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 developed by Heron Therapeutics, Inc. (ticker HRTX) for the prevention of chemotherapy-induced nausea and vomiting. It is a granisetron formulation given by subcutaneous injection and has been studied in Phase 3 clinical trials in adult patients receiving chemotherapy for cancer.
APF530 is being developed to prevent chemotherapy-induced nausea and vomiting, including in patients receiving highly emetogenic chemotherapy. It is also studied for nausea and vomiting more broadly. It is an investigational agent and has been evaluated in Phase 3 trials rather than being an approved product.
APF530 targets the 5-HT3 receptor, a serotonin receptor class. Granisetron, the active agent in APF530, acts at 5-HT3 receptors, which are involved in the nausea and vomiting reflex triggered by chemotherapy. This receptor target class is the basis for its use in preventing chemotherapy-induced nausea and vomiting.
APF530 is being developed by Heron Therapeutics, Inc., which trades under the ticker HRTX. The company has sponsored the Phase 3 clinical program evaluating APF530 for the prevention of chemotherapy-induced nausea and vomiting in patients receiving chemotherapy for cancer.
APF530 is in Phase 3 development. It is an investigational drug and is not described as FDA approved. The Phase 3 program includes completed trials in patients receiving chemotherapy, with the studies designed to assess APF530 for prevention of chemotherapy-induced nausea and vomiting.
APF530 has been studied in completed Phase 3 trials, including NCT02106494, which evaluated APF530 (granisetron) subcutaneously for prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy, and NCT00343460, which compared APF530 with palonosetron hydrochloride plus dexamethasone in patients receiving chemotherapy for cancer.