Novartis declares results of ELIANA Clinical Trial of kymriah

Novartis declared results from ELIANA Clinical Trial of kymriah in refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia.  Kymriah claimed to become one of the first chimeric antigen receptor T (CAR-T) cell therapy to receive regulatory approval in August 2017, when it was approved by the US Food and Drug Administration (FDA) for the treatment of patients up to 25 years of age with B-cell  New data suggests longer-term follow-up and efficacy in 75 infused patients, analysis of expansion and persistence of Kymriah, and longer-term safety.

Samit Hirawat, MD, Head, Novartis Oncology Global Drug Development claimed “Kymriah, the first FDA-approved CAR-T cell therapy, has shown the potential to be a definitive therapy, providing early, deep and durable remissions for children and young adults with relapsed or refractory ALL.”

75 infused patients with three or more months of follow-up, Kymriah demonstrated an overall remission rate of 81% (95% CI: 71% – 89%). Sixty percent of patients achieved complete remission (CR) and 21% of patients achieved CR with incomplete blood count recovery (CRi), with no minimal residual disease (MRD) detected among all responding patients (95% [58/61] by day 28).

ELIANA is the first pediatric global CAR-T cell therapy registration trial, examining patients in 25 centers in the US, Canada, Australia, Japan and the EU, including: Austria, Belgium, France, Germany, Italy Norway, and Spain, demonstrating effective distribution of CTL019 across four continents using a global supply chain.