Kite Pharma jumps after CAR-T cancer drug success
Shares of Kite Pharma (KITE) jumped in post-market trading after the cancer researcher reported data from an early analysis of its lead drug candidate KTE-C19, which met its goal of meaningfully shrinking tumors. KITE GIVES DATA ON CLOSELY-WATCHED TRIAL: After Monday's market close, Kite issued topline results from an interim analysis of "ZUMA-1," the pivotal trial of KTE-C19 in several types of non-Hodgkin lymphoma. KTE-C19 is a so-called "CAR-T" therapy, a new class of oncology drugs that reengineer a patient's own cells to attack the disease. Evaluating 51 diffuse large B-cell lymphoma patients, Kite's analysis showed an initial 76% overall response rate and 47% complete remission, with those numbers jumping to 91% and 73% for an 11-patient group with transformed follicular lymphoma and primary mediastinal B-cell lymphoma. At three months, ORR and CR declined to 39% and 33% for the 51 patients in the first group and fell to 64% and 64% for the second group. Two patients died from drug-related events, the company noted. KITE TO MEET WITH FDA: Speaking on a conference call following the company's press release, Kite executives said, "In the upcoming months, we plan to meet with FDA to discuss the data from this interim analysis in preparation of Biologics License Application submission." THREE MONTH DATA IN FOCUS: Informally commenting on tonight's announcement in a series of Twitter posts, noted biotech writer Adam Feuerstein highlighted the dip to a 39% response rate at three months, saying "that's quite the response drop off." Feuerstein also brought in fellow biotech observer Sally Church, who remarked that "it's not the number of CRs - it's how durable they are. Too many relapsing by 3 months. Come final data set that could be worse." In a follow-up article, Feuerstein said the three month gap "will raise questions about the durability." RECENT CAR-T DOUBTS: Kite's data follows news on August 31 that Novartis (NVS) planned to reabsorb its CAR-T division and lay off a number of employees, which itself followed a temporary FDA halt of a CAR-T trial by Juno (JUNO) in early July after several patient deaths. Weighing in on Novartis' plans, Piper Jaffray analyst Joshua Schimmer said at the time that the move could signal the new technology's challenges "are still not being adequately addressed." PRICE ACTION: After initially jumping as much as 12%, shares of Kite are up 10.59% to $60.80 in after-hours trading, while Juno is up 3.54%.