Olema Oncology and Bayer to Launch Phase 1b/2 OP-3136/Darolutamide Trial in 36 Patients
OLMA•Olema Oncology will launch a Phase 1b/2 study of its KAT6 inhibitor OP-3136 combined with Bayer’s darolutamide (NUBEQA) in about 36 metastatic castration-resistant prostate cancer patients, expected to start in H2 2026. Bayer will supply darolutamide while Olema leads the trial and jointly owns the resulting clinical data.
1. Collaboration Details
Olema Oncology has entered into a clinical trial collaboration and supply agreement with Bayer to evaluate its investigational KAT6 inhibitor OP-3136 in combination with Bayer’s androgen receptor inhibitor NUBEQA (darolutamide). This marks the first clinical partnership for OP-3136, expanding Olema’s oncology pipeline into metastatic castration-resistant prostate cancer.
2. Trial Design and Timeline
The Phase 1b/2 study will enroll approximately 36 patients with metastatic castration-resistant prostate cancer to assess safety, tolerability and preliminary anti-tumor activity of the OP-3136/darolutamide combination. Patient dosing is slated to begin in the second half of 2026 under Olema’s sponsorship.
3. Commercial and Intellectual Property Terms
Under the agreement, Bayer will supply darolutamide for the study while Olema will lead trial conduct and logistics. All clinical data and inventions arising from the combination will be jointly owned, and Olema retains full global commercial and marketing rights to OP-3136.
4. OP-3136 Pipeline Context
OP-3136 is an oral lysine acetyltransferase 6 (KAT6) inhibitor with preclinical anti-proliferative activity in breast and other cancers and demonstrated synergy with endocrine therapies. The agent cleared its IND in December 2024 and is currently in a Phase 1 monotherapy study, with initial data to be presented at ASCO on May 30, 2026.
