Postoperative Protective Immunotherapy (Nivolumab) for Esophageal Cancer Receives FDA Approval

On May 20, 2021, the FDA (US Food and Drug Administration) approved, for completely resected (surgically removed) esophageal or GEJ (gastroesophageal junction) cancer and following neoadjuvant chemoradiotherapy in people with residual pathological disease, the nivolumab (Opdivo, Bristol-Myers Squibb Company) immunotherapy as a treatment.

Efficacy of nivolumab as postoperative protection

Efficacy in completely resected (negative margins) esophageal or GEJ cancer was evaluated in 794 patients with residual pathological disease after concurrent chemoradiotherapy, in a randomized, multicenter, double-blind clinical trial called CHECKMATE-577 as the study.

Patients were randomized to receive 240 mg nivolumab every 2 weeks for 16 weeks or placebo, followed by 480 mg nivolumab or placebo every 4 weeks for 1 year starting at week 17.

The main efficacy outcome was defined as the time between randomization and the date of death from any cause or the first recurrence (at the original site, regionally or at a distant site), assessed by the investigator before subsequent anticancer treatment, and was called disease-free survival (DFS).

Results of the CHECKMATE-577 trial

The efficacy study demonstrated a statistically significant improvement in disease-free survival for patients receiving nivolumab compared with those in the placebo arm.

Median disease-free survival was 22.4 months in those receiving nivolumab versus 11 months in those receiving placebo.

The disease-free survival benefit was observed regardless of tumor PD-L1 expression and histology.

Side effects of nivolumab

The most common side effects in patients receiving nivolumab (20%) were:

Fatigue, rash, musculoskeletal pain, itching, diarrhea, nausea, asthenia, cough, shortness of breath, constipation, loss of appetite, back pain, arthralgia (joint pain), upper respiratory tract infection, fever, headache, abdominal pain and vomiting

Recommended dose of nivolumab

The recommended nivolumab dose for adjuvant treatment of resected esophageal or GEJ cancer is 480 mg every 4 weeks or 240 mg every 2 weeks for a total treatment duration of 1 year.

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