Trial Data on Kite’s Lead Candidate for B-Cell Lymphomas to Be Presented at Meeting

Trial Data on Kite’s Lead Candidate for B-Cell Lymphomas to Be Presented at Meeting

Kite Pharma will present data from multiple clinical trials of KTE-C19, the company’s lead candidate CAR-T cell therapy for B-cell lymphomas and leukemias at the American Society of Hematology (ASH) Annual Meeting Dec. 3-6 in San Diego, California.

“In the last year alone, Kite has made significant advancements in our efforts to transform the treatment of cancer and deliver the first, and potentially transformative, personalized CAR-T cell therapy,” David Chang, MD, PhD, executive vice president of research and development and chief medical officer of Kite, said in a press release.

KTE-C19 is a novel treatment where patients’ T-cells are genetically modified to express a chimeric antigen receptor (CAR) that targets the CD19 molecule, widely expressed at the surface of B-cell lymphomas and leukemias.

“At this year’s ASH meeting, we will show additional detail from the interim analysis from ZUMA-1 as well as new KTE-C19 data and reproducibility in our manufacturing process from our ZUMA-3 and ZUMA-4 trials,” Chang said. “The additional data sets continue to provide deeper insights into the therapy’s potential to transform the treatment of B-cell malignancies.”

Sattva Swarup Neelapu, MD, from MD Anderson Cancer Center in Houston, Texas, will give a presentation Dec. 5 titled “A Phase 2 Multicenter Trial of KTE-C19 (anti-CD19 CAR T Cells) in Patients with Chemorefractory Primary Mediastinal B-Cell Lymphoma (PMBCL) and Transformed Follicular Lymphoma (TFL): Interim Results From ZUMA-1.”

The ZUMA-1 (NCT02348216) study is a multicenter Phase 1/2 clinical trial assessing the safety and effectiveness of KTE-C19 in patients with refractory, aggressive non-Hodgkin’s lymphoma, in which patients were divided into two groups.

Cohort 1 included patients with diffuse large B-cell lymphoma (DLBCL), and cohort 2 included patients with transformed follicular lymphoma (TFL) and primary mediastinal large B-cell lymphoma (PMBCL). All received a single infusion of KTE-C19 after three days of chemotherapy.

In September, Kite reported data from a Phase 2 interim analysis that included the first 51 patients in cohort 1 and 11 patients from cohort 2, revealing the study met its primary endpoint with an objective response rate (ORR) of 76 percent in DLBCL patients, including 47 percent complete remissions (CR).

At three months follow-up, ORR for these patients was 39 percent and CR was 33 percent, while in all NHL patients evaluated, ORR was 44 percent and complete remission was 39 percent.

In the oral presentation, Neelapu will report initial results from cohort 2 in patients with chemorefractory PMBCL and TFL. Of the 11 patients included in the analysis, the objective response rate was 100 percent and all patients have ongoing complete remissions. The predominant toxicities of cytokine release syndrome (CRS) and neurotoxicity were generally reversible.

Marianna Sabatino, MD, Kite Pharma’s director of product sciences, will give an oral presentation Dec. 5 titled “Production of Anti-CD19 CAR T Cells for ZUMA-3 and -4: Phase 1/2 Multicenter Studies Evaluating KTE-C19 in Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (R/R ALL).”

This presentation will be focused on the manufacturing process used in the ZUMA-3 (NCT02614066) and ZUMA-4 (NCT02625480) studies for the production of KTE-C19 for adult and pediatric patients with relapsed/refractory acute lymphoblastic leukemia (ALL), with similar timelines for chemotherapy, hospitalization, and follow-up visits.

The manufacturing process developed for KTE-C19 in both trials generated products within six to seven days with a low failure rate, and a short duration from leukapheresis collection (a lab procedure in which white blood cells are separated from a sample of blood) to the shipment of KTE-C19 back to the clinical center to be administrated to patients in the trials.

Also at the ASH meeting Dec. 5, Jennifer Brudno, MD, a clinical fellow at the National Cancer Institute, will give an oral presentation titled “T cells Expressing a Novel Fully-human Anti-CD19 Chimeric Antigen Receptor Induce Remissions of Advanced Lymphoma in a First-in-humans Clinical Trial.”

The presentation will show data from a Phase 1 dose-escalation study to assess the effectiveness and safety of engineered T-cells with a fully-human anti-CD19 chimeric antigen receptor for the treatment of advanced lymphoma (HuCAR-19).

The analysis focuses on 11 HuCAR-19 T-cell infusions that were administered to nine patients. Results demonstrated that T-cells that express HuCAR-19 show substantial activity against advanced lymphoma, and infusions of HuCAR-19 T-cells caused reversible toxicities attributable to cytokine-release syndrome.

And on Dec. 4, B. Shah, MD, from the Department of Hematological Malignancies at H. Lee Moffitt Cancer Center and Research Institute, will present a poster titled “High Rates of Minimal Residual Disease-Negative (MRD−) Complete Responses (CR) in Adult and Pediatric and Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia (R/R ALL) Treated With KTE-C19 (Anti-CD19 Chimeric Antigen Receptor [CAR] T Cells): Preliminary Results of the ZUMA-3 and ZUMA-4 Trials.”

The poster will focus on the preliminary effectiveness and safety results from the Phase 1 portion of ZUMA-3 and ZUMA-4 clinical trials of KTE-C19 in three adult and two pediatric patients with R/R ALL. The data shows that the administered dose of KTE-C19 after low-dose chemotherapy Cytoxan/Fludara (CyFlu) regimen has been tolerable and appears to be safe for further analysis in adult and pediatric patients with R/R ALL.

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