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| Therapy Name | BNT327 |
| Synonyms | |
| Therapy Description |
BNT327 (PM8002) is a bispecific antibody that targets VEGFA and PD-L1 (CD274), which potentially induces antitumor activity (J Clin Oncol 42, no. 16_suppl (May 29, 2024) 5524). |
| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| BNT327 | PM8002|Pumitamig|BNT-327|BNT 327|BM-8002 | PD-L1/PD-1 antibody 136 VEGFA Antibody 5 | BNT327 (PM8002) is a bispecific antibody that targets VEGFA and PD-L1 (CD274), which potentially induces antitumor activity (J Clin Oncol 42, no. 16_suppl (May 29, 2024) 5524). |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT07361510 | Phase III | BNT327 Pembrolizumab | A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 >/= 50%. (ROSETTA Lung-202) | Not yet recruiting | USA | TUR | SWE | ROU | POL | NOR | NLD | ITA | HUN | GBR | FRA | FIN | ESP | DEU | CZE | CHE | CAN | BRA | BGR | BEL | AUT | AUS | ARG | 13 |
| NCT07291076 | Phase Ib/II | BNT327 Atezolizumab + Bevacizumab BNT327 + Ipilimumab | A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206) | Not yet recruiting | USA | POL | ITA | GBR | FRA | ESP | DEU | AUS | 5 |
| NCT07293351 | Phase Ib/II | BNT327 + Cabozantinib BNT327 + Ipilimumab Nivolumab Ipilimumab + Nivolumab BNT327 | A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208) | Not yet recruiting | USA | ROU | ITA | IRL | GBR | FRA | FIN | ESP | DEU | CZE | CHE | CAN | BRA | AUS | ARG | 5 |
| NCT07173751 | Phase III | Carboplatin Gemcitabine Eribulin BNT327 Nab-paclitaxel Paclitaxel | ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer | Recruiting | USA | 0 |
| NCT07111520 | Phase Ib/II | YL202 BNT327 + YL202 Pembrolizumab + Pemetrexed Disodium BNT327 Pembrolizumab Paclitaxel + Pembrolizumab Carboplatin + Pembrolizumab | A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC) | Recruiting | USA | 1 |
| NCT06449222 | Phase II | BNT327 + Nab-paclitaxel BNT327 + Eribulin BNT327 + Carboplatin + Gemcitabine BNT327 + Paclitaxel BNT327 | Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy | Recruiting | USA | TUR | GBR | AUS | 0 |
| NCT06827236 | Phase Ib/II | DB-1303 BNT327 + DB-1303 BNT327 | A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer | Recruiting | USA | GBR | 3 |
| NCT07361497 | Phase III | Durvalumab BNT327 | A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201) | Not yet recruiting | USA | TUR | SWE | ROU | POL | NLD | ITA | IRL | HUN | GRC | GBR | FRA | ESP | DEU | CHE | CAN | BRA | BGR | BEL | AUT | AUS | ARG | 12 |
| NCT07079631 | Phase Ib/II | BNT327 Bevacizumab BNT314 + BNT327 | A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment BNT327 and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer | Recruiting | USA | GBR | ESP | 0 |
| NCT06449209 | Phase II | BNT327 | Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy | Active, not recruiting | USA | TUR | GBR | AUS | 1 |