CancerNetwork® sat down with Fredrik Schjesvold, MD, PhD, at the 2021 International Myeloma Workshop to discuss key data that read out from the OCEAN trial for relapsed/refractory multiple myeloma.
At the 2021 International Myeloma Workshop, CancerNetwork® spoke with Fredrik Schjesvold, MD, PhD, founder and head of the Oslo Myeloma Center, about key highlights from the phase 3 OCEAN trial (NCT03151811).
The key data for this study is a bit complex. The primary end point [of progression-free survival] (PFS) is definitely better than pomalidomide [Pomalyst]/[dexamethasone]. In the total population, even though it [was not] statistically significant, [there was] an increase in death rates in the melflufen [Pepaxto] arm, which has led to partial clinical hold for ongoing studies with this drug. What we have [demonstrated in the OCEAN trial] is that [the] overall survival [OS] detriment is mainly for the patients who are transplanted, especially recently. For the patients who were not transplanted, the benefit of melflufen was even higher for PFS and also present for overall survival [OS]. For the patients who were transplanted, they benefitted more from pomalidomide, both in PFS and especially in OS.
Most randomized studies in myeloma are add-ons to this, where you have a standard and you add a new treatment. Then you get, more or less, not so interesting subgroups because they all benefit. [However], this is a head-to-head study with 2 different types of drugs, and then you get more interesting results from the subgroups, showing that some patients do benefit from 1 of the arms and the other subgroup benefits from the other treatment. Since transplants were present in about 50% of the total population, these are sort of large subgroups. It’s half of the population each and it’s quite clear that melflufen is beneficial for the patients who are not transplanted and opposite for the patients who are transplanted with the benefit from pomalidomide.
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.