AKYNZEO® provides superior CINV prevention in AC therapy
Complete response with AKYNZEO capsules following AC chemotherapy treatment1
Complete response (no emesis and no use of antiemetic rescue medication) for 5 days in AC-treated patients, cycle 11
|Oral palonosetron 0.5 mg
from Cochran-Mantel-Haenszel test, stratified by age, class, and region
|Complete response, delayed phase (25 to 120 hours after AC regimen)||77%||70%||P=.001|
|Major secondary endpoint:|
|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-treated patients receiving AKYNZEO capsules1,2
‡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 11,3
- 1438 patients (99%) completed cycle 11
- 1286 patients (88%) continued treatment in the multiple-cycle extension1
AKYNZEO study design in patients receiving AC chemotherapy treatment1
Phase III, 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:
- 98% 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 AKYNZEO for injection and AKYNZEO injection for the prevention of CINV has not been established in a clinical study of patients treated with AC chemotherapy1
- AC=anthracycline-cyclophosphamide; CINV=chemotherapy-induced nausea and vomiting; MEC=moderately emetogenic chemotherapy.
- *AKYNZEO for injection and AKYNZEO injection have not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.