Olema Pharmaceuticals (OLMA) 7th Annual Oncology Innovation Summit: Insights for ASCO & EHA summary

KAT6 inhibitor program and clinical data

• Lead molecule OP-3136 is advancing in phase I, with focus on monotherapy dose escalation and early efficacy data showing tumor shrinkage in breast and prostate cancer patients.

• OP-3136 demonstrates potent KAT6/KAT7 inhibition with reduced off-target effects, suggesting improved tolerability compared to less selective competitors.

• No dose-limiting toxicities or maximum tolerated dose identified yet; dose escalation continues, indicating a favorable safety profile.

• Combination trials with fulvestrant and palbociclib in breast cancer are ongoing, with a NUBEQA combination in prostate cancer starting soon.

• Lung cancer is included in the trial based on preclinical data, but future exploration will depend on accumulating evidence.

Combination strategies and differentiation

• Most future use is expected in combination with endocrine agents or targeted therapies, as monotherapy is less likely to be standard.

• Preclinical data for palbociclib combinations are promising, and the company is uniquely positioned to combine with this agent.

• The primary focus in breast cancer is on combinations, with fulvestrant as a comparator and palbociclib as the main strategic partner.

• Potential for future combinations with CDK4/6 inhibitors if tolerability remains favorable.

Clinical trial updates and timelines

• OPERA-01 phase III readout is expected in the fall, targeting both ESR1 mutant and wild type populations, with the wild type setting representing a significant unmet need.

• OPERA-02 is actively enrolling, with data potentially after 2028, though timelines may shift based on control arm performance and trial design adjustments.

• Upcoming data from persevERA and SERENA-4 trials may influence OPERA-02 design and patient numbers.