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

Trial 2 (MAGIC) results: complete response in delayed CINV due to HEC was 65% with SUSTOL, and 57% with 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

Patients were administered 10 mg of SUSTOL, while others were administered 0.15 mg of ondansetron
  • 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.

References:

  1. Schnadig et al. Future Oncol. 2016.
  2. Data on File [C2006-01]. Heron Therapeutics, Inc.
  3. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Antiemesis V.1.2022. ©National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed February 15, 2022. To view the most recent and complete version of the guideline, go to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
  4. Zhou et al. Ther Clin Risk Manag. 2015.
  5. Data on File [C2013-01]. Heron Therapeutics, Inc., San Diego, CA.
  6. Aapro et al. Ann Oncol. 2006.
  7. SUSTOL [prescribing information]. Heron Therapeutics, Inc., 2017.