CAR-T therapies need to overcome current limitations to unlock promising treatment possibilities for solid tumors: GlobalData

CAR-Ts are revolutionising the treatment of blood cancers, such as B-cell acute lymphocytic leukemia. However, their success has not yet extended to the realm of solid tumors, as no CAR-T therapy has advanced beyond Phase II in one of these indications. Overcoming current limitations and expanding the reach of CAR-T therapeutics could unlock promising new treatment possibilities for solid tumor patients, says GlobalData..

As per GlobalData’s Drugs Database, CAR-T therapeutics are a leading type of T-cell immunotherapy, accounting for over half of the approvals in the oncology cell and gene therapy landscape. This therapeutic modality involves genetically engineering autologous or allogeneic T-cells to express a chimeric antigen receptor so they actively recognise and destroy cancerous cells. In total, 13 CAR-T therapies have received regulatory authorisation, including the 2025 approval of Immuneel Therapeutics’ Qartemi (varnimcabtagene autoleucel), according to the GlobalData’s recent report “T-Cell Immunotherapy Landscape: Comprehensive Analysis of Current Drugs and Dynamics.”

In terms of sales, Gilead’s Yescarta is the leading CAR-T. Having received FDA approval in 2017, this product generated $1.6 billion globally in 2024. Yescarta, like all other CAR-Ts on the market, treats blood cancers and is redefining treatment paradigms for indications like B-cell acute lymphocytic leukemia.

Jasper Morley, Pharma Analyst at GlobalData, comments, “Solid tumors represent roughly 90 per cent of all adult human cancers, including breast, lung, and pancreatic cancer. Despite significant success in the field of blood cancers, CAR-Ts have not experienced a similar level of success in solid tumors, as there have been no CAR-T approvals in related indications. So far, the most advanced stage for a CAR-T in a solid tumor is Phase II.”

Currently, over 650 CAR-Ts are in active development for a solid tumor indication. Over 40 per cent of these are in the preclinical stage, and only 80 (12 per cent) products are in the most advanced stage, Phase II.

Morley adds, “There are a variety of challenges associated with developing CAR-Ts to treat solid tumors. The heterogeneity of solid tumors and absence of specific tumor antigens, alongside the immunosuppressive tumor microenvironment, make it difficult for CAR-Ts to infiltrate and persist within the tumor. These challenges limit the efficacy of CAR-Ts when treating solid tumors, which is confirmed by GlobalData’s Drugs Intelligence database, as no CAR-T has ever successfully completed a Phase II trial and entered Phase III for a solid tumor.”

Bristol Myers Squibb (BMS), which is a frontrunner in the CAR-T landscape, accounts for two of the 13 marketed products: Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel). It is also a joint leader in the solid tumor landscape, with 12 CAR-Ts in development. BMS is looking to extend the label for Breyanzi to solid tumors, as this product is currently in Phase II for primary and secondary central nervous system (CNS) lymphoma.

Elsewhere, China-based Shenzhen Geno-Immune Medical Institute is matching BMS in the solid tumor pipeline, with 12 CAR-Ts in development. However, Shenzhen’s portfolio is more advanced, with 11 Phase II products, compared to only one for BMS; as such, Shenzhen may overtake BMS as the front-runner in this area.

Morley concludes, “CAR-Ts have demonstrated remarkable potential, but so far, their success has remained confined to blood cancers with little success in other indications. Given the prevalence of solid tumors, overcoming the limitations of CAR-Ts in these indications is crucial, and as such, there is a strong focus on the CAR-T market in this area. Success could transform cancer treatment, providing new hope for patients and proving commercially beneficial for drugmakers.”