Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BNT327, PM8002, BNT327 Dose Level 1 (DL1), BNT327 Dose Level 1, BNT327 Optimized Dose, BNT327 Equivalent Q3W Dose, BMS-986545
Pumitamig · 21 trials · 22 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.
Progression-free survival is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on assessments by Blinded Independent Review Committee (BIRC) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.
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.
Objective response rate is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
AEs are graded according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 in the combination treatment regimen.
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.
In the combination treatment regimen according to the (US) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE version 5.0). By treatment arm and overall.
By treatment arm and overall.
Based on the investigator's tumor assessment according to RECIST 1.1. Defined as the change from baseline in percent to the minimal tumor size until tumor progression/recurrence or death (whichever occurs first). By treatment arm.
Defined as ≥10% decrease in the pretreatment sum of diameters at first post-treatment tumor scan in target lesions. By treatment arm.
In the combination treatment regimen according to the (US) National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0). By treatment arm and overall.
By treatment arm and overall.
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 \[RECIST 1.1\] based on the investigator's assessment) is observed as best overall response. By treatment arm.
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
To determine the dosing regimen of PM8002 in combination with PM1009
DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle (3weeks) of treatment.
| 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 | - |
| PM8002+Paclitaxel | EXPERIMENTAL | Subjects will be administered with PM8002 in combination with Paclitaxel via intravenously (IV) infusion. |
| Chemotherapy | ACTIVE_COMPARATOR | Subjects will be administered with Investigator's Choice(Topotecan or Paclitaxel) via intravenously (IV) infusion Q3W. |
| PM8002 Plus Nab-Paclitaxel | EXPERIMENTAL | Patients will receive both PM8002 and Nab-Paclitaxel. |
| Placebo Plus Nab-Paclitaxel | PLACEBO_COMPARATOR | Patients will receive both Placebo and Nab-Paclitaxel. |
| 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 |
| Chemotherapy regimen 1 group - PM8002 Dose 1 + chemotherapy regimen 1 | EXPERIMENTAL | Subjects will be administered with PM8002 (Dose 1) plus chemotherapy regimen 1 via intravenously (IV) Q2W until progression. |
| Chemotherapy regimen 1 group - PM8002 Dose 2 + chemotherapy regimen 1 | EXPERIMENTAL | Subjects will be administered with PM8002 (Dose 2) plus chemotherapy regimen 1 via intravenously (IV) Q2W until progression. |
| Chemotherapy regimen 2 group - PM8002 Dose 1 + chemotherapy regimen 2 | EXPERIMENTAL | Subjects will be administered with PM8002 (Dose 1) plus chemotherapy regimen 2 via intravenously (IV) and oral administration (PO) Q3W until progression. |
| Chemotherapy regimen 2 group - PM8002 Dose 2 + chemotherapy regimen 2 | EXPERIMENTAL | Subjects will be administered with PM8002 (Dose 2) plus chemotherapy regimen 2 via intravenously (IV) and oral administration (PO) Q3W until progression. |
| Chemotherapy regimen 3 group - PM8002 Dose 1 + chemotherapy regimen 3 | EXPERIMENTAL | Subjects will be administered with PM8002 (Dose 1) plus chemotherapy regimen 3 via intravenously (IV) Q2W until progression. |
| Chemotherapy regimen 3 group - PM8002 Dose 2 + chemotherapy regimen 3 | EXPERIMENTAL | Subjects will be administered with PM8002 (Dose 2) plus chemotherapy regimen 3 via intravenously (IV) Q2W until progression. |
| 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 (Arm 1) - Pumitamig Dose 1 + Carboplatin + Pemetrexed | EXPERIMENTAL | - |
| Substudy A Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + Pemetrexed | EXPERIMENTAL | - |
| Substudy A Phase 2 (Arm 1A - China only) - Pumitamig Dose 3 + Carboplatin + Pemetrexed | EXPERIMENTAL | - |
| Substudy A Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + Pemetrexed | EXPERIMENTAL | - |
| Substudy A Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + Pemetrexed | ACTIVE_COMPARATOR | - |
| Substudy B Phase 2 (Arm 1) - Pumitamig Dose 1 + Carboplatin + Paclitaxel | EXPERIMENTAL | - |
| Substudy B Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + Paclitaxel | EXPERIMENTAL | - |
| Substudy B Phase 2 (Arm 1A, China only) - Pumitamig Dose 3 + Carboplatin + Paclitaxel | EXPERIMENTAL | - |
| Substudy B Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + Paclitaxel | EXPERIMENTAL | - |
| Substudy B Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + Paclitaxel | ACTIVE_COMPARATOR | - |
| Cohort 1 Arm 1 - BNT327 DL1 + Nab-paclitaxel | EXPERIMENTAL | - |
| Cohort 1 Arm 2 - BNT327 DL2 + Nab-paclitaxel | EXPERIMENTAL | - |
| Cohort 2 Arm 1 - BNT327 Optimized dose + Paclitaxel | EXPERIMENTAL | - |
| Cohort 2 Arm 2 - BNT327 Equivalent Q3W dose + Gemcitabine + Carboplatin | EXPERIMENTAL | - |
| Cohort 2 Arm 3 - BNT327 Equivalent Q3W dose + Eribulin | EXPERIMENTAL | - |
| Cohort 1 Arm 1 - BNT327 DL1 + carboplatin + etoposide | EXPERIMENTAL | Participants with ES-SCLC without prior systemic anticancer therapy received in the ES setting |
| Cohort 1 Arm 2 - BNT327 DL2 + carboplatin + etoposide | EXPERIMENTAL | Participants with ES-SCLC without prior systemic anticancer therapy received in the ES setting |
| Cohort 2 Arm 1 - BNT327 DL1 + paclitaxel | EXPERIMENTAL | Participants with SCLC who have disease progression/relapse |
| Cohort 2 Arm 2 - BNT327 DL2 + paclitaxel | EXPERIMENTAL | Participants with SCLC who have disease progression/relapse |
| Cohort 3 Arm 1 - BNT327 DL1 + topotecan | EXPERIMENTAL | Participants with SCLC who have disease progression/relapse |
| Cohort 3 Arm 2 - BNT327 DL2 + topotecan | EXPERIMENTAL | Participants with SCLC who have disease progression/relapse |
| PM8002+Chemotherapy | EXPERIMENTAL | Subjects will be administered with PM8002 plus pemetrexed and carboplatin via intravenously (IV) Q3W for 4 cycles, followed by PM8002 and pemetrexed until progression or for a maximum of 2 years. |
| PM8002+Etoposide＋platinum | EXPERIMENTAL | Subjects will be administered with PM8002 plus Etoposide and platinum via intravenously (IV) Q3W for 4 cycles, followed by PM8002 until progression or for a maximum of 2 years. |
| PM8002+FOLFIRI | EXPERIMENTAL | Subjects will be administered with PM8002 plus FOLFIRI via intravenously (IV) Q2W until disease progression or intolerable toxicity for a maximum of 2 years. |
| PM8002+pemetrexed+platinum | OTHER | Subjects will be administered with PM8002 plus pemetrexed+platinum via intravenously (IV) Q3W for 4-6 cycles,followed by PM8002 until disease progression intolerable toxicity for a maximum of 2 years. |
| PM8002+FOLFOX-4 | EXPERIMENTAL | PM8002 20mg/kg Q2W day 1: oxaliplatin \[85 mg/m2, 2-h infusion\] plus leucovorin \[200 mg/m2, 2-h infusion\], followed by 5-fluorouracil \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\]; day 2: leucovorin \[200 mg/m2, 2-h infusion\], followed by 5-fluorouracil \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\] |
| Cohort 1 | EXPERIMENTAL | Combination of obrixtamig and pumitamig in patients with extensive stage small cell lung carcinoma (ES-SCLC) who progressed on or after a platinum-containing first line (1L) treatment or on or after one additional line of therapy (second line (2L) or third line (3L) patients). |
| Cohort 2 | EXPERIMENTAL | Combination of obrixtamig, pumitamig and chemotherapy (i.e., carboplatin and etoposide) in 1L ES-SCLC patients. |
| Cohort 1- combination treatment | EXPERIMENTAL | Combination regimen：PM8002 combined with PM1009. The drugs are administered on the first day every 3 weeks (Q3W), until disease progression or intolerable toxicity or patient withdrawal or study discontinuation(Whichever occurs first). |
| Cohort 2- combination treatment | EXPERIMENTAL | Combination regimen：PM8002 combined with PM1009(low dose). The drugs are administered on the first day every 3 weeks (Q3W), until disease progression or intolerable toxicity or patient withdrawal or study discontinuation(Whichever occurs first). |
| Cohort 3- monotherapy | EXPERIMENTAL | PM8002 administered on the first day every 3 weeks (Q3W), until disease progression or intolerable toxicity or patient withdrawal or study discontinuation(Whichever occurs first). |
| Cohort 4 | ACTIVE_COMPARATOR | Combination regimen：atezolizumab combined with bevacizumab. The drugs are administered on the first day every 3 weeks (Q3W), until disease progression or intolerable toxicity or patient withdrawal or study discontinuation(Whichever occurs first). |
| PM8002+nab-paclitaxel | OTHER | PM8002 at 20 mg/kg (Q2W) and nab-paclitaxel at 100 mg/m2 on the 1st, 8th, and 15th days of each cycle until unacceptable toxicity or disease progression were observed. Each cycle contains 28 days. |
| PM8002 | EXPERIMENTAL | PM8002 IV every 2 weeks(q2w) or every 3 weeks(q3w) |
| 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 |
| PM8002 | DRUG | Following a predefined dose and date. |
| Paclitaxel | DRUG | 175mg/m2 via IV infusion on Day 1 Q3W |
| Topotecan | DRUG | 1.25mg/m2/day via IV infusion on Days 1-5 Q3W |
| Nab-Paclitaxel | DRUG | Nab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle |
| Placebo | DRUG | Placebo 20 mg/kg via IV infusion on Days 1 and 15 of each 28-day cycle |
| Bevacizumab | DRUG | IV infusion |
| Temozolomide | DRUG | Oral |
| mFOLFIRINOX | DRUG | IV infusion |
| Chemotherapy Regimen 1 | DRUG | IV infusion |
| Chemotherapy Regimen 2 | DRUG | Oral administration and IV infusion |
| Chemotherapy Regimen 3 | DRUG | IV infusion |
| Docetaxel | DRUG | Intravenous infusion |
| Pembrolizumab | DRUG | Intravenous infusion |
| Pemetrexed | DRUG | Intravenous infusion |
| BNT327 Dose Level 1 (DL1) | DRUG | Intravenous (IV) infusion |
| BNT327 Dose Level 1 (DL2) | DRUG | IV infusion |
| Nab-placlitaxel | DRUG | IV infusion |
| BNT327 Optimized Dose | DRUG | IV infusion |
| BNT327 Equivalent Q3W Dose | DRUG | IV infusion |
| BNT327 Dose Level 2 (DL2) | DRUG | IV infusion |
| Platinum | DRUG | IV infusion |
| FOLFIRI | DRUG | IV infusion |
| Cisplatin | DRUG | IV infusion |
| FOLFOX regimen | DRUG | day 1: oxaliplatin \[85 mg/m2, 2-h infusion\] plus leucovorin \[200 mg/m2, 2-h infusion\], followed by 5-fluorouracil \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\]; day 2: leucovorin \[200 mg/m2, 2-h infusion\], followed by 5-fluorouracil \[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\] |
| Obrixtamig | DRUG | Obrixtamig |
| PM1009 | DRUG | PM8002 via IV infusion, Q3W |
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...
Pumitamig is an investigational bispecific antibody that targets PD-L1 and VEGF-A, being developed by BioNTech SE (NASDAQ: BNTX) for multiple solid tumor types. It is also known as BNT327 and PM8002. The drug is in Phase 3 clinical development and has been studied in breast cancer, colorectal cancer, extensive-stage small cell lung cancer, and hepatocellular carcinoma.
Pumitamig is being evaluated for the treatment of several cancers, including breast neoplasms (triple-negative breast cancer), colorectal cancer, extensive-stage small cell lung cancer, and hepatocellular carcinoma. It is also being tested in recurrent glioblastoma and pancreatic ductal adenocarcinoma. It is not yet approved for any indication and remains investigational.
Pumitamig targets both PD-L1 and VEGF-A. It is a bispecific antibody designed to bind these two proteins simultaneously. PD-L1 is an immune checkpoint that tumors use to suppress T-cell activity, while VEGF-A drives angiogenesis. By targeting both pathways, the drug aims to enhance anti-tumor immune responses and inhibit blood vessel growth that supports tumor progression.
Pumitamig is being developed by BioNTech SE, a biotechnology company traded on the Nasdaq under the ticker BNTX. BioNTech is the sponsor of the clinical trials evaluating Pumitamig across multiple cancer types.
Pumitamig is in Phase 3 clinical development. The Phase 3 trial is ROSETTA Breast-01 (NCT07173751) in triple-negative breast cancer. Additional Phase 2 and Phase 1 trials are ongoing in recurrent glioblastoma, pancreatic ductal adenocarcinoma, and small cell lung cancer. Pumitamig is investigational and has not been approved by the FDA or any regulatory agency.
Pumitamig is being studied in several clinical trials. These include NCT07173751, a Phase 3 trial in triple-negative breast cancer; NCT07297212, a Phase 2 trial in recurrent glioblastoma; NCT07255404, a Phase 2 trial in pancreatic ductal adenocarcinoma; and NCT07843940, a Phase 1 trial in extensive-stage small cell lung cancer. All are currently recruiting.
Yes, Pumitamig is also known as BNT327 and PM8002. BNT327 is BioNTech's designation for the compound, and PM8002 was an earlier name used during its development. Other related terms include BNT327 Dose Level 1 (DL1), BNT327 Optimized Dose, BNT327 Equivalent Q3W Dose, and the descriptive name bispecific antibody for PD-L1 and VEGF-A.