Barbara E. Gilmore
Frost & Sullivan, Santa Clara, USA

Abstract

Targeted immuno-oncology therapeutics, have the potential to replace traditional chemotherapies turning cancer from a once fatal disease, to a chronic one. Billions of dollars are currently being invested into targeted therapies allowing T-cells to be activated which in turn stimulates the elimination of some cancers. Staggering costs of these approved therapies have rattled the payors. There are over 200 drugs chimeric antigen receptor T-cell (CAR-T) drugs in development for both hematologic and solid tumors. Clinical trials of CAR-T drugs in combination with approved checkpoint inhibitors are in clinical across the globe. Supply chain challenges with CAR-T therapies are numerous. The FDA recognizes CAR-T drugs as breakthrough therapies, which will help get the drugs with successful clinical trial outcomes to market.

The concept of using a person’s own immune system to attack cancer cells is not a new concept; however recent approval of chimeric antigen receptor T-cell (CAR-T) therapies would lead one to believe otherwise. Gene transfer by retroviral vectors has been done since the late 1980’s (1). This early research facilitate further advances in the clinic through the expansion of circulating T-cells targeted to the CD19 antigen, to successfully promote an immune response in patients with B-cell malignancies, improving outcomes in diseases, ones with significant unmet medical needs. Until recently, some of these leukemias had very limited treatment options coupled with extremely poor outcomes. In 2017, the approvals of, Novartis’ KymriahTM and Kite/Gilead’s YescartaTM has accelerated the race forward in a new class of immunotherapies, CAR-T therapies. Most recently Celgene acquired Juno Therapeutics Inc. for $3B, to further their development and commercialization of other CAR-T therapies (2). Juno is one of the earliest innovators to focus their investments into the development of CAR-T drugs. Adoptive T-cell therapies are expected to generate an estim ...