Dr. Fukuoka on Dosage for Regorafenib/Nivolumab Combo in Gastric Cancer and CRC

Shota Fukuoka, MD, physician, National Cancer Center in Japan, discusses finding the recommended dosage of regorafenib (Stivarga) plus nivolumab (Opdivo) in patients with advanced gastric cancer or colorectal cancer (CRC).

The first cohort was used to determine the recommended dose, according to Kukuoka. Previously treated patients with advanced gastric cancer or CRC were given 80 to 160 mg of regorafenib daily for 21 days on and 7 days off with intravenous nivolumab at 3 mg/kg every 2 weeks. Researchers wanted to determine the dose-limiting toxicity (DLT) as the primary endpoint.

The dose-expansion cohort of patients received 80 mg of regorafenib plus nivolumab. The combination had a manageable safety profiles and encouraging antitumor activity in patients with gastric cancer and CRC. The objective response rate was 40% for all patients, 44% for patients with gastric cancer, and 36% for patients with CRC. The median progression-free survival was 6.3 months. Fukuoka believes these results warrant further research.