BASEL (dpa-AFX) - Novartis (NVS) announced 14-month results from the pivotal JULIET clinical trial showing ongoing durable responses are achievable with Kymriah (tisagenlecleucel) when administered to adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
In the JULIET study, the relapse-free probability at 12 months after a patient's first response was 65%. The overall response rate was 52% and median duration of response was not reached at a median follow-up of 14 months, signifying responses were durable.
With eight months of additional follow-up, response rates remained consistent with previous reports and the safety profile was maintained with no emergence of new safety signals, the compnay noted.
'These results from JULIET continue to show Kymriah delivers strong efficacy with durable responses, and a predictable and consistent safety profile more than a year after infused in patients with advanced DLBCL,' said Samit Hirawat, MD, Head, Novartis Oncology Global Drug Development.
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