Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 479 · 5 trials · 26 indications
The primary endpoint of the study was OS, defined as the time from randomization to death.
PFS was defined as the time from randomization to the first observation of disease progression (as classified by modified RECIST), symptomatic deterioration or death due to any cause, whichever occurs first. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
The incidence of adverse events and clinical laboratory abnormalities defined as DLTs. A DLT was defined as any grade 3 or higher hematologic or non-hematologic toxicity related to any study treatment.
The proportion of subjects alive at 6 months
| Arm | Type | Description |
|---|---|---|
| Placebo + gemcitabine | PLACEBO_COMPARATOR | Arm 1: AMG 479-placebo IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle |
| AMG 479 12 mg/kg dose + gemcitabine | EXPERIMENTAL | Arm 2: AMG 479 12 mg/kg IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle |
| AMG 479 20 mg/kg + gemcitabine | EXPERIMENTAL | Arm 3: AMG 479 20 mg/kg IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle |
| Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy | ACTIVE_COMPARATOR | - |
| Arm B: placebo IV Q2W + Endocrine Therapy | PLACEBO_COMPARATOR | - |
| Exploratory Cohort | EXPERIMENTAL | If a total of two or more responses (partial and complete) in EFTs/DSRCTs are documented in this or the ongoing phase 1 study (20050118), then the study will allow enrollment of up to 10 additional EFT/DSRCT subjects who have been exposed to prior anti-IGF-1R targeting therapy. |
| Main Cohort | EXPERIMENTAL | Subjects with relapsed Ewing's Family Tumors (EFTs) and Desmoplastic Small Round Cell Tumors (DSRCTs) who have not received prior anti-IGF-1R therapy will receive AMG 479 at 12mg/kg. |
| Phase 1b AMG 655 3mg/kg | EXPERIMENTAL | Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine. |
| Phase 1b AMG 655 10mg/kg | EXPERIMENTAL | Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine. |
| Phase 2 AMG 655 | EXPERIMENTAL | Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion. |
| Phase 2 AMG 479 | EXPERIMENTAL | Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion. |
| Phase 2 AMG 655-placebo | PLACEBO_COMPARATOR | Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion. |
| AMG 479 + Sorafenib cohorts | EXPERIMENTAL | The aim is to determine the safety, tolerability and PK of AMG 479 with sorafenib. AMG 479 will be given bi-weekly; sorafenib will be given daily. |
| AMG 479 + Erlotinib cohorts | EXPERIMENTAL | The aim is to determine the safety, tolerability and PK of AMG 479 with erlotinib. AMG 479 will be given bi-weekly; erlotinib will be given daily. |
| Name | Type | Description |
|---|---|---|
| AMG 479 | DRUG | AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle |
| Placebo | DRUG | Placebo administered intravenously on days 1 and 15 of a 28 day cycle |
| gemcitabine | DRUG | gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle |
| AMG 655 | DRUG | AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2). |
Inclusion Criteria: * Untreated metastatic adenocarcinoma of the pancreas * Adequate hematologic, renal and liver function * Eastern Cooperative Oncology Group (ECOG) 0 or 1 Exclusion Criteria: * Prior chemotherapy or radiotherapy for pancreatic cancer * Central nervous system metastases * Extern...
AMG 479 is an investigational oncology drug being studied for multiple cancer types, including adenocarcinoma of the pancreas, advanced malignancy, Askin's tumors, breast cancer, advanced solid tumors, and non-small cell lung cancer. It has been evaluated in clinical trials for pancreatic cancer and Ewing's family tumors.
AMG 479 is being developed by ImmunityBio, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IBRX. The drug is an investigational small molecule oncology therapy.
AMG 479 has completed Phase 3 clinical development. It remains an investigational drug and is not approved by the FDA. The drug has completed two trials, including a Phase 3 study in metastatic pancreatic cancer.
AMG 479 has been studied in completed trials including NCT01231347, a Phase 3 study of gemcitabine plus AMG 479 in metastatic adenocarcinoma of the pancreas with 800 participants, and NCT00563680, a Phase 2 study in relapsed or refractory Ewing's family tumors.
AMG 479 is also known by the name ganitumab. It is an investigational drug being developed by ImmunityBio, Inc. for oncology indications including pancreatic cancer and advanced solid tumors.