Shota Fukuoka, MD, PhD
The combination of regorafenib (Stivarga) and nivolumab (Opdivo) elicited an overall response rate (ORR) of 40% and a disease control rate (DCR) of 88% in previously treated patients with gastric cancer or colorectal cancer (CRC), according to phase Ib results of the REGONIVO trial, which were presented at the 2019 ASCO Annual Meeting.
In the study, two cohorts of 50 total patients with previously treated advanced or metastatic gastric cancer or CRC were enrolled and received the combination of regorafenib and nivolumab. Ninety-eight percent of patients had microsatellite stable (MSS) disease, 59% had PD-L1–negative tumors, and 14% had received prior treatment with a PD-1/PD-L1 inhibitor(s).
The purpose of the first cohort was to find the least toxic dosage for treatment (the dose-finding cohort), while the second cohort helped researchers develop an understanding of the combination’s safety and efficacy (the dose-expansion cohort). Patients in the dose-escalation cohort were given 80 mg, 120 mg, or 160 mg of regorafenib once daily for 21 days with 7-day gaps in between plus 3 mg of nivolumab every 2 weeks.
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