Oncopeptides AB (publ) (Nasdaq: ONCO) (Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the Oncologic Drugs Advisory Committee (ODAC), of the US Food and Drug Administration (FDA), has finalized the discussion on the benefit-risk profile of Pepaxto® (melphalan flufenamide, also called melflufen). A majority of the panel considered that OCEAN did not confirm a favorable benefit-risk profile in the current indicated patient population. Pepaxto is indicated in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM), 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.
In the light of the outcome of the OCEAN trial, the FDA has asked the ODAC panel to vote on the following question: "Given the potential detriment in overall survival (OS), failure to demonstrate a progression-free survival (PFS) benefit, and lack of an appropriate dose, is the benefit risk profile of melphalan flufenamide favorable for the currently indicated patient population?" In a 14 to 2 vote, the ODAC answered no to the question.
"We still have confidence in our science and data. The heart of the ODAC discussion was focused on the highly heterogenous survival result in OCEAN across patient groups and how to interpret the subgroup data considering the ITT OS result," says Jakob Lindberg, CEO of Oncopeptides. "One day I believe that OCEAN may be recognized as the canary in the coal mine for immunomodulatory drugs that in our view is the main cause behind the OS heterogeneity and dissociation between PFS and OS in OCEAN and show that Pepaxto has the potential to become a meaningful treatment option for elderly patients with RRMM."
The FDA will not issue a final determination on the issues discussed until input from the advisory committee process has been considered and all reviews have been finalized.
Background material can be reached at https://www.fda.gov/media/161678/download.
Webcast for investors, analysts and media
Investors, analysts and media are invited to listen to a webcast presentation and participate in a following Q&A session on September 26, at 14:00 (CET). The event will be hosted by CEO Jakob Lindberg, accompanied by CMO Klaas Bakker. The presentation will be held in English.
Participant number:
SE: +46 856642651, UK: +44 3333000804, US: +1 6319131422
PIN for all numbers: 76812383#
Weblink:
https://tv.streamfabriken.com/pressconference-september-2022. The link can also be found on the Company's website.
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