“A phase III study showed that APF530, a delayed release formulation of granisetron, could improve control of emesis in cancer patients receiving highly emetogenic chemotherapy (HEC). The results were presented at the 2015 American Society of Clinical Oncology (ASCO) Breast Cancer Symposium in San Francisco (abstract 68).
“Ian D. Schnadig, MD, of Compass Oncology in Portland, Oregon, presented the study, and said that with regards to supportive care, ‘we still have a ways to go to move the ball down the field in this important domain of cancer care.’ Specifically, managing delayed-phase chemotherapy-induced nausea and vomiting (CINV) is an unmet medical need, he said.
“The MAGIC trial was a phase III, prospective, randomized, placebo-controlled, double-dummy, double-blind trial including 942 patients receiving an HEC regimen. In one arm, patients received ondansetron and a placebo injection; in the other, they received an ondansetron placebo and a APF530 injection. Both groups received fosaprepitant and dexamethasone. The most common chemotherapy regimens were doxorubicin/cyclophosphamide-based and cisplatin-based.”
“In a phase III study reported in The Lancet Oncology, Schwartzberg et al found that the addition of rolapitant to serotonin (5-HT3) receptor antagonist and dexamethasone treatment significantly improved complete response rates in prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy or anthracycline and cyclophosphamide regimens.
“In this double-blind trial, patients from 170 sites in 23 countries were randomly assigned between March 2012 and September 2013 to receive oral rolapitant 180 mg or placebo 1 to 2 hours before the administration of moderately emetogenic chemotherapy. All patients received oral granisetron 2 mg and oral dexamethasone 20 mg on day 1 (except for those receiving taxanes, who received dexamethasone according to the package insert) and granisetron 2 mg on days 2 and 3. Treatment was given for up to six cycles, with a minimum of 14 days…
“The investigators concluded: ‘Rolapitant in combination with a 5-HT3 receptor antagonist and dexamethasone is well tolerated and shows superiority over active control for the prevention of chemotherapy-induced nausea and vomiting during the 5-day (0–120 h) at-risk period after administration of moderately emetogenic chemotherapy or regimens containing an anthracycline and cyclophosphamide.’ “
“Heron Therapeutics, Inc. HRTX, +60.00% today announced positive, top-line results from its recently completed Phase 3 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 3 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.”