Bristol Myers Squibb Secures EU Approval for Opdivo + Yervoy as First Dual Immunotherapy for dMMR/MSI-H Metastatic Colorectal Cancer
Jun 30, 2021 03:15
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03:15
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The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
Colorectal cancer (Image source: medicalnewstoday.com)
June 29, 2021 /《Bioon》BIOON/ -- Bristol-Myers Squibb (BMS) recently announced that the European Commission (EC) has approved the anti-PD-1 therapy Opdivo (nivolumab) in combination with the anti-CTLA-4 therapy Yervoy (ipilimumab), for the treatment of patients whose disease has progressed following prior treatment with a fluoropyrimidine-based combination chemotherapy,Mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H)Adult patients with metastatic colorectal cancer (mCRC).
It is worth noting that,Opdivo + Yervoy is the first EU-approved treatment for gastrointestinal cancer# Tumorof dual immunotherapy regimen.To date,This regimen has been approved in the European Union for the treatment of five different types of advanced cancer: mesothelioma, non-small cell lung cancer,Melanoma, renal cell carcinoma, colorectal cancer.
In July 2018, Opdivo+Yervoy was approved in the United States for the treatment of adult and pediatric patients aged 12 years and older with dMMR or MSI-H metastatic colorectal cancer (mCRC) that has progressed following prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan. In September 2020, Opdivo+Yervoy was approved in Japan for the treatment of patients with MSI-H unresectable, advanced, or recurrent colorectal cancer that has progressed following prior chemotherapy.
This EU approval is based on results from the Opdivo plus Yervoy combination cohort in the multicenter, open-label, Phase 2 CheckMate-142 trial. The study was conducted by Bristol-Myers Squibb and enrolled patients with advanced or recurrent dMMR or MSI-H CRC who experienced disease progression during or after chemotherapy (including fluoropyrimidine) or were intolerant to such chemotherapy.
Results with a minimum follow-up of 46.9 months showed: in this study,The objective response rate (ORR) of the Opdivo + Yervoy combination immunotherapy was 64.7% (95% CI: 55.4–73.2), the complete response rate (CR) was 12.6%, and the median duration of response (DOR) was not reached (range: 1.4 to >58.0 months).In the study, the safety profile of the Opdivo+Yervoy immunotherapy combination was consistent with the results reported in previous clinical studies, with no new safety signals identified.
Bristol-Myers Squibb Gastrointestinal`Tumor`Dr. Ian M. Waxman, M.D., Head of Development, stated: "Metastatic colorectal cancer is an aggressive disease with a poor prognosis, and patients urgently need additional treatment options beyond standard chemotherapy. With this approval, patients in the EU with metastatic colorectal cancer harboring mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H) biomarkers will now have access to the first dual immunotherapy, and we look forward to bringing this combination to eligible patients."
Colorectal cancer (CRC) is a cancer that occurs in the colon or rectum, which are part of the human digestive system or gastrointestinal tract. Globally, CRC is the third most commonDiagnosiscancer. It is estimated that in 2020, there were approximately 1.931 million new cases, making it the second leading cause of cancer-related deaths in both men and women. Deficient mismatch repair (dMMR) refers to the absence or loss of function of proteins responsible for correcting mismatch errors during DNA replication, resulting in tumors with high microsatellite instability (MSI-H). Approximately 5% of patients with metastatic CRC have dMMR or MSI-H.Tumor. have theseBiomarkerMetastatic CRC patients are unlikely to benefit from conventional chemotherapy and typically have a poor prognosis.
Opdivo + Yervoy (OY combination) is the first and only dual immunotherapy to receive regulatory approval.Opdivo + Yervoy is a unique combination of two immune checkpoint inhibitors with a potentially synergistic mechanism of action, targeting two distinct checkpoints (PD-1 and CTLA-4) to act in a complementary manner, helping the body destroy tumor cells. Yervoy helps activate and proliferate T cells, while Opdivo helps existing T cells recognizeTumor. Additionally, certain T cells stimulated by Yervoy also become memory T cells, which may lead to a long-term immune response.
To date,The Opdivo + Yervoy combination therapy has been approved for 7 treatment indications across 6 cancer types (Melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, malignant pleural mesothelioma).
In addition, the Opdivo + Yervoy combination therapy has already been in six Phase IIIClinical Trialdemonstrated significant improvement in overall survival (OS): non-small cell lung cancer (CheckMate-227, CheckMate-9LA), metastaticMelanoma(CheckMate-067), advanced renal cell carcinoma (CheckMate-214), malignant pleural mesothelioma (CheckMate-743), esophageal squamous cell carcinoma (CheckMate-648). (Bioon.com)