Policy & Regulation
Oncopeptides announces completion of enrolment in pivotal phase 3 study OCEAN
22 May 2020 -

Oncopeptides AB (STO:ONCO), a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat haematological diseases, announced on Friday the successful completion of enrolment in the pivotal phase 3 study OCEAN for the treatment of relapsed refractory multiple myeloma.

This study includes 450 patients from over 100 hospitals around the world. Top line results are expected to be presented later this year.

According to the company, OCEAN is a randomised, 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).

Based on the pivotal phase 3 data, the company intends to submit a supplemental New Drug Application (sNDA) to the US FDA in the second quarter of 2021, followed by a submission of a Marketing Authorisation Application (MAA) in Europe.