Zentalis reports azenosertib triplet achieves 35% ORR and 5.8-month PFS in BRAFi-naïve mCRC at ASCO 2025

Zentalis Pharmaceuticals, Inc.

ORR of 35.3% (12/34 confirmed responses) in BRAF inhibitor-naïve patients; median DoR 6.0 months (95% CI 4.4-NE).
Median PFS of 5.8 months (95% CI 3.9-9.2) in BRAF-naïve subset; prior BRAFi-treated patients had 1.8 months.
MTD set at azenosertib 300 mg + encorafenib 75 mg + cetuximab 500 mg/m2; no DLTs at MTD, manageable safety.
Most common TRAEs were asthenia (36%) and decreased appetite (34%); grade 3/4 asthenia occurred in 11% across all doses.
Efficacy exceeded historical encorafenib + cetuximab doublet (BEACON: ORR 20%, PFS 4.2 months) in BRAF-naïve mCRC.

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