Dr. Kim on the Investigation of Regorafenib in mCRC

Richard Kim, MD, medical oncologist, Gastrointestinal Oncology Department at Moffitt Cancer Center, discusses studies investigating regorafenib (Stivarga) in metastatic colorectal cancer (mCRC).

Regorafenib is an oral multikinase inhibitor approved for use in patients with mCRC following progression after prior therapy. The results of the phase III CORRECT trial showed improvement in progression-free survival (PFS) and overall survival (OS).

In the trial, patients in the regorafenib cohort had a median OS of 6.4 months versus 5.0 months in the placebo arm (hazard ratio [HR] = 0.77; 95% CI, 0.64—0.94; P = .0052). The regorafenib arm experienced a median PFS of 1.9 months versus 1.7 months in the placebo arm (HR = 0.49; 95% CI, 0.42—0.58; P < .000001).

The next step, Kim says, is to move regorafenib to the second-line setting in combination with the chemotherapy regimen FOLFIRI (leucovorin calcium, fluorouracil, irinotecan hydrochloride). To examine this, a multi-institution trial has begun to analyze FOLFIRI plus regorafenib compared to FOLFIRI plus placebo. The trial has accrued 50 patients to this point.