WALTHAM, Massachusetts, May 19, 2021 / PRNewswire / – Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotechnology company focused on developing therapies for difficult-to-treat hematologic diseases, today announces that three abstracts containing data on PEPAXTOÂ® (melphalan flufenamide, also known as melflufen) in relapsed refractory multiple myeloma, have been accepted by the American Society of Clinical Oncology 2021, ASCO, and have now been published online. Clinical data presentations include updates on the ANCHOR and LIGHTHOUSE studies of Oncopeptides as well as a pooled analysis of studies O-12-M1 and HORIZON in patients who have been exposed or have become refractory to prior alkylators.
âThe ANCHOR data are very promising and support the further development of melphalan flufenamide in the triplet regimen,â said Klaas Bakker, MD, PhD, Executive Vice President and Chief Medical Officer, Oncopeptides AB. “This provides a clear rationale for our LIGHTHOUSE phase 3 randomized study, comparing subcutaneous daratumumab with or without melphalan flufenamide.”
Here is a brief description of the abstracts that have been accepted by ASCO. They will be available online at https://www.asco.org at May 19 at 5:00 p.m. (ET).
ANCHOR (OP-104): MELFLUFEN PLUS DEXAMETHASONE AND BORTEZOMIB IN MULTIPLE PATIENTS WITH RELAPSE / REFRACTORY MYELOMA
ANCHOR is an open-label, non-randomized phase 1/2 study evaluating melphalan flufenamide plus dexamethasone in combination with bortezomib or daratumumab in patients with RRMM. Recruitment for this study is ongoing and updated data, including efficacy and safety, will be presented to ASCO.
- PHARE (OP-108): A PHASE 3 STUDY OF MELFLUFEN IN COMBINATION WITH DEXAMETHASONE AND DARATUMUMAB IN MULTIPLE RELAPSE / REFRACTORY MYELOMA PATIENTS
The LIGHTHOUSE phase 3 study is a randomized, open label, phase 3 study of melphalan flufenamide and dexamethasone in combination with daratumumab versus daratumumab alone in patients with relapsed refractory multiple myeloma (RRMM) and are double immune-modulating refractory (IMiD)) and proteasome inhibitor (PI) (regardless of the number of previous lines of treatment), or have received at least 3 previous lines of treatment, including one IMiD and one PI. Patient recruitment is underway with a planned recruitment of 240 patients. The study design will be presented to ASCO.
- A POOLED ANALYSIS OF O-12-M1 AND HORIZON STUDIES: MELFLUFEN PLUS DEXAMETHASONE IN MULTIPLE RELAPSE / REFRACTORY MYELOMA PATIENTS (RRMM) EXPOSED OR REFRACTORY TO PREVIOUS ALKYLATORS
This pooled review of studies O-12-M1 and HORIZON examines the efficacy and safety profile of melphalan flufenamide in combination with dexamethasone in patients with MMRD who have been exposed or have become refractory to prior alkylators. O-12-M1 is a phase 1/2, open-label, single-arm, multicenter study of melphalan flufenamide plus dexamethasone in patients with MMRD. HORIZON is a pivotal, single-arm, open-label, multicenter, phase 2 study of melphalan flufenamide plus dexamethasone in heavily treated, low-risk patients with MMRD.
PEPAXTOÂ® in combination with dexamethasone, achieved 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 previous lines of treatment and whose disease is refractory to at least one proteasome inhibitor, an immunomodulatory agent and a monoclonal antibody to CD38 .
Limitation of use
PEPAXTO is not indicated and is not recommended for use as a conditioning regimen for transplantation outside of controlled clinical trials.
For full prescribing information, please visit https://pepaxto.com/docs/pepaxto_pi.pdf
About multiple myeloma
Multiple myeloma is a cancer of the plasma cells, a type of white blood cell that makes antibodies to help fight infection. Multiple myeloma causes cancer cells to build up in the bone marrow. About 7 in 100,000 Americans a year are diagnosed with multiple myeloma, making it a rare disease. A growing subset of this population becomes refractory to three classes. The number of patients diagnosed with multiple myeloma is increasing and the number of cases diagnosed annually is expected to almost double in 20 years. The average age for diagnosis is 70 and there is currently no cure.
Oncopeptides is a global biotechnology company engaged in the development of targeted therapies for patients with difficult-to-treat hematologic diseases. Oncopeptides has a US FDA approved product, PEPAXTOÂ® (melphalan flufenamide), known in clinical development as melflufen. PEPAXTO is approved for certain patients with refractory three-class multiple myeloma and has been evaluated in several clinical studies, including the pivotal phase 2 HORIZON study and is currently being evaluated in the confirmatory phase 3 study OCEAN. The head office of Oncopeptides is at Stockholm, Sweden, with an American head office in Boston, Massachusetts. In addition to Boston, Oncopeptides has a fingerprint in San Francisco, California, another American biotechnology center. For more information, please visit our corporate website at https://oncopeptides.se/en/. You can also visit our US website at https://www.oncopeptides-us.com/en and follow us on our American social networks, Twitter and LinkedIn.
PEPAXTOÂ® is a trademark of Oncopeptides AB (publ).
For more information please contact:
Sarah connors, Head of Corporate Communications in the United States, Oncopeptides Inc.
E-mail: [emailÂ protected]
Cell Phone: 508-654-2277
Linda HolmstrÃ¶m, Director of Investor Relations, Oncopeptides AB (publ)
E-mail: [emailÂ protected]
Mobile phone: +46 70 873 40 95
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SOURCE Oncopeptides inc