…on an 11 patient phase one trial.
"In the Phase 1 trial, 11 patients were treated with KTE-C19 at two target dose levels (2.0×106/kg and 1.0x106/kg). No dose-limiting toxicities (DLT) occurred in the trial. Both doses were tolerable and responses were achieved at each level. Ongoing complete remissions have been observed at 2.0+ to 7.4+ months.
“The majority of adult patients diagnosed with ALL will experience disease relapse and subsequently face a poor prognosis,” said David Chang M.D., Ph.D., Executive Vice President, Research and Development, and Chief Medical Officer of Kite. “We are encouraged by the results from the ZUMA-3 trial to date in this extremely difficult-to-treat patient population. Before launching a pivotal Phase 2 study, we plan to optimize the cell dose of this potentially life-saving therapy for patients with significant unmet need.”
“Three of 11 (27 percent) patients had grade 3 or higher cytokine release syndrome (CRS) and six of 11 (55 percent) had grade 3 or higher neurologic events. These adverse events were generally reversible. As previously reported at ASH 2016, one patient experienced fatal CRS. In order to further improve the safety profile of KTE-C19, ZUMA-3 is also evaluating additional patients who will receive tocilizumab within 36 hours post-KTE-C19 infusion, and a lower dose of 0.5×106 CAR T cells/kg.”
Clinically, this is hypothesis generating at best. A much larger phase two study is needed. The good news is that they can manufacture within 6 days. The bad news is that the same issues seemingly plague KITE- a significant number of neurologic events. How this will play out with the FDA and with prescribers will remain unknown for quite some time.
In the meantime, enjoy the 7% pop.