On May 25, 2021 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported positive topline results from the head-to-head phase 3 OCEAN study evaluating the efficacy and safety of melflufen (INN melphalan flufenamide) versus pomalidomide in patients with relapsed refractory multiple myeloma (RRMM) (Press release, Oncopeptides, MAY 25, 2021, View Source [SID1234580584]). 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 will be presented at a webcast on May 25, 2021, at 11:00 (CET), log in details is available below.
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"Following the accelerated approval of Pepaxto in the U.S. earlier this year, the positive topline results from the OCEAN study marks another major milestone for Oncopeptides. It is very exciting news for patients and indicates that melflufen has the potential to become part of the standard of care in relapsed refractory multiple myeloma", says Marty J Duvall, Chief Executive Officer at Oncopeptides AB. "By demonstrating that melflufen is at least as efficacious as pomalidomide, we pave the way for a potential use of melflufen in earlier lines of therapy in a substantially larger patient population".
The PFS, as assessed by the independent review committee, demonstrated a Hazard Ratio* favoring melflufen of 0.817 (95% CI: 0.659-1.012, p=0.0640) for the primary endpoint and shows that melflufen is non-inferior to pomalidomide. The Hazard Ratio for PFS as per investigator assessment was 0.790 (95% CI: 0.639-0.976). In both assessments, the median PFS for the melflufen arm was more than 40% higher than for the pomalidomide arm. The Overall Response Rate for melflufen was 32.1% vs. 26.5% for pomalidomide.
"The efficacy and safety data from the OCEAN study are very encouraging, and the results will be of importance in physicians´ treatment decisions for patients with relapsed and refractory multiple myeloma", says Pieter Sonneveld, MD, PhD, Professor of Hematology at the Erasmus University of Rotterdam, and Principal Investigator of the OCEAN study. "Melflufen has a unique mode of action, which in addition with its tolerability profile, makes the drug an attractive treatment option for many patients."
Melflufen and pomalidomide had similar discontinuation rates for adverse events, and the safety profile of melflufen was in line with previous studies and consistent across age subgroups. The Company expects to present complete OCEAN data at an upcoming scientific congress.
"The outcome from the phase 3 OCEAN study is very good news for patients with relapsed refractory multiple myeloma", says Klaas Bakker, MD, PhD, Executive Vice President and Chief Medical Officer at Oncopeptides. "This head-to-head-comparison was a bold study with an optimal design for demonstrating melflufen’s true isolated treatment effects. I am truly looking forward to sharing these data with a broader audience, as the OCEAN data clearly show that melflufen may be an important therapeutic option for the increasing number of patients who need more treatment alternatives."
Based on these data, Oncopeptides intends to submit a supplementary New Drug Application to the US Food and Drug Administration FDA, in Q4 2021.
Pepaxto (melphalan flufenamide, also known as melflufen), in combination with dexamethasone, was granted accelerated approval by the FDA on February 26, 2021, 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.
Melflufen is evaluated in a comprehensive clinical study program. In addition to the phase 3 OCEAN study, Oncopeptides is currently enrolling patients in the phase 3 LIGHTHOUSE study, with the aim to establish the efficacy and safety of a combination therapy with melflufen plus daratumumab compared to daratumumab, based on the successful results from the ANCHOR study, presented at American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2020.
The information in the press release is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person above, on May 25, 2021, at 07:00 (CET).
Webcast for investors, analysts, and the media
The Company will host a webcast on May 25, 2021, at 11:00 (CET), including presentations by CEO Marty J Duvall, CSO Jakob Lindberg, CMO Klaas Bakker, and CFO Anders Martin-Löf.
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 melflufen 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 Progression Free Survival.