The primary endpoint was the percentage of subjects receiving RINVOQ 15 mg or 30 mg who achieved an ACR20 response after 12 weeks of treatment versus placebo. Ranked secondary endpoints included change from baseline in HAQ-DI at week 12, proportion of patients achieving PASI 75 at week 16 and proportion of patients achieving MDA at week 24. The trial is ongoing, and the long-term extension remains blinded to evaluate the long-term safety, tolerability and efficacy of the two once-daily doses (15 mg and 30 mg) of RINVOQ in patients who have completed the placebo-controlled period. More information on this trial can be found at www.clinicaltrials.gov (NCT03104400).
“Despite industry advancements, there are limited therapeutic options for treating patients with epithelioid sarcoma who struggle with high rates of recurrence and toxicities associated with currently used therapies,” said Gary K. Schwartz, M.D., chief of hematology and oncology at Columbia University and NewYork-Presbyterian Hospital, deputy director of the Herbert Irving Comprehensive Cancer Center, professor of oncology at Columbia University Vagelos College of Physicians and Surgeons and an investigator in Epizyme’s Phase 2 trial. “The TAZVERIK data from the ES cohort in Epizyme’s Phase 2 trial support its potential to provide clinically meaningful and durable responses, and tolerability for ES patients. This approval of TAZVERIK represents an important advancement in the treatment of patients with ES.”