The submission to the FDA for the investigational CAR T-cell therapy is based on data from the phase II ZUMA-II trial for the treatment of adult patients with relapsed/refractory mantle cell lymphoma.
A Biologics License Application (BLA) has been submitted to the FDA for the investigational CAR T-cell therapy, KTE-X19, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)resistant to prior therapies, according to the agent’s developer, Kite.1
The submission is based on data from the phase II ZUMA-II trial, which demonstrated that 93% of the study participants responded to the autologous anti-CD19 CAR T-cell therapy, with 67% of participants achieving a complete response.2
“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 Takeshite, MD, global head of clinical development for Kite, said in a press release.
Findings from the trial were presented on December 9, 2019 at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, Florida.
In the safety analysis, grade 3 or higher cytokine release syndrome (CRS) and neurologic events were seen in 15% and 31% of patients, respectively. No grade 5 CRS or neurologic events occurred.
The most commonly reported treatment-related adverse events (AEs) included pyrexia (94%), neutropenia (87%), thrombocytopenia (74%), anemia (68%), and hypertension (51%). Two grade 5 AEs were seen – one case of pneumonia related to conditioning chemotherapy, and one case of staphylococcal bacteremia related to the CAR T-cell infusion.
Kite plans to submit a Marketing Authorization Application for KTE-X19 in the European Union in early 2020, according to the developer. KTE-X19 has been granted Breakthrough Therapy Designation (BTD) by the FDA and Priority Medicines (PRIME) by the European Medicines Agency (EMA) for relapsed or refractory MCL.
KTE-X19 is still investigational and not currently approved anywhere globally. Its efficacy and safety have not been established. The CAR T-cell therapy is currently in phase I/II trials in acute lymphoblastic leukemia (ALL), MCL, and chronic lymphocytic leukemia (CLL).
1. Kite Submits Biologics License Application to U.S. Food and Drug Administration for Company’s Second CAR T Cell Therapy [news release]. Santa Monica, California. Published December 11, 2019. investors.gilead.com/news-releases/news-release-details/kite-submits-biologics-license-application-us-food-and-drug. Accessed December 13, 2019.
2. KTE-X19: A CAR T-Cell Option for Mantle Cell Lymphoma? [news release]. Orlando Florida. Published December 10, 2019. ashclinicalnews.org/on-location/ash-annual-meeting/kte-x19-car-t-cell-option-mantle-cell-lymphoma/. Accessed December 11, 2019.