Cancer Immunotherapy Pipeline Expands With Multiple New Drug Classes

Fifteen years have passed since the first immune checkpoint inhibitor received FDA approval for metastatic melanoma. Since then the number of approved agents and investigational programs has grown substantially.

Keytruda (pembrolizumab) now holds more than 40 FDA-approved indications and ranks as the top-selling oncology drug worldwide. Survival gains from checkpoint inhibitors range from several months to roughly 18 months, with wide variation across cancer types.

Additional checkpoint targets such as LAG-3, TIGIT, TIM-3, VISTA, B7-H3, and BTLA are in clinical testing, often in combination regimens. One LAG-3 drug was approved in 2022 together with a PD-1 inhibitor for metastatic melanoma.

and Bispecific Antibodies

Fifteen antibody-drug conjugates have received FDA approval, with more than 300 additional candidates in development. These agents deliver a cytotoxic payload after binding to tumor-surface antigens. Nine bispecific T-cell engagers are approved for blood cancers and uveal melanoma, while more than 500 others remain in the pipeline.

Combinations of these engagers with checkpoint inhibitors are under study.

CAR-T cell therapies were first approved in 2017 for certain blood cancers. Tumor-infiltrating lymphocyte therapy gained approval for melanoma in 2024. Researchers are testing natural killer cells, CAR-macrophages, and methods to reduce T-cell exhaustion.

Work is also under way to move from individualized, ex-vivo manufacturing to off-the-shelf, in-vivo delivery systems that could lower cost and shorten treatment timelines.