The Food and Drug Administration (FDA) has approved Opdivo® (nivolumab; Bristol Myers Squibb) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
The approval was based on data from the multicenter, active-controlled, open-label phase 3 ATTRACTION-3 trial that evaluated the efficacy and safety of nivolumab in 419 patients with unresectable advanced, recurrent, or metastatic ESCC, who were refractory or intolerant to at least 1 fluoropyrimidine- and platinum-based regimen. Patients were randomized to receive either nivolumab 240mg via intravenous (IV) infusion every 2 weeks (n=210) or an investigator’s choice of taxane chemotherapy (n=209) consisting of docetaxel 75mg/m2 IV every 3 weeks (n=65) or paclitaxel 100mg/m2 IV once weekly for 6 weeks followed by 1 week off (n=144).
Results showed that nivolumab met the primary end point achieving superior overall survival (OS) compared with taxane chemotherapy (hazard ratio [HR] 0.77; 95% CI, 0.62-0.96; P =.0189) regardless of tumor PD-L1 expression level. Patients treated with nivolumab had a median OS of 10.9 months (95% CI, 9.2-13.3) compared with 8.4 months (95% CI, 7.2-9.9) for taxane chemotherapy.
The 2 treatment arms were not statistically significantly different with regard to overall response rate (ORR: 19.3% [95% CI, 13.7-26] in the nivolumab arm vs 21.5% [95% CI, 15.4-28.8] in the taxane chemotherapy arm). The nivolumab arm demonstrated a median duration of response of 6.9 months vs 3.9 months for taxane chemotherapy arm. An improvement in progression free survival (PFS) was not observed in the trial (HR 1.1; 95% CI, 0.9-1.3).
“The approval of Opdivo as a new treatment option for previously treated patients with advanced esophageal squamous cell carcinoma, regardless of PD-L1 expression, highlights our commitment to providing new options to address the unmet needs of patients and brings us another step closer to understanding the full potential of immunotherapy for gastrointestinal cancers,” said Adam Lenkowsky, general manager and head, US, Oncology, Immunology, Cardiovascular, Bristol Myers Squibb.
Opdivo is supplied as 40mg/mL, 100mg/mL, and 240mg/24mL solution in single-dose vials.
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