NEW YORK – Novartis said on Tuesday that in a Phase III trial evaluating tisagenlecleucel (Kymriah) in patients with previously-treated aggressive B-cell non-Hodgkin lymphoma the autologous cell therapy did not meet its primary endpoint of event-free survival benefit.
Specifically, Novartis was unable to show that tisagenlecleucel improved patients' event-free survival outcomes versus standard-of-care therapy, which involved salvage chemotherapy and then, in cases where patients' cancers responded to the chemo, another high-dose chemotherapy regimen and a stem cell transplant.
In the Phase III trial, dubbed BELINDA, Novartis defined event-free survival as the time from the data of randomization to the date of disease progression; stable disease at or after 12 weeks; or death at any time. Secondary endpoints included overall survival, overall response rates, duration of response, time to response, and safety. According to the drugmaker, tisagenlecleucel's safety profile in the Phase III trial was consistent with what was already known.
Going forward, Novartis will perform a full evaluation of the trial and present its results.
"We were hopeful the BELINDA study would show that Kymriah could improve outcomes and the overall treatment experience for these patients in need," Michael Bishop, director of the University of Chicago's Hematopoietic Stem Cell Transplantation Program and chair of the BELINDA study's steering committee, said in a statement. "The study investigators will work together with Novartis in the coming weeks and months to understand the factors that contributed to this outcome."