– Yescarta Achieved a Complete Metabolic Response (CMR) of 71% at 3 Months Versus 12% Expected with Historical Standard of Care Controls –
– Results Published in Nature Medicine–
SANTA MONICA, CA, USA I September 18, 2023 I Kite, a Gilead Company (Nasdaq: GILD), today announced results from the Phase 2 ALYCANTE study, led and sponsored by the French collaborative group LYSA/LYSARC, for use of its chimeric antigen receptor (CAR) T-cell therapy Yescarta® (axicabtagene ciloleucel) in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) after one prior line of therapy who were deemed ineligible for high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT). The full findings from the study were published in Nature Medicine.
The ALYCANTE study, a multicenter, open-label Phase 2 LYSA study, evaluated for the first time the efficacy and safety of Yescarta as a second-line therapy in 62 patients with R/R LBCL who were deemed ineligible for HDCT and ASCT. The study met its primary endpoint, with a complete metabolic response (CMR) of 71% (n=44, 95% confidence interval [CI], 58.1%–81.8%) at 3 months versus 12% expected with standard of care (based on historical controls). At 6 months, 59.7% of patients (n=37) remained in CMR. CMR is defined as negative findings on a PET study during or following antitumor therapy.
“Transplant ineligible patients with aggressive relapsed or refractory B-cell lymphomas face poor prognosis,” said Prof. Roch Houot, Head of Haematology Department, University Hospital of Rennes, France and coordinator of the ALYCANTE study. “ALYCANTE is the first study to assess axicabtagene ciloleucel as second-line therapy for transplant ineligible R/R LBCL and the results showed high response rates and durable remission in this hard-to-treat population.”
Best objective response (OR) and complete response (CR) rates were 91.9% (n=57) and 82.3% (n=51), respectively. After a median follow-up of 12 months, median progression-free survival (PFS) from infusion was 11.8 months, and 48.8% (95% CI, 34.0-62.0%) of patients evaluated were alive and progression-free at 12 months. Median overall survival (OS) was not reached. OS at 12 months was 78.3% (95% CI, 64.7-87.1%). Yescarta showed an acceptable safety profile in this population, who are considered unfit for HDCT/ASCT; 8.1% (n=5) and 14.5% (n=9) experienced Grade 3-4 cytokine-release syndrome (CRS) or Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS), respectively.
In clinical practice, about half of patients with R/R LBCL are considered ineligible for HDCT/ASCT due to factors including advanced age, frailty, and coexisting medical conditions. The ALYCANTE study included patients deemed ineligible for HDCT/ASCT because of age ≥65 years (88.7%), high hematopoietic cell transplantation-specific comorbidity index score ≥3 (32.3%), and/or prior ASCT (3.2%).
“For patients who are deemed ineligible for stem cell transplant, the ALYCANTE data demonstrate that Yescarta can provide another option for a potential curative therapy,” said Frank Neumann, MD, PhD, SVP, Kite’s Global Head of Clinical Development. “The data generation for Yescarta continues to reaffirm its potential to bring hope to patients suffering from a variety of sub-types of large B-cell lymphoma and follicular lymphoma.”
About ALYCANTE study
ALYCANTE is a phase 2 study evaluating the efficacy and safety of axicabtagene ciloleucel in patients with R/R LBCL after one prior line of therapy who were deemed ineligible for high-dose chemotherapy and autologous stem cell transplantation, sponsored by the LYSA/LYSARC collaborative group (NCT04531046). The primary endpoint was the complete metabolic response (CMR) at 3 months from axicabtagene ciloleucel infusion. The study was funded by Kite, a Gilead Company, and carried out with axicabtagene ciloleucel CAR T-cell therapy manufactured by Kite.
About the LYSA/LYSARC Collaborative Group
LYSA, The Lymphoma Study Association, is a non-profit, internationally leading, academic cooperative group gathering multidisciplinary expertise in lymphoma. Its operational structure LYSARC, The Lymphoma Academic Research Organization, has all the integrated functions and platforms dedicated to pathology, biology and imaging to conduct multiple phase 1 to 4 clinical studies and registries. The LYSA has more than 500 members, researchers and medical experts, with a network of about 90 clinical research centers in France, Belgium and Portugal. The LYSA’s missions are to promote clinical research, to improve prevention, care and treatment of patients and to disseminate knowledge about all types of lymphoma.
About Yescarta
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:
- Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
- Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
Limitations of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.
- Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
About Kite
Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, focused on cell therapy to treat and potentially cure cancer. As the global cell therapy leader, Kite has treated more patients with CAR T-cell therapy than any other company. Kite has the largest in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Gilead Sciences acquired Kite in 2017.
SOURCE: Kite Pharma
