Bristol Myers Squibb Announces Phase 3 CheckMate -577 Trial Met Primary Endpoint of Disease-Free Survival with Opdivo as Adjuvant Therapy in Resected Esophageal and Gastroesophageal Junction Cancer

PRINCETON, N.J., Aug. 12, 2020 /PRNewswire/ -- Bristol-Myers Squibb (NYSE: BMY) announced that the Phase 3 clinical trial, CheckMate -577, met its primary endpoint of disease-free survival (DFS) following a pre-planned interim analysis. The study was designed to evaluateOpdivo(Nivolumab) as adjuvant therapy for the treatment efficacy in patients with esophageal cancer and gastroesophageal junction cancer after surgery. The study showed that, compared to placebo,OpdivoIt demonstrated a statistically significant advantage in the primary endpoint of disease-free survival (DFS) among patients who underwent neoadjuvant chemoradiotherapy (CRT) and surgical resection, with benefits observed across all enrolled patient subgroups. In this study,OpdivoThe safety profile was consistent with that reported in previous studies. Following melanoma, esophageal cancer and gastroesophageal junction cancer have becomeOpdivoThe second tumor type confirmed to benefit from adjuvant therapy.

“Approximately 50% of patients with esophageal cancer and gastroesophageal junction cancer who undergo tumor resection after neoadjuvant chemoradiotherapy will experience recurrence within four years. Among them, patients who do not achieve a complete response following neoadjuvant therapy tend to recur more quickly,” said Dr. Ronan J. Kelly, Director of the Charles A. Sammons Cancer Center at Baylor University Medical Center. “For patients who undergo tumor resection after neoadjuvant chemoradiotherapy but do not achieve pathological complete response, treatment options available from medical oncologists are very limited. Nivolumab is poised to become the first adjuvant therapy option for this patient population.”

“Opdivo“is the first and currently only treatment regimen that can help patients with esophageal cancer and gastroesophageal junction cancer improve disease-free survival after receiving neoadjuvant chemoradiotherapy and surgery, with manageable safety,” said Dr. Ian M. Waxman, Head of Gastrointestinal Cancer Research at Bristol-Myers Squibb. “The results of the CheckMate -577 study are crucial for both patients and physicians in this field, as they demonstrate”OpdivoIt holds promise to become the new standard of care for adjuvant therapy in patients with esophageal and gastroesophageal junction cancers undergoing surgical resection after neoadjuvant chemoradiotherapy. We plan to submit the study data to health regulatory authorities worldwide, so thatOpdivo“...as an adjuvant therapy to benefit these patients with urgent unmet treatment needs as early as possible.”

Bristol-Myers Squibb will subsequently complete a comprehensive evaluation of the existing data from the CheckMate -577 study and collaborate with investigators to present the results at upcoming academic conferences. Meanwhile, the Company will also discuss this study and its findings with health regulatory authorities. The CheckMate -577 study will continue as planned, with various data points, including the secondary endpoint of overall survival (OS), to be analyzed in the future.

*Nivolumab has not yet been approved in mainland China for the indications of esophageal cancer and melanoma