SpringWorks Therapeutics Inc. (SWTX) achieved full enrollment in its Section 2 trial evaluating nirogacestat
SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) introduced that it has achieved full enrollment in its Section 2 trial evaluating nirogacestat, an investigational gamma secretase inhibitor, as a monotherapy in sufferers with recurrent ovarian granulosa cell tumors (OvGCT). SpringWorks expects to report preliminary information from the trial in 2024.
OvGCT account for about 5% of all ovarian cancers and are the commonest subtype of ovarian intercourse wire tumors, representing 70% of all instances. Practically all OvGCT harbor a mutation within the FOXL2 gene and preclinical research have demonstrated that OvGCT cell strains are prone to gamma secretase inhibition.1,2
“Whereas early-stage OvGCT will be managed with surgical procedure, almost half of sufferers expertise post-surgical recurrence, and as soon as these tumors recur, there are restricted remedy choices and no FDA-approved therapies,” stated Saqib Islam, Chief Government Officer of SpringWorks. “We’re more than happy to have absolutely enrolled this trial nicely forward of our projections, which we imagine is a testomony to the excessive unmet want that is still for sufferers residing with OvGCT who’re in want of a rational, focused, oral remedy to deal with their tumors. We look ahead to persevering with to work intently with our investigators and to reporting preliminary information from this research subsequent yr.”
The Section 2 trial (NCT05348356) is a multi-center, single-arm, open-label research evaluating the efficacy, tolerability, security, and pharmacokinetics of nirogacestat in recurrent OvGCT. The goal enrollment for the research was roughly 40 contributors, with folks receiving 150mg of nirogacestat twice day by day. The research enrolled contributors with recurrent OvGCT who had acquired a number of prior strains of systemic remedy. The first endpoint of the trial is goal response price as measured by Response Analysis Standards in Stable Tumors (RECIST 1.1). Secondary endpoints embody progression-free survival, total survival, period of response, security and tolerability, and high quality of life assessments.
