Significant Clinical Benefit in Patients with Androgen Receptor-positive Salivary Gland Carcinoma Due to Darolutamide (ODM-201) Administration

Darolutamide for Salivary Gland Cancer

A clinical study of darolutamide (ODM-201) in patients with androgen receptor-positive salivary gland carcinoma was conducted where 24 subjects were administered the therapy until disease progression or unacceptable toxicity. The primary outcomes were objective response rate (ORR) assessed by investigators, while the secondary outcomes included duration of response (DOR), best overall response (BOR), disease control rate (DCR), clinical benefit rate (CBR), and others.

According to the results presented at ASCO 2023, no patients had a complete response (CR), while two patients had a partial response (PR). Eleven patients were reported to have stable disease (SD), nine patients have progressive disease (PD), and two patients were not assessed. However, the ORR by independent central review (ICR) was 20.8% whereas the ORR was just 8.3%.

The DCR was 58.3%, while the CBR was 41.7%. Additionally, the OS was not evaluable, whereas the PFS was 5.7 months.

As for safety is concerned, Grade I/II adverse events (AEs) with a frequency of 10% or above were gynecomastia (20.9%), nausea (16.7%), constipation, dermatitis, exhaustion, fever, aspartate aminotransferase rise, alanine transaminase increase, and anemia (12.5% each). One patient (4.2%) each experienced Grade III lymphocytopenia, neutropenia, edema, GTP rise, anaphylactic shock, shingles, urinary tract infection, drug rash, arthritis, and rhabdomyolysis. Grade IV lymphocytopenia and laryngeal edema occurred in one patient each (4.2%).

KOL insights

“Depending on the histology, androgen receptor overexpression has been found to be more prevalent in salivary duct carcinoma and has been suggested as a possible molecular target for salivary gland cancer.”-Expert Opinion.


Although the study did not meet the primary endpoint, clinically significant activity and a well-tolerated safety profile were validated by the response rate measured by the ICR and other secondary endpoints