ASH 2023 | Melflufen/dex versus pom/dex in patients with R/R multiple myeloma without previous transplant
Fredrik Schjesvold, MD, PhD, Oslo University Hospital, Oslo, Norway, comments on the long-term outcome data from the final analysis of the Phase III OCEAN trial (NCT03151811), which investigated the safety and efficacy of melflufen and dexamethasone (dex), compared to pomalidomide (pom) and dex, in patients with relapsed/refractory (R/R) multiple myeloma (MM) who received 2-4 prior lines of treatment and had not undergone a transplant. The long-term follow-up data verify the safety and efficacy of the melflufen plus dex combination in this patient population. This interview took place at the 65th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript (edited for clarity)
The Phase III OCEAN trial is a randomized trial with melflufen and dex, and pomalidamide + dex in third-line myeloma. The study met its primary endpoint of PFS benefit, and it turned out that for the transplanted patients, the survival trended to be worse. So after looking at the data from many angles, the company and the investigators and the EMA approved an indication this year for melflufen in patients that are not transplanted or have had a long progression-free survival after transplant...
The Phase III OCEAN trial is a randomized trial with melflufen and dex, and pomalidamide + dex in third-line myeloma. The study met its primary endpoint of PFS benefit, and it turned out that for the transplanted patients, the survival trended to be worse. So after looking at the data from many angles, the company and the investigators and the EMA approved an indication this year for melflufen in patients that are not transplanted or have had a long progression-free survival after transplant. So in this indication, we are now here at ASH, looking at the overall survival in that indication, which contains 50% of the patients in the study. And it turns out that, for this study population, the overall survival is clearly positive. I have to say it’s not statistically statistically significant, almost, but it’s definitely not a trend to the negative, which was in the other population, the transplanted patients. So it confirms the benefit and value of this drug in patients with the three previous lines of treatments that have not had a transplant or at least had a transplant a long time ago.
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Disclosures
Honoraria for lectures and educational material: Skylite DX, Schain, Novartis, Janssen-Cilag, Takeda, Pfizer, Oncopeptides, Amgen, Sanofi, Bristol Myers Squibb, Daiichi Sankyo, Celgene, GlaxoSmithKline, Abbvie
Consultancy: Janssen-Cilag, Takeda, Oncopeptides, Sanofi, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Abbvie
Research Funding: Janssen-Cilag, Oncopeptides, Sanofi, Targovax, Celgene, GlaxoSmithKline
