Analyses of Kite’s Yescarta® CAR T-Cell Therapy Support Curative Potential in Patients With Non-Hodgkin Lymphomas
- None.
- None.
– ZUMA-1 Post-Hoc Analysis Shows Five-Year Lymphoma-Related Event-Free Survival in a Substantial Proportion of Patients with Refractory Large B-cell Lymphoma –
– Four-Year Follow-up from ZUMA-5 Demonstrates Continued Durable Response and Long-Term Survival in Patients with Relapsed/Refractory Follicular Lymphoma –
– ZUMA-7 Overall Survival Subgroup Analysis in Patients Aged 65+ Shows that Age Alone is not a Barrier to Receiving CAR T –
“As we continue to follow up with patients living with difficult-to-treat types of lymphomas, we are witnessing a pattern of longer-term survival with a one-time treatment with Yescarta,” said Frank Neumann, MD, PhD, Senior Vice President, Global Head of Clinical Development, Kite. “The results of these studies, coupled with our rapid and reliable manufacturing, add to our body of knowledge on the benefits and utility of Yescarta as a treatment with curative intent, changing the way these cancers are treated and providing hope to thousands of lymphoma patients.”
Detailed Information on Yescarta Abstracts:
Abstract #4864
Curative Potential of Axicabtagene Ciloleucel (Axi-Cel): an Exploratory Long-Term Survival Assessment in Patients with Refractory Large B-Cell Lymphoma from ZUMA-1
ZUMA-1 is an ongoing, multicenter, single-arm, open-label Phase 1/2 trial evaluating the safety and efficacy of Yescarta CAR T-cell therapy in adult patients with refractory LBCL. In this post hoc analysis of ZUMA-1, with up to six years of follow-up, the five-year long-term lymphoma-related event-free survival (LREFS) was used as a measure to explore Yescarta’s curative potential. Yescarta had long-term LREFS in a substantial proportion of patients, with a five-year rate of
Abstract #4868
Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma: 4-Year Follow-Up from the Phase 2 ZUMA-5 Trial
ZUMA-5 is an ongoing, single-arm, open-label, international, multicenter Phase 2 trial evaluating 122 adult patients with R/R indolent non-Hodgkin lymphoma (iNHL; follicular lymphoma [FL] and marginal zone lymphoma [MZL]). In this study, at a median follow-up of 52.5 months (range, 20.3-69.4; FL: 53.7, MZL: 43.8), the overall response rate (ORR) remained consistent with prior analyses (
“Taken together with other studies, the results we saw in our four-year analysis from the ZUMA-5 trial and up to six years of follow-up from the ZUMA-1 trial support the durability and safety of axi-cel in patients with follicular lymphoma and large B-cell lymphoma who have progressed following previous lines of therapy,” said Dr. Sattva S. Neelapu, The University of Texas MD Anderson Cancer Center. “We are encouraged by these data, particularly the continued durable response and long-term survival in these patient populations that speak to the potentially curative benefit of this therapy. As we continue to follow these patients, our hope is that these positive survival trends are sustained.”
Abstract #1761
Improved Overall Survival With Axicabtagene Ciloleucel vs Standard of Care in Second-Line Large B-Cell Lymphoma Among the Elderly: A Subgroup Analysis of ZUMA-7
ZUMA-7 is a randomized, open-label, global, multicenter, Phase 3 trial evaluating the safety and efficacy of Yescarta versus standard of care (SOC; [chemoimmunotherapy followed by HDT-ASCT in patients who had a response]) for treatment of adult patients with refractory LBCL or relapse within 12 months of first-line therapy. In this analysis, investigators reported updated efficacy and safety results from the primary OS analysis among ZUMA-7 patients aged ≥65 years and ≥70 years. At a median follow-up of 46.6 months, OS was prolonged in the Yescarta vs. SOC arm in patients aged ≥65 years (HR, 0.691;
|
Yescarta Age 65+ |
SOC Age 65+ |
Yescarta Age 70+ |
SOC Age 70+ |
Median OS (months) |
43.5 ( |
19.5 ( |
24.7 ( |
11.2 ( |
Median PFS (months) |
28.6 ( |
5.0 ( |
11.4 ( |
2.7 ( |
“Traditionally, older patients with relapsed/refractory large B-cell lymphoma have not been able to access some treatments due to presumed concerns regarding increased toxicity related to their age and comorbidities,” said Professor Marie José Kersten, Amsterdam University Medical Centers. “However, what we’re seeing with this subgroup analysis from the landmark ZUMA-7 trial, is that the data clearly support the consideration of axi-cel also for older patients with relapsed/refractory large B-cell lymphoma. As more data become available, my hope is that patients can receive the therapies that offer them the greatest chance for response and prolonged survival, regardless of age.”
The Yescarta
About Follicular Lymphoma
FL is a form of iNHL in which malignant tumors slowly grow but can become more aggressive over time.
FL is the most common form of indolent lymphoma and the second most common type of lymphoma globally. It accounts for approximately 22 percent of all lymphomas diagnosed worldwide.
Despite advances in management and substantial improvements in long-term survival, patients living with FL have varied outcomes. Currently, there are no standard of care treatments for relapsed and refractory FL after two or more lines of therapy.
About Large B-Cell Lymphoma
Globally, LBCL is the most common type of NHL. In
About Yescarta
Please see full US 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 the response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the 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 in 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 programs for indications that are currently under evaluation and, as a result, these programs may never be successfully commercialized for such indications; the risk that physicians may not see the benefits of prescribing Yescarta; 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 September 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20231211635873/en/
Jacquie Ross, Investors
investor_relations@gilead.com
Meaghan Smith, Gilead Media
msmith@gilead.com
Anna Padula, Kite Media
apadula@kitepharma.com
Source: Gilead Sciences, Inc.
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