Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pumitamig · 6 trials · 5 indications
PFS is defined as the time from randomization to first documented tumor progression (progressive disease assessed by BICR per response evaluation criteria in solid tumors \[RECIST\] v1.1), or death from any cause, whichever occurs first.
OS is defined as the time from randomization to death from any cause.
For Treatment Arms 1 and 2 only. Defined as the percentage of study participants in whom a confirmed complete response (CR) or confirmed partial response (PR) (assessed by the blinded independent central review \[BICR\] per RANO 2.0) is observed as best overall response.
According to (United States National Cancer Institute) Common Terminology Criteria for Adverse Events version 5.0 \[CTCAE v5.0\]). By relationship. For Treatment Arms 1 and 3 only.
For Treatment Arms 1 and 3 only.
For each treatment arm. Defined as the percentage of study participants in whom a confirmed complete response (CR) or confirmed partial response (PR) (assessed by the investigator per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]) is observed as best overall response.
For each treatment arm.
During the DLT evaluation period by dose level
Graded according to the (United States) National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)
Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) based on investigator's review) is observed as best overall response.
For substudies A and B. AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0) in the combination treatment regimen.
For substudies A and B.
For substudies A and B. ORR is defined as the proportion of participants in whom a confirmed complete response (CR) or confirmed partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] based on the investigator's assessment) is observed as best overall response.
For substudies A and B. Based on investigator's tumor assessment according to RECIST v1.1.
For substudies A and B. PFS defined as the time from randomization to first documented tumor progression (progressive disease per RECIST v1.1), or death from any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Arm 1: Pumitamig + Treatment of Physician's Choice (TPC) Chemotherapy | EXPERIMENTAL | Participants will be administered with pumitamig (BNT327) plus chemotherapy regimen. |
| Arm 2: Placebo + TPC Chemotherapy | PLACEBO_COMPARATOR | Participants will be administered with matching placebo plus chemotherapy regimen. |
| Stage 1 Control Arm - Atezolizumab + Etoposide + Carboplatin | ACTIVE_COMPARATOR | - |
| Stage 1 Treatment Arm 1 - Pumitamig Dose 1 + Etoposide + Carboplatin | EXPERIMENTAL | - |
| Stage 1 Treatment Arm 2 - Pumitamig Dose 2 + Etoposide + Carboplatin | EXPERIMENTAL | - |
| Stage 2 Control Arm - Atezolizumab + Etoposide + Carboplatin | ACTIVE_COMPARATOR | - |
| Stage 2 Treatment Arm - Pumitamig Dose 3 + Etoposide + Carboplatin | EXPERIMENTAL | - |
| Arm 1: Pumitamig Monotherapy | EXPERIMENTAL | - |
| Arm 2: Bevacizumab Monotherapy | ACTIVE_COMPARATOR | - |
| Arm 3: Pumitamig + temozolomide | EXPERIMENTAL | - |
| Arm 1: Pumitamig (dose level 1) + chemotherapy | EXPERIMENTAL | Participants will be administered pumitamig plus chemotherapy regimen. |
| Arm 2: Pumitamig (dose level 2) + chemotherapy | EXPERIMENTAL | Participants will be administered pumitamig plus chemotherapy regimen. |
| Arm 3: Pumitamig (dose level 2) + chemotherapy | EXPERIMENTAL | Participants will be administered pumitamig plus chemotherapy regimen. |
| Arm 4A (exploratory): Pumitamig (dose level 2) + treatment of physician's choice chemotherapy | EXPERIMENTAL | Participants will be administered pumitamig plus chemotherapy regimen. |
| Arm 4B (exploratory): Pumitamig (dose level 2) + treatment of physician's choice chemotherapy | EXPERIMENTAL | Participants will be administered pumitamig plus chemotherapy regimen |
| Part 1A - Pumitamig Dose 1 + docetaxel | EXPERIMENTAL | - |
| Part 1B - Pumitamig Dose 2 + docetaxel | EXPERIMENTAL | - |
| Part 2: Selected doses of pumitamig + docetaxel | EXPERIMENTAL | Pumitamig and docetaxel will be administered at the dose level recommended by an internal review committee based on the observed safety profile from Part 1. |
| Substudy A Phase 2 - Pumitamig Dose 1 + Carboplatin + Pemetrexed | EXPERIMENTAL | - |
| Substudy A Phase 2 - Pumitamig Dose 2 + Carboplatin + Pemetrexed | EXPERIMENTAL | - |
| Substudy A Phase 3 - Pumitamig + Carboplatin + Pemetrexed | EXPERIMENTAL | Pumitamig dose 3 for Phase 3 |
| Substudy A Phase 3 - Pembrolizumab + Carboplatin + Pemetrexed | ACTIVE_COMPARATOR | - |
| Substudy B Phase 2 - Pumitamig Dose 1 + Carboplatin + Paclitaxel | EXPERIMENTAL | - |
| Substudy B Phase 2 - Pumitamig Dose 2 + Carboplatin + Paclitaxel | EXPERIMENTAL | - |
| Substudy B Phase 3 - Pumitamig + Carboplatin + Paclitaxel | EXPERIMENTAL | Pumitamig dose 3 for Phase 3 |
| Substudy B Phase 3 - Pembrolizumab + Carboplatin + Paclitaxel | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Pumitamig | DRUG | Solution for intravenous (IV) infusion |
| Nab-paclitaxel/Paclitaxel | DRUG | IV infusion |
| Gemcitabine | DRUG | IV infusion |
| Carboplatin | DRUG | IV infusion |
| Eribulin | DRUG | IV infusion |
| Matching placebo | DRUG | IV infusion |
| Atezolizumab | DRUG | Intravenous infusion |
| Etoposide | DRUG | Intravenous infusion and capsules |
| Carboplatin (or cisplatin if carboplatin is not tolerated) | DRUG | Intravenous infusion |
| Bevacizumab | DRUG | IV infusion |
| Temozolomide | DRUG | Oral |
| Nab-paclitaxel | DRUG | IV infusion |
| mFOLFIRINOX | DRUG | IV infusion |
| Docetaxel | DRUG | Intravenous infusion |
| Pembrolizumab | DRUG | Intravenous infusion |
| Pemetrexed | DRUG | Intravenous infusion |
| Paclitaxel | DRUG | Intravenous infusion |
Inclusion Criteria: * Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting immunotherapy plus chemotherapy as per their tumor PD-L1 expression status. * Have confirmed locally recurrent inoperable or metastatic TNBC, or estrogen receptor (ER)-low, human epidermal...