Regorafenib: Additional Phase III data

Additional data from the double-blind, international Phase III GRID trial in 199 patients showed that oral regorafenib plus best supportive care (BSC) non-significantly improved OS, a secondary endpoint, vs. placebo plus BSC (HR=0.772, p=0.199). Bayer said the OS endpoint did not reach statistical significance due to the crossover design of the trial in which patients who received placebo were eligible to receive regorafenib following disease progression. Additionally, regorafenib plus BSC significantly improved DCR vs. placebo plus BSC (52.6% vs. 9.1%, p<0.000001). The trial enrolled patients with metastatic and/or unresectable GIST whose disease had progressed despite prior treatment with at least imatinib and sunitinib to receive placebo or once-daily 160 mg oral regorafenib for the first 3 weeks of a 4-week cycle, plus BSC. BSC excluded any disease-specific anti-cancer therapy such as any kinase inhibitor, chemotherapy, radiation therapy or surgery. Data were published in The Lancet. Bayer previously reported that regorafenib plus BSC met the primary endpoint of median PFS vs. placebo plus BSC (4.8 vs. 0.9 months, p<0.0001) (see BioCentury, April 9 & June 18).

In October, FDA accepted and granted Priority Review to an NDA for regorafenib to treat metastatic and/or unresectable GIST in patients whose disease has progressed despite prior treatment. Bayer submitted the NDA in late August; a 6-month Priority Review would place the PDUFA date in late February or early March. A specific date was not disclosed (see BioCentury, Nov. 5). In September, FDA approved regorafenib as Stivarga to treat previously treated metastatic colorectal cancer (mCRC). An MAA is also under review in Europe for regorafenib to treat mCRC (see BioCentury, Oct. 1). ...