Context Therapeutics - Initial data from the SMILE study encouraging

Context Therapeutics has announced encouraging four-month progression-free survival (PFS) data from the Phase II SMILE trial, which is investigating the company’s first-in-class, oral progesterone receptor antagonist ONA-XR (onapristone extended release) in HR+/HER2- metastatic breast cancer (mBC). The preliminary findings, presented recently at the San Antonio Breast Cancer Symposium (SABCS), demonstrate that patients treated with ONA-XR in combination with fulvestrant had a four-month PFS of 44% (n=9) and the combination was well-tolerated. Considering the fulvestrant monotherapy following progression of CDK4/6 inhibitors has been shown to offer a median PFS of approximately two months in the same population, we view the reported results as encouraging, although it is too early to draw definitive conclusions from the preliminary data. Nevertheless, we view this as another positive development following the recent readout for endometrial cancer.