Bayer’s colorectal cancer drug increases survival
pharmafile | January 19, 2012 | News story | Research and Development, Sales and Marketing | Bayer, colectoral cancer, regorafenib
Bayer and Onyx’s colorectal cancer drug regorafenib increased overall survival for late-stage patients, according to new data.
The Phase III study tested regorafenib plus best supportive care (BSC), versus placebo plus BSC in patients with metastatic colorectal cancer, whose disease has progressed after use with Roche’s Avastin and chemotherapy.
The study met its primary endpoint of improving overall survival by 1.4 months compared to placebo (6.4 months versus 5 months), and increased progression-free survival by 0.2 months compared to placebo (1.9 months versus 1.7 months).
Bayer and its partner Onyx said they were now looking to submit the drug for marketing authorisation this year based on these results.
The firms expect to make more than €2 billion ($2.8 billion) in peak annual sales from the treatment.
The CORRECT data also showed that regorafenib increased the disease control rate by 44.8% compared to 15.3% for the placebo group.
But the drug failed to improve the objective response rate, meaning that the percentage of people whose cancer has decreased over time was no better compared to placebo.
Professor Eric van Cutsem, University Hospital Leuven, Belgium, who was involved in the study, said: “These data are noteworthy because they demonstrate that regorafenib can stabilise disease, even at an advanced stage, and prolong life in patients with metastatic colorectal cancer who have no other treatment options available.”
The drug is as an oral multi-kinase inhibitor of angiogenic, stromal and oncogenic kinases, and has a similar mode of action to Bayer’s liver and kidney cancer treatment Nexavar.
Professor van Cutsem added: “To date regorafenib is the only oral multi-kinase inhibitor as monotherapy that has demonstrated in a large Phase III trial the ability to improve clinical outcomes in patients with advanced refractory colorectal cancer.
“The data suggest that regorafenib may provide a new standard of care for the treatment of refractory metastatic colorectal cancer.”
The CORRECT study is being presented at the ASCO GI cancer conference, which focuses on treatments aimed at treating gastrointestinal cancers.
Bayer is also testing regorafenib against a number of tumour types, including kidney cancer and for gastrointestinal stromal tumours.
Ben Adams
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