Despite immunotherapy combinations revolutionising the treatment of most cancer indications, the acute myeloid leukemia (AML) market has lagged behind.

However, with a large number of new agents that target novel antigens in the pipeline, this is set to change in the next five to ten years.

Recently, Sellas Life Sciences started a Phase III trial (NCT04229979) for their first-in-class peptide vaccine galinpepimut-S (GPS) for cancers, expressing the WT1 antigen. Given its fast-track designation, GlobalData expects that GPS could launch in the US as early as H1 2022 if the trial’s primary endpoint is reached.

Other immunotherapy classes that are under development in AML are CAR-T cells, bi-specific antibodies, dendritic vaccines, and checkpoint inhibitors. According to GlobalData’s Pharma Intelligence Center, there are 39 immunotherapy agents in Phase I, 34 agents in Phase II, and two agents in Phase III.

Another immunotherapy agent in late-stage clinical development is a CLL1/CD123 CAR-T cell-based therapy developed by the Medical University of Fujian, China (NCT03631576). However, this agent does not have a clear route to market as the university does not have a commercial partner. Its closest competitor is Mustang Bio’s MB102, a CD28/CD123 CAR-T agent, which is currently in Phase I/II (NCT04109482). Given compelling data upon future analysis, Mustang Bio could file for registration as early as 2024.

Since the majority of immunotherapy trials involve the second and third-line AML population, previous GlobalData estimates suggest that immunotherapy agents could target as many as 16,000 patients with relapsed / refractory AML in the seven major markets (7MM – US, France, Germany, Italy, Spain, UK, and Japan) every year.

The approval of immunotherapy agents in this setting will have clear commercial implications and will likely lead to a large expansion of the market value for AML.

Currently, a significant percentage of patients receiving second and third-line therapy do not have branded treatment options. The entry of immunotherapy agents with premium prices could displace generics and push up the value of the market.