Oncopeptides has announced that the last patient has been successfully enrolled in the phase 3 study OCEAN in relapsed refractory multiple myeloma (RRMM).
The original enrollment target of 450 patients was reached in May 2020, but an analysis indicated that patients were staying longer on treatment than initially estimated. Thus, a decision was made to leave recruitment open to ensure that the number of disease progression events needed to complete the study would be reached within a reasonable timeframe. An additional 45 patients have now been recruited. The company has closed enrollment and reiterates that the topline results will be available in the first half of 2021.
OCEAN is a randomized, comparative study between melflufen (INN melphalan flufenamide), and pomalidomide in patients with RRMM. The study was initiated in 2017 and today includes 495 patients from more than 100 hospitals around the world. The patients have previously been treated with at least an immunomodulator (IMiD) and a proteasome inhibitor (PI) and have all developed resistance to their last line of therapy and to lenalidomide (IMiD), the most commonly used multiple myeloma drug. The primary endpoint of the phase 3 OCEAN study is Progression Free Survival. The data will be evaluated once 339 patients have progressed in their disease.
“This is very exciting news. Thanks to the dedicated participation from patients, investigators and study teams around the world, we have managed to reach our extended enrollment target faster than anticipated, despite these challenging times,” says Marty J Duvall, CEO of Oncopeptides. “I am really impressed by the journey that Oncopeptides has made ever since the study start in 2017, from being a small Stockholm based R&D company, to becoming a fully- fledged, integrated, global biopharma company, preparing the first commercial launch”.
The U.S. Food and Drug Administration, FDA, has recently granted priority review for Oncopeptides´ New Drug Application seeking approval of melflufen in combination with dexamethasone for the treatment of adult patients with triple class refractory multiple myeloma. The decision was based on the results from the ongoing pivotal phase 2 study HORIZON, evaluating melflufen in RRMM patients.