Business
Olema Oncology Reports Third Quarter 2023 Financial Results and Provides Corporate Update
OPERA-01 pivotal Phase 3 monotherapy clinical trial on track, with clinical site activation ongoing and first patient expected to be enrolled in fourth
About this update from Olema Pharmaceuticals, Inc.
[{"type":"text","content":"OPERA-01 pivotal Phase 3 monotherapy clinical trial on track, with clinical site activation ongoing and first patient expected to be enrolled in fourth quarterNew clinical data for palazestrant (OP-1250) in combination with CDK4/6 inhibitors to be presented at the 2023 San Antonio Breast Cancer Symposium (SABCS) in December Strong cash, cash equivalents and marketable securities position of $276.9 million as of September 30, 2023 SAN FRANCISCO, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema”, “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update. “With the recent oral presentation of our Phase 2 monotherapy clinical results at ESMO in Madrid, we are already experiencing increased awareness of and interest in our OPERA-01 Phase 3 monotherapy clinical trial,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “Our Phase 2 study of palazestrant in combination with ribociclib is now rapidly enrolling and we look forward to presenting new palazestrant combination data at SABCS in December, including a Poster Spotlight Discussion for our interim Phase 2 palbociclib combination clinical results. We are proud of the advancements we are making across our business, and as we progress our CERAN and KAT6 programs we remain focused on defining the next generation of targeted therapies for women’s cancers.” Recent Corporate Highlights OPERA-01, Olema’s first pivotal Phase 3 clinical trial testing palazestrant as a monotherapy in second- and third-line metastatic breast cancer is ongoing, including clinical site activation and first patient expected to be enrolled in the fourth quarter.Presented palazestrant Phase 2 monotherapy clinical study results as an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, on October 22, 2023. Results demonstrated that, across all 86 heavily pretreated patients, the median progression-free survival (PFS) was 4.6 months with a clinical benefit rate (CBR) of 40%; in patients with ESR1 mutations at baseline, the median PFS was 5.6 months with a CBR of 52%. In a subset ...