Oncopeptides announced today that it completed patient enrollment for its Phase 2 Port study of its multiple myeloma treatment.
Waltham, Mass.-based Oncopeptides’ Port study is an open-label, randomized, crossover study comparing the safety, tolerability and efficacy of peripheral or central intravenous administration of Pepaxto (melphalan flufenamide) in combination with dexamethasone to treat relapsed refractory multiple myeloma.
Pepaxto links a peptide carrier to a cytotoxic agent, resulting in a lipophilic compound that helps to deliver the therapeutic into cells to leverage aminopeptidases that are overexpressed in multiple myeloma cells and cause the release of the cytotoxic agents. It is administered once a month in a 30-minute infusion process.
Oncopeptides expects topline data from the Port trial in the third quarter for the combination of Pepaxto and dexamethasone, which received accelerated FDA approval for adult patients with relapsed or refractory multiple myeloma on Feb. 26 and, one month later, launched in the U.S.
The treatment has indication for 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, according to a news release.
“I am very pleased that we have enrolled the final patient in the PORT study,” Oncopeptides CMO Dr. Klaas Bakker said in the release. “The data could potentially provide a pathway for us to work with the U.S. Food and Drug Administration to add an additional mode of administration for Pepaxto.”