Clinical data demonstrate the efficacy of AKYNZEO® in preventing CINV for 5 days

90% of patients receiving cisplatin experienced complete response in the overall phase with AKYNZEO capsules1

Complete response (no emesis and no use of rescue medication) for 5 days in the overall phase (across both acute and delayed CINV) in cisplatin-treated patients1
AKYNZEO complete response data for CINV in overall phase

99% of patients receiving cisplatin experienced complete response during the acute phase with AKYNZEO capsules1

Complete response (no emesis and no use of rescue medication) in acute and delayed CINV in cisplatin-treated patients1
AKYNZEO complete response in acute and delayed CINV

*Secondary endpoint. Adjusted P-values for multiple comparisons using Cochran-Mantel-Haenszel test, stratified by gender.


AKYNZEO capsules study design in patients receiving cisplatin-based chemotherapy1,2

Multicenter, randomized, double-blind, double-dummy, parallel-group study1,2:

  • Primary endpoint: complete response in overall phase (0–120 hours)1
  • Patients received a HEC regimen that included cisplatin (≥50 mg/m2 either alone or in combination with other chemotherapy agents)2
    — Median cisplatin dose: 75 mg/m2 for each group1
  • Patients treated with AKYNZEO capsules primarily had a diagnosis of lung/respiratory cancer (25.9%), head and neck cancer (24.4%), or ovarian cancer (17.8%)2
  • AKYNZEO is given with dexamethasone; dosing schedule1,2:
    — AKYNZEO capsules arm:
    • Day 1: AKYNZEO capsules and oral dexamethasone 12 mg.
    • Days 2–4: Oral dexamethasone 8 mg once a day
    — Palonosetron arm:
    • Day 1: Oral palonosetron 0.5 mg and oral dexamethasone 20 mg.
    • Days 2–4: Oral dexamethasone 8 mg twice a day

AKYNZEO for injection: Efficacy was established based on bioequivalence and noninferiority studies1,3,4

The efficacy of AKNYZEO for injection for the prevention of CINV has not been established in a clinical study of patients treated with AC chemotherapy

View clinical trial data supporting the safety and efficacy of AKYNZEO for injection:

See IV Data


AC
=anthracycline-cyclophosphamide.
CINV
=chemotherapy-induced nausea and vomiting.
HEC
=highly emetogenic chemotherapy.