A death in Kite Pharma’s ZUMA-1 trial saw the company’s shares drop 15% in after-hours trading. The patient, who had non-Hodgkin’s lymphoma, was enrolled in the safety expansion trial for the company’s novel cancer CAR T treatment; KTE-C19.
Cause of death was determined to be cerebral edema, the same condition that resulted in five fatalities in rival Juno’s CAR T trial for JCAR015. Following the deaths, Juno had discontinued the trial and scrapped JCAR015, which was considered to have an extremely similar construct to KTE-C19.
Despite the regrettable outcome of a death, Kite remains committed to the planned development studies of the drug; reasoning that KTE-C19 was considered a last ditch effort for the patient who suffered from an ‘explosive’ and ‘rapidly progressing’ form of the disease. The company will however be amending their consent form for current and future enrollments, to include the risk of fatal cerebral edema.
Kite is currently using a combination of an anticonvulsant and tocilizumab to reduce the risk of severe Cytokine release syndrome (CRS) or Neurologic Events associated with their therapy. Early results point towards this approach yielding the intended outcome.
A spokesperson for the company stated, ‘We remain confident in the KTE-C19 development program and look forward to review by the FDA and potential approval by the end of 2017.’ CMO David Chang also commented, ‘The FDA looks at the totality of data and it is important to note that the overall incidence of KTE-C19 related grade 5 events remains at 2% in approximate 200 patients treated in our study supports the benefit of axi-cel and KTE-C19.’
Kite’s ZUMA-1 trial is in a close competition with Novartis and its JULIET trial to attain the first approval from the FDA for this cutting edge approach to cancer medication. Data from the latter is expected in June and will give a clearer indication of each company’s place in the CAR T race.
Source: Investors spooked by Kite CAR-T death, but biotech remains confident Press Release