Multicenter randomized phase 3 trial of HR20013 for prevention of chemotherapy-induced nausea and vomiting

HR20013 is a novel fixed-dose intravenous antiemetic mixed formulation of fosrolapitant and palonosetron (PALO). The multicenter noninferiority phase 3 PROFIT trial in China compared HR20013 plus dexamethasone (DEX) versus fosaprepitant (FAPR) plus PALO plus DEX for preventing chemotherapy-induced nausea and vomiting (CINV) in patients receiving cisplatin-based highly emetogenic chemotherapy (HEC). In cycle 1, HR20013 + DEX was noninferior to FAPR + PALO + DEX for the endpoint complete response in overall phase (0-120 hours). In cycle 2, greater proportions of patients receiving HR20013 + DEX than of patient receiving FAPR + PALO + DEX reported no impact of CINV on daily life at the delayed (24-120 hours) and beyond delayed (120-168 hours) phases. The authors conclude that HR20013 + DEX was noninferior to FAPR + PALO + DEX for preventing HEC-CINV and was well tolerated, with the potential to reduce the impact of CINV on daily life.