STOP-CINV STUDY: Safety and Effectiveness of I.V. Akynzeo® (Fosnetupitant 235 mg and Palonosetron 0.25 mg) in the Prevention of Chemotherapy- Induced Nausea and Vomiting in Indian Patients

Purpose IV Akynzeo® (Intravenous fosNEtupitant + PAlonosetron) is the first fixed intravenous combination designed to target key pathways of emesis, allowing for convenient single-dose administration. This study aimed to evaluate the safety and efficacy of IV Akynzeo® in a real-world context in India. Methods This open-label, single-arm, multicentre, prospective phase IV trial assessed single dose I.V. Akynzeo® for prevention of CINV in patients receiving highly emetogenic/ moderately emetogenic chemotherapy (HEC/MEC). I.V. Akynzeo® (Fosnetupitant 235 mg and Palonosetron 0.25 mg) was administered over 30 minutes before the start of chemotherapy. The primary endpoints were number of patients with drug related and serious treatment-emergent adverse events (TEAEs) which were assessed for a period of 10 days (± 2 days). The key secondary endpoints were complete response, protection and control in acute (up to 24 hours), delayed (24–120 hours), extended phase (120–240 hours) phase. Results In all, 178 patients were enrolled (median: 48.5 years; 64% males) 176 patients completed the study. I.V. Akynzeo® was well-tolerated with 17 (9.55%) patients reporting 23 AEs, 22 (95.65%) were mild and one (4.35%) was fatal. The injection site reaction with I.V. Akynzeo® was low (1.68%). The complete responsee rates with I.V. Akynzeo® 84.27% (95% CI, 78.01, 89.29) for the acute phase, 93.26% (95% CI, 88.52, 96.47) for the delayed phase and 83.15% (95% CI, 76.82, 88.33) for the overall phase. Conclusion I.V. Akynzeo® was well tolerated and it exhibited substantial efficacy in mitigating CINV in patients undergoing HEC/MEC across acute, delayed and extended delayed phases.