Safety of nivolumab in treating Indian patients with non-small-cell lung carcinoma and renal cell carcinoma: A prospective multicenter study

ABSTRACT Background: Nivolumab has shown significant therapeutic benefits in treating non-small-cell lung carcinoma (NSCLC) and renal cell carcinoma (RCC). Objectives: The primary objective of the study was to assess safety and tolerability of nivolumab in Indian patients with advanced NSCLC or RCC. The secondary objective was to evaluate frequency and severity of TRAEs. Materials and Methods: In this single-arm, open-label, multicenter, prospective Phase IV study, we enrolled 100 patients (70 with locally advanced/metastatic NSCLC and 30 with advanced RCC) from seven sites in India between April 2018 and July 2019. Patients received nivolumab as a second-line treatment (3 mg/kg intravenous (IV) every 2 weeks for 24 weeks). Safety was evaluated based on incidence and severity of TRAEs. In the RCC group, 22 patients (73.3%) underwent prior cancer-related surgery, and 7 patients (23.3%) received radiotherapy. Results: Among 100 patients [median age 56 (range 26 -74) years, 78% (n = 78) male], 95% (n = 95) experienced adverse events (AEs), with 25% (n = 25) reporting TRAEs. Grade 3-4 TRAEs (4%) included hyponatremia, respiratory infections, electrolyte imbalances, and pneumonitis. TRAEs leading to discontinuation was observed in 2 patients in NSCLC and none in RCC. 4 patients (5.7%) experienced at least one treatment-related SAE of any grade. No treatment-related SAEs were reported in the RCC group. Conclusion: This study confirms safety of nivolumab in Indian patients with NSCLC and RCC, consistent with global trials as monotherapy after prior chemotherapy.