The European Commission recently announced that Stivarga (regorafenib) from Bayer has been approved in the European Union (EU) as a third line treatment for adult patients with unresectable or metastatic GIST. Adult patients who have progressed on or are intolerant to prior treatmentswith imatinib (Glivec) and sunitinib (Sutent) will now have this drug available. The approval of regorafenib for GIST is based on results from the pivotal Phase III study (GRID) that demonstrated a statistically significant improvement in progression-free survival (PFS) compared to placebo in patients with GIST whose disease had progressed after prior treatments.
Results from this study showed that regorafenib plus best supportive care (BSC) significantly improved progression-free survival (PFS) compared to placebo plus BSC (HR=0.268 [95% CI 0.185-0.388], p<0.0001) in patients with metastatic and/or unresectable GIST who were previously treated with imatinib and sunitinib, reducing the risk of progression or death by 73%. The median PFS was 4.8 months in the regorafenib arm versus 0.9 months in the placebo arm (p<0.0001). The increase in PFS was consistent and independent of patient age, sex, geographic region, prior lines of treatment or ECOG performance status.
In addition to the EU, Stivarga is also approved for GIST in the US and Japan, having been approved in the US on February 25, 2013, and in Japan on August 20, 2013. Regorafenib is already approved in the EU for the treatment of patients with metastatic colorectal cancer (mCRC).