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FDA Approves Nivolumab for Treatment of Certain Patients With ESCC
On June 10, 2020, the FDA approved nivolumab (Opdivo; Bristol-Myers Squibb) for the treatment of patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) who previously received fluoropyrimidine- and platinum-based chemotherapy. Nivolumab was given priority review and orphan drug designation by the FDA.
This approval was based on efficacy data from the multi-center, open-label ATTRACTION-3 clinical trial of 419 patients with unresectable advanced, recurrent, or metastatic ESCC. These patients were randomized in a 1:1 ratio to receive nivolumab 240 mg every 2 weeks (n = 210) or investigator’s choice of taxane chemotherapy comprising docetaxel 75 mg/m2 every 3 weeks or paclitaxel 100 mg/m2 once weekly for 6 weeks followed by 1 week without treatment (n = 209).
The major efficacy end point of the ATTRACTION-3 study was overall survival (OS); overall response rate (ORR), response duration, and progression-free survival (PFS) were additional outcome measures.
Overall, a statistically significant improvement in OS was observed, with median OS for patients receiving nivolumab versus investigator’s choice of taxane chemotherapy at 10.9 months (95% CI, 9.2-13.3) versus 8.4 months (95% CI, 7.2-9.9), respectively (hazard ratio [HR], 0.77; 95% CI, 0.62-0.96; P = .0189).
Of note, the investigators observed an OS benefit regardless of tumor PD-L1 expression level.
The ORR was 19.3% (95% CI, 13.7-26) with nivolumab compared with 21.5% (95% CI, 15.4-28.8) with taxane chemotherapy, and the median durations of response were 6.9 months (95% CI, 5.4-11.1) and 3.9 months (95% CI, 2.8-4.2), respectively.
An improvement in PFS was not shown (HR, 1.1; 95% CI, 0.9-1.3).
The most common (≥10%) adverse events associated with nivolumab were rash, decreased appetite, diarrhea, constipation, musculoskeletal pain, upper respiratory tract infection, cough, pyrexia, pneumonia, anemia, fatigue, pruritus, nausea, and hypothyroidism.—Hina M. Porcelli
Source: US Food and Drug Administration. FDA approves nivolumab for esophageal squamous cell carcinoma. Updated June 11, 2020. www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-nivolumab-esophageal-squamous-cell-carcinoma. Accessed June 11, 2020.
