NICE Recommends BMS’s Opdivo + Yervoy for MSI-H/dMMR Advanced Colorectal Cancer Patients Post-Fluoropyrimidine Failure

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The UK National Institute for Health and Care Excellence (NICE) recently issued a Final Appraisal Document (FAD) recommending Bristol-Myers Squibb's Opdivo plus Yervoy immunotherapy combination for the treatment of certain patients with advanced colorectal cancer, specifically those who have failed fluoropyrimidine-based chemotherapy and harbor rare microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) mutations.

In a statement, Bristol-Myers Squibb said that this approval makes Opdivo+Yervoy the first combination immunotherapy approved in the UK for these patients.

The approval was based on data from the ongoing Phase 2 CheckMate-142 trial. The study was conducted in patients with advanced or recurrent colorectal cancer (CRC) that is MSI-H or dMMR, who experienced disease progression during or after chemotherapy (including fluoropyrimidine anticancer drugs), or who were intolerant to these chemotherapies. Results showed that after 51 months of follow-up, the objective response rate (ORR) was 65% among patients treated with Opdivo plus Yervoy.

Colorectal cancer (CRC) is a cancer that occurs in the colon or rectum. Globally, CRC is the third most commonly diagnosed cancer type. In 2020, there were approximately 1.931 million new cases, making it the second leading cause of cancer-related deaths. dMMR refers to the deficiency or loss of function of proteins that repair mismatch errors during DNA replication, leading to MSI-H tumors. Approximately 5% of patients with metastatic CRC have dMMR or MSI-H tumors. Metastatic CRC patients with these biomarkers are unlikely to benefit from conventional chemotherapy and typically have a poor prognosis.

Opdivo + Yervoy is the only dual immunotherapy regimen to receive regulatory approval. For the treatment of CRC, the Opdivo + Yervoy regimen was approved by the U.S. FDA in July 2018 for adult and pediatric patients aged ≥12 years with dMMR or MSI-H metastatic CRC that has progressed following prior treatment with fluorouracil, oxaliplatin, and irinotecan. In September 2020, the Opdivo + Yervoy regimen was approved in Japan for the treatment of patients with MSI-H unresectable, advanced, or recurrent CRC whose disease has progressed following anti-cancer chemotherapy.

Last month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) also issued a positive opinion for the Opdivo + Yervoy regimen, recommending its approval for the treatment of adult patients with dMMR or MSI-H metastatic colorectal cancer (CRC) that has progressed following prior fluoropyrimidine-based combination chemotherapy.

Opdivo + Yervoy is a unique immunotherapy combination that targets two distinct immune checkpoints (PD-1 and CTLA-4). With a synergistic mechanism and complementary mode of action, it helps the body's immune system destroy tumor cells.

According to information on the Bristol-Myers Squibb website, to date, the Opdivo + Yervoy regimen has been approved for 6 types of cancer and 7 therapeutic indications, with variations across different countries. Specifically, these include: melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, and malignant pleural mesothelioma.

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