Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT324 · 2 trials · 2 indications
By arm. rPFS is defined as time from randomization to radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, or death from any cause, whichever occurs first.
By arm. OS is defined as time from randomization to death from any cause.
ORR defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) is observed as best overall response (per response evaluation criteria in solid tumors \[RECIST\] version 1.1 based on the investigator's assessment).
ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per RECIST version 1.1 based on the investigator's assessment).
| Arm | Type | Description |
|---|---|---|
| BNT324 | EXPERIMENTAL | - |
| Docetaxel plus prednisone/ prednisolone | ACTIVE_COMPARATOR | - |
| Part 1 - BNT324 + BNT327 combination therapy | EXPERIMENTAL | Escalating combination dose levels of BNT324 and BNT327 to define RP2D and RP2D-1 for NSCLC and SCLC. |
| Part 2 - Cohort 1: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327 | EXPERIMENTAL | In subpopulation 1 of NSCLC actionable oncogenic alteration (AGA) negative, first-line (1L) |
| Part 2 - Cohort 2: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327 | EXPERIMENTAL | In SCLC, second-line plus (2L+) |
| Part 2 - Cohort 3: RP2D of BNT324 + BNT327 | EXPERIMENTAL | In subpopulation 1 of NSCLC AGA negative, 2L+ |
| Part 2 - Cohort 4: RP2D of BNT324 + BNT327 | EXPERIMENTAL | In subpopulation 2 of NSCLC AGA negative, 1L |
| Part 2 - Cohort 5: RP2D of BNT324 + BNT327 | EXPERIMENTAL | In subpopulation 2 of NSCLC AGA negative, 2L+ |
| Part 2 - Cohort 6: RP2D of BNT324 + BNT327 | EXPERIMENTAL | In NSCLC AGA positive |
| Part 2 - Cohort 7: RP2D of BNT324 + BNT327 | EXPERIMENTAL | In SCLC, 1L |
| Name | Type | Description |
|---|---|---|
| BNT324 | DRUG | Intravenous infusion |
| Docetaxel | DRUG | Intravenous infusion |
| Prednisone/prednisolone | DRUG | Oral |
| BNT327 | BIOLOGICAL | Intravenous infusion |
Key Inclusion Criteria: * Are male adults (defined as ≥18 years of age or of an acceptable age according to local regulations at the time of giving informed consent). * Must have documented progressive prostate cancer based on at least one of the following criteria: * Serum/plasma PSA progressio...