Olema gets FDA IND clearance for OP-3136; palazestrant combo shows 73% 6-month PFS

Olema Pharmaceuticals, Inc.

FDA cleared IND for KAT6 inhibitor OP-3136; Phase 1 to start early 2025.
Phase 1b/2 palazestrant + ribociclib: median PFS not reached at 12-month follow-up.
6-month PFS rate 73% overall, 81% in ESR1 mutant patients, 68% after prior CDK4/6i.
ORR 27% (10/37) in measurable disease; 76% CBR overall.
Combination well tolerated with no new safety signals; plans for Phase 3 OPERA-02 in 2025.

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