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Positive Results for Regorafenib (Stivarga) in Colorectal Cancer and GIST

Findings reported from two phase III trials (Nov. 27)

The results of two pivotal phase III studies of regorafenib (Stivarga, Bayer) have been published online in The Lancet. Data from the CORRECT (Metastatic COloRectal Cancer Treated With REgorafenib or PlaCebo After Failure of Standard Therapy) and GRID (GIST — Regorafenib In Progressive Disease) trials support the efficacy of regorafenib in patients with metastatic colorectal cancer (mCRC) or gastrointestinal stromal tumor (GIST) who have exhausted all other treatment options.

In the CORRECT trial, regorafenib plus best supportive care (BSC) significantly improved overall survival (OS) (hazard ratio [HR] = 0.77; P = 0.0052) and progression-free survival (PFS) (HR = 0.49; P < 0.000001) compared with placebo plus BSC in patients with mCRC whose disease had progressed after approved standard therapies. The median period of OS was 6.4 months with regorafenib versus 5.0 months with placebo. The median periods of PFS were 1.9 months and 1.7 months with regorafenib and placebo, respectively.

The data also showed a survival benefit in the regorafenib arm across nearly all subgroups analyzed, including no significant difference between patients with KRAS wild-type tumor and those with KRAS mutant tumor. No difference in the overall response rate was observed.

The most common grade 3+ adverse events (≥ 5% of patients) were hand–foot skin reactions (16.6% with regorafenib vs. 0.4% with placebo), fatigue (15.0% vs. 8.3%), diarrhea (8.2% vs. 2.0%), hypertension (7.6% vs. 0.8%), and rash/desquamation (5.8% vs 0.4%). Quality of life was not adversely affected by regorafenib. The most serious adverse drug reactions in patients receiving regorafenib were severe liver injury, hemorrhage, and gastrointestinal perforation.

The GRID trial showed that regorafenib plus BSC significantly improved PFS compared with placebo plus BSC (HR = 0.27; P < 0.000001) in patients with metastatic and/or unresectable GIST who were previously treated with imatinib or sunitinib, which equates to a 73% reduction in the risk of progression or death.

Moreover, a significantly greater disease control rate (DCR) was observed with regorafenib plus BSC compared with placebo plus BSC (52.6% vs. 9.1%, respectively; P < 0.000001). DCR was defined as the rate of complete response (CR) plus partial response (PR) plus durable stable disease (SD) maintained for at least 12 weeks.

The most common grade 3 regorafenib-related adverse events (≥ 5% of patients) were hypertension (27.3% with regorafenib vs. 4.5% with placebo), hand–foot skin reaction (20.5% vs. 0%), and diarrhea (7.6% vs. 0%). Grade 4 adverse events were reported at a similar incidence with regorafenib plus BSC versus placebo plus BSC (6.8% vs. 6.1%, respectively).

Source: Bayer HealthCare; November 27, 2012.

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