Gilead Sciences announced on its third-quarter earnings call Oct. 29 that it has placed a partial clinical hold on two studies for the CAR-T cell therapy KITE-753 in diffuse large B-cell lymphoma (DLBCL).
The company paused the two trials, which include the phase 2 second-line PALISADES-1 and the phase 3 third-line plus relapsed or refractory PALISADES-2, “to investigate safety differences we’ve noted between phase 1 and phase 2,” Gilead chief medical officer Dietmar Berger, MD, Ph.D., said on its earnings call.
A spokesperson confirmed to Fierce that, after an initial voluntary pause, the company “aligned with the FDA” on a partial clinical hold to conduct a review of the safety data for the anti-CD19/CD20 treatment. The drug is being developed from Gilead's $11.9 billion buyout deal of Kite Pharma back in 2017, which has now been integrated into the pharma.
Cindy Perettie, EVP and head of Gilead’s cell therapy division Kite Pharma, said on the call that there were no cases of death or grade 5 adverse events.
“We made a decision to take a look at differences emerging, specifically with grade 3 and grade 4 ICANS in a small number of patients,” Perettie said, referring to immune effector cell-associated neurotoxicity syndrome, which can result in fever, confusion, tremors and other neurologic complications. “We have decided to take some time, pause and investigate that before we move forward.”
Kite revealed data late last year from a phase 1 trial of KITE-753 alongside fellow CAR-T cell therapy KITE-363 that showed the treatments resulted in complete responses of 71% and that safety was comparable to the company’s multiple myeloma CAR-T anito-cel.
KITE-753 had been poised to make a mark as a next-generation candidate, particularly with potential competitor Johnson & Johnson dropping out of the race in May this year.
The announcement of the clinical hold came amid an upbeat earnings call in which the company reported a 13% year-over-year increase in third-quarter sales to $8.3 billion led by HIV products Biktarvy and Descovy, as well as liver disease drug Livdelzi and cancer treatment Trodelvy.
The cell therapy division, however, was a weak spot for Gilead, with sales decreasing 18% to $355 million in the third quarter, with “ongoing competitive headwinds” to blame. The B-cell lymphoma CAR-T cell therapy Yescarta made up the bulk of the third-quarter cell therapy sales with $249 million, declining from $349 million in last year’s third quarter.