Nivolumab in addition to chemotherapy is approved by FDA for metastatic gastric cancer and esophageal adenocarcinoma

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August 2021: For advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in conjunction with fluoropyrimidine- and platinum-containing treatment.

CHECKMATE-649 (NCT02872116) was a randomised, multicenter, open-label trial that enrolled 1,581 patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma who had previously received no treatment. The Agilent/Dako PD-L1 IHC 28-8 pharmDx test was used to calculate the combined positive score (CPS) for PD-L1. Patients were given nivolumab in combination with chemotherapy (n=789) or chemotherapy alone (n=792), with the following study treatment regimen:

Nivolumab 240 mg every two weeks with mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or mFOLFOX6 every two weeks
Every 3 weeks, Nivolumab 360 mg with CapeOX (capecitabine and oxaliplatin) or CapeOX.
Progression-free survival (PFS) measured by blinded independent central review and overall survival were the key efficacy outcome measures in patients with PD-L1 CPS 5 (n=955) (OS). For patients with PD-L1 CPS 5, CHECKMATE-649 showed a statistically significant increase in PFS and OS. The median OS in the nivolumab + chemotherapy arm was 14.4 months (95 percent confidence interval: 13.1, 16.2) compared to 11.1 months (95 percent confidence interval: 10.0, 12.1) in the chemotherapy alone arm (HR 0.71; 95 percent confidence interval: 0.61, 0.83; p0.0001). The median PFS in the nivolumab + chemotherapy arm was 7.7 months (95 percent CI: 7.0, 9.2) versus 6.0 months (95 percent CI: 5.6, 6.9) in the chemotherapy alone arm (HR 0.68; 95 percent CI: 0.58, 0.79; p0.0001).

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

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

The following are the recommended nivolumab dosages:

Every three weeks, take 360 mg in combination with fluoropyrimidine- and platinum-containing treatment.
Every two weeks, take 240 mg in combination with fluoropyrimidine- and platinum-containing treatment.

 

Reference : https://www.fda.gov/

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