Clinical data demonstrate the efficacy of AKYNZEO® in preventing CINV for 5 days
90% of AKYNZEO patients receiving cisplatin had no vomiting and no rescue antiemetic medication use over 5 days1
Study design: Phase II, multicenter, randomized, parallel, double-blind, controlled trial in chemotherapy-naïve patients (N=694) who received CINV prophylaxis with either a single dose of AKYNZEO Capsules + oral dexamethasone 12 mg on Day 1 followed by 8 mg oral dexamethasone once daily on Days 2-4 (n=135) vs a 0.5 mg oral dose of palonosetron + oral dexamethasone 20 mg on Day 1 followed by oral dexamethasone 8 mg twice daily on Days 2-4 (n=136). All patients received cisplatin (median cisplatin dose was 75 mg/m2 for each group) alone or with other chemotherapy agents. The AKYNZEO patients primarily had a diagnosis of lung/respiratory cancer (25.9%), head and neck cancer (24.4%), or ovarian cancer (17.8%). The primary endpoint was complete response in the overall phase (0-120 hours).1,2
AKYNZEO Capsules demonstrated superior efficacy to palonosetron1,2
AKYNZEO for Injection (IV) has established efficacy based on bioequivalence of fosnetupitant to netupitant, and a noninferiority study with palonosetron1,3
≥90% complete response with AKYNZEO in the acute and delayed phase of CINV1
FDA-approved AKYNZEO demonstrated significant improvement for secondary endpoints† in acute (Day 1) and delayed (Days 2-5) phases of CINV vs palonosetron, including no emesis, no significant nausea, and complete protection (P≤.05)1,2
- AC=anthracycline-cyclophosphamide; CINV=chemotherapy-induced nausea and vomiting; HEC=highly emetogenic chemotherapy; VAS=visual analog scale.
- *AKYNZEO for Injection has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.
- †Protocol-defined secondary endpoints included rates of no emesis, no significant nausea (VAS <25 mm), and complete protection (complete response + no significant nausea) during acute, delayed, and overall phases.1,2