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July 12, 2022

Acute lymphocytic leukaemia leads in cell therapy clinical development

While CAR-T cells account for most blood cancer cell therapy pipelines, they have struggled to achieve efficacy in solid tumours.

By GlobalData Healthcare

The success of chimeric antigen receptor T-cells (CAR-T) in blood cancers has led to the US Food and Drug Administration’s (FDA) approval of six products with a pipeline of cell therapies that numbers in the thousands. An analysis of GlobalData’s Pharma Intelligence Centre for cell therapies in major oncology indications in the eight major markets (8MM: the US, France, Germany, Italy, Spain, the UK, Japan and China) suggests that acute lymphocytic leukaemia (ALL) dominates that pipeline, with more than 300 cell therapy products in active development (Figure 1), the vast majority of which are CAR-T cell products.

Despite the market size for B-cell non-Hodgkin’s lymphoma (NHL) being at least five times that of ALL, NHL has a smaller pipeline of cell therapies. GlobalData views the ALL pipeline as unsustainable given the rarity of the disease and, unfortunately, most of the pipeline CAR-T cell products for ALL will never reach the market due to strategic decisions, potentially prioritizing other cancers.  

Unsurprisingly, while CAR-T cells make up the majority of the cell therapy pipelines in all blood cancers examined, that is not the case for solid tumours, where CAR-T cells have struggled to achieve efficacy. A number of problems have been identified by key opinion leaders (KOLs), including a tumour microenvironment hostile to CAR-T cells, a lack of good antigens to target, and a simple lack of access to the tumour. In solid tumours, other technologies, many of which are very novel in nature and do not fall under established classes of therapy, capture a significant share of the industry’s interest. T-cell receptor-modified cells and tumour-infiltrating lymphocytes (TILs) have a high number of products in the pipeline, particularly in ovarian cancer, melanoma and non-small cell lung cancer (NSCLC).

The leading marketed CAR-T cell products, Gilead’s Yescarta (axicabtagene ciloleucel) and Novartis’ Kymriah (tisagenlecleucel), achieved $695m and $587m in sales respectively last year, demonstrating the high potential for sales of successful new cell therapies. The total market for cell therapies in oncology is projected to exceed $37bn worldwide by 2028. Despite the cell therapy field having advanced significantly in the past five years, the technologies that will allow its full fruition have not advanced far yet. KOLs interviewed by GlobalData believe that the next iterations of the technology will be the most successful, having solved several current problems, namely long-term cell persistence, a need for inpatient admission for administration, and manufacturing/access challenges.

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