Opdivo (nivolumab) was approved by FDA for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.
Efficacy was investigated in ATTRACTION-3 (NCT02569242), a multicenter, randomized (1:1), active-controlled, open-label trial in 419 patients with unresectable advanced, recurrent, or metastatic ESCC. Patients who were refractory or intolerant to at least one fluoropyrimidine- and platinum‑based regimen received nivolumab 240 mg by intravenous infusion over 30 minutes every 2 weeks (n=210), or investigator’s choice of taxane chemotherapy consisting of docetaxel (75 mg/m2 intravenously every 3 weeks) or paclitaxel (100 mg/m2 intravenously once a week for 6 weeks followed by 1 week off) (n=209).
The major efficacy outcome measure was overall survival. Additional efficacy outcome measures were overall response rate, response duration, and progression-free survival as assessed by the investigator using RECIST 1.1.
The trial demonstrated a statistically significant improvement in OS. Median OS for patients receiving nivolumab was 10.9 months (95% CI: 9.2, 13.3) compared with 8.4 months (95% CI: 7.2, 9.9) for patients receiving investigator’s choice of taxane chemotherapy (HR: 0.77; 95% CI: 0.62, 0.96; p=0.0189). OS benefit was observed regardless of tumor PD-L1 expression level. 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 taxane chemotherapy arm, with median response duration of 6.9 months (95% CI: 5.4, 11.1) and 3.9 months (95% CI: 2.8, 4.2), respectively. The trial did not demonstrate an improvement in PFS (HR: 1.1; 95% CI: 0.9, 1.3).
