What: Shares of Kite Pharma (NASDAQ: KITE), a clinical-stage oncology and hematology company, saw its shares rise by as much as 11% today on heavier than normal volume. This spike was driven by a clinical update/clarification, where the company informed investors that the rumors of a patient death in its Phase 1 trial for the CAR-T cell therapy, KTE-C19, as a potential treatment for refractory aggressive non-Hodgkin's lymphoma patients who have failed prior chemotherapy treatments, were indeed true, but unrelated to the treatment. After consulting with the U.S. Food and Drug Administration following the death, Kite was given the green light to continue enrolling patients in the trial, according to the company.
So what: CAR-Ts have been reporting some truly impressive early stage results across a diversity of blood-based disorders this year. But the outstanding safety issues remain paramount due to the fact that some adult patients with heavy tumor burdens have experienced a serious condition known as cytokine-release syndrome, even causing a handful of deaths in prior clinical trials. So, this clarification by management that this particular death wasn't directly associated with KTE-C19 is certainly welcome news by investors.
Now what: Given that KTE-C19 has already led to several complete responses in the first part of this trial for a condition with essentially no treatment options, the company believes that the Phase 2 portion could serve as the basis for an accelerated regulatory filing. The entire study is projected to enroll around 112 patients and conclude in the first half of 2017. So, if KTE-C19 can avoid any major landmines on the safety side of the equation, and continue to prove to be an effective treatment of last resort for non-Hodgkin's lymphoma patients, Kite could thus have its first product on the market by perhaps late 2017. Investors therefore might want to let this promising technology mature a bit further before the adding this stock to their portfolios.