AKYNZEO® demonstrated safety and efficacy over multiple cycles of chemotherapy

Study designed with patients undergoing initial and repeat cycles of chemotherapy who received AKYNZEO capsules1

  • Multinational, multicenter, randomized, double-blind, double-dummy, parallel-group study1
  • The primary assessment of this multi-cycle study was safety, measured primarily by treatment-emergent adverse events; efficacy over multiple cycles was also evaluated1
  • Patients were randomized (3:1 for AKYNZEO capsules) on Day 1 (AKYNZEO, n=309; aprepitant/palonosetron, n=104) of their first chemotherapy cycle before administration of1:
Highly emetogenic chemotherapy regimens (HEC)
  • Cisplatin*
  • Mechlorethamine
  • Streptozocin
  • Cyclophosphamide
    (≥1500 mg/m2)
  • Carmustine*
  • Dacarbazine*
Moderately emetogenic chemotherapy regimens (MEC)
  • Oxaliplatin*
  • Carboplatin*
  • Epirubicin*
  • Idarubicin
  • Ifosfamide
  • Irinotecan*
  • Daunorubicin*
  • Doxorubicin*
  • Cyclophosphamide*
    (<1500 mg/m2)
  • Cytarabine (>1 g/m2)
  • Azacitidine
  • Alemtuzumab
  • Bendamustine
  • Clofarabine

*Cycle 1 chemotherapy.1

  • There was no limit to the number of consecutive cycles for each patient1

AKYNZEO safety and efficacy results in multi-cycle chemotherapy1

  • Treatment-emergent adverse events of AKYNZEO were comparable to aprepitant and palonosetron
  • Efficacy in the AKYNZEO arm was maintained throughout all cycles

AKYNZEO for injection: Efficacy was established based on bioequivalence and noninferiority studies2-4

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.
MEC
=moderately emetogenic chemotherapy.