CAR-T therapies in Haematological Malignancy: Update Bulletin #2 [October 2018]

Gain new key opinion leader (KOL) insights on the latest events happening in the CAR-T treatment landscape.Topics covered include expert opinions on; the European Commission approval of Yescarta (Gilead/Kite) for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy; the European Commission approval of Kymriah (Novartis) for paediatric and young adult patients with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant, or in second or later relapse, and for the treatment of adults with relapsed or refractory DLBCL after two or more lines of systemic therapy; the FDA clinical hold placed on a Phase I study evaluating Ziopharm Oncology’s non-viral anti-CD19 CAR-T therapy manufactured under point-of-care in patients with leukaemias and lymphomas; Shanghai Yake Biotech’s announcement of preliminary data from an early stage trial of its anti-CD22 CAR-T therapy in paediatric patients with refractory or relapsed B-cell ALL.

Business Questions:

• How do KOLs react to the EC approval of Kymriah and Yescarta?
• What are the KOLs predictions for the use of Kymriah and Yescarta in the near future in the EU and what might be the barriers to patient access?
• What are the benefits of a non-viral based anti-CD19 CART therapy such as that manufactured by Ziopharm Oncology?
• How do KOLs view Ziopharm Oncology’s Sleeping Beauty platform which has been reported to manufacture CAR-T cells in two days?
• Could an anti-CD22 CAR-T therapy approach be a promising approach to the treatment of relapsed/refractory B-cell ALL?
• How do KOLs react to the idea of dual therapies targeting both CD19 and CD22?