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 therapy being studied for melanoma, including Stage III melanoma. It has been tested in patients with advanced melanoma that has not responded to other forms of treatment, including Stage III and Stage IV unresectable melanoma. It is not an approved treatment and remains in clinical development.
BNT111 is being developed by BioNTech SE, which trades on the Nasdaq under the ticker BNTX. BioNTech is the sponsor of the clinical program evaluating BNT111 in melanoma.
BNT111 is in Phase 2 development. Its clinical program in advanced melanoma has completed a Phase 2 study, and the drug is investigational rather than approved. No Phase 3 trial of BNT111 has been reported.
BNT111 has been evaluated in one clinical trial, NCT04526899, a completed Phase 2 study. That trial enrolled 184 patients with advanced melanoma, including Stage III and Stage IV unresectable disease, and tested BNT111 and cemiplimab in combination or as single agents. It ran in the United States, Australia, Germany, Italy, Poland, Spain, and the United Kingdom.
The Phase 2 trial NCT04526899 was a randomized, controlled study of 184 patients with advanced melanoma that had not responded to other treatments. It evaluated BNT111 and cemiplimab in combination or as single agents in adults aged 18 years and older, and enrolled patients across seven countries.