SpringWorks Therapeutics has achieved complete patient enrolment in a Phase II clinical trial of nirogacestat to treat recurrent ovarian granulosa cell tumours (OvGCT).
The open-label, single-arm, multi-centre study will assess the safety, tolerability, efficacy, and pharmacokinetics of nirogacestat as a single agent in patients with recurrent OvGCT.
It enrolled nearly 40 patients who had previously received one or more lines of systemic therapy. They will receive 150mg of nirogacestat two times a day.
The objective response rate as measured by Response Evaluation Criteria in Solid Tumours (RECIST 1.1) is the primary endpoint of the study.
Secondary endpoints include safety, tolerability, quality of life assessments, progression-free survival, overall survival as well as duration of response.
SpringWorks CEO Saqib Islam said: “While early-stage OvGCT can be managed with surgery, nearly half of the patients experience post-surgical recurrence, and once these tumours recur, there are limited treatment options and no FDA-approved therapies.
“We are very pleased to have fully enrolled on 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 tumours.
“We look forward to continuing to work closely with our investigators and to reporting initial data from this study next year.”
Nirogacestat is an oral, selective, small-molecule gamma-secretase inhibitor that is currently in Phase III clinical development for desmoid tumours.
In addition to OvGCT, SpringWorks is evaluating nirogacestat for multiple myeloma.