A phase 2 trial designed to evaluate the safety and efficacy of lurbinectedin for patients with relapsed small cell lung cancer met its primary endpoint of overall response rate, according to the agent’s manufacturer.
The multicenter, single-arm trial assessed lurbinectedin (PM1183, PharmaMar), an RNA polymerase II inhibitor, for 105 patients with relapsed small cell lung cancer.
ORR served as the primary endpoint. The trial met this endpoint by both investigator review and independent review committee assessment, according to a PharmaMar-issued press release.
Secondary endpoints included PFS and OS.
Trial results will be presented at an upcoming medical meeting, according to the release.
The FDA previously granted orphan drug status to lurbinectedin.
Orphan drug designation is granted to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.
An estimated 28,000 to 34,000 people in the United States will be diagnosed with small cell lung cancer this year, according to American Cancer Society. – by Drew Amorosi