Oncopeptides has announced completion of enrollment in the phase 3 study OCEAN for the treatment of relapsed refractory multiple myeloma.
The study includes 450 patients from more than 100 hospitals around the world. Results are expected to be presented later this year.
About the OCEAN study
OCEAN is a randomized, comparative study between melflufen and pomalidomide in patients with relapsed refractory multiple myeloma (RRMM). The patients have been treated with immunomodulatory inhibitors (IMiD) and proteasome inhibitors (PI), they have developed resistance to their last line of therapy and are refractory to lenalidomide (IMiD), the most commonly used drug for the treatment of multiple myeloma. The primary endpoint is Progression Free Survival (PFS).
“I am very pleased to announce that we managed to complete enrollment in the OCEAN study despite the strenuous situation that our research and healthcare providers currently are facing. A positive OCEAN comparison between melflufen and the standard of care in RRMM will provide critical insights on how to optimize treatment of RRMM patients,” says Jakob Lindberg, CEO of Oncopeptides. “This comparison will enable us to file for label expansion of melflufen in the US and submit for regulatory approval in the EU and the rest of world”.
A supplemental New Drug Application
Oncopetides is preparing an application for accelerated approval in Q2 2020 based on the results from the ongoing phase 2 study HORIZON, evaluating melflufen in RRMM patients. Recently announced results from HORIZON demonstrate an Overall Response Rate of 26 % in triple-class refractory patients.
Based on these phase 3 data, the company intends to submit a supplemental New Drug Application (sNDA) to the US FDA in Q2 2021, followed by a submission of a Marketing Authorization Application (MAA) in Europe.
Photo of Jakob Lindberg: Oncopeptides