Pharmaceuticals: US FDA Grants Approval For Nivolumab As Treatment Drug For Esophageal Squamous Cell Carcinoma
: The US Food and Drug Administration has approved nivolumab (OPDIVO) by Bristol-Myers Squibb for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
Proof for 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 drug efficacy outcome measure was overall survival (OS). Additional efficacy outcome measures were overall response rate (ORR), response duration, and progression-free survival (PFS) as assessed by the investigator using RECIST 1.1.
The clinical 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).
However the most common adverse reactions in less than 10% patients receiving nivolumab were rash, decreased appetite, diarrhea, constipation, musculoskeletal pain, upper respiratory tract infection, cough, pyrexia, pneumonia, anemia, fatigue, pruritus, nausea, and hypothyroidism.
The approved recommended nivolumab dose for ESCC is 240 mg every 2 weeks or 480 mg every 4 weeks.
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