Bayer, Baxger: Immuno combination therapy to treat metastatic colorectal cancer

Bayer, Baxger and Ono Pharmaceutical Co., Ltd. recently announced that three companies have reached clinical cooperation agreements to evaluate Bayer's kinase inhibitors Stivarga® and Baxalta Stauber/ Ono Pharmaceutical Co., Ltd.'s anti-PD-1 monoclonal antibody Opdivo (nivolumab) combination therapy is effective in treating patients with microsatellial stable metastatic colorectal cancer (MSS mCRC), the most common form of metastatic colorectal cancer.
Colorectal cancer is a cancer that starts in the colon or rectum. In the United States, when the number of male and female patients is added, it is the third most common cancer diagnosed and the second leading cause of cancer-related deaths. An estimated 145,600 Americans will be diagnosed with colorectal cancer in 2019. It is predicted that one in 23 people will be diagnosed with the disease in their lifetime.
Although significant progress has been made in CRC treatment, including cancer immunotherapy for certain CRC sub-groups, about 95% of metastatic colorectal cancer patients have MSS tumors, of which cancer immunotherapy monotherapy has limited effectiveness. As a result, the demand for treatment options, including combination methods, remains high.
Previously, Stivarga was approved for use in patients with hepatocellular ® treated with Nexavar (Soraphinib). In the United States, Stivarga is also suitable for the treatment of patients with metastatic colorectal cancer (CRC), who have previously received chemotherapy based on fluorine, oxalipal and olithycon, anti-VEGF treatment, and, in the case of RAS wild type, anti-EGFR therapy. It is also suitable for the treatment of patients with localized advanced, non-removable or metastasis gastrointestinal mesothelioma (GIST), who have previously been treated with methyl sulfonate imatini and macaroni.
Opdivo is a PD-1 inhibitor designed to help restore an anti-tumor immune response.
Opdivo
important treatment option for cancer across multiple cancers by harnessing the body's own immune system to fight cancer.
Stivarga, as a monotherapy, showed overall survival benefits over placebo in the key Phase III CORRECT study, and in retrospective analysis of the study showed activity unrelated to microsatellite status, although the observed response was limited. The combined period data for Stivarga and Opdivo are encouraging, and the combination therapy of Stivarga and Opdivo has shown good initial results in a Phase 1b trial called REMONIVO in Japan.
“ Stivarga has proven its efficacy and positive safety as a three-line monodrug, and we are pleased to be able to work clinically to evaluate this combination in the hope of providing additional therapeutic benefits to patients," said Scott Z. Fields, Senior Vice President and Head of Oncology Development, Bayer Pharmaceuticals.
“ We continue to invest in innovative approaches to maximize the potential of our drug pipeline and develop new combinations to help more cancer patients who do not respond to cancer immunotherapy," said Dr. Fouad Namouni, Director of Oncology Development at Baxter Mercer. "
" we have been actively involved in the development of nivolumab, including in the form of combined treatments with other drugs. We are pleased to be working clinically with Bayer and Baxger to investigate this combination therapy as a new treatment for patients with colorectal and other types of cancer," said Kiyoaki Idemitsu, Executive Director of Clinical Development at Ono. （cyy123.com）