ONO PHARMA partners with Bristol Myers SquibbBristol-Myers Squibb ( BMY ), Bayer and Ono Pharmaceutical (OPHLY) have entered into a clinical collaboration agreement to evaluate the combination of Bayer's kinase inhibitor Stivarga and Bristol-Myers Squibb's / Ono's anti-PD-1 immune checkpoint inhibitor, Opdivo in patients with micro-satellite stable metastatic colorectal cancer, the most common form of mCRC. Regorafenib as monotherapy has demonstrated an overall survival benefit versus placebo in a Phase III study and has shown activity irrespective of micro-satellite status in a retrospective analysis from this study, though with limited responses observed. Around 95% of mCRC patients have MSS tumors, for which I-O monotherapy treatment approaches have shown limited activity. In a Phase 1b trial from Japan, the combination of regorafenib and nivolumab has shown 'promising' preliminary efficacy results. Further terms of the clinical collaboration were not disclosed.
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