- Kite Pharma took another step forward in its march to market, announcing over the weekend the initiation of a rolling submission to the Food and Drug Administration of its application for approval of its lead CAR-T therapy, KTE-C19.
- The company expects its submission to be completed by the end of the first quarter of 2017, a timeline which still gives it the chance to win the first U.S. approval of a CAR-T therapy
- CAR-T rival Novartis is quickly advancing its own therapy, however, aiming to complete a filing with the FDA in early 2017 as well. Novartis' treatment, CTL019, is aimed at B-cell acute lymphoblastic leukemia (ALL) while Kite is shooting for approval in B-cell non-Hodgkin lymphoma (NHL).
Note: This post has been updated to include details from Kite Pharma's presentation on Tuesday.
Kite updated results from its ZUMA-1 trial on Tuesday, presenting a late-breaking abstract at the annual meeting of the American Society of Hematology (ASH) in San Diego.
While no new three-month follow-up results were released, Kite updated safety data on an expanded pool of 93 patients with a minimum of one month of follow-up (compared to 62 in September). Grade 3 or higher cytokine release syndrome (CRS) affected 13% of patients, while 29% of patients experienced neurological events.
Kite also reported another patient death due to a "treatment-emergent" adverse event, this time from pulmonary embolism. The September update had disclosed two patient deaths, one from hemophagocytic lymphohistiocytosis and another from cardiac arrest in the setting of CRS
Notably, no patients died from cerebral edema — the adverse event which led to the deaths of five patients in rival Juno Therapeutics' ROCKET study.
Durability of response is a crucial question for both KTE-C19 and the CAR-T space in general. Some NHL patients who initially responded to treatment, for example, ended up relapsing, driving down the overall response and complete response rates for KTE-C19.
But six-month follow-up data won't be available until the first quarter of 2017. Even so, Kite believes it's ready to go with the data it has in hand, as evidenced by its rolling submission.
Kite has been laying the groundwork to move quickly if KTE-C19 passes muster with the FDA next year. The company has targeted 10 institutions that already have experience with CAR-T for an initial launch, which will then be expanded to a total of 72 institutions over the first year post-launch.
With Juno falling behind, Kite looks well-positioned to take a leading position in the CAR-T market, staring down Novartis for first-to-market laurels.