FDA approves Opdivo for advanced esophageal cancer after chemotherapy
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The FDA approved nivolumab for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after receiving fluoropyrimidine- and platinum-based chemotherapy.
This marks the first FDA approval of an immunotherapy for this patient population regardless of tumor PD-L1 expression level, according to the manufacturer.
The FDA based the approval, in part, on data from the phase 3 multicenter, randomized, active-controlled, open-label ATTRACTION-3 trial, for which researchers compared nivolumab (Opdivo, Bristol-Myers Squibb; n = 210) with investigator’s choice of docetaxel (n = 65) or paclitaxel (n = 144) for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma that was refractory or intolerant to a prior fluoropyrimidine- and platinum-based regimen.
Researchers reported significantly prolonged OS, which served as the major efficacy outcome of the trial, among patients who received nivolumab vs. chemotherapy (median OS, 10.9 months vs. 8.4 months; HR = 0.77; 95% CI, 0.62-0.96).
Overall response rate (19.3% vs. 21.5%) and median PFS (1.7 months vs. 3.4 months; HR = 1.1; 95% CI, 0.9-1.3) did not appear significantly different between the nivolumab and chemotherapy groups.
The most common adverse events associated with nivolumab included rash (22%) and decreased appetite (21%). Serious adverse events occurred among 38% of patients assigned nivolumab, including pneumonia, esophageal fistula, interstitial lung disease and pyrexia.
“Many cases of esophageal cancer are diagnosed at the advanced stage, when the disease could have a significant impact on a patient’s health. Treatment options can be limited once patients with advanced esophageal squamous cell carcinoma progress,” Adam Lenkowsky, general manager and head of U.S. oncology, immunology and cardiovascular at Bristol-Myers Squibb, said in a press release. “The approval of Opdivo as a new treatment option for previously treated patients with advanced esophageal squamous cell carcinoma, regardless of PD-L1 expression, highlights our commitment to providing new options to address the unmet needs of patients and brings us another step closer to understanding the full potential of immunotherapy for gastrointestinal cancers.”
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