After Denying Data Leak, Olema Shares First Data For Lead Program In Breast Cancer Patients

Olema Pharmaceuticals Inc (NASDAQ: OLMA) had been preparing to present the first clinical data from its lead program in development for metastatic breast cancer at a conference next week. But its poster supposedly leaked online on Monday. 

• In response, Olema issued a statement saying the image was falsified and published topline results today.
• Early Tuesday morning, Olema issued another press release detailing the topline results from the Phase 1/2 trial of OP-1250.
• Olema said it observed only two confirmed partial responses (PR) and one unconfirmed PR, as well as a 17% overall response rate (ORR), and the clinical benefit rate (CBR) was 46% among patients taking a dose in the recommended Phase 2 range of 60-120 mg, OP-1250 once daily. 
• The data showed target lesion reduction up to 100% in a heavily pretreated patient population.
• 32% of patients (13/41) remained on treatment with efficacy data continuing to mature, including patients with confirmed partial responses.
• The first Phase 1b combination study with a CDK4/6 inhibitor is expected to initiate in Q1 2022, with additional combination studies with CDK4/6 and PIK3CA inhibitors planned in 2022. 
• A pivotal study for OP-1250 in the metastatic setting is expected to initiate in 2023.
• OP-1250 is an orally available small molecule with combined activity as a complete estrogen receptor antagonist and a selective ER degrader.
• Price Action: OLMA shares are down 60.7% at $8.61 during the market session on the last check Tuesday.