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PF-05082566 · 2 trials · 8 indications
Severity of adverse events (AEs) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs occurring during the DLT observation period that were attributable to one or both study drugs were classified as DLTs. 1) Hematologic: Grade 4 neutropenia; Febrile neutropenia, defined as absolute neutrophil count (ANC) \<1000/mm3 with a single temperature of \>38.3C(101F) or a sustained temperature of 38C (100.4F) for more than 1 hour; Grade\>=3 neutropenic infection; Grade\>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia. 2) Non hematologic: Grade\>=3 toxicities (non-laboratory); Grade\>=3 nausea, vomiting or diarrhea despite maximal medical therapy; Grade 4 aspartate aminotransferase (AST) and alanine aminotransferase (ALT). 3) Other (non-AST/ALT) non-hematologic Grade\>=3 laboratory value. 4) Inability to complete 2 infusions of MK-3475 and PF-05082566 during the DLT observation period.
DLT: Any of the following adverse events (AEs) occurred in the first 2 cycles of treatment (up to 28 days post second dose) which was attributed to PF-05082566 alone for Portion A and not related to progressive disease. Hematologic: Grade 4 neutropenia lasting more than (\>)7 days; febrile neutropenia; neutropenic infection; Grade ≥3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade ≥3 hemolysis. Non-Hematologic: Grade ≥3 toxicities, except those Grade 3 events that responded to treatment (eg, Grade 3 nausea, vomiting, diarrhea responding to standard medical supportive care within 48 hours would not be considered a DLT). Severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). Each cycle=28 days.
DLT: Any of the following AEs occurred in the first 2 cycles of treatment (up to 28 days post second dose) which was attributed to PF-05082566 in combination with rituximab for Portion B and not related to progressive disease. Hematologic: Grade 4 neutropenia lasting more than (\>)7 days; febrile neutropenia; neutropenic infection; Grade ≥3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade ≥3 hemolysis. Non-Hematologic: Grade ≥3 toxicities, except those Grade 3 events that responded to treatment (eg, Grade 3 nausea, vomiting, diarrhea responding to standard medical supportive care within 48 hours would not be considered a DLT). Severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). Each cycle=28 days.
| Arm | Type | Description |
|---|---|---|
| PF-05082566 +MK-3475 | EXPERIMENTAL | PF-05082566 +MK-3475 |
| Portion A | EXPERIMENTAL | PF-05082566 single agent in patients with advanced cancer |
| Portion B | EXPERIMENTAL | PF-05082566 in combination with rituximab in patients with Non-Hodgkin's Lymphoma |
| Name | Type | Description |
|---|---|---|
| PF-05082566 | DRUG | Starting dose of 0.45 mg/kg q3wks IV, dose escalation |
| MK-3475 | DRUG | 2 mg/kg q3wks, IV |
| rituximab | DRUG | Intravenous, 375 mg/m2, once per week for 4 weeks |
Inclusion Criteria: * Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy which has progressed on standard therapy or for which no standard therapy is available. * Measurable disease per RECIST v1.1. * Adequate bone marrow, renal and liver functioning Exclusion Crit...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
PF-05082566 is an investigational small molecule being studied for the treatment of advanced solid tumors, lymphoma, and non-Hodgkin lymphoma. It has been evaluated in clinical trials for conditions including follicular lymphoma, diffuse large B-cell lymphoma, non-small-cell lung carcinoma, renal cell carcinoma, squamous cell carcinoma of the head and neck, and malignant melanoma.
PF-05082566 is a 4-1BB agonist, meaning it targets and activates the 4-1BB receptor, a costimulatory molecule on immune cells. By stimulating 4-1BB, it is designed to enhance the activity of T cells and other immune cells to promote an anti-tumor immune response.
PF-05082566 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational oncology therapy in Phase 1 clinical development.
PF-05082566 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed, and the drug remains under investigation for its safety and efficacy in treating certain cancers.
PF-05082566 has been studied in two completed Phase 1 clinical trials. The first, NCT01307267, evaluated the drug as a single agent and in combination with rituximab in patients with lymphoma and other cancers. The second, NCT02179918, studied the drug in combination with the PD-1 inhibitor pembrolizumab in patients with advanced solid tumors.
PF-05082566 is also known as utomilumab. This alternative name is used in some clinical and scientific contexts to refer to the same investigational drug developed by Pfizer.