May 19, 2024

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Colorectal cancer: Bristol-Myers Opdivo+Yervoy program is recommended by CHMP

Colorectal cancer (CRC) immunotherapy! Bristol-Myers Opdivo+Yervoy program is recommended and approved by EU CHMP: treatment of dMMR/MSI-H patients!



Colorectal cancer: Bristol-Myers Opdivo+Yervoy program is recommended by CHMP.   Bristol-Myers Squibb (BMS) recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive review opinion recommending the approval of the anti-PD-1 therapy Opdivo (common name: nivolumab) , Nivolumab) combined with anti-CTLA-4 therapy Yervoy (ipilimumab, ipilimumab), used to treat disease progression, mismatch repair defects (dMMR) or hypermicrosatellite failure after previous fluoropyrimidine-based combination chemotherapy Adult patients with stable (MSI-H) metastatic colorectal cancer (mCRC).

Colorectal cancer: Bristol-Myers Opdivo+Yervoy program is recommended by CHMP

Now, CHMP’s opinions will be submitted to the European Commission (EC) for review, which will usually make an approval decision within the next 2 months.

In July 2018, Opdivo+Yervoy was approved in the United States for the treatment of disease progression, dMMR or MSI-H metastatic disease after treatment with fluoropyrimidine, oxaliplatin, irinotecan Rectal cancer (mCRC) adults and pediatric patients 12 years and older. In September 2020, Opdivo+Yervoy was approved in Japan for the treatment of patients with unresectable, advanced or recurrent MSI-H colorectal cancer who have progressed after anticancer chemotherapy.

Colorectal cancer: Bristol-Myers Opdivo+Yervoy program is recommended by CHMP


Colorectal cancer (CRC) is a cancer that occurs in the colon or rectum, which is part of the human digestive system or gastrointestinal system. Globally, CRC is the third most commonly diagnosed cancer. It is estimated that there will be approximately 1.931 million new cases in 2020, which is the second leading cause of cancer-related deaths in men and women. Mismatch repair defect (dMMR) refers to the loss or loss of function of the protein that repairs mismatch errors in DNA replication, leading to high microsatellite instability (MSI-H) tumors. Approximately 5% of patients with metastatic CRC have dMMR or MSI-H tumors. Patients with metastatic CRC with these biomarkers are unlikely to benefit from conventional chemotherapy and often 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 potential synergistic mechanism. It targets two different checkpoints (PD-1 and CTLA-4) and acts in a complementary way to help the body destroy tumors. cell. Yervoy can help activate and proliferate T cells, while Opdivo can help existing T cells find tumors. In addition, some T cells stimulated by Yervoy also become memory T cells, which may lead to a long-term immune response.

Up to now, the Opdivo+Yervoy combination therapy has been approved for 7 treatment indications for 6 types of cancer (melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, malignant pleural mesothelioma). In addition, the Opdivo+Yervoy combination therapy has shown significant improvement in overall survival (OS) in 6 phase 3 clinical trials: non-small cell lung cancer (CheckMate-227, CheckMate-9LA), metastatic melanoma (CheckMate-067) , Advanced renal cell carcinoma (CheckMate-214), malignant pleural mesothelioma (CheckMate-743), esophageal squamous cell carcinoma (CheckMate-648).

CHMP’s positive review opinions are based on the results of the Opdivo+Yervoy combined cohort in the multi-center, open-label Phase 2 CheckMate-142 study. The study was carried out by Bristol-Myers Squibb. The enrolled patients were dMMR or MSI-H advanced or recurrent CRC patients who had progressed during or after chemotherapy (including fluoropyrimidine), or were intolerant to these chemotherapy. The results showed that in this study, the objective response rate (ORR) of the Opdivo+Yervoy immune combination was 55%, proving its effectiveness in the primary endpoint. In this study, the safety of the Opdivo+Yervoy immune combination is consistent with the results reported in previous clinical studies, and there is no new safety signal.

Ian M. Waxman, MD, head of gastrointestinal tumor development at Bristol-Myers Squibb, said: “Metastatic colorectal cancer with mismatch repair defects (dMMR) or high microsatellite instability (MSI-H) biomarkers is very It is difficult to treat. Despite the overall progress made in this field, patients who progressed during or after first-line chemotherapy still face huge unmet needs. The positive view of CHMP further supports our goal of advancing different 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 may have on patients in need across the EU.”




Colorectal cancer: Bristol-Myers Opdivo+Yervoy program is recommended by CHMP

(source:internet, reference only)

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