Kite, Novartis update CAR T timelines at ASH
Kite Pharma Inc. (NASDAQ:KITE) and Novartis AG (NYSE:NVS; SIX:NOVN) each provided updates on their lead chimeric antigen receptor (CAR) T cell therapies targeting CD19. Updates for both programs, which are nearing FDA review, occurred at the American Society of Hematology (ASH) meeting in San Diego.
Kite said it began submitting a rolling BLA for axicabtagene ciloleucel (KTE-C19) to treat relapsed or refractory aggressive B cell non-Hodgkin lymphoma (NHL). It hopes to complete the submission in 1Q17. The BLA is based on data from the Phase I/II ZUMA-1 study, in which the therapy led to an initial ORR of 76% in patients with refractory diffuse large B cell lymphoma (DLBCL). After three months of follow-up, the ORR fell to 39% (see BioCentury Extra, Sept. 26)...