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CAR-T r/r CLL global market forecast

Published: October 2017

Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in western countries with an age-adjusted incidence of ~4.4 per 100,000 persons in the United States. In 2017, the US recorded ~20,000 diagnosed cases and ~4,600 deaths. Global1 estimates are ~36,000 diagnosed cases per year.

Symptomatic CLL disease remains incurable with standard therapies although HSCT can offer a cure, dependent on patient age; comorbidity and the potential for GvHD. Recent improvements in standard (chemo-immunotherapeutic) therapy have been achieved with small molecule inhibitors of B cell receptor signalling such as Ibrutinib (Imbruvica®, AbbVie, Janssen) (a Bruton’s Tyrosine Kinase (BTK) inhibitor) and Idelalisib (Zydelig®, Gilead) (a PI3Kd-isoform selective inhibitor) and the apoptosis regulation inhibitor Venetoclax (Venclexta®, Abbvie, Genentech Roche) (an inhibitor of B-cell lymphoma-2 (BCL-2)). Despite their benefits these agents require continuous administration and are not curative. BTK refractory CLL remains an issue. High risk patients with cytogenetic aberrations (e.g. del(17p), del(11q), TP53 mutation, unmutated IGHV) have a poor prognosis and unfavourable/short outcomes.

Novel immune-therapeutic approaches in development for CLL include monoclonal antibodies, bi-specific antibodies, anti-PD-1/PDL-1 checkpoint inhibitors, and the CAR-T cell therapies including JCAR014/JCAR017 (Juno Therapeutics), KTE-C19 (Kite Pharma), and CTL019 (tisagenlecluecel-T) (Novartis Pharmaceuticals). These potential CAR-T therapies or their next generations e.g. ‘armoured’ CARs and humanized versions are in development.

This MarketVIEW product consists of a detailed Executive presentation (~130 slides, .pdf) and MS-Excel workbook forecasting the commercial potential ($ 000s) of novel CAR-T therapies in r/r CLL across 9 major Western1 markets to 2030. A patient-based flow methodology has been devised where possible intervention scenarios for CAR-T introduction are visualised so that the optimum product positioning can be assessed. In addition, an up-to-date review of CLL disease background, epidemiology, current and future treatments is presented along with a comprehensive review of the CAR-T CLL competitive landscape. Pricing, cost effectiveness, manufacturing and logistical considerations are also discussed. All assumptions are clearly provided.


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