New Indication: Darolutamide in Androgen Receptor Positive Salivary Gland Carcinoma

The DISCOVARY trial investigated darolutamide as monotherapy and in combination with goserelin in patients with AR-positive salivary gland carcinoma. The combination cohort demonstrated a numerically higher objective response rate of 45.2% compared to 8.3% in the monotherapy cohort. Median progression-free survival was also more favorable in the combination arm at 13.1 months versus 5.7 months for monotherapy.

Study

Phase II, multicenter, single-arm, sequential cohort study [DISCOVARY]

Adults with AR-positive unresectable or recurrent/metastatic salivary gland carcinoma

Darolutamide monotherapy (n=24) vs Darolutamide plus goserelin (n=33)

Efficacy

ORR: 8.3% (monotherapy) vs 45.2% (combination)

mPFS: 5.7 mos (monotherapy) vs 13.1 mos (combination)

12-month OS: 91.3% (monotherapy) vs 87.0% (combination)

Safety

Grade >=3 AE: neutropenia (4.2% vs 3.0%), laryngeal edema (4.2% vs Not reported), drug rash (4.2% vs Not reported), arthritis (4.2% vs Not reported), rhabdomyolysis (4.2% vs Not reported), hypercalcemia (Not reported vs 3.0%), infection (Not reported vs 3.0%), hypersensitivity (Not reported vs 3.0%), atrial fibrillation (Not reported vs 3.0%), jawbone necrosis (Not reported vs 3.0%)