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NICE Recommends BMS's Opdivo Plus Chemo for HER2-Negative, PD-L1-Positive Gastric Cancer

NEW YORK – The UK's National Institute for Health and Care Excellence last week recommended Bristol Myers Squibb's Opdivo (nivolumab) plus chemotherapy for previously untreated patients with HER2-negative PD-L1-expressing advanced or metastatic gastric or gastroesophageal cancer.

In its final guidance document issued last Wednesday, NICE recommended the treatment based on results from the Phase III CheckMate 649 trial comparing Opdivo plus platinum- and fluoropyrimidine-based chemotherapy against chemo alone.

Patients were enrolled in the trial regardless of PD-L1 status. However, treatment benefit was greater for patients whose tumors expressed PD-L1. Because of this, NICE recommended the treatment combination for patients with a PD-L1 combined positive score (CPS) of 5 or more. The median overall survival among PD-L1-positive patients on Opdivo-chemo was 14.4 months compared to 11.1 months for those who only received chemo. In the all-comer population, overall survival was 13.8 months for those on Opdivo-chemo and 11.6 months for those receiving just chemo, according to data presented last year.

NICE estimated that about 3,000 people in the UK could be eligible for the Opdivo-chemo combination treatment.

The list price for a 240 mg dose of Opdivo for infusion is £2,633 ($3,167). NICE noted in the guidance that BMS would provide Opdivo to the National Health Service at an undisclosed discount.

In October 2021, the Opdivo-chemo combination also received approval in Europe for patients with HER2-negative PD-L1-positive advanced or metastatic gastric, gastroesophageal junction, or esophageal cancer.

The European approval and NICE's recommendation differ from the US Food and Drug Administration's decision in this setting. In April 2021, the FDA approved Opdivo plus chemo and Opdivo plus BMS's Yervoy (ipilimumab) for patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal cancer regardless of PD-L1 and HER2 expression, based on data from the same trial.