In short
Pumitamig (also known as BNT327) is an investigational bispecific antibody that targets both vascular endothelial growth factor A (VEGF-A) and programmed death-ligand 1 (PD-L1). It is being studied in 16 clinical trials covering conditions such as non-small cell lung cancer, colorectal cancer, and triple-negative breast cancer. The largest trial enrols 1,495 participants with non-small cell lung cancer and is in Phase 4.
Key points
- Pumitamig is an investigational bispecific antibody targeting VEGF-A and PD-L1.
- It is being studied across 16 clinical trials, mainly in advanced solid tumours.
- The most studied condition is non-small cell lung cancer, appearing in five trials.
- Trials range from Phase 1 dose-finding to Phase 4 confirmatory studies.
- The largest trial enrols 1,495 participants and combines pumitamig with chemotherapy.
- Most trials are currently in the Authorised status.
What is pumitamig?
Pumitamig, also referred to as BNT327, is an investigational bispecific antibody against vascular endothelial growth factor A (VEGF-A) and programmed death-ligand 1 (PD-L1). It is a protein-based substance and has not received a marketing authorisation in the records reviewed here. The substance is studied in oncology, specifically in neoplasms, according to its therapeutic area classification. The name pumitamig is used interchangeably with the development code BNT327 across the trial records.
How does pumitamig work?
Pumitamig is designed to bind to two different targets at the same time. One target is VEGF-A, a protein that helps tumours build new blood vessels to obtain nutrients and oxygen. By blocking VEGF-A, pumitamig may reduce the blood supply that tumours need to grow. The second target is PD-L1, a protein that some cancer cells use to hide from the immune system. By blocking PD-L1, pumitamig may help immune cells recognise and attack cancer cells. This dual mechanism is why pumitamig is called a bispecific antibody.
Which conditions is pumitamig being studied for?
- Non-small cell lung cancer (NSCLC) — the most common type of lung cancer, studied in several trials including first-line and stage III settings.
- Small-cell lung cancer — a faster-growing type of lung cancer, studied in the extensive-stage form.
- Colorectal cancer — cancer of the colon or rectum, including untreated, unresectable or metastatic disease.
- Gastric, gastroesophageal junction, or esophageal adenocarcinoma — cancers of the stomach and food pipe.
- Triple-negative breast cancer — a type of breast cancer that lacks three common receptors, studied in the first-line setting.
- Hepatocellular carcinoma — the most common form of liver cancer, studied when advanced or unresectable.
- Renal cell carcinoma — the most common type of kidney cancer, studied in advanced stages.
- Advanced solid tumours — a broad category covering various cancers, including those with MTAP deletion.
How is pumitamig given?
Pumitamig is given as a solution for intravenous infusion, meaning it is administered directly into a vein. The trial records describe two strengths: BNT327 20 mg/ml and BNT327 50 mg/ml, both for intravenous infusion. In some trials, pumitamig is given alone, while in others it is combined with chemotherapy or other investigational agents. The route of administration is consistently intravenous across the records.
What do the clinical trials show?
Sixteen clinical trials involving pumitamig are listed in the registry records. They cover a range of solid tumours, with non-small cell lung cancer being the most frequently studied condition, appearing in five trials.The largest trial enrols 1,495 participants and is in Phase 4, investigating pumitamig in combination with chemotherapy for lung cancer. The smallest trial enrols 58 participants and is a Phase 1/2 study in advanced solid tumours.
Which phases and statuses do the trials have?
The trials span from Phase 1 to Phase 4. Phase 1 trials focus on safety and dose-finding, Phase 2 on early efficacy, Phase 3 on comparison against standard treatments, and Phase 4 on further evaluation after initial approval. All 16 trials are currently in the Authorised status, meaning they have received regulatory approval to proceed. The distribution of phases is shown in the table below.
| Phase | Number of trials | Conditions |
|---|---|---|
| Phase 1 | 4 | Advanced solid tumours, hepatocellular carcinoma, renal cell carcinoma, colorectal cancer |
| Phase 1/2 | 3 | Advanced solid tumours, advanced or metastatic cancers |
| Phase 2 | 2 | Advanced solid tumours with MTAP deletion, non-small cell lung cancer |
| Phase 3 | 4 | Non-small cell lung cancer, small-cell lung cancer, triple-negative breast cancer |
| Phase 4 | 3 | Non-small cell lung cancer, colorectal cancer, gastric or esophageal adenocarcinoma |
What are the trials measuring?
The trials measure several outcomes. Objective response rate (ORR) is the proportion of participants whose cancer shrinks or disappears, assessed by imaging according to RECIST v1.1 criteria. Progression-free survival (PFS) is the time from randomisation until the cancer grows or the participant dies. Overall survival (OS) is the time from randomisation until death from any cause. Safety outcomes include treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities.
Who can take part in these trials?
Eligibility varies by trial. Many trials enrol adults aged 18 and older with specific advanced or metastatic cancers. For example, one trial requires participants with advanced non-small cell lung cancer and PD-L1 expression of at least 50%. Another trial focuses on participants with untreated, unresectable or metastatic colorectal cancer. Some trials include participants with specific genetic features, such as MTAP deletion in solid tumours.