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Much Anticipated JULIET Data Show Novartis Playing Catch-Up On CAR-T Manufacturing

 
• By Mandy Jackson

Novartis reported positive early results for its lead CAR-T candidate CTL019 in DLBCL that appear to be consistent with Kite's competing therapy in the same indication, but the data show the Swiss big pharma ran into manufacturing issues that weren't resolved until later in the JULIET study.

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Novartis AG had some explaining to do on June 7 regarding the company's lead chimeric antigen receptor T cell (CAR-T) therapy, because an early look at CTL019 in diffuse large B cell lymphoma (DLBCL) showed efficacy comparable to Kite Pharma Inc.'s axicabtagene ciloleucel, but nine patients enrolled in the Phase II JULIET clinical trial were never treated due to manufacturing issues.

Novartis explained after the interim data for CTL019 (tisagenlecleucel) in DLBCL became available – the results will be presented on June 14 at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland – that the company experienced manufacturing delays that were resolved later in the study

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