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VTX-2337 · 2 trials · 3 indications
PFS was based on central assessment by a blinded independent radiologist per immune related response evaluation criteria for solid tumors (irRECIST) and was summarized and displayed by treatment arm using Kaplan-Meier methods. Treatments were compared using a stratified log-rank test controlling for randomization stratification factors. The hazard ratio between the 2 treatment arms, as well as the associated one-sided 90% CI and p-value, were presented using a Cox proportional hazards regression model.
| Arm | Type | Description |
|---|---|---|
| chemotherapy and cetuximab plus VTX-2337 | EXPERIMENTAL | VTX-2337 (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. |
| chemotherapy and cetuximab plus placebo | ACTIVE_COMPARATOR | Placebo (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression. |
| Name | Type | Description |
|---|---|---|
| VTX-2337 | DRUG | TLR8 Agonist |
| Carboplatin | DRUG | - |
| Cisplatin | DRUG | - |
| 5-fluorouracil | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Ability and willingness to provide written informed consent * Histologically or cytologically confirmed squamous cell carcinoma of the head and neck * Locoregionally recurrent or metastatic disease that has not previously been treated with systemic therapy of recurrent or meta...
VTX-2337 is an investigational small molecule being studied for the treatment of advanced solid tumors and squamous cell carcinoma of the head and neck. It is being developed by Bristol-Myers Squibb Company (BMY) and is currently in clinical development, though it is not yet approved.
VTX-2337 is a small molecule that targets Toll-like receptor 8 (TLR8), an immune receptor involved in activating innate immune responses. By stimulating TLR8, it is intended to enhance anti-tumor immunity, though it remains investigational and its efficacy is not established.
VTX-2337 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker BMY. The drug is currently in clinical trials for oncology indications.
VTX-2337 has completed a Phase 1 trial and a Phase 2 trial. The Phase 1 study evaluated safety and pharmacology in advanced cancer patients, while the Phase 2 study tested it in combination with chemotherapy and cetuximab for head and neck cancer. It remains investigational.
VTX-2337 has been studied in two completed trials: NCT00688415, a Phase 1 safety and pharmacologic study in patients with advanced solid tumors and lymphoma, and NCT01836029, a Phase 2 study combining VTX-2337 with chemotherapy and cetuximab in recurrent or metastatic squamous cell carcinoma of the head and neck.
VTX-2337 is also known as motolimod, a Toll-like receptor 8 agonist. It is being developed by Bristol-Myers Squibb for oncology indications, including advanced solid tumors and head and neck cancer.