SpringWorks Therapeutics Inc. (SWTX) achieved full enrollment in its Phase 2 trial evaluating nirogacestat
SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) announced that it has achieved full enrollment in its Phase 2 trial evaluating nirogacestat, an investigational gamma secretase inhibitor, as a monotherapy in patients with recurrent ovarian granulosa cell tumors (OvGCT). SpringWorks expects to report initial data from the trial in 2024.
OvGCT account for approximately 5% of all ovarian cancers and are the most common subtype of ovarian sex cord tumors, representing 70% of all cases. Nearly all OvGCT harbor a mutation in the FOXL2 gene and preclinical studies have demonstrated that OvGCT cell lines are susceptible to gamma secretase inhibition.1,2
“While early-stage OvGCT can be managed with surgery, nearly half of patients experience post-surgical recurrence, and once these tumors recur, there are limited treatment options and no FDA-approved therapies,” said Saqib Islam, Chief Executive Officer of SpringWorks. “We are very pleased to have fully enrolled this trial well ahead of our projections, which we believe is a testament to the high unmet need that remains for patients living with OvGCT who are in need of a rational, targeted, oral therapy to treat their tumors. We look forward to continuing to work closely with our investigators and to reporting initial data from this study next year.”
The Phase 2 trial (NCT05348356) is a multi-center, single-arm, open-label study evaluating the efficacy, tolerability, safety, and pharmacokinetics of nirogacestat in recurrent OvGCT. The target enrollment for the study was approximately 40 participants, with people receiving 150mg of nirogacestat twice daily. The study enrolled participants with recurrent OvGCT who had received one or more prior lines of systemic therapy. The primary endpoint of the trial is objective response rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Secondary endpoints include progression-free survival, overall survival, duration of response, safety and tolerability, and quality of life assessments.
