Moving on from a trial disaster, Juno reports positive data for JCAR017 -- and a death
Looking to distance itself from a trial disaster that claimed 5 lives last year, Juno Therapeutics $JUNO today turned to a batch of positive early-stage non-Hodgkin lymphoma data on its new lead CAR-T therapy, JCAR017.
Investigators for the biotech say that they have gathered data that demonstrate its promise, outlining a combined overall response rate of 86% and a complete response rate of 59% — 26 out of 44 patients.
At the three-month mark, the ORR was 66% with a 50% complete response rate. As of the May 4 data cutoff level, 37 out of the 38 responding patients were still alive.
The safety profile, though, included the death of one 82-year-old patient suffering from diffuse alveolar damage which was linked to the drug and the flu/cy conditioning regimen that is used to prepare patients for a better response to therapy.
Also, while only one patient suffered from severe cytokine release syndrome, which was not fatal, there were 8 cases — 18% of the total — of neurotoxicity.
Juno was forced to scrap its lead, JCAR015, after it tried and failed to make it safe enough for patients. Five patients in that study died from cerebral edema, two after the study was briefly suspended by a clinical hold put on by the FDA after the first three deaths. That disaster forced Juno well behind the two leaders in the field: Novartis and Kite, which are both posting fresh data this week.
“Today’s update of data from the TRANSCEND trial shows continued compelling results in patients with a wide range of aggressive NHL,” said Sunil Agarwal, Juno’s president of research and development. “We are encouraged by the high rates of durable responses and the early survival data in these patients. We are also encouraged by the early safety data—a majority of patients treated experienced no cytokine release syndrome or neurotoxicity of any grade, which suggests the potential for outpatient administration.”