Context Therapeutics Inc. announced preliminary Phase 2 data from the ongoing SMILE trial of onapristone extended release (ONA-XR), the company’s novel, first-in-class, potent, orally administered progesterone receptor (PR) antagonist, in metastatic breast cancer. Being conducted in collaboration with the Wisconsin Oncology Network, the Phase 2 SMILE trial is evaluating ONA-XR in combination with fulvestrant in patients with ER+, HER2- advanced or metastatic breast cancer who progressed on prior CDK4/6 inhibitor therapy. Preliminary Phase 2 findings highlight a 4-month progression free survival (PFS) rate of 44%, and favorable safety and tolerability.

The data were presented at the 2022 San Antonio Breast Cancer Symposium® (SABCS®). Also at SABCS, an initial look at the trial design of the recently initiated ELONA Phase 1b/2 clinical trial evaluating the combination of ONA-XR with The Menarini Group’s oral selective estrogen degrader, elacestrant, in patients with second- or third-line advanced or metastatic ER+, PR+, HER2- breast cancer was presented. Data from the Phase 1b portion of the trial is expected in Fourth Quarter 2023.

The Company also recently announced preliminary Phase 2 findings for ONA-XR in combination with anastrozole in progesterone receptor-positive (PR+) metastatic endometrial cancer, highlighting a 4-month PFS rate of 77% and favorable safety and tolerability.