NICE Recommends Opdivo as Adjuvant Therapy for Resected Esophageal or Gastroesophageal Junction Cancer

Translated and edited by | Fan Dongdong

Recently, the UK National Institute for Health and Care Excellence (NICE) has recommended Bristol-Myers Squibb's Opdivo (nivolumab) as a treatment option for certain patients with resected esophageal or gastroesophageal junction (GEJ) cancer.

Consequently, Opdivo has been approved as adjuvant treatment for adults with completely resected esophageal or gastroesophageal junction (GEJ) cancer who have residual disease following neoadjuvant chemoradiotherapy. In May of this year, the drug received approval from the U.S. Food and Drug Administration (FDA) for this indication. This positive recommendation by NICE is based on clinical trial evidence demonstrating that, for patients with residual disease following chemoradiotherapy and surgery, Opdivo extended recurrence-free survival compared with placebo.

According to the results of the randomized, double-blind, placebo-controlled phase 3 CheckMate-577 trial, patients treated with Opdivo demonstrated a statistically significant improvement in disease-free survival (DFS) compared with the placebo group. The median DFS in the Opdivo group was 22.4 months, compared with 11.0 months in the control group. A DFS benefit was observed with Opdivo treatment regardless of tumor PD-L1 expression status or histology. The most common adverse reactions (incidence ≥20%) in patients receiving Opdivo were fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia, headache, abdominal pain, and vomiting.

The two main types of esophageal cancer are squamous cell carcinoma and adenocarcinoma. Squamous cell carcinoma typically involves the upper and middle esophagus, while adenocarcinoma usually occurs in the lower esophagus, including the gastroesophageal junction. In a statement, the UK's NICE added that Opdivo has the potential to more effectively extend overall survival, although there is currently no clinical trial evidence to substantiate this. According to Bristol-Myers Squibb, following the approval of Opdivo, approximately 200 patients in England will be eligible for this treatment. Additionally, the company has signed a commercial agreement stipulating that Bristol-Myers Squibb will provide Opdivo to the UK's National Health Service (NHS) at a discounted price.

To date, Opdivo has been approved in the UK for the treatment of multiple tumor types. Just four months ago, the UK's National Institute for Health and Care Excellence (NICE) issued a final appraisal document approving Bristol-Myers Squibb’s anti-PD-1 therapy, Opdivo, for the treatment of advanced esophageal squamous cell carcinoma (ESCC) following chemotherapy failure and not amenable to surgical resection. With this approval, Opdivo became the first immuno-oncology therapy in the UK for patients with advanced ESCC who have failed prior chemotherapy and are ineligible for surgery, providing a crucial treatment option for this patient population. In September, the drug was further recommended by NICE for routine commissioning within the UK National Health Service (NHS) for the treatment of patients with metastatic and recurrent head and neck cancer.

Reference: NICE clears Opdivo for resected oesophageal or gastro-oesophageal junction cancer