Olema Oncology Announces Promising New Data for Palazestrant in Combination with Ribociclib Presented at the 2024 ESMO Breast Cancer Congress

Core Insights - Olema Pharmaceuticals announced interim results from a Phase 1b/2 clinical study of palazestrant (OP-1250) in combination with ribociclib for treating ER+/HER2- metastatic breast cancer, with results to be presented at the 2024 ESMO Breast Cancer Annual Congress [1][2] Enrollment and Study Design - As of March 13, 2024, 50 patients with recurrent, locally advanced or metastatic ER+/HER2- breast cancer were treated, with 74% being 2nd/3rd line+ and 70% having prior CDK4/6 inhibitors [3] - The study is fully enrolled with a total of 60 patients [3] Pharmacokinetics and Safety - Palazestrant showed high oral bioavailability, a half-life of eight days, and was well tolerated with no new safety signals [4][5] - The combination treatment had an 85% clinical benefit rate (CBR) across all eligible patients, indicating promising preliminary efficacy [4][5] Efficacy Results - The CBR was 83% in ESR1-mutant patients and 86% in ESR1-wild-type patients, with partial responses observed in five patients [5][8] - 66% of patients remained on treatment as of the data cut-off, with the longest duration on treatment being 44 weeks [8] Company Overview - Olema Oncology is focused on transforming the standard of care for women with cancer, advancing a pipeline of novel therapies including palazestrant, which has received FDA Fast Track designation [11][12]