Bristol Myers Squibb announces positive results from Opdivo clinical trials
pharmafile | August 12, 2020 | News story | Research and Development | Bristol-Myers Squibb, Cancer, bristol myers squibb
Bristol Myers Squibb has announced positive data from two Phase 3 clinical trials of its drug Opdivo.
The first trial compared Opdivo combined with chemotherapy to chemotherapy alone as a treatment for metastatic gastric cancer, gastroesophageal junction (GEJ) cancer or esophageal adenocarcinoma. The overall survival benefit was seen in the randomised population and the study met its two primary endpoints of overall survival and progression-free survival.
The second trial was for patients with resected esophageal or gastroesophageal junction (GEJ) cancer. The trial also met it primary endpoints of disease-free survival. When these patients where treated with the drug and neoadjuvant chemoradiation therapy (CRT) and complete surgical resection, it showed a statistically significant improvement in DFS compared to placebo in the all-randomized population.
Ronan J Kelly, Director of the Charles A. Sammons Cancer Center at Baylor University Medical Center, commented on the study and said: “Approximately 50% of patients with esophageal or gastroesophageal junction cancer who undergo neoadjuvant chemoradiation therapy followed by tumour resection will have disease recurrence within four years, and among those who do not respond completely to neoadjuvant treatment, recurrence will occur sooner.
“Medical oncologists have had limited to no treatment options to offer esophageal cancer patients who undergo neoadjuvant chemoradiation therapy followed by surgery and fail to demonstrate a complete pathological response. For the first time, we have a potential therapeutic option with nivolumab in the adjuvant setting for these patients.”
Bristol Myers Squibb plans to conduct a full evaluation of the available data from both these trials and are set to present them to an upcoming medical conference.
Opdivo was first approved for use in July 2014, and is now approved in more than 65 countries. In October 2015, Opdivo and Yervoy were approved as a combination treatment for metastatic melanoma and is now available in more than 50 countries.
Conor Kavanagh
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