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Bayer, Bristol-Myers Squibb and Ono Pharmaceutical enter into a clinical collaboration agreement

Bayer, Bristol-Myers Squibb Company (NYSE: BMY) and Ono Pharmaceutical Co., Ltd. (“Ono”) announced today the three companies have entered into a clinical collaboration agreement to evaluate the combination of Bayer’s kinase inhibitor Stivarga® (regorafenib) and Bristol-Myers Squibb’s / Ono’s anti-PD-1 immune checkpoint inhibitor, Opdivo® (nivolumab) in patients with micro-satellite stable metastatic colorectal cancer (MSS mCRC), the most common form of mCRC.(1)

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.(2,3) 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.(4) Thus, the need for additional treatment options including combination approaches remains high.(4) Encouraging early data have been seen with the combination of regorafenib and nivolumab. In a Phase 1b investigator sponsored trial from Japan called REGONIVO (NCT03406871, EPOC1603), 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.

“We continue to invest in innovative approaches to maximize the potential of our pipeline, and interrogate new combinations to help more patients with cancers typically not responsive to I-O therapy,” said Fouad Namouni, M.D., head of development, oncology, Bristol-Myers Squibb. “We are looking forward to a strong collaboration to investigate nivolumab with regorafenib, with the goal of serving more patients who have cancer.”

“We have been actively engaged in the development of nivolumab including combination therapies with other agents. We are excited to initiate the clinical collaboration with Bayer and Bristol-Myers Squibb to investigate this combination therapy as a new treatment option for patients with colorectal cancer and other types of cancer,” said Kiyoaki Idemitsu, Corporate Officer, Executive Director, Clinical Development, Ono.

Further terms of the clinical collaboration were not disclosed.