Biopharma company Kite, a subsidiary of Gilead, has submitted a biologics license application to the FDA for the company’s investigational chimeric antigen receptor T-cell therapy KTE-X19 for the treatment of adults with relapsed or refectory mantle cell lymphoma.
KTE-X19 is an anti-CD19 autologous CAR T-cell therapy that targets the CD19 protein when it is expressed on the surface of cancer cells. Approval of KTE-X19 would make Kite the first manufacturer with more than one FDA-approved CAR T-cell therapy. Axicabtagene ciloleucel (Yescarta; Kite, Gilead) was approved by the FDA in October 2017 for adults with relapsed or refractory large B-cell lymphoma.
“There remains a significant need for new treatments for patients with relapsed/refractory MCL despite recent advances, so this regulatory filing is an especially important milestone for the MCL community,” Ken Takeshita, MD, Kite’s global head of clinical development, said in a press release. “We look forward to working with the FDA to bring KTE-X19 to appropriate patients as quickly as possible and continuing to deliver on the promise of our industry-leading cell therapy development program with a second CAR T therapy.”Kite said it plans to submit a similar approval application to the European Medicines Agency in early 2020; KTE-X19 has already been designated as a breakthrough therapy for relapsed or refractory mantle cell lymphoma in both the United States and the European Union.
The BLA submission was based on phase 2 data from the multicenter ZUMA-2 trial, which were recently presented at the 2019 ASH Annual Meeting and Exposition. The results showed an overall response rate of 93% and a complete response rate of 67%. Grade 3 or 4 cytokine release syndrome was experienced by 15% of patients, whereas grade 3 or 4 neurotoxicity was reported in 31% of patients. There were no reported cases of grade 5 CRS or neurotoxicity.
Kite had received previous FDA approval for axicabtagene ciloleucel (Yescarta; Kite, Gilead) in October 2017 for adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. Kite said that KTE-X19 has the same CAR construct as axicabtagene ciloleucel, but that the manufacturing process for KTE-X19 differs in that it includes the enrichment of lymphocytes that is necessary to treat specific B-cell malignancies.
KTE-X19 is currently being tested in clinical trials for additional indications that include adult acute lymphoblastic leukemia (ZUMA-3), pediatric ALL (ZUMA-4) and chronic lymphocytic leukemia (ZUMA-8).