Drugs / Pumitamig
Pumitamig
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/210 trials | ||||||
| Phase 1/2 | NCT07843940 | Oct 2026 → Apr 2030 expected | small cell lung carcinoma | Boehringer Ingelheim | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07579221 | Jul 2026 → Aug 2029 expected | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07293351 | Mar 2026 → Nov 2029 expected | renal cell carcinoma | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07291076 | Mar 2026 → Oct 2029 expected | hepatocellular carcinoma | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07325136 | Feb 2026 → Apr 2029 expected | small cell lung carcinoma | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07147348 | Aug 2025 → Nov 2027 expected | neoplastic disease or syndrome | BioNTech SE | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07070232 | Aug 2025 → Mar 2028 expected | neoplasm | BioNTech SE | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07079631 | Jul 2025 → Dec 2030 expected | colorectal cancer | BioNTech SE | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06618287 | Feb 2025 → Feb 2031 expected | breast cancer, lung cancer | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04895709 | May 2021 → Aug 2031 expected | cervical cancer, colorectal cancer, gastroesophageal adenocarcinoma, head and neck squamous cell carcinoma +7 | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07492680 | Jul 2026 → Aug 2028 expected | cancer | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 2 | NCT07297212 | Jan 2026 → Jan 2028 expected | IDH-wildtype glioblastoma | BioNTech SE | Recruiting | No outcome recorded |
| Phase 2 | NCT07255404 | Dec 2025 → Dec 2027 expected | pancreatic ductal adenocarcinoma | BioNTech SE | Recruiting | No outcome recorded |
| Phase 2 | NCT06841055 | Mar 2025 → Oct 2028 expected | non-small cell lung carcinoma | BioNTech SE | Recruiting | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT07221149 | Mar 2026 → Nov 2030 expected | gastroesophageal adenocarcinoma | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 2/3 | NCT07221357 | Dec 2025 → Feb 2030 expected | colorectal cancer | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06712316 | Jan 2025 → Jan 2029 expected | non-small cell lung carcinoma | BioNTech SE | Recruiting | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT07361497 | Mar 2026 → Sep 2030 expected | non-small cell lung carcinoma | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 3 | NCT07361510 | Mar 2026 → Oct 2031 expected | non-small cell lung carcinoma | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 3 | NCT07173751 | Oct 2025 → Dec 2029 expected | breast neoplasm | BioNTech SE | Recruiting | No outcome recorded |
| Phase 3 | NCT06712355 | Feb 2025 → Dec 2028 expected | small cell lung carcinoma | BioNTech SE | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT07680764 Background | Sep 2026 → Sep 2028 expected | non-small cell lung carcinoma | Bristol-Myers Squibb | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-05-30 | BioNTech SE | Results Global Data for BioNTech and Bristol Myers Squibb’s PD-L1xVEGF-A Bispecific Pumitamig Shows Encouraging Efficacy in Patients with Non-Small Cell Lung Cancer in ROSETTA Lung-02 Trial biontech.com ↗
The data showed encouraging anti-tumor activity, with high response rates observed in both non-squamous and squamous NSCLC and at each PD-L1 expression level (TPS ˂ 1%, TPS 1 – 49%, and TPS ≥ 50%). |
| 2026-05-30 | Bristol-Myers Squibb | Results Global Data for BioNTech and Bristol Myers Squibb’s PD-L1xVEGF-A Bispecific Pumitamig Shows Encouraging Efficacy in Patients with Non-Small Cell Lung Cancer in ROSETTA Lung-02 Trial bms.com ↗
The data showed encouraging anti-tumor activity, with high response rates observed in both non-squamous and squamous NSCLC and at each PD-L1 expression level (TPS ˂ 1%, TPS 1 – 49%, and TPS ≥ 50%). |
| 2026-05-22 | BioNTech SE | Results BioNTech to Showcase Progress Across Late-Stage Oncology Pipeline at the 2026 ASCO Annual Meeting biontech.com ↗
These data mark the third global data set to consistently show encouraging anti-tumor activity for pumitamig plus chemotherapy, adding to the reported global data in small cell lung cancer and triple-negative breast cancer. |
| 2026-03-24 | BioNTech SE | Results BioNTech Clinical Data at ELCC 2026 Highlight Potential of Differentiated Late-Stage Portfolio in Lung Cancer biontech.com ↗
Data from a Phase 2 clinical trial ( NCT05756972 ) conducted in China showed clinically meaningful survival outcomes and a manageable safety and tolerability profile for pumitamig combined with chemotherapy in patients with EGFR-mutant advanced or metastatic NSCLC, regardless of PD-L1 expression level. |
| 2025-12-09 | BioNTech SE | Results BioNTech and Bristol Myers Squibb Present First Global Phase 2 Data for PD-L1xVEGF-A Bispecific Antibody Pumitamig Showing Encouraging Efficacy in Advanced Triple-Negative Breast Cancer biontech.com ↗
The data showed encouraging anti-tumor responses and a manageable safety profile for pumitamig plus chemotherapy in first-line and second-line treatment setting. |
| 2025-12-09 | Bristol-Myers Squibb | Results BioNTech and Bristol Myers Squibb Present First Global Phase 2 Data for PD-L1xVEGF-A Bispecific Antibody Pumitamig Showing Encouraging Efficacy in Advanced Triple-Negative Breast Cancer bms.com ↗
The data showed encouraging anti-tumor responses and a manageable safety profile for pumitamig plus chemotherapy in first-line and second-line treatment setting. |
| 2025-11-03 | BioNTech SE | Results BioNTech Announces Third Quarter 2025 Financial Results and Corporate Update biontech.com ↗
Demonstrated encouraging anti-tumor activity and manageable safety profile of pumitamig (BNT327/BMS986545), a bispecific antibody candidate targeting PD-L1 1 and VEGF-A, in first disclosed interim data from global Phase 2 trial in extensive-stage small cell lung cancer |
| 2025-09-08 | BioNTech SE | Results First Disclosure of Global Interim Phase 2 Data for BioNTech and Bristol Myers Squibb PD-L1xVEGF-A Bispecific Antibody Pumitamig (BNT327/BMS986545) in Patients with Extensive-Stage Small Cell Lung Cancer Shows Encouraging Antitumor Activity biontech.com ↗
The data, which are consistent with data presented at the European Lung Cancer Congress (“ELCC”) 2025 from a Phase 2 trial conducted in China ( NCT05844150 ), showed encouraging anti-tumor responses with a positive trend in the secondary endpoint progression free survival. |
| 2025-09-08 | Bristol-Myers Squibb | Results First Disclosure of Global Interim Phase 2 Data for BioNTech and Bristol Myers Squibb PD-L1xVEGF-A Bispecific Antibody Pumitamig (BNT327/BMS986545) in Patients with Extensive-Stage Small Cell Lung Cancer Shows Encouraging Antitumor Activity bms.com ↗
Global interim Phase 2 data showed a 76.3% confirmed objective response rate (cORR), 100% disease control rate (DCR), a median progression free survival (PFS) of 6.8 months and a manageable safety profile |
| 2025-04-29 | DualityBio Inc. | Results DualityBio Presented Early Clinical and Preclinical Data for Novel ADC Therapy Candidates at AACR 2025 dualitybiologics.com ↗
Preliminary clinical data of the ongoing global Phase 1/2 trial (NCT05438329) for the combination of BNT325/DB-1305 with BNT327 involving 67 patients with advanced/metastatic solid tumors were presented. |
All press releases naming this drug 13 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pumitamig | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07173751 ↗ |
| Known as | BNT327 | “pumitamig, which is a cancer immunotherapy drug also known as BNT327 and PM8002” NCT07079631 ↗1“pumitamig (also known as BNT327 or PM8002)” NCT07147348 ↗ |
| Known as | PM8002 | “pumitamig, which is a cancer immunotherapy drug also known as BNT327 and PM8002” NCT07079631 ↗1“pumitamig (also known as BNT327 or PM8002)” NCT07147348 ↗ |
| Modality | Protein / enzyme biologic | “Pumitamig, A PD-L1/VEGF Bispecific Fusion Protein” NCT07579221 ↗ |
| Route | Intravenous | “Intravenous infusion” NCT06712316 ↗ |