Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT111 · 1 trial · 3 indications
ORR was defined as the percentage of participants in whom a complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) was observed as best overall response by blinded independent central review (BICR). Per RECIST 1.1 criteria, CR defined as the disappearance of all target lesions and PR was defined as the \>=30% decrease in the sum of the longest diameter of target lesions.
| Arm | Type | Description |
|---|---|---|
| BNT111 + cemiplimab | EXPERIMENTAL | - |
| BNT111 monotherapy | EXPERIMENTAL | - |
| Cemiplimab monotherapy | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BNT111 | BIOLOGICAL | IV injection |
| Cemiplimab | BIOLOGICAL | IV infusion |
Inclusion Criteria: * Patients must sign the written informed consent form (ICF) before any screening procedure. * Patients must be aged \>=18 years on the date of signing the informed consent. * Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests...
BNT111 is an investigational monoclonal antibody being studied for the treatment of melanoma, specifically Stage III melanoma. It is also being evaluated in patients with Stage IV and unresectable melanoma. The drug is intended for patients whose melanoma has not responded to other forms of treatment.
BNT111 is being developed by BioNTech SE, a biotechnology company traded on the Nasdaq under the ticker BNTX. BioNTech is conducting clinical research to evaluate the safety and efficacy of BNT111 in patients with advanced melanoma.
BNT111 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness in treating melanoma.
BNT111 has been studied in a Phase 2 clinical trial with the identifier NCT04526899. This trial investigated BNT111 in combination with cemiplimab or as a single agent in patients with advanced melanoma that had not responded to other treatments. The trial enrolled 184 participants and has been completed.
No, BNT111 is not the same as cemiplimab. BNT111 is a monoclonal antibody developed by BioNTech, while cemiplimab is a separate drug. In the clinical trial NCT04526899, BNT111 was studied both in combination with cemiplimab and as a single agent in patients with advanced melanoma.