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Also known as BNT316, A humanized anti-CTLA4 IgG1 monoclonal antibody, ONC-392
Gotistobart · 1 trial · 1 indication
OS is defined as the time from randomization to the date of death by any cause. Kaplan-Meier estimates of median OS time will be presented by treatment arm with two sided 95% CIs.
| Arm | Type | Description |
|---|---|---|
| Arm 1: Gotistobart 6 mg/kg with 2 loading doses of 10 mg/kg, Q3W | EXPERIMENTAL | Gotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days. |
| Arm 2: Docetaxel 75 mg/m2, Q3W | ACTIVE_COMPARATOR | Docetaxel will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days. |
| Name | Type | Description |
|---|---|---|
| Gotistobart | DRUG | Gotistobart will be administrated through IV infusion over 60 minutes, once every 21 days in assigned dose. |
| Docetaxel | DRUG | Docetaxel will be administrated through IV infusion over 60 minutes, once every 21 days in 75mg/m2 dose. |
Inclusion Criteria (Major criteria): 1. Adult (≥ 18 years), all genders, capable of signing informed consent. 2. Histologically- or cytologically- confirmed diagnosis of metastatic squamous NSCLC, metastasis can be regional lymph nodes or distant organs. 3. Radiographic progression after treatment ...
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Gotistobart is being developed for the treatment of non small cell lung cancer, specifically in patients with metastatic disease that has progressed after treatment with PD-1 or PD-L1 inhibitors. It is an investigational therapy and has not been approved for commercial use.
Gotistobart targets CTLA-4, a checkpoint protein on T cells. By binding CTLA-4, this small molecule is designed to modulate an immune checkpoint pathway in oncology. Targeting CTLA-4 is an established approach in cancer immunotherapy, and Gotistobart is being studied in that context.
Gotistobart is being developed by BioNTech SE, which trades under the ticker BNTX. BioNTech is the sponsor responsible for advancing the program, and the drug is also known by the code name BNT316.
Gotistobart is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The program has received FDA Fast Track and Orphan Drug designations, which are intended to support and expedite development in the relevant indication.
Gotistobart is being evaluated in the Phase 3 trial NCT05671510, titled ONC-394 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors. The trial is active but not recruiting, has an enrollment of 630 participants, and is randomized and active controlled across sites in the United States, Europe, Asia, and Australia.
Yes, Gotistobart is also known as BNT316. Both names refer to the same investigational small molecule being developed by BioNTech SE for non small cell lung cancer. Readers may encounter either name in company communications, trial listings, or scientific literature.