News

FDA approves nivolumab in combination with chemotherapy for metastatic gastric cancer and oesophageal adenocarcinoma

19 Apr 2021
FDA approves nivolumab in combination with chemotherapy for metastatic gastric cancer and oesophageal adenocarcinoma

the Food and Drug Administration approved nivolumab in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and oesophageal adenocarcinoma.

Efficacy was evaluated in CHECKMATE-649, a randomised, multicentre, open-label trial that enrolled 1,581 patients with previously untreated advanced or metastatic gastric cancer, gastroesophageal junction cancer, or oesophageal adenocarcinoma.

PD-L1 combined positive score (CPS) was determined centrally using the Agilent/Dako PD-L1 IHC 28-8 pharmDx test. Patients received nivolumab in combination with chemotherapy (n=789) or chemotherapy alone (n=792); study treatment was administered as follows:

Nivolumab 240 mg with mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) every 2 weeks, or mFOLFOX6 every 2 weeks.

Nivolumab 360 mg with CapeOX (capecitabine and oxaliplatin) every 3 weeks, or CapeOX every 3 weeks.

The main efficacy outcome measures, assessed in patients with PD-L1 CPS ≥5 (n=955), were progression-free survival (PFS) assessed by blinded independent central review and overall survival (OS).

CHECKMATE-649 demonstrated a statistically significant improvement in PFS and OS for patients with PD-L1 CPS ≥5. Median OS was 14.4 months (95% CI: 13.1, 16.2) in the nivolumab plus chemotherapy arm vs. 11.1 months (95% CI: 10.0, 12.1) in the chemotherapy alone arm (HR 0.71; 95% CI: 0.61, 0.83; p<0.0001). Median PFS was 7.7 months (95% CI: 7.0, 9.2) in the nivolumab plus chemotherapy arm versus 6.0 months (95% CI: 5.6, 6.9) in the chemotherapy alone arm (HR 0.68; 95% CI: 0.58, 0.79; p<0.0001).

As an additional efficacy outcome measure, a statistically significant improvement in OS was also demonstrated for all randomised patients (n=1,581) irrespective of CPS, with a median OS of 13.8 months (95% CI: 12.6, 14.6) in the nivolumab plus chemotherapy arm vs. 11.6 months (95% CI: 10.9, 12.5) in the chemotherapy alone arm (HR 0.80; 95% CI: 0.71, 0.90; p=0.0002).

The most common adverse reactions (incidence ≥20%) observed in patients receiving nivolumab in combination with fluoropyrimidine- and platinum-containing chemotherapy were peripheral neuropathy, nausea, fatigue, diarrhoea, vomiting, decreased appetite, abdominal pain, constipation, and musculoskeletal pain.

The recommended nivolumab dosages are:

360 mg every 3 weeks in combination with fluoropyrimidine- and platinum-containing chemotherapy every 3 weeks.
240 mg every 2 weeks in combination with fluoropyrimidine- and platinum-containing chemotherapy every 2 weeks.

View full prescribing information for nivolumab.