Novartis has released longer-term analyses of data from the ELIANA and JULIET trials showing that its CAR-T cell therapy Kymriah demonstrated “strong efficacy” and “durable responses” in certain blood cancer patients.
In the updated analysis from ELIANA, Kymriah (tisagenlecleucel) showed an 82% remission rate within three months in paediatric patients with relapsed or refractory (r/r) acute lymphoblastic leukemia (ALL); relapse-free survival was 62% at 24 months, with median duration of remission still not reached.
The longer follow-up from the JULIET study in adult with r/r diffuse large B-cell lymphoma (DLBCL) reported 64% relapse-free probability and a 43% probability of overall survival at 18 months, with median duration of response still not reached.
“These analyses underscore the longer-term durability of response with Kymriah and its consistent safety profile, reinforcing our belief in the potential for CAR-T cell therapy to extend the lives of patients with these advanced B-cell malignancies,” said Samit Hirawat, head, Novartis Oncology Global Drug Development, commenting on the data.
Kymriah is approved in the US, the EU, Canada and Switzerland for children and young adults with r/r ALL and in adult patients with r/r DLBCL, making it the only CAR-T cell therapy approved for two distinct indications and “delivering the transformative potential for durable responses for patients who relapse or don’t respond to initial therapies and for whom the outlook is poor,” Novartis said.
In the UK, the treatment is being funded on the NHS for children and young adults with r/r ALL, but draft guidelines from the National Institute for Health and Care Excellence recommended against the treatment’s use for adults with r/r DLBCL, concluding that it is not cost effective for routine funding or use within the Cancer Drugs Fund (CDF).