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Nivolumab + chemotherapy receives European commission approval for patients with HER2 negative, advanced or metastatic gastric, gastroesophageal junction or oesophageal adenocarcinoma

22 Oct 2021
Nivolumab + chemotherapy receives European commission approval for patients with HER2 negative, advanced or metastatic gastric, gastroesophageal junction or oesophageal adenocarcinoma

Bristol Myers Squibb announced that the European Commission (EC) has approved nivolumab in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction (GEJ), or oesophagal adenocarcinoma (EAC) whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5.

The EC’s decision is based on results from the Phase 3 CheckMate -649 trial, in which first-line treatment with nivolumab plus leucovorin, 5-fluorouracil and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin was compared with chemotherapy alone.

Results from the trial showed a statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS) in patients with unresectable advanced or metastatic gastric cancer (GC), GEJ cancer (GEJC) or EAC whose tumours express PD-L1 with a CPS ≥ 5 (the primary endpoints of the study).

The statistically significant OS benefit shown with nivolumab plus chemotherapy was also observed in PD-L1 positive patients with CPS ≥ 1 and in the all-randomized population.

The safety profile observed for nivolumab plus chemotherapy in the CheckMate -649 trial was consistent with the known safety profiles of the individual treatments.

“This approval marks a great achievement for many patients with gastric, gastroesophageal junction and oesophagal adenocarcinomas, who now have a new treatment option that has demonstrated superior overall survival compared to the long-standing standard of care,” said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb.

“With limited advances for HER2-negative gastric cancers made in the past ten years, we are especially pleased to move the field forward and introduce this Opdivo-based combination for patients in the European Union.”

The EC approval allows for the use of nivolumab in combination with fluoropyrimidine and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric cancer, gastroesophageal junction (GEJ), or oesophagal adenocarcinoma (EAC), whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5 in the 27 member states of the European Union, as well as Iceland, Liechtenstein, and Norway.

CheckMate -649 Efficacy and Safety Results in Patients with PD-L1 CPS ≥ 5

Results from CheckMate -649 include:

OS (minimum follow‑up of 19.4 months): Median OS was 14.4 months in patients receiving nivolumab chemotherapy (95% Confidence Interval [CI]: 13.1 to 16.3) compared to 11.1 months (95% CI: 10.0 to 12.1) in patients receiving chemotherapy alone (Hazard Ratio [HR] 0.69; 95% CI: 0.60 to 0.81).

PFS (minimum follow‑up of 19.4 months): Median PFS was 8.31 months in patients receiving nivolumab chemotherapy (95% CI: 7.03 to 9.26) vs. 6.05 months (95% CI: 5.55 to 6.90) in patients receiving chemotherapy alone (HR = 0.68; 95% CI: 0.59 to 0.79).

Safety: The most frequent adverse reactions were peripheral neuropathy (53%), nausea (48%), fatigue (44%), diarrhoea (39%), vomiting (31%), decreased appetite (29%), abdominal pain (27%), constipation (25%), musculoskeletal pain (20%), pyrexia (19%), rash (18%), stomatitis (17%), palmar-plantar erythrodysaesthesia syndrome (13%), cough (13%), oedema (including peripheral oedema) (12%), headache (11%), and upper respiratory tract infection (10%).

Source: Bristol Myers Squibb