On September 22, 2015 Heron Therapeutics, Inc. (NASDAQ:HRTX), a biotechnology company focused on improving the lives of patients by developing best-in-class medicines that address major unmet medical needs, reported that data from Heron’s recently completed MAGIC Study of SUSTOL (granisetron) Injection, extended release, for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC), will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2015 Breast Cancer Symposium on Saturday, September 26, 2015 in San Francisco, CA (Press release, Heron Therapeutics, SEP 22, 2015, View Source;p=RssLanding&cat=news&id=2089440 [SID:1234507513]).
Heron will present a poster and give an oral presentation for the abstract titled "Phase III Study of APF530 versus Ondansetron with a Neurokinin 1 Antagonist + Corticosteroid in Preventing Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: MAGIC Trial."
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Presentation details are as follows:
Session Title: Oral Abstract Session B
Author/Presenter: Ian D. Schnadig, MD, Chair, Pharmacy and Therapeutics, Compass Oncology
Abstract Number: 68
Date/Time: Saturday, September 26, 2015 from 1:15 PM – 2:45 PM PT
Location: Yerba Buena Ballroom, Salon 9
Session Title: Poster Session B
Author/Presenter: Ian D. Schnadig, MD, Chair, Pharmacy and Therapeutics, Compass Oncology
Poster Number: Board #A5
Date/Time: Saturday, September 26, 2015 from 11:50 AM – 1:15 PM PT and 4:45 PM – 5:45 PM PT
Location: Yerba Buena Ballroom, Salon 8
About SUSTOL for Chemotherapy-Induced Nausea and Vomiting
SUSTOL (granisetron) Injection, extended release, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is Heron’s novel, long-acting formulation of granisetron for the prevention of chemotherapy-induced nausea and vomiting (CINV). Granisetron, an FDA-approved 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist was selected due to its broad use by physicians based on a well-established record of safety and efficacy. SUSTOL has been shown to maintain therapeutic drug levels of granisetron for five days with a single subcutaneous injection. SUSTOL is being developed for the prevention of both acute (day 1 following the administration of chemotherapy agents) and delayed (days 2-5 following the administration of chemotherapy agents) CINV associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC). While other 5-HT3 antagonists are approved for the prevention of CINV, SUSTOL is the first agent in the class to demonstrate efficacy in reducing the incidence of delayed CINV in patients receiving HEC, a major unmet medical need, in a randomized Phase 3 study.
Affecting 70-80% of patients undergoing chemotherapy, CINV is one of the most debilitating side effects of such treatments, often attributed as a leading cause of premature discontinuation of cancer treatment. 5-HT3 receptor antagonists have been shown to be among the most effective and preferred treatments for CINV. However, an unmet medical need exists for patients suffering from CINV during the delayed phase, which occurs on days 2-5 following the administration of chemotherapy agents. Only one 5-HT3 receptor antagonist is approved for the prevention of delayed CINV associated with MEC, and no 5-HT3 receptor antagonists are approved for prevention of delayed CINV associated with HEC.
SUSTOL was the subject of a recently completed, multi-center, placebo-controlled, Phase 3 clinical study in patients receiving HEC regimens known as MAGIC. The MAGIC study evaluated the efficacy and safety of SUSTOL as part of a three-drug regimen with the intravenous (IV) neurokinin-1 (NK1) receptor antagonist fosaprepitant and the corticosteroid dexamethasone. The MAGIC study, which was conducted entirely in the U.S. using the 2011 ASCO (Free ASCO Whitepaper) guidelines for classification of emetogenic potential, is the only Phase 3 CINV prophylaxis study in a HEC population performed to date to use the currently recommended, standard-of-care, three-drug regimen as a comparator: a 5-HT3 receptor antagonist, fosaprepitant, and dexamethasone. The study’s primary endpoint was achieved. Specifically, the percentage of patients who achieved a Complete Response in the delayed phase was significantly higher in the SUSTOL arm compared with the comparator arm (p=0.014). Adverse events reported in the study were generally mild to moderate in severity and of short duration, with the most common being injection site reactions (ISRs). In July 2015, Heron resubmitted its New Drug Application (NDA) for SUSTOL to the U.S. Food and Drug Administration (FDA), and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016. SUSTOL is not approved by the FDA or any other regulatory authority.