Kite Pops

…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.


The key here is that the neurological events are “generally reversible.” That is good news for investors and patients. As long as that is the case and the remission rate continues to be high the stock has legs to run. Do not forget how sick these patients are at the outset. If I’m dying and there is something that can put me in remission but might make me terribly sick for a while… as long as the side effects are outweighed by the benefit (in this case, life over death), I’ll take the remission.

Still a long way to go for KITE but this seems to be a step in the right direction. I’ll keep my very small 1% position.