Melflufen + dex was superior to pom + dex in pts with RRMM based on the primary endpoint of progression-free survival (hazard ratio [HR], 0.79 [95% CI, 0.64-0.98]; P=.0311), but showed no overall survival benefit (HR, 1.10 [95% CI, 0.85-1.44]) in the phase 3 randomized OCEAN study (NCT03151811; Oncopeptides. Press release. Jul 8, 2021). This abstract reports the first high-level safety and tolerability data from OCEAN.