July 25, 2024

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Colorectal cancer: EU approved Opdivo+Yervoy dual immunotherapy

Colorectal cancer (CRC): EU approved Opdivo+Yervoy dual immunotherapy



Colorectal cancer (CRC): EU approved Opdivo+Yervoy dual immunotherapy.  Colorectal cancer (CRC) precision immunotherapy! The European Union approved Opdivo+Yervoy dual immunotherapy: treatment of dMMR/MSI-H patients!


Bristol-Myers Squibb (BMS) recently announced that the European Commission (EC) has approved the anti-PD-1 therapy Opdivo (Odivo, generic name: nivolumab) combined with anti-CTLA-4 therapy Yervoy (ipilimumab, Yipu Limumar) is used to treat adult patients with disease progression, mismatch repair defects (dMMR) or high microsatellite instability (MSI-H) metastatic colorectal cancer (mCRC) after previous fluoropyrimidine-based combination chemotherapy.

It is worth mentioning that Opdivo+Yervoy is the first dual immunotherapy program approved by the European Union for gastrointestinal cancer tumors. So far, the program has been approved in the European Union to treat 5 different types of advanced cancer: mesothelioma, non-small cell lung cancer, melanoma, renal cell carcinoma, and colorectal cancer.


Colorectal cancer (picture source: medicalnewstoday.com)

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.

The EU approval is 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 of a minimum follow-up of 46.9 months showed that in this study, the objective response rate (ORR) of the Opdivo+Yervoy immune combination was 64.7% (95%CI: 55.4-73.2), the complete response rate (CR) was 12.6%, and the median The duration of remission (DOR) has not been reached (range: 1.4 months, 58.0 months or more). In the 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 is an aggressive disease with a poor prognosis. In addition to standard chemotherapy, patients urgently need additional treatment options. With this approval, EU metastatic colorectal cancer with mismatch repair defect (dMMR) or high microsatellite instability (MSI-H) biomarkers will now receive the first dual immunotherapy, and we look forward to This combination brings qualified patients.”

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 2 immune checkpoint inhibitors, with a potential synergistic mechanism. It targets 2 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).


(source:internet, reference only)

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