With the clock ticking down the final hours of Q1, Kite Pharmaceuticals $KITE has kept its pledge to file an application for its pioneering CAR-T therapy in the first quarter. The move puts Kite one step behind Novartis $NVS, which two days ago announced that it had the FDA’s commitment for a speedy review of its own CAR-T.
The question now is whether the FDA will give the Kite’s application a priority review as well, perhaps lining up back-to-back advisory committee meetings to examine the pros and cons of this new wave of cancer therapy.
Kite filed the BLA for axicabtagene ciloleucel (KTE-C19, designated as a breakthrough therapy by the FDA) as a treatment for patients with relapsed or refractory aggressive non-Hodgkin lymphoma who are ineligible for autologous stem cell transplant.
Kite was held up a few months by the need to complete 6-month data on axicabtagene ciloleucel, a goal it accomplished a month ago.
At six months, the ORR in diffuse large B-cell lymphoma (DLBCL) hit 36%, down only three points from month three. The CR rate was 31%, down two points. Bigger drops were also recorded for primary mediastinal B-cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL) enrolled in Cohort 2, but the six-month numbers posted were all clearly statistically significant, which helped quiet some dogged criticism of the drug’s ability to provide a durable response.
On Friday, Kite also updated its data at AACR in an oral plenary presentation. And the numbers had improved with more patients to report on:
The ORR in the mITT analysis set of 101 pts was 82% (CR 54%, PR 28%), and was consistent across key covariates including disease subtype, refractory status, stage, and IPI score. At a median follow up of 8.7 m, 44% of pts were in response and 39% were in CR.
That’s up from 41% and 36% reported in February.
Kite — led by CEO Arie Belldegrun — and Novartis are racing to be right at the forefront of introducing personalized cell therapies that reengineer patients’ immune cells to target cancer. And it’s offered some significant responses for a number of patients with advanced cases of blood cancer.
Now Kite and Novartis will try to outdo each other on manufacturing and delivery, with the pharma giant and the biotech needing to show that they can provide quick and reliable treatment.
That may be a particularly difficult question for Novartis. As we reported Thursday afternoon, the pharma giant’s head of cell manufacturing — Karen Walker, responsible for CAR-T — is leaving the company today after a lengthy stint. Her departure follows the unexpected move at Novartis to dissolve its cell therapy unit last summer, laying off staffers and absorbing the group in its oncology R&D division.
Walker and two other execs were put in charge of Novartis’ efforts on CAR-T last fall, after the company chopped up the separate cell and gene therapy group that had been created specifically to drive these new therapies to commercialization. That move followed the departure of Usman “Oz” Azam, who left Novartis in the wake of the reorganization.
Left on the sidelines today: Juno Therapeutics. Once a leader in the CAR-T area, Juno was forced to shelve its lead therapy after it killed a string of patients. Two of those patients died after a brief R&D halt ordered by the FDA. But Juno never was able to firmly establish why the CAR-T caused lethal cases of brain swelling. Now the biotech has moved on to a follow-up program, putting the company well behind the frontrunners.
Two years ago CAR-T was science fiction.
A year ago it could never be a commercial product.
Today there are two applications at FDA
— Brad Loncar (@bradloncar) March 31, 2017
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