Melflufen plus dexamethasone improved progression-free survival (PFS), compared with pomalidomide plus dexamethasone, in patients with relapsed or refractory multiple myeloma (MM), according to phase 3 results published in The Lancet Haematology.

The phase 3 OCEAN trial (ClinicalTrials.gov Identifier: NCT03151811) enrolled 495 patients with MM who had received 2 to 4 previous lines of therapy and whose disease was refractory to lenalidomide and the last line of therapy.

Patients were randomly assigned to receive melflufen plus dexamethasone (246 patients) or pomalidomide plus dexamethasone (249 patients). In both treatment arms, the median age was 68 years, and less than half of patients were women.


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The trial met its primary endpoint of superior PFS. The median PFS was 6.8 months in the melflufen arm and 4.9 months in the pomalidomide arm (hazard ratio [HR], 0.79; 95% CI, 0.64-0.98; P =.032).

On the other hand, there was no significant difference in overall survival (OS) or overall response rate (ORR) between the treatment arms.

The median OS was 19.8 months in the melflufen arm and 25.0 months in the pomalidomide arm (HR, 1.10; 95% CI, 0.85-1.44; P =.47). The ORR was 33% and 27%, respectively (P =.16).

Serious treatment-emergent adverse events (TEAEs) were observed in 42% of patients in the melflufen arm and 46% of those in the pomalidomide arm. The most common of these events (in the melflufen and pomalidomide arms, respectively) were pneumonia (6% and 9%), COVID-19 pneumonia (5% and 4%), and thrombocytopenia (4% and 1%).

Two patients in the melflufen arm had fatal TEAEs considered possibly related to treatment — acute myeloid leukemia and pancytopenia/acute cardiac failure.

Four patients in the pomalidomide arm had fatal TEAEs that were considered possibly related to treatment — pneumonia (n=2), myelodysplastic syndrome (n=1), and COVID-19 pneumonia (n=1).

Disclosures: This research was supported by Oncopeptides AB. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Schjesvold FH, Dimopoulos M-A, Delimpasi S, et al. Melflufen or pomalidomide plus dexamethasone for patients with multiple myeloma refractory to lenalidomide (OCEAN): A randomised, head-to-head, open-label, phase 3 study. Lancet Haematol. Published online January 12, 2022. doi:10.1016/S2352-3026(21)00381-1