Opdivo Combination Therapy Receives Priority Review for Treatment of Colorectal Cancer
March 28, 2018 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Today, Bristol-Myers Squibb (BMS) announced that the US FDA has accepted its Supplemental Biologics Licensing Application (sBLA), which is expected to allow Opdivo (nivolumab) and Yervoy (ipilimumab) to jointly treat microsatellite instability (MSI-H) or Mismatch repair-deficient (dMMR) metastatic colorectal cancer (mCRC) in adults with progression after treatment with fluoropyrimidine, oxaliplatin, and irinotecan. The FDA also granted the application priority review and is expected to respond by July 10 this year. It is worth mentioning that the combination therapy was awarded a breakthrough therapy in February this year for the treatment of this potential indication.
Colorectal cancer (CRC) is a cancer that occurs in the colon or rectum. In the United States, CRC is the third most common cancer and the third leading cause of cancer deaths in men and women, with more than 140,000 new cases being diagnosed each year. DNA mismatch repair defects (dMMR) occur when proteins responsible for mismatch repair in DNA replication are absent or non-functional, resulting in microsatellite instability (MSI-H) tumors. Approximately 15% of CRC patients and 4-5% of mCRC patients have MSI-H or dMMR biomarkers. Patients with mCRC with MSI-H or dMMR are less likely to benefit from conventional chemotherapy and often have a poor prognosis. These patients are in urgent need of new and effective treatments to alleviate the disease.
Opdivo is BMS's heavy PD-1 immunological checkpoint inhibitor that uses the body's own immune system to restore anti-tumor immune responses. In July 2014, Opdivo became the world's first regulatoryly approved PD-1 immunological checkpoint inhibitor. It has been approved in more than 60 countries and regions, including the United States, the European Union and Japan. In October 2015, the Opdivo and Yervoy combination regimen became the first immunooncology portfolio approved for the treatment of metastatic melanoma, and the portfolio has now been approved by more than 50 countries including the United States and the European Union.
The application for this combination therapy for mCRC treatment is based on an ongoing Phase 2 study of CheckMate-142. This study evaluated the efficacy of Opdivo in combination with Yervoy in mCRC patients who had been treated with MSI-H or dMMR. The study's data was published at the 2018 Gastrointestinal Cancers Symposium in January and published in the Journal of Clinical Oncology.
“The FDA's acceptance of this application's priority review further strengthens our confidence in Opdivo plus Yervoy combination therapy for patients with metastatic colorectal cancer who have been treated with MSI-H or dMMR biomarkers. "This is our long-term commitment to exploring the IO/IO portfolio for highly unmet patient populations," said Dr. Ian M. Waxman, Head of BMS Gastrointestinal Cancer Research. "We look forward to working with the FDA with the goal of Combination therapy is given to these colorectal cancer patients."
Reference materials:
[1] US Food and Drug Administration (FDA) Accepts Bristol-Myers Squibb's Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for Previously Treated Patients with MSI-H or dMMR Metastatic Colorectal Cancer for Priority Review
[2] FDA Accepts Bristol-Myers Combo Application
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