May 19, 2021
WALTHAM — May 19, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announces that three abstracts with data on PEPAXTO® (melphalan flufenamide, also known as melflufen) in relapsed refractory multiple myeloma, have been accepted by the 2021 American Society of Clinical Oncology, ASCO, and have now been published online. The clinical data presentations include updates on Oncopeptides’ ANCHOR and LIGHTHOUSE studies as well as a pooled analysis of the O-12-M1 and HORIZON studies in patients who have been exposed to or become refractory to prior alkylators.
“The ANCHOR data are very promising and support further development of melphalan flufenamide in triplet regimen,” said Klaas Bakker, MD, PhD, Executive Vice President and Chief Medical Officer, Oncopeptides AB. “This provides a clear rationale for our randomized phase 3 LIGHTHOUSE study, comparing subcutaneous daratumumab with or without melphalan flufenamide.”
Below is a brief description of the abstracts that have been accepted by the ASCO. They will be available online at https://www.asco.org on May 19th at 5:00 pm (ET).
- ANCHOR (OP-104): MELFLUFEN PLUS DEXAMETHASONE AND BORTEZOMIB IN RELAPSED/REFRACTORY MULTIPLE MYELOMA PATIENTS
ANCHOR is a non-randomized, open label, phase 1/2 study evaluating melphalan flufenamide plus dexamethasone in combination with either bortezomib or daratumumab in patients with RRMM. Recruitment for this study is ongoing and updated data including efficacy and safety will be presented at ASCO.
- LIGHTHOUSE (OP-108): A PHASE 3 STUDY OF MELFLUFEN IN COMBINATION WITH DEXAMETHASONE AND DARATUMUMAB IN RELAPSED/REFRACTORY MULTIPLE MYELOMA PATIENTS
The phase 3 LIGHTHOUSE study is a randomized, open-label, phase 3 study of melphalan flufenamide and dexamethasone in combination with daratumumab compared to daratumumab alone in patients with relapsed and refractory multiple myeloma (RRMM) and are double refractory to an Immunomodulatory Drug (IMiD) and a Proteasome Inhibitor (PI) (regardless of the number of prior lines of therapy), or have received at least 3 prior lines of therapy including an IMiD and a PI. Patient recruitment is ongoing with a planned enrolment of 240 patients. The study design will be presented at ASCO.
- A POOLED ANALYSIS OF THE O-12-M1 AND HORIZON STUDIES: MELFLUFEN PLUS DEXAMETHASONE IN RELAPSED/REFRACTORY MULTIPLE MYELOMA PATIENTS (RRMM) WHO ARE EXPOSED OR REFRACTORY TO PRIOR ALKYLATORS
This pooled analysis of the O-12-M1 and HORIZON studies looks at the efficacy and safety profile of melphalan flufenamide in combination with dexamethasone in patients with RRMM who had been exposed or become refractory to prior alkylators. O-12-M1 is a single-arm, open-label, multicenter phase 1/2 study of melphalan flufenamide plus dexamethasone in patients with RRMM. HORIZON is a pivotal, single-arm, open-label, multicenter phase 2 study of melphalan flufenamide plus dexamethasone in heavily treated and poor-risk patients with RRMM.
PEPAXTO® 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.
Limitation of Use
PEPAXTO is not indicated and is not recommended for use as a conditioning regimen for transplant outside of controlled clinical trials.
To view the full prescribing information please visit https://pepaxto.com/docs/pepaxto_pi.pdf
About Multiple Myeloma
Multiple myeloma is a cancer of plasma cells, a type of white blood cell which produces antibodies to help fight infection. Multiple myeloma causes cancer cells to accumulate in the bone marrow. Approximately 7 per 100,000 Americans per year are diagnosed with multiple myeloma, making it a rare disease. A growing subset of this population is becoming triple-class refractory. The number of patients diagnosed with multiple myeloma is growing and the number of cases diagnosed annually is expected to almost double in 20 years. The average age for diagnosis is 70 years of age, and there is currently no cure.
Oncopeptides is a global biotech company committed to developing targeted therapies for patients facing hard-to-treat hematological diseases. Oncopeptides has one U.S. FDA approved product, PEPAXTO® (melphalan flufenamide), known during clinical development as melflufen. PEPAXTO is approved for some patients with triple-class refractory multiple myeloma and was evaluated in several clinical studies including the pivotal Phase 2 HORIZON study and is currently being evaluated in the confirmatory Phase 3 OCEAN study. Oncopeptides’ headquarters is in Stockholm, Sweden, with a U.S. headquarters in Boston, Massachusetts. In addition to Boston, Oncopeptides has a footprint in San Francisco, California, another U.S. biotech hub. For more information, please visit our corporate website at https://oncopeptides.se/en/. You may also visit our U.S. website at https://www.oncopeptides-us.com/en and follow us on our U.S. social media channels, Twitter and LinkedIn.
PEPAXTO® is a trademark of Oncopeptides AB (publ).