SpringWorks Therapeutics Reports First Patient Dosing in the P-II Trial of Nirogacestat for the Treatment of Ovarian Granulosa Cell Tumors
Shots:
- The first patient has been dosed in a P-II trial evaluating nirogacestat (150mg, BID) as a monothx. in ~40 patients with recurrent ovarian GCT
- The 1EPs of the trial are ORR as measured by RECIST 1.1 while the 2EPs include PFS, OS, DoR, safety, tolerability & QoL assessments. The preclinical studies showed that ovarian GCT cell lines are susceptible to gamma-secretase inhibition
- Nirogacestat is an oral, selective, small molecule gamma-secretase inhibitor & is currently in the P-III clinical development for desmoid tumors & in P-II for ovarian GCT. The company plans to submit nirogacestat’s NDA to the US FDA in H2’22 & will be reviewed under the US FDA’s RTOR program
Ref: Globenewswire | Image: SpringWorks Therapeutics
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
