Myovant's relugolix falls short in metastatic prostate cancer with FDA verdict looming - fiercebiotech.com
Last fall, Myovant’s prostate cancer drug outshone the standard of care at keeping patients’ testosterone levels down, a phase 3 showing that teed up an FDA filing. Now, as the agency ponders the case, the company is unveiling data for patients with metastatic disease—and they’re not so rosy. The company pitted the drug, relugolix, against the standard of care, leuprolide, in 934 patients with advanced prostate cancer. Nearly all patients taking relugolix (97%) kept their testosterone levels down over 48 weeks, compared with 89% of patients taking leuprolide, Myovant reported last November. However, the drug staved off cancer progression at about the same rate as the incumbent in a subgroup of patients whose cancer had spread beyond the prostate, the new data show. After 48 months, 74% of metastatic patients on relugolix were castration resistance-free, compared with 75% of patients on leuprolide. Prostate cancer that is castration-resistant keeps growing even when the amount of tes...