Kite submits supplemental BLA for Tecartus to treat advanced ALL
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Kite Pharma submitted a supplemental biologics license application to the FDA for brexucabtagene autoleucel to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, according to the agent’s manufacturer.
Brexucabtagene autoleucel (Tecartus, Kite Pharma/Gilead) is a gene-edited, autologous chimeric antigen receptor T-cell therapy that targets the CD19 protein on the surface of cancer cells.
If approved, brexucabtagene autoleucel would become the first CAR T-cell therapy available for commercial use among adults with ALL. The agent previously received the FDA’s breakthrough therapy designation for adults with relapsed or refractory precursor ALL.
In July, brexucabtagene autoleucel became the first CAR T-cell therapy indicated for mantle cell lymphoma when the FDA granted accelerated approval for its use among adults with relapsed or refractory disease.
The supplemental BLA is supported by data from the ongoing multicenter phase 1/phase 2 ZUMA-3 trial, which includes adults with relapsed or refractory ALL. An updated analysis of the trial’s phase 2 data will be presented at an upcoming major medical meeting, according to the manufacturer.
An analysis of phase 1 results from ZUMA-3, presented in 2019 at the ASCO Annual Meeting, showed that among 45 patients treated with brexucabtagene autoleucel, about 30% experienced severe (grade 3 or greater) cytokine release syndrome and 38% experienced severe neurotoxicity, Bijal D. Shah, MD, associate professor in the department of malignant hematology at Moffitt Cancer Center, told Healio at the time of the presentation. No grade 5 events occurred, he added.
Efficacy analysis showed a complete response rate of 68% across all doses examined in the phase 1 trial. Additionally, researchers observed a complete response rate of 84% among patients who received the recommended phase 2 dose of 1 × 106 cells/kg, Shah said. Median duration of response was 12.9 months for patients who received this dose, he added.
Shah called the efficacy results “highly encouraging” and said they showed the therapy had the ability to induce durable remissions among patients with heavily pretreated ALL.
“Tecartus has already begun to transform the outlook for many patients with relapsed or refractory mantle cell lymphoma, and we’re encouraged by the data we’ve seen in adult patients with relapsed or refractory ALL, as survival rates among these patients remain poor with the most commonly used therapeutic agents,” Frank Neumann, MD, PhD, global head of clinical development for Kite, said in the release. “We are working closely with the FDA to progress our application and to bring the benefits of CAR-T to patients with this particularly intractable leukemia.”
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