Policy & Regulation
Bayer, Bristol-Myers Squibb and Ono Pharmaceutical Enter Into a Clinical Collaboration Agreement to Investigate Stivarga (regorafenib) and Opdivo (nivolumab) as Combination Therapy in Patients With Metastatic Colorectal Cancer
19 July 2019 - - German drugmaker Bayer, US-based Bristol-Myers Squibb Company (NYSE: BMY) and Japan-based Ono Pharmaceutical Co., Ltd. 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, the companies said.
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 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.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.
The detailed data of the study were presented at the 2019 American Society of Clinical Oncology annual meeting.
Further terms of the clinical collaboration were not disclosed.
Colorectal cancer is a cancer that starts in the colon or the rectum. In the US, it is currently the third most common cancer diagnosed and the second leading cause of cancer-related deaths when estimates for men and women are combined.
In 2019, an estimated 145,600 Americans will be diagnosed with colorectal cancer.
General estimates predict that 1 in 23 will be diagnosed with the disease in their lifetime.
In April 2017, Stivarga was approved for use in patients with hepatocellular carcinoma who have been previously treated with Nexavar (sorafenib).
In the United States, Stivarga is also indicated for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy.
It is also indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor who have been previously treated with imatinib mesylate and sunitinib malate.
Regorafenib is a compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx, now an Amgen subsidiary, under which Onyx receives a royalty on all global net sales of regorafenib in oncology.
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol-Myers Squibb expanded its territorial rights to develop and commercialise Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time.
On July 23, 2014, Ono and Bristol-Myers Squibb further expanded the companies' strategic collaboration agreement to jointly develop and commercialise multiple immunotherapies as single agents and combination regimens for patients with cancer in Japan, South Korea and Taiwan.


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