Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT116 · 1 trial · 1 indication
Cohort EGFR and Cohort ALK/RET will enroll only at selected sites in the US.
According to National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0). Cohort EGFR and Cohort ALK/RET will enroll only at selected sites in the US.
| Arm | Type | Description |
|---|---|---|
| Cohort 1A - BNT116 Monotherapy | EXPERIMENTAL | - |
| Cohort 1B - BNT116 Monotherapy | EXPERIMENTAL | - |
| Cohort 2 - BNT116 + Cemiplimab (PD-1/PD-L1 Inhibitor Refractory/Relapsed Participants) | EXPERIMENTAL | - |
| Cohort 3 - BNT116 + Docetaxel | EXPERIMENTAL | - |
| Cohort 4 - BNT116 + Cemiplimab (Frail Participants) | EXPERIMENTAL | - |
| Cohort 5 - BNT116 + Cemiplimab (After Concurrent Chemoradiotherapy [CRT]) | EXPERIMENTAL | - |
| Cohort 6 - BNT116 + Cemiplimab + Carboplatin + Paclitaxel | EXPERIMENTAL | BNT116 + cemiplimab + carboplatin + paclitaxel as neo-adjuvant treatment followed by surgery, thereafter adjuvant treatment with BNT116 + cemiplimab |
| Cohort 7 - BNT116 + BNT316 | EXPERIMENTAL | Dose finding for the combination of BNT116 with BNT316 (CTLA4 antibody) with dose escalation of BNT316 |
| Cohort 8: BNT116 + Anti-B7-H3 Antibody Conjugated to Topoisomerase I Inhibitor | EXPERIMENTAL | Dose finding for the combination of BNT116 with an anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor with dose escalation of the anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor |
| Cohort 9: BNT116 + Anti-HER3 Antibody Conjugated to Topoisomerase I Inhibitor | EXPERIMENTAL | Dose confirmation for the combination of BNT116 with an anti-HER3 antibody conjugated to a topoisomerase I inhibitor with dose escalation of the anti-HER3 antibody conjugated to a topoisomerase I inhibitor |
| Cohort 10: BNT116 + Bispecific Antibody for PD-L1 and VEGF-A (Frail Participants) | EXPERIMENTAL | Dose confirmation for BNT116 in combination with a bispecific antibody for programmed death ligand 1 (PD-L1) and vascular endothelial growth factor A (VEGF-A) will be established. |
| Cohort 11: BNT116 + Bispecific Antibody for PD-L1 and VEGF-A (After Concurrent CRT) | EXPERIMENTAL | Dose confirmation for BNT116 in combination with a bispecific antibody for PD-L1 and VEGF-A will be established in participants after concurrent CRT. |
| Cohort EGFR : BNT116 + osimertinib | EXPERIMENTAL | Dose confirmation for BNT116 in combination with ongoing osimertinib therapy. Treatment with osimertinib is standard of care. Cohort will enroll only at selected sites in the US. |
| Cohort ALK/RET: BNT116 + ALK TKI or RET TKI | EXPERIMENTAL | Dose confirmation for BNT116 in combination with either ongoing ALK-inhibitor or ongoing RET-inhibitor therapy. Treatment with ALK TKI or RET TKI is standard of care. Cohort will enroll only at selected sites in the US. |
| Name | Type | Description |
|---|---|---|
| BNT116 | BIOLOGICAL | Intravenous injection |
| Cemiplimab | BIOLOGICAL | Intravenous infusion |
| Docetaxel | DRUG | Intravenous infusion |
| Carboplatin | DRUG | Intravenous infusion |
| Paclitaxel | DRUG | Intravenous infusion |
| BNT316 | BIOLOGICAL | Intravenous infusion |
| anti-B7-H3 antibody conjugated to topoisomerase I inhibitor | BIOLOGICAL | Intravenous infusion |
| anti-HER3 antibody conjugated to topoisomerase I inhibitor | BIOLOGICAL | Intravenous infusion |
| Bispecific antibody for PD-L1 and VEGF-A | BIOLOGICAL | Intravenous infusion |
| Osimertinib | BIOLOGICAL | Oral |
| ALK-inhibitor or RET-inhibitor | BIOLOGICAL | Oral |
Key Inclusion Criteria: * Participants must have histologically confirmed NSCLC and measurable disease by RECIST v1.1. Note: Participants in Cohorts 1, 5 and 11 as well as in Cohorts EGFR and ALK/RET do not have to present with measurable disease. 1. Participants must present with unresectable S...
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BNT116 is being developed for the treatment of advanced non-small cell lung cancer. It is an investigational therapy that is being studied in patients with this form of lung cancer, including in combination with other treatments. It has not been approved for any indication and remains in clinical development.
BNT116 is being developed by BioNTech SE, which trades on the Nasdaq under the ticker BNTX. BioNTech is the sponsor of the clinical program evaluating BNT116 in advanced non-small cell lung cancer.
BNT116 is in Phase 1 clinical development. The program consists of one active, recruiting Phase 1 trial in advanced non-small cell lung cancer. BNT116 is investigational and has not been approved by the FDA or any other regulatory agency.
BNT116 is being evaluated in the Phase 1 trial NCT05142189, titled a study of the safety, tolerability and preliminary efficacy of BNT116 alone and in combinations in patients with advanced non-small cell lung cancer. The trial is recruiting and plans to enroll 320 patients across the United States, Australia, Germany, Hungary, Poland, Spain, Turkey, and the United Kingdom.
No. BNT116 is an investigational drug in Phase 1 clinical development and has not been approved by the FDA. It is available only to participants enrolled in its clinical trial.