On July 8, 2021 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported updated results and safety measures based on the head-to-head phase 3 OCEAN study evaluating the efficacy and safety of melphalan flufenamide plus dexamethasone versus pomalidomide plus dexamethasone in patients with relapsed refractory multiple myeloma who have received 2 – 4 prior lines of therapy (Press release, Oncopeptides, JUL 8, 2021, View Source [SID1234584733]). The randomized study was initiated in 2017 and includes 495 patients from more than 100 hospitals in 21 countries around the world. The topline results were announced on May 25th.
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The updated OCEAN results follow a blinded reassessment by the Independent Review Committee (IRC). During the preparations of the clinical study report and regulatory documents it became apparent that the IRC was not provided with all the information available in the clinical database during the time of their initial assessment. This led to a thorough investigation of all 495 patients where a comparison was made between the data provided to the IRC and what data was available in the clinical database. Consequently, data from 29 patients had to be reassessed. In the final analysis melphalan flufenamide met the primary endpoint of superior Progression Free Survival (PFS) compared to pomalidomide with a Hazard Ratio (HR) of 0.792 (95% CI 0.640-0.979, p-value 0.0311) as determined by the IRC.
Overall Survival (OS) was a key secondary endpoint in the OCEAN study. The OS HR was 1.104 (0.846-1.441) in favor of pomalidomide for the Intention to Treat population. Oncopeptides has performed analyses of the OS data and the Company believes that the OS results are primarily explained by substantial HR differences between pre-specified subgroups in both directions.
Based on the observed large differences in overall survival in pre specified subgroups, the FDA has requested a partial clinical hold of all clinical studies with melphalan flufenamide, pending further investigation. Oncopeptides will co-operate closely with the FDA to expeditiously perform necessary analysis to fully understand the benefit/risk profile of melphalan flufenamide in earlier lines of treatment in relapsed refractory multiple myeloma.
The partial clinical hold for melphalan flufenamide is specific to clinical studies. The ongoing commercialization of PEPAXTO (Melphalan flufenamide) remains unaffected in accordance with the current U.S. indication. PEPAXTO in combination with dexamethasone was approved by the FDA under accelerated approval on February 26, 2021, based upon the HORIZON study for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. Healthcare Providers may reach out to Oncopeptides’ Medical Information with any questions at +1-866-522-8894 or [email protected].
To learn more about the phase 3 OCEAN study you may access a replay of the global webcast at View Source
Limitation of Use
PEPAXTO is not indicated and is not recommended for use as a conditioning regimen for transplant outside of controlled clinical trials.
To view the full prescribing information please visit View Source
About phase 3 OCEAN study
The phase 3 OCEAN study is a global, randomized, head-to-head, open-label study, evaluating the efficacy and safety of melphalan flufenamide and dexamethasone, versus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma who have received 2-4 prior therapies. The patients have previously been treated with at least an immunomodulator agent and a proteasome inhibitor. They have all developed resistance to their last line of therapy, and within 18 months from the study start to lenalidomide, the most used drug in multiple myeloma. The study was initiated in 2017 and includes 495 patients from more than 100 hospitals around the world. The primary efficacy endpoint is superiority of Progression Free Survival as measured by IRC.
About Multiple Myeloma
Multiple myeloma is a cancer of plasma cells, a type of white blood cell which produces antibodies to help fight infection. Multiple myeloma causes cancer cells to accumulate in the bone marrow. Approximately 7 per 100,000 Americans per year are diagnosed with multiple myeloma, making it a rare disease. A growing subset of this population is becoming triple-class refractory. The number of patients diagnosed with multiple myeloma is growing and the number of cases diagnosed annually is expected to almost double in 20 years. The average age for diagnosis is 70 years of age, and there is currently no cure.