MAGIC Phase III study success for Sustol (granisetron injection, extended release) for CINV- Heron Therapeutics

Heron Therapeutics, Inc., announced positive, top-line results from its recently completed Phase III MAGIC study. MAGIC evaluated the efficacy and safety of the Company's 5-HT3 receptor antagonist product candidate Sustol (granisetron injection, extended release) as part of a three-drug regimen with the intravenous (IV) neurokinin-1 (NK1) receptor antagonist fosaprepitant and the IV corticosteroid dexamethasone for the prevention of delayed-onset chemotherapy-induced nausea and vomiting (CINV) following administration of highly emetogenic chemotherapy (HEC) agents.

The MAGIC study is the only Phase III CINV prophylaxis study in a HEC population performed to date to use as a comparator the currently recommended, standard-of-care, three-drug regimen: a 5-HT3 receptor antagonist (in this case ondansetron), fosaprepitant and dexamethasone. The study was conducted entirely in the U.S. and enrolled over 900 patients undergoing HEC treatment for various tumor types. The primary endpoint in this study was the proportion of patients who achieved a Complete Response, defined as no emesis and no rescue medications during the delayed-onset phase of CINV, occurring 24-120 hours following administration of HEC agents.

The study's primary endpoint was achieved. The percentage of patients who achieved a Complete Response was significantly higher in the Sustol group than the comparator group (64.7% vs. 56.6%, p=0.014). The percentage of patients who achieved Complete Control, defined as Complete Response plus no more than mild nausea during the delayed-onset phase, also reached statistical significance in favour of Sustol (p = 0.022). The percentage of patients who experienced no nausea or infrequent nausea during the delayed-onset phase was significantly higher in the Sustol arm compared with the comparator arm (p = 0.032). Significantly more patients in the Sustol arm were satisfied with their therapy based on a quality-of-life questionnaire (p = 0.040). Sustol was well tolerated, with no clinically significant differences in the rate or severity of adverse events between the Sustol arm and the comparator arm.