Olema reports palazestrant + ribociclib Phase 1b/2 mPFS of 15.5 months in ER+/HER2- MBC

Olema Pharmaceuticals, Inc.

As of July 8, 2025, 72 patients enrolled across 90 mg and 120 mg palazestrant dose cohorts with ribociclib 600 mg.
Median PFS for 120 mg cohort (56 patients) was 15.5 months for all; 12.2 months in prior CDK4/6i patients.
In prior CDK4/6i patients, mPFS was 9.2 months (ESR1 wild-type) and 13.8 months (ESR1 mutant tumors).
Combination well tolerated, no new safety signals, no drug-drug interactions, consistent with known profiles.
Data support ongoing Phase 3 OPERA-02 trial evaluating palazestrant + ribociclib in frontline MBC.

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