Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
APF530 · 2 trials · 3 indications
Percentage of Participants with no emesis and no rescue medication in patients receiving HEC in the delayed phase (24 to 120 hours) of CINV.
Complete Response is defined as no emetic episodes and no use of rescue medications
Complete Response is defined as no emetic episodes and no use of rescue medications
| Arm | Type | Description |
|---|---|---|
| APF530 500 mg SC | EXPERIMENTAL | APF530 500 mg (granisetron 10 mg) SC and ondansetron placebo IV (0.15 mg/kg) and fosaprepitant 150 mg IV and dexamethasone 12 mg IV on Day 1 of Cycle 1 in association with HEC |
| ondansetron 0.15 mg/kg IV | ACTIVE_COMPARATOR | Ondansetron 2 mg/mL solution to be administered at 0.15 mg/kg IV (up to a maximum of 16 mg) and APF530 placebo SC and fosaprepitant 150 mg IV and dexamethasone 12 mg IV on Day 1 of Cycle 1 |
| Arm I | ACTIVE_COMPARATOR | Patients receive palonosetron hydrochloride IV, placebo subcutaneously (SC), and dexamethasone IV on day 1 of chemotherapy course 1. Patients in the high-risk (level 5) stratum also receive oral dexamethasone on days 2-4 of all treatment courses. |
| Arm II | EXPERIMENTAL | Patients receive APF530 SC, placebo IV, and dexamethasone IV on day 1 of chemotherapy course 1. Patients then receive APF530 SC and dexamethasone IV on day 1 of chemotherapy courses 2-4. Patients in the high-risk (level 5) stratum also receive oral dexamethasone as in arm I. |
| Arm III | EXPERIMENTAL | Patients receive APF530 SC at a higher dose, placebo IV, and dexamethasone IV on day 1 of chemotherapy course 1. Patients then receive APF530 SC (at the same higher dose) and dexamethasone IV on day 1 of chemotherapy courses 2-4. Patients in the high-risk (level 5) stratum also receive oral dexamethasone as in arm I. |
| Name | Type | Description |
|---|---|---|
| APF530 | DRUG | - |
| Ondansetron | DRUG | - |
| Ondansetron placebo | DRUG | - |
| APF530 placebo | DRUG | - |
| Fosaprepitant | DRUG | - |
| Dexamethasone | DRUG | - |
| Palonosetron Hydrochloride | DRUG | Given IV |
| placebo | OTHER | Given subcutanously or IV |
Inclusion Criteria: * Subjects will be males or nonpregnant females who are 18-87 years of age at the time of enrollment. * Subjects must have histologically or cytologically confirmed malignant disease. * Subjects must be undergoing treatment with a HEC regimen according to the 2011 ASCO CINV guid...
APF530 is an investigational small molecule being developed for the prevention of nausea and vomiting in patients receiving chemotherapy, specifically chemotherapy-induced nausea and vomiting (CINV). It is a granisetron formulation administered subcutaneously. As of the available data, APF530 is in Phase 3 clinical development and is not yet approved by the FDA.
APF530 contains granisetron, a serotonin 5-HT3 receptor antagonist. It works by blocking serotonin from binding to 5-HT3 receptors, which are involved in triggering the vomiting reflex during chemotherapy. This mechanism helps prevent nausea and vomiting caused by cancer treatment.
APF530 is being developed by Heron Therapeutics, Inc., a biopharmaceutical company. Heron Therapeutics is publicly traded under the ticker symbol HRTX on the NASDAQ stock exchange.
APF530 is in Phase 3 clinical development. Two Phase 3 clinical trials have been completed, one with 1,428 participants and another with 942 participants. The drug is investigational and has not received FDA approval based on the available information.
APF530 has been studied in two completed Phase 3 clinical trials. The first, NCT00343460, enrolled 1,428 patients and compared APF530 to Aloxi (palonosetron hydrochloride) combined with dexamethasone in preventing nausea and vomiting in patients receiving chemotherapy. The second, NCT02106494, enrolled 942 patients and evaluated APF530 (granisetron) subcutaneous for prevention of CINV in patients receiving highly emetogenic chemotherapy.
APF530 is a formulation of granisetron, a 5-HT3 receptor antagonist. While granisetron is the active pharmaceutical ingredient, APF530 is a specific extended-release or sustained-release formulation designed for subcutaneous administration. It is not the same as oral or intravenous granisetron products, as it uses a proprietary delivery technology.