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Bayer's regorafenib boosts survival in colorectal cancer

Pharma firm's Xarelto also approved in Japan for stroke prevention in patients with non-valvular atrial fibrillation

Bayer's cancer drug regorafenib prospect has been shown to improve overall survival by 29 per cent in patients with advanced colorectal cancer in a phase III trial.

The scale of the improvement, particularly as it was seen in patients with metastatic colorectal cancer who had already failed prior treatment regimens, has prompted suggestions it could be a new "standard of care" in this indication.

Top-line data from the 760-patient CORRECT trial showed that in addition to improvement in overall survival, regorafenib was associated with a significant increase in progression free survival and disease control rate, according to Bayer.

Overall survival was extended from 5.0 months with placebo to 6.4 months with regorafenib, both given on top of best supportive care.

Similarly, median progression-free survival increased to 1.9 months from 1.7 months, and disease control rates were 15.3 per cent for placebo and 44.8 per cent with Bayer's drug.

The difference in overall response rates between regorafenib and placebo did however no reach statistical significance.

"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," said Professor Eric van Cutsem of the University Hospital Leuven in Belgium, one of the lead investigators for CORRECT.

"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," he added.

Bayer will present the CORRECT results at the forthcoming 2012 Gastrointestinal Cancers Symposium, and said the data would be the basis for a regulatory filing in colorectal cancer later this year. Regorafenib is also in testing for gastrointestinal stromal tumours (GIST).

Regorafenib is one of four late-stage compounds that Bayer has predicted could collectively add €5bn to its revenues at peak.

Xarelto cleared in Japan

Another of Bayer's bright prospects - the oral anticoagulant Xarelto (rivaroxaban) - has just been approved in Japan for stroke prevention in patients with non-valvular atrial fibrillation.

The drug was first introduced in the US earlier this year for the prevention of deep vein thrombosis in people undergoing knee or hip replacement surgery.

Xarelto was cleared for stroke prevention in AF patients in the US last November, despite earlier reservations by FDA staff reviewing the application, and has been recommended for approval in this indication by the EMA.

18th January 2012

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