Bristol Myers Squibb Submits sBLA for Opdivo in Gastric and Esophageal Cancers, Granted FDA Priority Review

Bristol-Myers Squibb (BMS) announced today that the U.S. FDA has accepted its supplemental Biologics License Application (sBLA) for the PD-1 inhibitor Opdivo (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer (GEJC), or esophageal adenocarcinoma (EAC). The FDA has also granted priority review to this application, with a decision expected by May 25 of this year. The press release noted that, if approved, this would represent the first immunotherapy-based treatment option for first-line therapy of gastric cancer.

Meanwhile, Opdivo (nivolumab) has also been granted another Priority Review designation by the FDA for use as adjuvant therapy in patients with gastroesophageal junction cancer and esophageal adenocarcinoma following neoadjuvant therapy and resection surgery.

Gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer-related deaths. In 2018, there were over 1 million new cases and more than 780,000 deaths. In China, gastric cancer is the second most common cancer, following lung cancer. Esophageal cancer is the seventh most common cancer globally. In China, it is the fourth leading cause of cancer-related deaths, after lung, gastric, and liver cancers. The high incidence of esophageal cancer in China may be associated with the dietary habit of “eating while hot.”

Opdivo is a PD-1 immune checkpoint inhibitor developed by Bristol-Myers Squibb (BMS). It restores the body’s anti-tumor immune response by blocking the binding of the PD-1 receptor to its ligands. Since receiving initial FDA approval in 2014, it has been approved in more than 65 countries and regions worldwide for the treatment of various cancer types, including melanoma and non-small cell lung cancer.

The BLA for first-line treatment of gastric cancer and esophageal cancer was supported by data from the randomized, multicenter, open-label Phase 3 clinical trial named CheckMate-649. The results of the trial, presented at last year’s ESMO 2020 virtual congress, showed that compared to chemotherapy alone, the combination therapy of Opdivo and chemotherapy reduced the risk of death in patients by 20% (HR=0.80, 95% CI, 0.68-0.94, p=0.0002). The median OS for patients in the Opdivo combination therapy group was 13.8 months, while this value was 11.6 months in the chemotherapy control group.

In patients with tumors expressing PD-L1 (CPS > 5), Opdivo combination therapy demonstrated superior efficacy, achieving a median overall survival (OS) of 14.4 months compared to 11.1 months in the chemotherapy control group. Opdivo combination therapy reduced the risk of death by 29% (HR = 0.71; 98.4% CI, 0.59–0.86; p < 0.0001).

▲Survival Data from CheckMate-649 (Image source: BMS official website)

As an adjuvant therapy, Opdivo also demonstrated outstanding results in the Phase 3 CheckMate-577 clinical trial involving patients with esophageal cancer and gastroesophageal junction cancer. The disease-free survival (DFS) for postoperative patients treated with Opdivo reached 22.4 months, significantly superior to the 11.0 months observed in the placebo group (HR=0.69, 96.4% CI, 0.56-0.86, p=0.0003).

“Today’s acceptance of our application by the FDA represents a significant advancement for the gastrointestinal oncology community,” said Dr. Ian M. Waxman, Head of Gastrointestinal Cancer Development at Bristol-Myers Squibb. “The positive results from the CheckMate-649 trial have the potential to change medical practice, and we look forward to working with the FDA to bring the first immunotherapy-based first-line treatment option to patients who have not seen new therapies in the past decade.”

Note: This article is intended to introduce medical and health research and does not constitute a recommendation for treatment plans. For guidance on treatment options, please consult a licensed healthcare provider at a reputable hospital.

References:

[1] U.S. Food and Drug Administration Accepts for Priority Review Application for Opdivo® (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer. Retrieved January 20, 2021, from https://www.businesswire.com/news/home/20210120005097/en

[2] U.S. Food and Drug Administration Accepts for Priority Review Application for Opdivo® (nivolumab) Combined with Chemotherapy as First-Line Treatment in Metastatic Gastric Cancer, Gastroesophageal Junction Cancer and Esophageal Adenocarcinoma. Retrieved January 20, 2021, from https://www.businesswire.com/news/home/20210120005166/en

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