Lee JS, et al. - In Korean patients with stage IIIB/IV or recurrent non-small-cell lung cancer (NSCLC) who failed platinum-based chemotherapy, researchers tested the efficacy and safety of nivolumab. Historical reports state that overall survival in refractory NSCLC is <1 year. The efficacy and safety demonstrated by nivolumab in Korean patients with advanced or recurrent squamous or non-squamous NSCLC in this study were found to be consistent with previous reports.

Methods

• This is a multicenter, open-label, Phase II study.
• Nivolumab 3 mg/kg every 2 weeks for 6 weeks per treatment cycle was administered to 100 patients with stage IIIB or IV squamous (n = 44) or non-squamous (n = 56) NSCLC.
• Treatment was continued until disease progression or intolerable adverse events, and then patients entered a follow-up phase.
• The centrally assessed objective response rate (ORR) was the primary efficacy endpoint.

Results

• In the total population, the observed ORR was 20.0% (95% CI: 13.3–28.9%).
• In patients with squamous NSCLC and in those with non-squamous NSCLC, the reported ORR was 15.9% (7/44 patients; 95% CI: 7.9–29.4%) and 23.2% (13/56 patients; 95% CI: 14.1–35.8%), respectively.
• The observed median overall survival was: 13.9 (95% CI: 10.8–18.5) months in the total population, 12.3 (95% CI: 8.2–18.5) months in squamous NSCLC, and 16.3 (95% CI: 10.8, -) months in non-squamous NSCLC.
• Researchers found that the median progression-free survival was 2.8 (95% CI: 1.4–5.7), 2.6 (95% CI: 1.3–5.7), and 5.3 (95% CI: 1.4–7.1) months in the total, squamous, and non-squamous NSCLC populations, respectively.
• In the total, squamous, and non-squamous NSCLC populations, the observed median duration of response was 11.7 (95% CI: 5.6, -), 12.0 (95% CI: 4.8, -), and 12.1 (95% CI: 3.0, -) months, respectively.
• Adverse events (AEs) most frequently experienced were decreased appetite, dyspnea, and cough in 43 (43.0%), 32 (32.0%) and 29 (29.0%) patients, respectively.
• Pneumonia, occurring in 7.0% of patients, was documented as the most common Grade ≥3 AE.
• Decreased appetite (14.0%) and pruritus (6.0%), neither of which was Grade ≥3, were common treatment-related AEs.