Antibody therapy targeting PD-1 or PD-L1 checkpoints has become a standard treatment for various types of cancer. As of 2023, the US FDA has approved 8 monoclonal antibodies against PD-1 (Pembrolizumab, Nivolumab, Cemiplimab, Dostarlimab, Retifanlimab) or PD-L1 (Atezolizumab, Avelumab, Durvalumab), with applications spanning over 85 oncology indications. Additionally, there are an impressive 5000 active clinical trials exploring at least 33 novel candidates in the field.
Despite the successes, individual tumor differences necessitate personalized approaches for PD-1/PD-L1 therapy. To address this need, companion diagnostics (CDx) play a crucial role by measuring specific biomarkers in patients. These tests help identify suitable candidates for clinical trials and enable tailored therapy.
This presentation aims to provide an update on FDA approvals of anti-PD-1/PD-L1 monoclonal antibodies and their corresponding CDx tests (Twomey JD, Zhang B. AAPS J. 2021, 23(2):39). We will outline the regulatory pathways for incorporating biomarkers into drug development programs. Furthermore, we will discuss potential strategies to optimize biomarkers and CDx tests with the goal of enhancing the clinical application of anti-PD-1/PD-L1 therapy.
Learning Objectives:
Participants will gain an understanding of the significance of antibody therapy targeting PD-1/PD-L1 checkpoints for the treatment of various cancer types.
Participants will become familiar with the FDA-approved monoclonal antibodies against PD-1/PD-L1 and their associated companion diagnostics (CDx).
Participants will learn about regulatory pathways and strategies to optimize biomarkers and CDx tests for improving the clinical application of anti-PD-1/PD-L1 therapy.