FDA Approves Opdivo as First Adjuvant Immunotherapy for Resected Esophageal or GEJ Cancer, Doubling Disease-Free Survival

Today, Bristol-Myers Squibb (BMS) announced that the U.S. FDA has approved an expanded indication for Opdivo (nivolumab) as adjuvant therapy for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer who have residual pathological disease following neoadjuvant chemoradiotherapy (CRT). The press release noted that Opdivo is the first immunotherapy approved for adjuvant treatment in this patient population.

Esophageal cancer is the seventh most common cancer globally and the sixth leading cause of cancer death. Squamous cell carcinoma and adenocarcinoma are the two most prevalent histological subtypes, accounting for approximately 84% and 15% of all esophageal cancer cases, respectively; however, histological characteristics vary by region. In China, esophageal cancer ranks as the sixth most common cancer and the fourth leading cause of cancer death, following lung, gastric, and liver cancers. Most patients are diagnosed at an advanced stage, which significantly impacts daily life, including dietary intake.

This approval is based on the results of CHECKMATE-577, a randomized, double-blind, placebo-controlled phase 3 trial involving 794 patients with esophageal or gastroesophageal junction (GEJ) cancer who underwent complete surgical resection.

The trial results demonstrated that, compared with the placebo group, patients treated with Opdivo experienced a statistically significant improvement in disease-free survival (DFS). The median DFS was 22.4 months (95% CI: 16.6, 34.0) in the Opdivo group versus 11 months (95% CI: 8.3, 14.3) in the control group. A DFS benefit was observed regardless of tumor PD-L1 expression or histology.

The most common adverse reactions (≥20%) in patients receiving Opdivo treatment are 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.

Note: The original text has been abridged.

References:

[1] U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as Adjuvant Treatment of Completely Resected Esophageal or Gastroesophageal Junction Cancer in Patients who have Received Neoadjuvant Chemoradiotherapy. Retrieved May 20, 2021, from https://www.businesswire.com/news/home/20210520005931/en

[2] FDA approves nivolumab for resected esophageal or GEJ cancer. Retrieved May 20, 2021, from https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-nivolumab-resected-esophageal-or-gej-cancer

Note: This article aims to introduce advances in medical and health research and does not constitute a recommendation for treatment regimens. For professional treatment guidance, please visit a qualified hospital for consultation.

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