Olema Pharma's OP-3136 Phase 1 shows anti-tumor activity
Olema Pharmaceuticals announced preliminary Phase 1 clinical data for OP-3136, a potent KAT6 inhibitor, demonstrating acceptable tolerability and promising anti-tumor activity as a monotherapy across multiple advanced solid tumor types. The study observed tumor shrinkage in over two-thirds of evaluable patients, including 3 partial responses (2 confirmed), with no dose-limiting toxicities or discontinuations due to adverse events. These results, supported by on-target engagement and predictable pharmacokinetics, reinforce confidence in OP-3136's potential and support ongoing Phase 1 evaluation, including combination studies. Olema will present these data and a Phase 3 trial-in-progress poster at the upcoming ASCO Annual Meeting.
Key Highlights
- OP-3136 monotherapy was well-tolerated with no dose-limiting toxicities observed up to 45 mg/day.
- No treatment discontinuations occurred due to treatment-related adverse events.
- Tumor shrinkage was observed in 13 of 19 (over two-thirds) response-evaluable patients.
- 3 partial responses (PRs) were observed, with 2 confirmed PRs, in measurable disease.
- The longest duration of treatment is 62 weeks, with 11 patients remaining on treatment.
- OP-3136 demonstrated rapid, sustained, and significant reduction in KAT6 target levels.
- Preliminary Phase 1 data for OP-3136 will be presented at ASCO on May 30, 2026.
- A trial-in-progress poster for the Phase 3 OPERA-02 trial will be presented at ASCO on June 1, 2026.
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