Olema Pharmaceuticals announced updated clinical results from the ongoing Phase 1b/2 study of palazestrant in combination with CDK4/6 inhibitor, ribociclib, in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. Results as of September 25, 2024, will be presented in a poster session at the San Antonio Breast Cancer Symposium being held December 10-13 at the Henry B. Gonzalez Convention Center in San Antonio, Texas. Interim Results from the Phase 1b/2 Study of Palazestrant in Combination with Ribociclib: With a median follow-up of 12 months, the median PFS was not reached as of the data cutoff date. Across all patients, the 6-month PFS rate was 73%. In those who received prior treatment with a CDK4/6i plus an endocrine therapy, the 6-month PFS rate was 68%. The 6-month PFS rate in ESR1 mutant patients was 81% and in ESR1 wild-type patients it was 70%. In those who were clinical benefit rate 1-eligible, the CBR was 76% in all patients, 81% in patients with ESR1 mutations, and 74% in ESR1 wild-type patients. In patients with prior CDK4/6i treatment, the CBR was 71%, 81% in patients with ESR1 mutations, and 65% in ESR1 wild-type patients. As of the data cutoff date, there were 11 responses. Among 37 response-evaluable patients with measurable disease, the ORR was 27%. 60% of the 37 had a reduction in target lesion size.
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