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Context Therapeutics® and Wisconsin Oncology Network Announce First Patient Dosed in Phase 2 Trial of ONA-XR in Metastatic Breast Cancer
Trial Will Evaluate Progesterone Receptor ONA-XR in Combination with Estrogen Receptor Antagonist to Determine Potential of Complete Hormone Blockade on
About this update from Context Therapeutics Inc.
[{"type":"text","content":"Trial Will Evaluate Progesterone Receptor ONA-XR in Combination with Estrogen Receptor Antagonist to Determine Potential of Complete Hormone Blockade on Metastatic Breast Cancer Outcomes\nPHILADELPHIA, Oct. 27, 2021 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (Nasdaq: CNTX), a women’s oncology company developing advanced small molecule and immunotherapy treatments to transform care for hormone-driven breast and gynecological cancers, and Wisconsin Oncology Network (WON), today announced the first patient has been dosed in the Phase 2 Trial of OnapriStone in CoMbInation with FuLvestrant for Patients with ER-positive, and HER2-negative Metastatic Breast Cancer after Progression on Endocrine therapy and CDK 4/6 Inhibitors (The SMILE Study). The single-arm trial conducted by the WON will evaluate the effect of progesterone receptor (PR) antagonist onapristone extended release (ONA-XR) in combination with Faslodex (fulvestrant) for women and men with ER+, PR+, HER2-negative metastatic breast cancer after treatment failure of CDK4/6 inhibitor and/or PIK3α inhibitors. Estrogen and progesterone drive progression in many breast cancer patients, but resistance after endocrine therapy is a clinical challenge given the broad use of antiestrogens. ONA-XR is an investigational, orally-administered full antagonist of PR, a key unchecked mechanism in women’s cancers, and this clinical trial will evaluate the potential of ONA-XR and fulvestrant to address this resistance and improve patient outcomes. ONA-XR is currently being evaluated in ongoing Phase 2 clinical trials in hormone-driven breast, ovarian and endometrial cancers. The trial will enroll up to 39 patients with ER+, PR+, HER2- metastatic breast cancer who have progressed on aromatase inhibitor and CDK4/6 inhibitor combination therapy. The primary endpoint will be the overall response rate (ORR), which is the proportion of patients with a complete or partial tumor response. Secondary endpoints will include duration of tumor response, progression-free survival (PFS), disease control rate, time to response and incidence of adverse events. “Context is honored to have WON Co-Principal Investigators Sailaja Kamaraju, MD, MS, Associate Professor at the Medical College of Wisconsin, Milwaukee and Kari Wisinski, MD, Professor, Interim Chief of the Division of Hematology, Medical Oncology and...