Gilead places partial hold on KITE-753 studies

Gilead Sciences has placed a partial clinical hold on two studies of its anti-CD19/CD20 CAR-T cell therapy KITE-753 in diffuse large B-cell lymphoma, according to Fierce Biotech. The company disclosed the action during its third-quarter earnings call on Oct. 29.

The affected studies are the phase 2 second-line PALISADES-1 trial and the phase 3 third-line plus relapsed or refractory PALISADES-2 trial. Fierce Biotech reported that Gilead initially paused the trials voluntarily and then aligned with the FDA on a partial clinical hold to review safety data.

Safety review focuses on ICANS differences

Gilead chief medical officer Dietmar Berger said the company paused the studies to investigate safety differences observed between phase 1 and phase 2. Kite Pharma head Cindy Perettie said the review concerns grade 3 and grade 4 immune effector cell-associated neurotoxicity syndrome, or ICANS, in a small number of patients.

According to Fierce Biotech, Perettie said there were no deaths or grade 5 adverse events. The publication described ICANS as a condition that can involve fever, confusion, tremors and other neurologic complications.

For pharmaceutical and biotech sales professionals, the development places attention on the role of safety monitoring and regulator alignment in the progress of cell therapy programs. Gilead’s stated next step is to investigate the emerging differences before advancing the trials.

Program context within Gilead’s cell therapy business

Fierce Biotech reported that KITE-753 had previously produced complete responses in a phase 1 trial reported late last year alongside KITE-363. The publication said the therapies showed complete responses of 71% and safety comparable to Gilead’s multiple myeloma CAR-T anito-cel.

The hold arrives as Gilead reported third-quarter sales growth, while its cell therapy division recorded declining sales. According to Fierce Biotech, cell therapy sales decreased 18% to $355 million in the third quarter, with ongoing competitive headwinds cited. Yescarta accounted for $249 million of the division’s sales.

• Event: Partial clinical hold on two KITE-753 trials.
• Company rationale: Review safety differences between phase 1 and phase 2.
• Focus of review: Grade 3 and grade 4 ICANS in a small number of patients.