NICE Endorses BMS Immunotherapy Combo for Colorectal Cancer

Bristol Myers Squibb (BMS) has made strides in the treatment of colorectal cancer with its dual immunotherapy approach, now recognized by the National Institute for Health and Care Excellence (NICE). This breakthrough involves the use of Opdivo (nivolumab) and Yervoy (ipilimumab) as a first-line treatment for adults diagnosed with specific subtypes of colorectal cancer. These patients have either mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) tumors, which can be particularly challenging to treat with traditional chemotherapy.

Each year, around 44,000 individuals in the UK face a diagnosis of colorectal cancer, also known as bowel cancer. A significant challenge arises for those with metastatic disease, particularly the 7% who possess dMMR or MSI-H tumors. These specific genetic markers often lead to a reduced response to standard chemotherapy and a generally poor prognosis for patients.

The recent recommendation from NICE follows the Medicines and Healthcare products Regulatory Agency’s earlier extension of the indication for this dual immunotherapy. Supporting the agency's decision are compelling findings from the phase 3 CheckMate 8HW trial. This study demonstrated that patients receiving the Opdivo plus Yervoy combination therapy had a 72% progression-free survival rate at 24 months. This is a stark contrast to the 14% rate observed in patients treated with the chemotherapy option chosen by investigators, underscoring the potential of this immunotherapy combination.

Furthermore, the safety profile of Opdivo plus Yervoy has remained consistent with prior data, with no new safety concerns emerging, which reinforces the reliability of this treatment in clinical use.

Guy Oliver, who manages operations in the UK and Ireland for BMS, emphasized the importance of providing cancer patients with access to innovative therapies. He highlighted the significance of NICE's decision for eligible patients with unresectable or metastatic colorectal cancer in England, Wales, and Northern Ireland.

Echoing these sentiments, Kai-Keen Shiu, a consultant medical oncologist at University College London Hospitals NHS Foundation Trust, lauded the recommendation as a substantial advancement for those suffering from MSI-H/dMMR metastatic colorectal cancer. Shiu pointed out that this dual immunotherapy offers a valuable alternative to existing treatments, potentially enhancing the quality of life for patients compared to traditional chemotherapy.

This recommendation by NICE comes on the heels of a similar decision by the US Food and Drug Administration. Just two weeks earlier, the FDA approved the Opdivo and Yervoy combination as a first-line treatment for both adult and pediatric patients aged 12 years and older with unresectable or metastatic MSI-H or dMMR colorectal cancer. This combination therapy also recently gained approval in the United States as a first-line treatment for adults dealing with unresectable or advanced hepatocellular carcinoma, a prevalent form of liver cancer.

The recognition and recommendation of the Opdivo and Yervoy combination therapy by both NICE and the FDA mark a promising advancement in the available treatment options for those dealing with challenging forms of colorectal cancer. These developments hold the potential to significantly impact the management of this disease, offering new hope to patients and healthcare providers alike.