Bayer has provided more details about its recently-halted late-stage trial of its colorectal cancer drug regorafenib which shows that it improved overall survival by 29%.
In October, the Phase III CORRECT trial, which involved 760 patients with metastatic colorectal cancer was topped early so that all participants would be offered treatment with regorafenib, an oral multi-kinase inhibitor. Now the German group says that people on the drug lived a median 6.4 months longer, compared with five months for those on placebo.
The CORRECT trial also met two secondary efficacy endpoints, namely significant improvements in progression-free survival and in the disease control rate. Bayer plans to submit regorafenib for approval in metastatic colorectal cancer in 2012 and the drug is also in trials to evaluate its potential to treat patients with various tumour types.
The company quoted Eric van Cutsem of the University Hospital Leuven in Belgium and a coordinating investigator of the study, as saying that "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". He added that "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" and the data suggest it may provide "a new standard of care".
Bayer and partner Onyx Pharmaceuticals settled their long-running battle over rights concerning regorafenib in October last year. In May 2009, Onyx sued over the rights to the drug, claiming it is a variant of the two firms' Nexavar (sorafenib) while Bayer had always insisted that regorafenib is not covered by a collaboration the companies signed in 1994.
The settlement recognised that regorafenib is a Bayer compound, while Onyx will receive a 20% royalty. The US biotech will not have to pay any development and commercialisation costs and has a co-promotion option in the USA.
Xarelto approved in Japan for stroke prevention
Meantime Bayer received a further boost with the news that its once-daily oral anticoagulant Xarelto (rivaroxaban) has been approved for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation by the Japanese Ministry of Health, Labor and Welfare.
The approval is based on the results of the global ROCKET AF study and the J-ROCKET AF study, which was run entirely in Japan. Both studies investigated rivaroxaban versus dose-adjusted warfarin in patients with non-valvular AF at risk of stroke.