Global First! BMS’s Opdivo Approved for Unresectable Advanced or Recurrent Esophageal Cancer in Japan

On February 22, Bristol-Myers Squibb (BMS) announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) had approved its PD-1 inhibitor Opdivo (nivolumab) for the treatment of patients with unresectable advanced or recurrent esophageal cancer whose disease progressed after chemotherapy. This marks the first approval of Opdivo for the treatment of advanced esophageal cancer and the first cancer immunotherapy approved in Japan for this indication.

Esophageal cancer is challenging to treat. Its tumor cells originate in the inner lining of the esophagus and expand outward, with two main types: squamous cell carcinoma and adenocarcinoma. Globally, esophageal cancer is the seventh most common cancer and the sixth leading cause of cancer-related death, with a five-year survival rate of only 8% for patients with advanced-stage disease. In Japan, approximately 20,000 patients are diagnosed with esophageal cancer annually, resulting in 12,000 deaths. China has the highest incidence rate of esophageal cancer worldwide, which may be closely associated with the dietary habit of consuming food while it is still hot. According to statistics from the National Cancer Center of China, esophageal cancer ranks as the fourth leading cause of cancer-related mortality in the country. Worldwide, there are approximately 572,000 new cases of esophageal cancer each year, with 508,000 deaths. In China, there are approximately 307,000 new cases annually, resulting in 283,000 deaths.

Opdivo is a PD-1 immune checkpoint inhibitor designed to help restore anti-tumor immune responses. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option for various types of cancer. In July 2014, Opdivo became the first approved PD-1 immune checkpoint inhibitor worldwide. Currently, this therapy is approved in mainland China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are negative for epidermal growth factor receptor (EGFR) gene mutations and anaplastic lymphoma kinase (ALK), and whose disease has progressed after or who are intolerant to prior platinum-based chemotherapy.

This approval is based on the results of a Phase 3 clinical trial named ATTRACTION-3, which aimed to evaluate the efficacy and safety of Opdivo compared with chemotherapy (docetaxel or paclitaxel) in patients with unresectable advanced or recurrent esophageal squamous cell carcinoma (ESCC) who were intolerant to fluoropyrimidine and platinum-based combination therapy. The trial results demonstrated that, compared with chemotherapy, Opdivo showed a statistically significant benefit in the primary endpoint of overall survival (OS), reducing the risk of death by 23% and extending median survival by 2.5 months.

“We are honored to partner with Ono Pharmaceutical Co., Ltd. to provide a new chemotherapy alternative for patients with esophageal cancer in Japan, regardless of their tumors’ PD-L1 expression levels,” said Fouad Namouni, M.D., Head of Oncology Development at BMS. “This marks the first marketing approval of Opdivo for the treatment of patients with esophageal cancer, reflecting our commitment to advancing cutting-edge therapies.”

References:

[1] Japan Ministry of Health, Labor and Welfare Approves Opdivo (nivolumab) for the Treatment of Patients with Unresectable Advanced or Recurrent Esophageal Cancer, Retrieved February 21, 2020, from https://www.businesswire.com/news/home/20200221005172/en

Original Title: World’s First! BMS Blockbuster Immunotherapy Approved for Esophageal Cancer Treatment for the First Time

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