Pharma Focus Asia

New Kite Research Highlights Yescarta® Effectiveness in Earlier Treatment Stages for Large B-Cell Lymphoma

Saturday, June 15, 2024

Kite, a Gilead Company (Nasdaq: GILD), has shared new results from three studies on Yescarta® (axicabtagene ciloleucel) for treating relapsed/refractory (R/R) large B-cell lymphoma (LBCL) at the 2024 European Hematology Association (EHA) Annual Congress in Madrid from June 13-16. The studies include clinical research and real-world data on the manufacturing and administration of Yescarta and Tecartus® (brexucabtagene autoleucel).

One significant analysis, presented as abstract P1425, compared real-world and clinical trial data. It found that Yescarta had a higher manufacturing success rate and better T-cell performance when used as a second-line treatment rather than as a third-line or later treatment for R/R LBCL. This analysis of 4,175 patients showed that 95.08% of 1,341 patients treated in the second-line achieved first-pass manufacturing success, compared to 92.48% of 2,834 patients treated in the third-line and beyond. This 2.60% increase suggests a significant improvement in manufacturing efficiency for second-line treatments.

Moreover, the study compared the percentage of naïve-like T-cells in apheresis samples from patients in ZUMA-1 (third-line) and ZUMA-7 (second-line) trials. It found that second-line patients had a median of 9.28% naïve-like T-cells, compared to 4.11% in third-line patients, indicating that earlier intervention might lead to better outcomes.

Dr. Jason Westin, leading the study and director of the Lymphoma Clinical Research Program at MD Anderson Cancer Center, emphasized the potential benefits of using axi-cel as a second-line treatment, noting the higher manufacturing success rate and the larger proportion of naïve-like T-cells.

In addition to this, Kite presented findings on the outpatient administration of Yescarta and Tecartus. Preliminary data from the ZUMA-24 study (abstract P1159) showed that outpatient administration of Yescarta is feasible with appropriate monitoring at qualified centers. This Phase 2 study evaluated 30 patients and found consistent safety and efficacy compared to previous studies.

Another study (abstract P1191) analyzed outpatient administration trends for Yescarta and Tecartus at the Mayo Clinic, focusing on safety and hospitalization rates. The analysis indicated that outpatient administration did not increase toxicity levels.

Yescarta is approved for treating adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line treatment, and for those with relapsed or refractory LBCL after two or more lines of systemic therapy. It is also approved under accelerated approval for treating relapsed or refractory follicular lymphoma after two or more lines of therapy, contingent upon further verification of clinical benefits.

Both Yescarta and Tecartus carry significant safety warnings, including risks of cytokine release syndrome (CRS) and neurologic toxicities, which can be life-threatening. They are available through a restricted program requiring certified healthcare facilities to have specific safety protocols in place, including the availability of tocilizumab for treating CRS.

Kite's commitment to improving outcomes for patients with difficult-to-treat blood cancers is reflected in these new data, supporting the use of Yescarta in earlier treatment lines and demonstrating the feasibility of outpatient administration.

 

Source: gilead.com

magazine-slider-imageCytiva - Supor Prime filtersMFA + MMA 20244th Annual Cleaning Validation 20242nd Annual Pharma Impurity Conclave 2024CPHI Korea 2024CHEMICAL INDONESIA 2024World Orphan Drug Congress Europe 2024INALAB 2024Thermo Fisher - Drug Discovery and the impact of mAbsAdvanced Therapies USA 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals Conference