Fredrik Schjesvold, MD, PhD, Discusses the Rationale for the OCEAN Trial in Relapsed/Refractory Multiple Myeloma
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.
Transcript:
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.
Reference
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.
![A third of patients had a response [to lifileucel], and of the patients who have a response, half of them were alive at the 4-year follow-up.](/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fcancernetwork%2F6b7c9a3270c71a70749ba86000cfc78a29d74309-2988x1702.png%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=30 "A third of patients had a response [to lifileucel], and of the patients who have a response, half of them were alive at the 4-year follow-up.")
![We have the current CAR [T-cell therapies], which target CD19; however, we need others.](/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fcancernetwork%2F6d5ddb2c2098f525a65b378ece6ca55a114f95fc-2974x1660.png%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=30 "We have the current CAR [T-cell therapies], which target CD19; however, we need others.")
![“Every patient [with multiple myeloma] should be offered CAR T before they’re offered a bispecific, with some rare exceptions,” said Barry Paul, MD.](/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fcancernetwork%2F70a5f0fed7009863fe30cf0740cf32014ebaf5be-2974x1660.png%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=30 "“Every patient [with multiple myeloma] should be offered CAR T before they’re offered a bispecific, with some rare exceptions,” said Barry Paul, MD.")
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