Results from the multicenter, randomized, open-label, global, phase III ATTRACTION-3 trial presented at the ESMO Congress 2019 found that Opdivo® (nivolumab) improves overall survival (OS) compared with chemotherapy in patients with unresectable advanced or recurrent esophageal squamous cell carcinoma that is refractory or intolerant to combination therapy with fluoropyrimidine and platinum-based drugs.
Patients were randomized to receive nivolumab 240 mg every two weeks (n=210) or investigator’s choice of chemotherapy with paclitaxel or docetaxel (n=209) as second-line treatment. Patients were followed for a minimum of 17.6 months.
Improved survival with nivolumab
Nivolumab was associated with a 23% reduction in risk of death (hazard ratio = 0.77; 95% CI, 0.62-0.96; P=0.019) and a 2.5-month improvement in median OS (10.9 months; 95% CI, 9.2-13.3) compared with chemotherapy (8.4 months; 95% CI, 7.2-9.9).
More patients in the nivolumab cohort remained alive at 12 (47% vs. 34%) and 18 months (31% vs. 21%).
The objective response rates were similar in the nivolumab and chemotherapy arms (19% vs. 22%); however, the nivolumab cohort had a substantially increased median duration of response (6.9 vs. 3.9 months).
The nivolumab cohort had fewer any-grade adverse events than chemotherapy (66% vs. 95%).