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Context Therapeutics® Reports Encouraging Preliminary Phase 2 Data for ONA-XR in Metastatic Breast Cancer
Data presented at San Antonio Breast Cancer Symposium® demonstrate preliminary 4-month PFS rate of 44% in ongoing Phase 2 trial in second- or third-line
About this update from Context Therapeutics Inc.
[{"type":"text","content":"Data presented at San Antonio Breast Cancer Symposium® demonstrate preliminary 4-month PFS rate of 44% in ongoing Phase 2 trial in second- or third-line metastatic breast cancer PFS follows recently disclosed positive preliminary data in ongoing Phase 2 endometrial cancer trial PHILADELPHIA, Dec. 08, 2022 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a women’s oncology company developing novel treatments for breast and gynecologic cancers, 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 Q4 2023. “We are pleased to be building a robust package of data supporting the safety and tolerability of ONA-XR and its potentially meaningful improvement over single agent standards of care,” said Martin Lehr, CEO of Context Therapeutics. “We’re encouraged by the improvement in preliminary PFS observed in the SMILE trial presented at SABCS this week, which is consistent with the significant improvement in PFS recently reported in the ongoing Phase 2 endometrial cancer trial. We look forward to the continued evaluation of ONA-XR across multiple ongoing breast cancer clinical trials, including the SMILE and ELONA trials.” The Company also recently announced preliminary Phase 2 findings for ONA-XR in combination with anastrozole in progesterone receptor-positive (PR+) ...