With Juno Therapeutics seriously delayed by a brief but painful clinical hold by the FDA, rival Kite Pharma outlined plans today to shoot for an accelerated approval after it gathers the first round of data on 50 patients from its pivotal study of a rival CAR-T, due in just a few months. And company executives say their manufacturing operations will be ready to start producing this therapy in commercial quantities before the end of this year.
If successful, Kite could be the first to the market, especially if the FDA opts to act quickly for one of its ‘breakthrough’ therapies, which provides for a swift review. Juno has already said that it won’t be able to reach the market before 2018. And Novartis has yet to detail what kind of timeline it is looking at.
Their SEC filing includes this statement:
“We have completed enrollment of all 72 patients in the DLBCL (diffuse large B cell lymphoma) cohort and 20 patients in the PMBCL (primary mediastinal B cell lymphoma) and TFL (transformed follicular lymphoma) cohort in ZUMA-1. We plan to open an additional cohort in ZUMA-1 to allow us to continue to dose patients with KTE-C19 in the United States and to expand the clinical trial to Europe. We plan to report ZUMA-1 top-line data from the first 50 DLBCL patients with at least three-months of follow-up by the end of the third quarter of 2016. If we believe the data are compelling, we plan to discuss with the FDA the filing of a Biologics License Application, or BLA, for accelerated approval of KTE-C19 as a treatment for patients with refractory DLBCL, PMBCL and TFL. Subject to the interim results and discussions with the FDA, we plan to submit the BLA at the end of 2016. If approved, we plan to commercially launch KTE-C19 in 2017. We plan to report data from ZUMA-2 and the Phase 2 portions of ZUMA-3 and ZUMA-4 in 2017. If we believe the data are compelling, we plan to pursue FDA approval for these additional indications.”
The race between Kite and Juno for a pioneering FDA OK has become one of the most closely followed rivalries in R&D. Both had been shooting for a 2017 launch. But just days ago Juno acknowledged in its quarterly review that a 6-day hold on JCAR015 would postpone any commercial effort until 2018.
An aggressive Kite is clearly taking advantage of every angle it can think of. CAR-T therapies rely on cells extracted from patients which are then reengineered to include a chimeric antigen receptor that can hunt down cancer cells.
I'm still flabbergasted by $KITE saying they will file with data on 50 patients with just 3 months follow up by YE2016.
— Maxim Jacobs, CFA (@MaxJacobsEdison) August 8, 2016
Juno has said that its problems with JCAR015 were triggered by the addition of fludarabine to the regimen used to prep patients to better respond to their drug. The biotech fingered fludarabine for the deaths of four patients, which spurred the hold. Notably, while Juno was grappling with the FDA, Kite put out an announcement that it was staying on track with its lead program.
In a call with analysts Monday evening, Kite CEO Arie Belldegrun also said that while investigators are using fludarabine in their preconditioning regimen, they have yet to see any of the unusually lethal adverse events with neurotoxicity that tripped up Juno. “I have to say that adverse event profile has been very much on par with what we have been predicting based on the earlier studies,” the CEO told analysts.
Less than two months ago, Kite held a ribbon cutting ceremony for its new manufacturing facility, a 43,500-square-foot plant that will be used to make its personalized KTE-C19.
“Our commercial facility will have the capacity to produce up to 5,000 patient therapies per year and we expect it to be operational in producing clinical materials by year-end,” noted Belldegrun. “Overall, we have continuously been optimizing key aspect of our manufacturing, supply chain, and quality control and possess a proprietary process that dramatically reduces the time to approximately 14 days for when a patients material are shift to our facility to when the engineered T-cells are released to the patient. This is one of the fastest rates in the industry.”
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