Kite’s Car T-cell Therapy Yescarta® Demonstrates High Response Rate and Durable Remission in ALYCANTE Study as Initial Treatment for Transplant Ineligible Patients With Relapsed/Refractory Large B-cell Lymphoma
- Complete metabolic response (CMR) of 71% at 3 months, higher than the expected 12% with standard of care
- 59.7% of patients remain in CMR at 6 months
- Best objective response rate of 91.9% and complete response rate of 82.3%
- Median progression-free survival from infusion is 11.8 months
- Acceptable safety profile in patients deemed unfit for high-dose chemotherapy and autologous stem cell transplantation
- None.
– Yescarta Achieved a Complete Metabolic Response (CMR) of
– Results 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
“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,
Best objective response (OR) and complete response (CR) rates were
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 (
“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
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.
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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).
BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES
- Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
- Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids as needed.
- YESCARTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS Program.
CYTOKINE RELEASE SYNDROME (CRS)
CRS, including fatal or life-threatening reactions, occurred. CRS occurred in
Key manifestations of CRS (≥
The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events, CRS occurred in
Ensure that 2 doses of tocilizumab are available prior to YESCARTA infusion. Monitor patients for signs and symptoms of CRS at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.
NEUROLOGIC TOXICITIES
Neurologic toxicities (including immune effector cell-associated neurotoxicity syndrome) that were fatal or life- threatening occurred. Neurologic toxicities occurred in
The most common neurologic toxicities (≥
The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in
Monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly.
REMS
Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program called the YESCARTA and TECARTUS REMS Program which requires that: Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after YESCARTA infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer YESCARTA are trained about the management of CRS and neurologic toxicities. Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483).
HYPERSENSITIVITY REACTIONS
Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of YESCARTA.
SERIOUS INFECTIONS
Severe or life-threatening infections occurred. Infections (all grades) occurred in
Febrile neutropenia was observed in
In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.
PROLONGED CYTOPENIAS
Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. ≥ Grade 3 cytopenias not resolved by Day 30 following YESCARTA infusion occurred in
HYPOGAMMAGLOBULINEMIA
B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia was reported as an adverse reaction in
SECONDARY MALIGNANCIES
Secondary malignancies may develop. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.
ADVERSE REACTIONS
The most common non-laboratory adverse reactions (incidence ≥
The most common adverse reactions (incidence ≥
The most common non-laboratory adverse reactions (incidence ≥
About Kite
Kite, a Gilead Company, is a global biopharmaceutical company based in
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
Forward-Looking Statements
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical studies, including those involving Yescarta; the possibility that Gilead and Kite may make a strategic decision to discontinue development of Yescarta for indications currently under evaluation and, as a result, Yescarta may never be successfully commercialized for such indications; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, as filed with the
Kite, the Kite logo, Yescarta, and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.
For more information on Kite, please visit the company’s website at www.kitepharma.com. Follow Kite on social media on X (@KitePharma) and LinkedIn.
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Jacquie Ross, Investors
investor_relations@gilead.com
Anna Padula, Media
apadula@kitepharma.com
Source: Gilead Sciences, Inc.