APF530 (Granisetron Injection Extended-Release) in a Three-Drug Regimen for Delayed CINV in Highly Emetogenic Chemotherapy

Abstract

APF530 versus the standard three-drug regimen provided superior control of delayed-phase CINV following HEC. ClinicalTrials.gov : NCT02106494.

APF530 versus ondansetron, each in a guideline-recommended three-drug regimen, for the prevention of chemotherapy-induced nausea and vomiting due to anthracycline plus cyclophosphamide–based highly emetogenic chemotherapy regimens: a post hoc subgroup analysis of the Phase III randomized MAGIC trial

“…Ondansetron, the active comparator, has been used in large-scale CINV studies as the positive comparator for other 5-HT 3 RAs22,23 and is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin 24. In MAGIC, the APF530 arm demonstrated superior CR versus ondansetron in delayed CINV following HEC (64.7% vs 56.6%; P =0.014; 8% absolute improvement) 25. APF530 is the first and only 5-HT 3 RA to demonstrate superiority over another 5-HT 3 RA in a three-drug versus three-drug pivotal Phase III efficacy trial.…”

NCCN Guidelines Insights: Antiemesis, Version 2.2017

“…46 No 5-HT3 antagonists were administered on days 2 to 5. When administered subcutaneously, granisetron extended-release injection is effective for ≥5 days.…”

Hydration Requirements with Emetogenic Chemotherapy: Granisetron Extended-Release Subcutaneous Versus Palonosetron

“…Treatment-related injection site reactions (primarily bruising) occurred more frequently in patients who received GERSC than in those who received palonosetron, but these events were generally mild and resolved over time [17,18]. In the Phase III MAGIC trial comparing GERSC with ondansetron, each in a three-drug regimen with an NK-1 receptor antagonist and dexamethasone, GERSC was superior to ondansetron in complete response (no emesis or rescue medication) during the delayed phase of CINV in patients receiving HEC [19]. Both agents were well tolerated, and the incidence of injection site reactions was similar in both treatment groups [19].…”

“…In the Phase III MAGIC trial comparing GERSC with ondansetron, each in a three-drug regimen with an NK-1 receptor antagonist and dexamethasone, GERSC was superior to ondansetron in complete response (no emesis or rescue medication) during the delayed phase of CINV in patients receiving HEC [19]. Both agents were well tolerated, and the incidence of injection site reactions was similar in both treatment groups [19]. GERSC is approved by the US FDA for use in combination with other antiemetics for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of MEC or anthracycline and cyclophosphamidebased regimens [20].…”

“…It is recommended by the National Comprehensive Cancer Network antiemesis guidelines as a 5-HT 3 receptor antagonist option for use in combination with dexamethasone and an NK-1 receptor antagonist for the prevention of CINV associated with HEC and as a preferred 5-HT 3 receptor antagonist for use in combination with dexamethasone for the prevention of CINV associated with MEC [11]. To our knowledge, GERSC is the only 5-HT 3 receptor antagonist to demonstrate superiority over another 5-HT 3 receptor antagonist (ondansetron) in a three-drug versus three-drug pivotal Phase III trial [19]. Breakthrough CINV can occur in up to 40% of patients, despite the use of guideline-recommended prophylactic antiemetic regimens [21].…”