Olema reports Phase 2 palazestrant results: median PFS 4.6 mo in all patients; 7.2 mo in 2nd/3rd-line subset

Olema Pharmaceuticals, Inc.

Palazestrant (OP-1250) median PFS of 4.6 months (CBR 40%) in 86 heavily pretreated metastatic ER+/HER2- breast cancer patients.
In ESR1-mutant patients (48% of ctDNA-assessed), median PFS 5.6 months, CBR 52%; in 2nd/3rd-line subset PFS 7.3 mo, CBR 59%.
Safety: well-tolerated at 120 mg; Grade 4 neutropenia in 6 patients (all prior CDK4/6i), managed with dose reduction/discontinuation.
Company plans to initiate OPERA-01, a Phase 3 pivotal monotherapy trial in 2nd/3rd-line metastatic breast cancer.
Results presented at ESMO 2023; Olema hosted investor call on Oct 23, 2023.

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