Bayer To Submit Regorafenib After Positive Survival Statistics

Bayer has provided more information about their recently-halted late-stage trial of their colorectal cancer drug, regorafenib, which shows that the drug improved overall survival by 29%, meeting its primary endpoint.

In October, the Phase III CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial, which contained 760 patients with metastatic colorectal cancer, was stopped prematurely so that all the participants could be offered treatment with regorafenib, an oral multi-kinase inhibitor.  The German group have now announced that patients on the drug lived a median of 6.4 months longer, compared with five months for those on placebo.

The CORRECT trial also met its two secondary efficacy endpoints, to significantly improve progression-free survival and improve the disease control rate.

Eric van Cutsem of Belgium’s University Hospital Leuven, and coordinating investigator of the study, commented 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”.

“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,” he added.

Bayer plans to submit regorafenib for approval in metastatic colorectal cancer in 2012 and the drug is currently in trials to assess it’s potential to treat patients with numerous tumour types.

Kemal Malik, MD, Member of the Bayer HealthCare Executive Committee and Head of Global Development stated that “we look forward to generating further data for this compound, including results from our other Phase III trial of regorafenib in gastrointestinal stromal tumours.”

Bayer and 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.

Japanese Approval for Xarelto

Meanwhile, Bayer received an additional boost with the news that their 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 authorisation is centred on the outcome of the worldwide 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.


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