CAR-T therapeutics, a cutting-edge T-cell immunotherapy, have taken a front seat in the fight against cancer, accounting for over half of the approvals in the oncology cell and gene therapy arena. This innovative approach involves the genetic modification of autologous or allogeneic T-cells to express chimeric antigen receptors (CARs), enabling them to actively target and annihilate cancer cells.
To date, 13 CAR-T therapies have been granted regulatory authorization, including Qartemi from Immuneel Therapeutics, which received the nod in 2025, as reported in the comprehensive analysis of the T-Cell Immunotherapy Landscape. However, Gilead’s Yescarta, approved by the FDA in 2017, holds the leading position in sales, generating a global revenue of $1.6bn in 2024. Primarily used for the treatment of blood cancers like B-cell acute lymphocytic leukaemia, Yescarta, like all other CAR-T therapies currently available, is transforming treatment paradigms.
However, the current CAR-T landscape, while evolving, is still faced with significant limitations. Despite their revolutionizing effect on the treatment of blood cancers, CAR-T therapies haven’t achieved a similar level of success with solid tumours. To put this into perspective, solid tumours, including breast, lung, and pancreatic cancer, represent approximately 90% of all adult human cancers. Yet, no CAR-T therapy has advanced past the Phase II trial stage for any of these indications.
Currently, over 650 CAR-T therapies are under active development for solid tumour indications. While over 40% of these are in the preclinical stage, only 80 (12%) are in the most advanced stage, Phase II. The reason for this limited progress is multifaceted.
Solid tumours present unique challenges to the successful deployment of CAR-T therapies. Their heterogeneity and the lack of specific tumour antigens, coupled with the immunosuppressive microenvironment within the tumour, impede the infiltration and persistence of CAR-Ts. This often results in diminished efficacy when treating solid tumours.
Further, these challenges are exacerbated by the fact that no CAR-T therapy has ever completed a Phase II trial and successfully transitioned to Phase III for a solid tumour, as confirmed by GlobalData’s Drugs Intelligence database.
Despite these obstacles, the potential of CAR-T therapies to overturn the current treatment modalities for solid tumours remains undiminished. The key lies in overcoming these challenges and expanding the reach of CAR-T therapeutics. Doing so could unlock a range of promising new treatment possibilities for patients with solid tumours, reshaping oncology treatment paradigms once again. The journey may be arduous, but the potential rewards could revolutionize the field of oncology.
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