Bayer has announced positive results from a Phase III trial of regorafenib for the treatment of metastatic colorectal cancer to the extent that the study has been halted.
The CORRECT trial, which involved 760 patients with mCRC whose disease has progressed after approved standard therapies, met its primary endpoint of statistically significantly improving overall survival. After an interim analysis by an independent data monitoring committee, the study has been unblinded and patients in the placebo arm will be offered treatment with regorafenib, an oral multi-kinase inhibitor.
Kemal Malik, head of global development at Bayer, said these data are significant because "they demonstrate that regorafenib increases overall survival in patients with heavily pretreated mCRC, an area of high unmet medical need". The company will continue discussions with health authorities worldwide regarding the next steps in filing for approval.
The data has been published a fortnight after Bayer and partner Onyx Pharmaceuticals settled their long-running battle over rights concerning regorafenib. 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.