Olema reports positive Phase 1b/2 combo data for palazestrant; Phase 3 OPERA-01 enrolling

Olema Pharmaceuticals, Inc.

Palazestrant + ribociclib (19 patients) well-tolerated; no dose-limiting toxicities, no drug-drug interaction.
Palazestrant + palbociclib (46 patients): clinical benefit rate 46% overall, 60% in ESR1 mutant, 71% in CDK4/6-naïve.
OPERA-01 Phase 3 monotherapy trial initiated; first patient dosed November 2023; sites activated.
Company anticipates potential Phase 3 combo trial start with ribociclib as early as end 2024.

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