Stivarga: a new oral multikinase inhibitor

PHARMACOLOGY

Regorafenib is an oral tumour deactivation agent that inhibits multiple protein kinases, including those involved in tumour angiogenesis, oncogenesis and the tumour microenvironment.^1,2

CLINICAL STUDIES

The safety and efficacy of regorafenib were evaluated in the double-blind, phase III CORRECT study involving 760 patients with metastatic colorectal cancer that had progressed after failure of standard therapy.^1,2

Patients were randomised to receive best supportive care plus regorafenib 160mg (n=505) or placebo (n=255) once daily for the first 3 weeks of each monthly treatment cycle. Treatment was continued until disease progression or unacceptable toxicity occured. The primary outcome measure was overall survival.^1,2

Survival increased

Regorafenib produced a significant improvement in overall survival compared with placebo, of 6.4 versus 5 months (HR 0.77, 95% CI 0.64–0.94, p=0.0052). A significant improvement in progression-free survival, a secondary endpoint, was also observed (HR 0.494, p<0.000001).^1,2

Safety profile

The most common adverse effects observed in patients receiving regorafenib were hand-foot skin reaction, fatigue, diarrhoea, hypertension and rash.^1,2

References:

1. Stivarga Summary of Product Characteristics, August 2013.
2. Grothey A et al. Lancet 2013; 381: 303–12.

View Stivarga drug record

Further information: Bayer plc

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