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

Olema Pharmaceuticals Inc 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.