In June 2020, the FDA approved a new indication for the immunotherapy Opdivo (nivolumab; from Bristol Myers Squibb), a PD-1 inhibitor, for the treatment of patients with unresectable (cannot be removed by surgery) advanced, recurrent, or metastatic (spreading) esophageal squamous-cell carcinoma after the use of chemotherapy. Esophageal squamous-cell carcinoma is among the most common types of esophageal cancer.
Opdivo has been previously approved by the FDA, alone or in combination with other therapies, for the treatment of many solid tumors, including lung, colorectal, liver, melanoma, urothelial, and head and neck cancers, as well as for classical Hodgkin lymphoma. This is the first FDA approval for this immunotherapy for patients with esophageal cancer.
The FDA approved this indication based on the ATTRACTION-3 study, a randomized clinical trial that included 419 patients with unresectable advanced, recurrent, or metastatic esophageal squamous-cell carcinoma. All patients had disease that did not respond to at least 1 chemotherapy regimen. Patients were divided into 2 groups; one group received
Opdivo and the other group received chemotherapy.
The overall survival was significantly better with Opdivo than with chemotherapy. The average overall survival was 10.9 months with Opdivo compared with 8.4 months with chemotherapy. The survival benefit was reported regardless of whether the tumor involved any PD-L1 expression or not.
The average duration of the response to therapy was almost twice as long with Opdivo, at 6.9 months, compared with only 3.9 months with chemotherapy.
The most common side effects in patients receiving nivolumab in this study were rash, decreased appetite, diarrhea, constipation, musculoskeletal pain, upper respiratory tract infection, cough, pyrexia, pneumonia, anemia, fatigue, pruritus, nausea, and hypothyroidism.
