Bayer, Bristol-Myers Squibb and Ono Pharmaceutical Enter Into a Clinical Collaboration Agreement to Investigate Stivarga and Opdivo® as Combination Therapy in Patients With Metastatic Colorectal Cancer
Regorafenib as monotherapy has demonstrated an overall survival benefit versus placebo in the pivotal Phase III CORRECT study and has shown activity irrespective of micro-satellite status in a retrospective analysis from this study, though with limited responses observed. Despite progress in the treatment of CRC, including the advance of effective immuno-oncology (I-O) treatments for certain subsets of CRC, around 95% of mCRC patients have MSS tumors, for which I-O monotherapy treatment approaches have shown limited activity. Thus, the need for additional treatment options including combination approaches remains high. Encouraging early data have been seen with the combination of regorafenib and nivolumab. In a Phase 1b investigator sponsored trial from Japan called REGONIVO, the combination of regorafenib and nivolumab has shown promising preliminary efficacy results.1 The detailed data of the study were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. “The data seen in REGONIVO warrant further exploration of the combination of regorafenib and nivolumab in patients with colorectal cancer. Regorafenib has proven its efficacy and positive safety profile as a third-line monotherapy and we are excited to enter into a clinical collaboration to evaluate this combination with the hope to deliver an additional therapeutic benefit to patients,” said Scott Z. Fields, M.D., senior vice president and head of Oncology Development at Bayer’s Pharmaceuticals Division.