Bayer, Bristol-Myers Squibb and Ono Pharma Team on Colorectal Cancer
The three companies will collaborate to test Bayer’s kinase inhibitor Stivarga (regorafenib) and Bristol-Myers Squibb’s and Ono’s anti-PD-1 checkpoint inhibitor Opdivo (nivolumab) in microsatellite stable metastatic colorectal cancer (MSS mCRC). The effectiveness of immuno-oncology treatments for some subpopulations of CRC have been observed, but about 95% of mCRC have MSS tumors, where immuno-oncology monotherapies haven’t been as effective.
Colorectal cancer is the third most common cancer diagnosed in the U.S. and the second leading cause of cancer-related deaths. This year, it is projected that 145,600 people in the U.S. alone will be diagnosed with colorectal cancer.
Alone, Stivarga showed an overall survival benefit compared to placebo in the Phase III CORRECT trial and has demonstrated activity regardless of micro-satellite status in a retrospective data analysis of the trial, although only limited responses were seen.
However, early data in a combination of Stivarga and Opdivo have been encouraging. A Japanese Phase Ib clinical trial, REGONIVO showed promising preliminary efficacy data, which 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,” stated Scott Z. Fields, senior vice president and head of Oncology Development at Bayer’s Pharmaceuticals Division. “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.”
In 2011, Ono Pharmaceutical and Bristol-Myers Squibb expanded territorial rights to develop and commercialize Opdivo around the world, except in Japan, South Korea and Taiwan. In those territories, Ono retained all rights at the time. On July 23, 2014, the two companies expanded their strategic collaboration to jointly develop and commercialize several immunotherapies, both as monotherapies and in combinations, for cancer in Japan, South Korea and Taiwan.
Opdivo is approved in more than 65 countries, and the Opdivo and Yervoy combination has been approved in more than 50 countries.
Stivarga was approved in 2017 for hepatocellular carcinoma, as well as for mCRC, and locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST). Bayer developed regorafenib, and in 2011, entered into a deal with Amgen subsidiary Onyx where Onyx receives royalties on all global net sales of regorafenib in oncology.
“We have been actively engaged in the development of nivolumab including combination therapies with other agents,” stated Kiyoaki Idemitsu, corporate officer, executive director, Clinical Development, Ono. “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.”
Ono Pharma recently held an opening ceremony for the completion of a new manufacturing facility in Yamaguchi Prefecture. The company owns its main facility in Shizuoka Prefecture, but established the Yamaguchi Plant in preparation for future business expansion and to decrease any risk of business continuity problems. The new plant will manufacture Opdivo and another cancer drug, Kyprolis.