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What is Pumitamig?

Pumitamig is an investigational cancer medicine called a bi‑specific antibody. This means it is designed to attach to two different proteins in the body at the same time to help the immune system fight cancer.

• The immune system and cancer:

  The immune system is the body’s natural defense against disease. Cancer cells can sometimes hide from the immune system, allowing them to grow and spread.
• Role of PD‑L1:
  
Some cancer cells use a protein called PD‑L1 to hide from the immune system. When PD‑L1 is active, immune cells have a harder time seeing and attacking cancer cells.
• How PD‑L1 targeting may help:

  One part of pumitamig attaches to PD‑L1. By blocking PD‑L1, pumitamig may help the immune system better recognize and attack cancer cells.
• Role of VEGF‑A:

  Cancer cells and normal cells make a protein called VEGF‑A, which helps form new blood vessels. Tumors can use these blood vessels to grow and can also use VEGF‑A to make it harder for the immune system to work properly.
• How VEGF‑A targeting may help:
  The other part of pumitamig attaches to VEGF‑A. Blocking VEGF‑A may help normalize blood vessel growth and make it easier for immune cells to reach and attack tumor cells.
• How pumitamig is thought to work overall:
  By targeting both PD‑L1 and VEGF‑A, pumitamig is designed to help the immune system better see cancer cells and improve its ability to attack them. This combination is being studied to see how it may help slow or stop tumor growth in many different tumor types.
• What is known so far:
  Pumitamig has been shown to slow tumor growth in laboratory studies and in some studies involving people.

How many patients will be involved?

Approximately 690 participants worldwide are expected to take part in this clinical study

How long will participation last?

The length of time you will be in the study depends on several factors, including how your cancer responds to the study treatment and whether you experience side effects. Your study participation may include a treatment period followed by a follow‑up period. Some participants may be followed for several years after treatment ends. Will I know which treatment I receive? This is a randomized clinical study.

• Randomized means participants are assigned by chance to one of the study treatment groups.
• Participants will receive one of the following:
• All study treatments are administered by intravenous infusion every 2- 3 weeks.

The study is designed so that all participants receive active treatment.

Study Periods

Screening Period:

During the screening period, the study doctor will conduct tests and assessments to determine whether the study is appropriate for you. These tests help confirm that you meet the study’s eligibility criteria. If the screening results show that the study is not suitable for you, the study doctor will explain the reasons. If you qualify and decide to participate, you will be asked to sign an informed consent form before any study‑related procedures take place.

Treatment Period:

If you are enrolled, you will receive the study treatment to which you are assigned:

• Either the investigational treatment plus chemotherapy, or
• Nivolumab (standard‑of‑care) plus chemotherapy

Study treatments are given as intravenous infusions every 2 weeks. The duration of the treatment period varies and depends on factors such as how the cancer responds, safety considerations, and your decision to continue participation.

Follow‑Up Period:

After you stop receiving study treatment, the study team will continue to monitor your health. The follow‑up period includes:

• A safety follow‑up visit approximately 1 month after your last dose
• A safety follow‑up visit approximately 3 months after your last dose
• Ongoing follow‑up contacts, typically every 3 months, or as determined by the study doctor

If the study treatment is stopped because it is no longer appropriate, your study doctor will discuss other available care options with you.