Fredrik Schjesvold, MD, PhD, speaks about the FDA approval of melflufen in relapsed/refractory multiple myeloma and its next phase of development at the 2021 International Myeloma Workshop.
At the 2021 International Myeloma Workshop, CancerNetwork® spoke with Fredrik Schjesvold, MD, PhD, founder and head of the Oslo Myeloma Center, about the rationale for the phase 3 OCEAN trial (NCT03151811), and why investigators decided to examine melflufen (Pepaxto) in combination with dexamethasone compared with pomalidomide (Pomalyst)/dexamethasone in patients with relapsed/refractory multiple myeloma.
The rationale [behind the] OCEAN trial was to take the drug melflufen that was already approved in the [United States] for patients who have received at least 4 previous lines of treatment. The next phase in the development of treatment was to compare this in an earlier line of treatment [with] the standard pomalidomide/dexamethasone in patients who are already lenalidomide [Revlimid] refractory and exposed to proteasome inhibitors. …The study was to show that [melflufen/dexamethasone is better than pomalidomide/dexamethasone.
Schjesvold F, Dimopoulos MA, Delimpasi S, et al. OCEAN (OP-103): a Phase 3, randomized, global, head-to-head comparison study of melflufen and dexamethasone (Dex) versus pomalidomide (Pom) and dex in relapsed refractory multiple myeloma (RRMM). Presented at: International Myeloma Workshop; September 8-11, 2021; Vienna, Austria. Accessed September 11, 2021.