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Bristol Myers Squibb’s Opdivo recommended by NICE for rare gastroesophageal cancers

The PD-1 inhibitor demonstrated a statistically significant benefit in overall survival


Bristol Myers Squibb’s Opdivo (nivolumab) has been recommended by the National Institute of Health and Care Excellence (NICE) as a first-line treatment, alongside chemotherapy, for rare forms of advanced gastroesophageal cancer.

Specifically, NICE’s recommendation is extended to patients with untreated HER2-negative, advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma if the tumours express PD-L1 with a combined positive score (CPS) of five or more. Around 3,000 people could be eligible for the new combination therapy.

Opdivo is a targeted immunotherapy designed to recognise and attach to a specific protein called programmed death-1 receptor (PD-1), which can shut off the body’s immune system. By attaching to PD-1, Opdivo blocks its action and allows the body’s immune system to continue to attack the gastric, oesophageal or gastro-oesophageal junction cancer cells.

NICE based its recommendation on clinical evidence from the CheckMate-649 trial in which patients treated with Opdivo in combination with FOLFOX or CapeOX chemotherapy demonstrated a significant improvement in overall survival and progression-free survival.

Helen Knight, interim director of medicines evaluation at NICE, said: “The combination of [Opdivo] plus chemotherapy not only has the potential to slow the disease down and extend life for people with these forms of cancer, but there is some promise of long-term remission.

“We know there is a significant impact on the quality of life for people with these forms of advanced cancer and therefore I’m delighted that we have been able to recommend this innovative treatment for people with these rare forms of gastroesophageal cancer."

Stomach and oesophageal cancers represent two of the six less survivable cancers, and these six cancers together account for half of all deaths from common cancers in the UK.

Gastric, gastro-oesophageal junction and oesophageal adenocarcinoma significantly impact quality of life, with major symptoms including difficulty swallowing and malnutrition, which can lead to severe fatigue, weight loss and the need to use a feeding tube.

These symptoms can be painful and distressing, limiting the patient’s ability to live normally and participate in social events. Diagnosis is often at an advanced stage, and around 40% of all new
cases are diagnosed in patients aged 75 and over.

“Patients may experience painful and life-limiting symptoms, and currently, many will need to come to terms with the sad reality that their treatment options are limited. It is crucial that more treatments are made available for patients with advanced forms of these cancers, which is why we are delighted by NICE’s decision to recommend [Opdivo] plus chemotherapy as a first-line treatment option,” said Julie Harrington, chief executive officer, Guts UK.

Article by
Emily Kimber

25th November 2022

From: Research, Regulatory



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