ESSA Pharma

ESSA Pharma terminated a phase 2 trial combining masofaniten and enzalutamide for metastatic castration-resistant prostate cancer after a futility analysis showed single-agent enzalutamide outperformed historical controls and was comparable to the combination. The decision was made as the study was unlikely to meet its primary endpoint of PSA90 response, with 64% in the combination arm vs 73% in the monotherapy arm achieving PSA90. The combination was well-tolerated, but the company plans to terminate other masofaniten trials.

ESSA Pharma terminates Phase 2 trial of masofaniten plus enzalutamide in mCRPC patients due to futility analysis showing no clear efficacy benefit over enzalutamide monotherapy. Additional masofaniten studies, including combinations with abiraterone acetate and apalutamide, will also be terminated. The company will explore strategic options to maximize shareholder value.

Masofaniten + enzalutamide well-tolerated, showing durable PSA reductions in mCRPC patients. Phase 2 expansion ongoing with 600 mg BID masofaniten + 160 mg QD enzalutamide. 88% achieved PSA90, 69% in <90 days, 63% PSA <0.2ng/mL. Median time to PSA/radiographic progression not yet reached after 15.2 months.