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Opdivo Approved for Advanced Esophageal Squamous-Cell Carcinoma

Web Exclusives - FDA Approvals

On June 10, 2020, the FDA accelerated the approval of a new indication for nivolumab (Opdivo; Bristol Myers Squibb), a PD-1 inhibitor, for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous-cell carcinoma (ESCC) after fluoropyrimidine-based and platinum-based chemotherapy. This indication was approved under the accelerated approval guidelines; final approval may be contingent on confirmatory clinical trials demonstrating clinical benefits.

Nivolumab 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 indication for nivolumab for the treatment of esophageal cancer.

The FDA approved this indication based on the ATTRACTION-3 study, a multicenter, randomized, active-controlled, open-label clinical trial that included 419 patients with unresectable advanced, recurrent, or metastatic ESCC. All patients had disease refractory to or intolerant of at least 1 fluoropyrimidine- and platinum‑based regimen. Patients were randomized in a 1:1 ratio to nivolumab 240 mg by intravenous infusion over 30 minutes every 2 weeks (N = 210) or to investigator’s choice of taxane chemotherapy with docetaxel (75 mg/m2 every 3 weeks) or paclitaxel (100 mg/m2 once weekly for 6 weeks, followed by 1 week off; N = 209).

The major efficacy end point was overall survival (OS). Additional outcome measures included overall response rate (ORR), duration of response, and progression-free survival (PFS) as assessed by the investigator using RECIST 1.1 criteria.

The OS was significantly better with nivolumab than with chemotherapy. The median OS was 10.9 months (95% confidence interval [CI], 9.2-13.3) with nivolumab compared with 8.4 months (95% CI, 7.2-9.9) with chemotherapy (hazard ratio [HR], 0.77; 95% CI, 0.62-0.96; P = .0189). This OS benefit was reported regardless of consideration of tumor PD-L1 expression.

The ORR was 19.3% (95% CI, 13.7-26) in the nivolumab arm versus 21.5% (95% CI, 15.4-28.8) in the chemotherapy arm, and the median response duration was 6.9 months (95% CI, 5.4-11.1) with nivolumab versus 3.9 months (95% CI, 2.8-4.2) with chemotherapy. The results did not show an improvement in PFS (HR, 1.1; 95% CI, 0.9-1.3).

The most common (≥10%) adverse reactions 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.

The recommended dose of nivolumab for ESCC is 240 mg every 2 weeks or 480 mg every 4 weeks.

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Last modified: June 22, 2020
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