Trial 2 (MAGIC*)—the only 5-HT3 RA to demonstrate superiority in a Phase 3, 3-drug vs 3-drug trial in HEC1
SUSTOL demonstrated superiority in the delayed phase of CINV vs ondansetron

- Modified Absorption of Granisetron In the Prevention of CINV.
- 2-sided hypothesis test. Significance level at α=0.05.1
- All patients were concomitantly administered intravenous dexamethasone.
- SUSTOL demonstrated superiority vs ondansetron IV in the prevention of delayed CINV in a trial of over 900 patients receiving HEC regimens encompassing AC, cisplatin, and other regimens1
- A prespecified subgroup analysis of the cisplatin and non-cisplatin strata demonstrated consistent treatment benefit compared to the overall study population. However, the study was not powered to show statistical significance within subset analyses1
- Due to the number of cisplatin-treated patients in SUSTOL Phase 3 clinical trials (n=358; 26% of HEC-treated patients), efficacy in this population has not been established1,2
- Data shown are not included in the SUSTOL Prescribing Information. SUSTOL is not indicated in patients treated with cisplatin
“This was the first published trial that compared a single dose of two different 5-HT3 antagonists when used in combination with dexamethasone and an NK1 RA.
“As a result, granisetron extended-release injection was the first FDA-approved 5-HT3 antagonist indicated for the prevention of delayed CINV associated with AC anticancer agents.”
– NCCN Guidelines®3§
§ | NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Antiemesis. |
MAGIC was the first Phase 3 study to compare 3-drug vs 3-drug, guideline-recommended antiemetic regimens for the prevention of CINV in patients receiving HEC.1,4

- 100% community-based setting5
- The most common chemotherapy regimens were AC-based regimens (65%) and cisplatin-based regimens (≥50 mg/m2) (28%)1
- Complete response was defined as no emetic episodes, including retching, and no use of rescue medication1
- SUSTOL was compared to ondansetron following US FDA guidance because prior to MAGIC, no 5-HT3 RA had shown superiority to ondansetron in preventing delayed CINV due to HEC1
- Although palonosetron IV is commonly used, it has not shown superiority to ondansetron in a Phase 3 trial for delayed CINV due to HEC1,6
- Based on current antiemetic guidelines for HEC, palonosetron is not preferred over any other 5-HT3 RA3
5-HT3 RA=5-hydroxytryptamine receptor antagonist; AC=anthracycline/cyclophosphamide; CINV=chemotherapy-induced nausea and vomiting; CR=complete response; HEC=highly emetogenic chemotherapy; IV=intravenous; NCCN=National Comprehensive Cancer Network; NK1 RA=neurokinin 1 receptor antagonist; SC=subcutaneous.