ALOXI® vs.
Ondansetron in Highly Emetogenic Chemotherapy
ALOXI prevents acute CINV
- Complete Response was the primary endpoint of this noninferiorty trial1,2
- The most common types of cancer for patients in this trial were ovarian, lung, Hodgkin’s
disease, breast, and gastric (≥5% of patients in any group)2
- The most common chemotherapy regimens for patients in this trial were cisplatin,
cyclophosphamide, and dacarbazine (≥10% of patients in any group)2
Complete Response1,2†
(No emetic episode and no use of rescue medication)
* Phase III, multinational, randomized, double-blind, double-dummy, stratified,
parallel-group, active-comparator noninferiority trial with primary endpoint of
CR. Significance level = 0.025 (adjusted post-hoc, 2-sided Fisher’s exact test comparisons
of ALOXI with ondansetron; 97.5% CI).
† ITT cohort.
- ALOXI was demonstrated to be noninferior to ondansetron in the
acute phase1,2
- Concomitant dexamethasone 20 mg IV on Day 1 was administered
prophylactically to 447 patients (67% of ITT population)1,2
- Efficacy was greater when prophylactic steriods were administered
concomitantly
- Clinical superiority over other 5-HT3 receptor antagonists
has not been adequately demonstrated in the acute phase