Site Editor
William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Thursday, October 27, 2022
The randomized, phase II UCBG3-06 START trial, testing darolutamide’s effect in patients with triple-negative, androgen receptor (AR)-positive advanced breast cancer, demonstrated clinical activity for some study participants, although the primary endpoint of clinical benefit rate was not met at 16 weeks. Monica Arnedos, MD, PhD, of the Institut Bergonié, Bordeaux, France, and colleagues presented study findings during the European Society for Medical Oncology (ESMO) Congress 2022 (Abstract 213MO). The team explained that the AR inhibitor darolutamide will continue to be the focus of a research program to identify predictive biomarkers of sensitivity.
The trial included 94 patients previously treated with up to one line of chemotherapy for advanced disease; they were randomly assigned on a 2:1 basis to receive darolutamide (n = 61) or capecitabine (n = 33) until disease progression or unacceptable toxicity. A clinical benefit at 16 weeks was observed in 13 of the 53 evaluable patients in the darolutamide arm (24.5%), including one complete response and two partial responses. A total of 11 of the 23 evaluable patients in the capecitabine arm (47.8%) demonstrated a clinical benefit. The sensitivity analysis revealed clinical benefit rates at 16 or more weeks of 29.3% and 59.4% in the darolutamide and capecitabine arms, respectively (17 of 58 and 19 of 32 evaluable patients).
Median progression-free survival, a secondary endpoint, was 1.8 months and 3.6 months in the darolutamide and capecitabine arms, respectively. Another secondary endpoint was safety. In the darolutamide arm, asthenia (26.7%), nausea (25%), and increased aspartate aminotransferase levels (21.7%) were the most common adverse events. “The majority were grade 1 or 2, similar to previous safety data,” noted Dr. Arnedos and co-investigators. Three patients taking darolutamide and four taking capecitabine reported drug-related serious adverse events.
Disclosure: The study was funded by Bayer. The study authors reported no conflicts of interest.
JNCCN Spotlights
