Melphalan Flufenamide Versus Pomalidomide in Combination Therapy for Myeloma: OCEAN Trial

By: Lauren Harrison, MS
Posted: Monday, April 4, 2022

Melphalan flufenamide is an alkylating peptide-drug conjugate which, when used in combination with dexamethasone, led to an improvement in progression-free survival over pomalidomide and dexamethasone in patients with multiple myeloma; these findings are based on the randomized, open-label, phase III OCEAN trial. Fredrik H. Schjesvold, MD, of the University of Oslo, Norway, and colleagues published these results in The Lancet Haematology.

This phase III study enrolled 495 patients from 108 hospitals across Europe, North America, and Asia who had relapsed or refractory multiple myeloma. Patients were eligible if their disease was refractory to lenalidomide and they had received two to four prior lines of therapy. Patients were randomly assigned 1:1 to receive 28-day cycles of either melphalan flufenamide and dexamethasone or pomalidomide and dexamethasone.

At the time of data cutoff in February 2021, 228 patients had received at least one dose of the melphalan flufenamide treatment and 246 had received at least one dose of the pomalidomide therapy. The median progression-free survival was 6.8 months with melphalan flufenamide and 4.9 months with pomalidomide (hazard ratio = 0.79, P = .032). The median follow-up was 15.5 months and 16.3 months for the melphalan flufenamide and pomalidomide groups, respectively. The median overall survival among patients receiving melphalan flufenamide was 19.8 months, whereas those receiving pomalidomide had a median overall survival of 25 months (hazard ratio = 1.10, confidence interval = 0.85–1.44).

Common grade 3 or 4 adverse events seen in both cohorts included thrombocytopenia (63% with melphalan flufenamide, 11% with pomalidomide), neutropenia (54%, 41%), and anemia (43%, 18%). The most common serious treatment-emergent adverse events were pneumonia (6% with melphalan flufenamide, 9% with pomalidomide), COVID-19 pneumonia (5%, 4%), and thrombocytopenia (4%, 1%). Two patients in the melphalan flufenamide group had fatal treatment-related adverse events, as did four patients in the pomalidomide group.

Disclosure: For a full list of authors’ disclosures, visit thelancet.com.

The Lancet Haematology

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