Bayer, Bristol-Myers Squibb and Ono Pharmaceutical have entered into a clinical collaboration to evaluate the combination of Stivarga (regorafenib) with Opdivo (nivolumab) in patients with micro-satellite stable metastatic colorectal cancer (MSS mCRC).
Stivarga on its own has previously demonstrated an overall survival benefit versus placebo in the pivotal Phase III CORRECT study, and has shown activity irrespective of micro-satellite status.
Encouraging early data have been seen with the studied combination, such as in a Phase Ib investigator sponsored trial from Japan called REGONIVO, the combination of Opdivo and Stivarge showed promising preliminary efficacy results. 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, senior vice president and head of Oncology Development at Bayer's Pharmaceuticals Division.
Colorectal cancer, also known as bowel cancer, is a cancer that starts in the colon or the rectum. It is one of the most common types of cancer diagnosed in the UK. Most people diagnosed with it are over the age of 60.