AKYNZEO® capsules provide superior CINV prevention in AC therapy*

Complete response following AC chemotherapy

Complete Response (no Emesis And No Use Of Rescue Medication) For 5 Days In Ac-treated Patients, Cycle 11

AKYNZEO capsules
(n=724)
Oral Palonosetron 0.5 mg
(n=725)
P-values
from Cochran-Mantel-Haenszel test, stratified by age class and region
Primary endpoint:
Complete response, delayed phase (25 to 120 hours after AC regimen) 77% 70% P=.001
Major secondary endpoints:
Complete response, acute phase
(0 to 24 hours after AC regimen)
88% 85% P=.047
Complete response, overall phase
(0 to 120 hours after AC regimen)
74% 67% P=.001

See safety profile in AC-treated patients


Sustained efficacy across multiple cycles in AC patients treated with AKYNZEO capsules

Complete Response In Delayed Cinv In Cycles 2–6 In Ac-treated Patients1,2,†
AKYNZEO complete response in Cycles 2-6

Secondary endpoint.

95% confidence interval.


Complete response in the delayed phase was higher with AKYNZEO among patients receiving AC chemotherapy treatment during all cycles (Cycles 2–6)1

After completion of Cycle 1, patients had the option to participate in a multiple-cycle extension, receiving the same treatment as assigned in Cycle 1.1

  • 88.4% of patients continued treatment in the multiple-cycle extension1
  • 62.3% of patients completed the multiple-cycle extension up to a maximum of 8 treatment cycles1

AKYNZEO study design in patients receiving AC chemotherapy treatment1

Phase 3, multinational, multicenter, randomized, double-blind, double-dummy, parallel-group study evaluating AKYNZEO capsules (n=724) vs oral palonosetron (n=725) in AC-based chemotherapy, which was considered MEC at the time the study was conducted1,3:

  • 97% of patients were undergoing chemotherapy for breast cancer3
  • Day 1: AKYNZEO capsule + dexamethasone 12 mg vs palonosetron 0.5 mg + dexamethasone 20 mg1
  • Days 2–3: No antiemetic treatment1

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

AC
=anthracycline-cyclophosphamide.
CINV
=chemotherapy-induced nausea and vomiting.
MEC
=moderately emetogenic chemotherapy.