Dr. Barzi on Combination Regorafenib and Pembrolizumab in MSS CRC

Afsaneh Barzi, MD, PhD, medical oncologist, director, Employer Strategy (AccessHope), associate professor, Department of Medical Oncology and Therapeutics Research, City of Hope, discusses the combination of regorafenib (Stivarga) and pembrolizumab (Keytruda) in patients with microsatellite stable colorectal cancer.

The combination was evaluated in a phase 1/2 dose escalation study (NCT03657641) with the primary end point of determining the recommended phase 2 dose (RP2D) of regorafenib to be used with a fixed dose of 200 mg pembrolizumab every 3 weeks, Barzi says.

In phase 1, regorafenib was given daily at 80 mg in cohort 1, 120 mg in cohort 2, and 160 mg in cohort 3 on days 1-14 for each 21-day cycle, Barzi explains. After determining the RP2D of 80 mg of regorafenib, phase 2 had the primary end point of progression-free survival, compared with historical data from the phase 3 CORRECT trial (NCT01103323), which evaluated single-agent regorafenib vs placebo, Barzi adds.

After being initiated in June 2019, the phase 1/2 trial completed accrual in July 2021. Of 74 patients enrolled, 73 met the eligibility criteria, with 10 patients treated in phase 1 and 63 treated in phase 2, Barzi concluded.