NEW YORK – The European Commission on Thursday approved Bristol Myers Squibb's nivolumab (Opdivo) in combination with chemotherapy for patients with HER2-negative PD-L1-positive advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma.
Simultaneously, Agilent Technologies announced it has received a CE-IVD mark for its PD-L1 IHC 28-8 pharmDx assay, which can identify advanced gastric, gastroesophageal junction, and esophageal cancer patients who have a PD-L1 combined positive score of at least 5 and therefore would be eligible for first-line treatment with the recently approved nivolumab-chemo regimen.
The EC approved the treatment based on results from the Phase III CheckMate-649 trial, which compared first-line nivolumab treatment plus FOLFOX or CapeOX chemotherapy against chemo alone. Advanced gastric, gastroesophageal junction, and esophageal cancer patients who had a PD-L1 combined positive score of 5 or higher and received the nivolumab regimen had statistically significant better overall survival and progression-free survival compared to those on chemo.
Even though BMS has continued to highlight that in CheckMate-649 patients with lower levels of PD-L1 expression and all patients, regardless of biomarker status, saw a statistically significant overall survival improvement with nivolumab-chemo, the EC decided to restrict the label to those with a PD-L1 combined positive score of at least 5. The approval allows for the availability of nivolumab-chemo for this subset of patients in 27 EU member states, and in Iceland, Liechtenstein, and Norway.
The EC's decision, however, departs from the US Food and Drug Administration's approval based on CheckMate-649. Earlier this year, the FDA approved nivolumab-chemotherapy for advanced or metastatic gastric, gastroesophageal junction, and esophageal cancer patients regardless of PD-L1 tumor expression status.