FDA approves nivolumab for resected oesophageal or GEJ cancer

21 May 2021
FDA approves nivolumab for resected oesophageal or GEJ cancer

On May 20, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) for patients with completely resected oesophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy.

Efficacy was evaluated in CHECKMATE-577 (NCT02743494), a randomised, multicentre, double-blind trial in 794 patients with completely resected (negative margins) oesophageal or GEJ cancers who had residual pathologic disease following concurrent chemoradiotherapy.

Patients were randomised (2:1) to receive either nivolumab 240 mg or placebo every 2 weeks for 16 weeks followed by 480 mg of nivolumab or placebo every 4 weeks beginning at week 17 for up to one year of treatment.

The main efficacy outcome measure was disease-free survival (DFS), defined as the time between randomisation date and the first recurrence (local, regional, or distant from the primary resected site) date, or death, from any cause, as assessed by the investigator prior to subsequent anti-cancer therapy.

CHECKMATE-577 demonstrated a statistically significant improvement in DFS for patients receiving nivolumab as compared to those on the placebo arm. The median DFS was 22.4 months (95% CI: 16.6, 34.0) versus 11 months (95% CI: 8.3, 14.3), respectively (HR 0.69; 95% CI: 0.56, 0.85; p=0.0003).

The DFS benefit was observed regardless of tumour PD-L1 expression and histology.

The most common adverse reactions (incidence ≥20%) in patients receiving nivolumab are fatigue, rash, musculoskeletal pain, pruritus, diarrhoea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia, headache, abdominal pain, and vomiting.

The recommended nivolumab dose for adjuvant treatment of resected oesophageal or GEJ cancer is 240 mg every 2 weeks or 480 mg every 4 weeks for a total treatment duration of 1 year. Both doses are administered as 30-minute intravenous infusions.

View full prescribing information here.

Source: FDA