Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Opdivo (nivolumab) plus Yervoy (ipilimumab) for dMMR/MSI-H Metastatic Colorectal Cancer

May 27, 2021 01:13 CST Updated 01:13

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Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.

European Medicines Agency

The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.

May 27, 2021 /BioonBIOON/ -- Bristol-Myers Squibb (BMS) recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of anti-PD-1 therapy Opdivo (nivolumab) in combination with anti-CTLA-4 therapy Yervoy (ipilimumab) for the treatment of adult patients with mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) who have progressed following prior fluoropyrimidine-based combination chemotherapy. The CHMP opinion will now be submitted to the European Commission (EC) for review, which typically makes a final approval decision within the next two months.

In July 2018, Opdivo + Yervoy was approved in the United States for the treatment of adult and pediatric patients 12 years of age and older with dMMR or MSI-H metastatic colorectal cancer (mCRC) that has progressed following prior treatment with a 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 after anticancer chemotherapy.

Colorectal cancer (CRC) is a cancer that occurs in the colon or rectum, which are parts of the human digestive system or gastrointestinal system. 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 among both men and women. Mismatch repair deficiency (dMMR) refers to the absence or loss of function of proteins responsible for repairing 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. Having theseBiomarkerPatients with metastatic CRC are unlikely to benefit from conventional chemotherapy and generally have a poor prognosis.

Opdivo + Yervoy (OY combination) is the first and only regulatory-approved dual immunotherapy.Opdivo+Yervoy is a unique combination of two immune checkpoint inhibitors with a potential synergistic mechanism of action. Targeting two distinct checkpoints (PD-1 and CTLA-4), it functions in a complementary manner to help the body destroy tumor cells. Yervoy helps activate and proliferate T cells, while Opdivo helps existing T cells detectTumor. Additionally, certain T cells stimulated by Yervoy also become memory T cells, which may lead to a long-term immune response.

To date,Opdivo + Yervoy combination therapy has been approved for 7 therapeutic indications across 6 types of cancer (Melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, malignant pleural mesothelioma). Additionally, the Opdivo + Yervoy combination therapy has been6 Phase III trialsClinical Trialshowed a 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).

The CHMP's positive review opinion is based on results from the Opdivo + Yervoy combination cohort in the multicenter, open-label Phase 2 CheckMate-142 study. Conducted by Bristol-Myers Squibb, the study enrolled patients with advanced or recurrent dMMR or MSI-H CRC who experienced disease progression during or after prior chemotherapy (including fluoropyrimidine), or who were intolerant to such chemotherapy. The results showed that, in this study,The objective response rate (ORR) for the Opdivo + Yervoy immunotherapy combination was 55%,Efficacy was demonstrated at the primary endpoint. In this study, the safety profile of the Opdivo + Yervoy immunotherapy combination was consistent with results from previously reported clinical trials, with no new safety signals identified.

Bristol-Myers Squibb GastrointestinalTumorDr. Ian M. Waxman, Head of Development, stated: “Metastatic colorectal cancer with mismatch repair-deficient (dMMR) or high microsatellite instability (MSI-H) biomarkers is challenging to treat. Despite overall progress in this field, patients whose disease progresses during or after first-line chemotherapy still face a significant unmet need. The CHMP’s positive opinion further supports our goal of advancing rational combinations that target distinct but complementary immune pathways. We look forward to the European Commission’s decision later this year and are excited about the potential positive impact this new combination could have on patients in need across the EU.” (Bioon.com)

Source: Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Opdivo (nivolumab) plus Yervoy (ipilimumab) for Treatment of Mismatch Repair Deficient or Microsatellite Instability–High Metastatic Colorectal Cancer After Prior Chemotherapy