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CAR-T Therapy in Haematological Malignancy: Update Bulletin [December 2017]

Product Code:
Publication Date:
December 2017

This edition presents leading US and EU key opinion leader (KOL) views on recent developments in the CAR-T therapy space. Topics covered include expert opinions on the FDA approvals of Novartis’ Kymriah (tisagenlecleucel-T; CTL019) and Gilead/Kite’s Yescarta (axicabtagene ciloleucel; KTE-C19) for the treatment of patients with paediatric acute lymphoblastic leukaemia (ALL) and adult diffuse large B-cell lymphoma (DLBCL) respectively. KOLs discuss the three-month data reported in the DLBCL setting for Juno Therapeutics’ and Celgene’s JCAR017 in the TRANSCEND study and also offer their candid insights on allogeneic CAR-T therapies such as Cellectis and Servier/Pfizer’sUniversal Chimeric Antigen Receptor T-cells (UCARTs) and the recent progress made in diseases such as multiple myeloma and acute myeloid leukaemia (AML).

Business Questions:

• According to the KOLs, how are Kymriah and Yescarta faring on the US market so far?
• What are the experts’ initial views on the cost of the two CAR-T therapies?
• In terms of distribution and centre capacity, how do the KOLs view the roll-out of the two CAR-T therapies? Are there any major setbacks to successful roll-out?
• What challenges lie ahead in terms of infrastructural and production capacity?
• Do the experts have any remaining concerns about the manufacturing processes for CAR-T?
• What challenges face the two CAR-T therapies if and when they are approved in Europe?
• What do KOLs think CAR-T companies can do to help in terms of further training, support and education?
• Are KOLs impressed with the three-month data for Juno and Celgene’s JCAR017 in the TRANSCEND study?
• How does JCAR017 match up to Kymriah and Yescarta so far in terms of efficacy and safety?
• Do the benefits of a defined composition CAR-T product outweigh the potential disadvantages?
• How do the KOLs view allogeneic CAR-T cells, in particular Cellectis/Servier/Pfizer’s UCART programme?
• What are KOLs’ main concerns about ‘off-the-shelf’ allogeneic CAR-T approaches?
• How do KOLs view the safety issues with UCART123 in patients with AML? Where does the opportunity for CAR-T exist in AML?
• With Bluebird Bio reporting early data for anti-BCMA CAR-T cells in multiple myeloma, how do the experts view the recent progress made with this novel CAR-T approach?


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