Olema Oncology has aligned with the FDA to select 90mg once-daily palazestrant as the dose for Part 2 of the Phase 3 OPERA-01 monotherapy trial in second- and third-line ER+/HER2- metastatic breast cancer.
Olema Oncology's novel KAT6 inhibitor OP-3136 demonstrated potent anti-tumor activity in preclinical models of ovarian, prostate, and non-small cell lung cancer, expanding its potential beyond breast cancer.
Olema Oncology is progressing its pivotal Phase 3 OPERA-01 trial of palazestrant monotherapy in second/third-line metastatic breast cancer, with top-line data anticipated in 2026.
Olema Oncology has received FDA clearance for its Investigational New Drug (IND) application for OP-3136, a novel KAT6 inhibitor, marking a key regulatory milestone.