Darolutamide + Leuprolide Yields 40% PR Rate in AR+ Salivary Gland Cancer
- Trial ID
- NCT05669664 on ClinicalTrials.gov
- Cancer type
- Salivary Gland Head and Neck Cancer
- Published in
- DOUBLE ISSUE: New in Oncology - July 8, 2026
Darolutamide is a nonsteroidal androgen-receptor inhibitor, combined here with leuprolide acetate to deepen androgen-axis suppression in hormone-therapy-naïve recurrent/metastatic or unresectable AR+ salivary gland cancer. In the Phase 2 ETCTN 10553 trial (NCT05669664), 20 patients had 8 partial responses (40%; 7 confirmed), 10 stable diseases (50%), and 1 progressive disease, with 65% still on treatment at cutoff. The response rate is similar to prospective combined androgen blockade benchmarks in AR+ salivary duct carcinoma and appears better than prior enzalutamide monotherapy, though PFS and OS are not yet reported.
Take home
This supports AR blockade as a real treatment lane in AR+ salivary gland cancer, but darolutamide still needs durability data to prove it improves on older combined androgen blockade rather than simply matching it.
Source: Read the original publication
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