Please note that this summary only contains information from the full scientific abstract: View ESMO Scientific Abstract

Early response to and safety of PF-06801591 (an anti-PD-1 immunotherapy) in people with non-small cell lung cancer and urothelial cancer

Date of summary: September 2019

Study number: NCT02573259


Study start date: February 2016


Estimated study end date: November 2020


The full title of this abstract is: Safety and clinical activity of subcutaneously (SC) administered anti-PD-1 antibody PF-06801591 in phase I dose-expansion cohorts of locally advanced or metastatic non-small-cell lung cancer (NSCLC) and urothelial carcinoma (UC)

This study drug is not approved to treat the conditions under study that are discussed in this summary.


Researchers must look at the results of many types of studies to understand whether a study drug works, how it works, and whether it is safe to prescribe to patients.

This summary reports the results of only one study. The results of this study might be different from the results of other studies that the researchers look at.


More information can be found in the scientific abstract of this study, which you can access here:
View ESMO Scientific Abstract

What did this study look at?

  • Non-small cell lung cancer (NSCLC for short) is the most common type of lung cancer. Urothelial cancer affects the bladder or other parts of the urinary system.
    • In some people, these cancers have spread to nearby tissues to the point they cannot be surgically removed (known as locally advanced).
    • These cancers can also spread to other parts of the body (known as metastatic).
  • PF-06801591 is an investigational immunotherapy for certain types of solid tumors. A solid tumor is a cancer that does not contain any liquid areas.
    • Investigational means that a medicine is approved for testing in people with a certain condition in clinical trials. It is not approved for sale.
    • Immunotherapy is a type of treatment that boosts the body’s immune system to help fight cancer.
    • PF-06801591 is called an anti-PD-1 immunotherapy as it targets the PD-1 protein, which is found on immune cells.
    • PD-1 binds to the PD-L1 protein found on some cancer cells, and prevents cancer cells from being attacked by the immune system.
    • PF-06801591 can block this binding to help the body’s immune system to recognize and destroy cancer cells.
  • The first part of this ongoing study found it was possible to give PF-06801591 as either an infusion into the bloodstream or as an injection under the skin. The second part of this study is looking at PF-06801591 given as an injection under the skin to people with NSCLC and urothelial cancer. Researchers want to know:
    • What are the most common medical problems that people develop, and
    • how effective PF-06801591 given as an injection under the skin will be in reducing tumor size.
  • This summary describes the safety of and response to PF-06801591 given as an injection under the skin in people with NSCLC or urothelial cancer.

Who took part in this study?

What were the results of the study?

  • At the time of the results reported here, most people had been receiving PF-06801591 for around 3 months.

** A medical problem is considered “serious” when it is life-threatening, needs hospital care, or causes lasting problems.

More results from this study can be found here:
View ESMO Scientific Abstract

What was the main conclusion reported by the researchers?

  • In this study, PF-06801591 given monthly as an injection under the skin was effective in reducing tumor size in some people with NSCLC or urothelial cancer.
    • Ongoing research will help to determine the long-term safety of and response to PF-06801591 in people with NSCLC or urothelial cancer.

Who sponsored this study?

Pfizer Inc.
235 East 42nd Street NY, NY 10017
Phone (United States): +1 212-733-2323

Pfizer would like to thank all of the people who took part in this study.

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