NEW KITE CLINICAL RESEARCH AND REAL-WORLD EVIDENCE FOR YESCARTA® (AXICABTAGENE CILOLEUCEL) DEMONSTRATE BENEFIT FROM EARLIER LINES OF TREATMENT

NEW KITE CLINICAL RESEARCH AND REAL-WORLD EVIDENCE FOR YESCARTA^® (AXICABTAGENE CILOLEUCEL) DEMONSTRATE BENEFIT FROM EARLIER LINES OF TREATMENT

 

– Analysis Shows Manufacturing of Axicabtagene Ciloleucel in Second-Line Treatment of Relapsed/Refractory Large B-Cell Lymphoma Can Help Reduce Time from Leukapheresis
to Infusion vs. Third-Line plus Treatment –

 

– Data Builds on Previous Evidence on the Association Between Timely Infusion and Patient Outcomes –

 

– Preliminary Results Supporting Safety and Feasibility of Outpatient Administration of Axicabtagene Ciloleucel and Tecartus^® (Brexucabtagene Autoleucel) to be Presented –

 

 

Stockley Park, UK – 14 June 2024 – Kite, a Gilead Company today announced results from three new analyses for Yescarta^® (axicabtagene ciloleucel) in relapsed/refractory (R/R) Large B-cell Lymphoma (LBCL), including both new clinical research and real-world evidence, highlighting manufacturing, product characteristics, and outpatient administration of axicabtagene ciloleucel at the 2024 European Haematology Association (EHA) Annual Congress, 13-16 June, Madrid, Spain.

 

A comparative analysis of real-world and clinical trial data (poster P1425) show higher manufacturing success rate and improved T-cell performance for axicabtagene ciloleucel in second-line versus third-line plus treatment of R/R LBCL CAR T-cell therapy, can help reduce the time from leukapheresis to cell therapy infusion.¹

 

“We are committed to improving survival outcomes for people living with difficult-to-treat blood cancers,” said Ibrahim Elhoussieny, MD, VP, Global Head of Medical Affairs, Kite. “These new data support the potential benefits axicabtagene ciloleucel in earlier lines of treatment, both in terms of manufacturing success and product characteristics. Additional data support the safety and feasibility of administering CAR T-cell therapy in the outpatient setting. These data contribute to the body of evidence for efficient utilisation and delivery of CAR T-cell therapy and further support our ambition for patients.”

 

 

Poster P1425

Real-World Manufacturing Experience of Axicabtagene Ciloleucel for Patients with Relapsed or Refractory Large B-Cell Lymphoma Treated in Second Line versus Third Line of Therapy and Beyond

 

An analysis of 4,175 patients compared the real-world manufacturing experience and clinical trial product characteristics for patients with R/R LBCL in second-line versus third-line plus treatment. The analysis found a statistically significant higher number of patients with R/R LBCL (95.08% of 1,341 patients) who received axicabtagene ciloleucel as a second-line treatment achieved first-pass manufacturing success rate (FP-MSR); compared with 92.48% of the 2,834 patients treated third-line and beyond.¹ This 2.60% difference suggests that 26 more lots of axicabtagene ciloleucel are successfully manufactured per 1,000 in the first attempt for patients in second-line versus patients in third-line and beyond. The FP-MSR is defined as the ability to manufacture and disposition patient lots within specification at first attempt, critical to maintaining a timely and dependable manufacturing process. Given that higher FP-MSR lessens the need for multiple manufacturing attempts, patients receiving axicabtagene ciloleucel in second-line could potentially experience shorter vein-to-vein times.^1,2

 

Results further assessed the percentage of naïve-like T-cells in apheresis among evaluable patients from ZUMA-1 (third-line) and ZUMA-7 (second-line).¹ The analysis found the median percentage of naïve-like T-cells in patient leukapheresis was 9.28% (range, 0.20-45.07; n=126; P<.0001) for second-line, versus 4.11% (range, 0.09-56.60; n=100) for third-line plus; demonstrating patients treated in second-line setting displayed a median of approximately two times as many naive-like T-cells versus third-line plus patients.¹ These results indicate capturing a greater naïve-like T-cell population in the initial leukapheresis material with earlier CAR T-cell therapy intervention, which is numerically associated with improved response.^3,4

 

“These data suggest a notable number of patients living with relapsed/refractory large B-cell lymphoma could benefit from receiving Axi-Cel as second-line versus third-line treatment and beyond,” said Dr. Jason Westin study lead and Director of Lymphoma Clinical Research Program and Section Chief of Aggressive Lymphoma research team at the University of Texas MD Anderson Cancer Center. “Patients treated in second-line have both a higher rate of success of having their cell therapy manufactured at the first attempt, as well as twice as many, naïve-like T-cells collected during leukapheresis, both of which support patients potentially having a shorter vein-to-vein time. When combining these two factors, we hope this will lead to improved patient outcomes.”

 

 

Additional Data Presented for Outpatient Administration

 

Kite will also present two studies which evaluate the safety and efficacy of cell therapy administration within the outpatient setting. Preliminary findings, including safety data, from the ZUMA-24 study suggest that outpatient administration of axicabtagene ciloleucel is feasible, when administered at a qualified treatment center, at the physician’s discretion with appropriate monitoring.

 

Abstract P1159

ZUMA-24 Preliminary Analysis: A Phase 2 Study of Axicabtagene Ciloleucel in the Outpatient Setting with Prophylactic Corticosteroids in Patients with Relapsed/Refractory Large B-Cell Lymphoma

 

ZUMA-24 is an ongoing, single-arm, open-label, multicentre, Phase 2 study evaluating the safety and efficacy of axicabtagene ciloleucel with prophylactic corticosteroid use in patients with R/R LBCL, after one or more prior lines of therapy, in the outpatient setting.² The preliminary analysis of 30 patients who underwent outpatient dosing of axicabtagene ciloleucel, after a median follow-up of five months, demonstrated that the safety and efficacy of axicabtagene ciloleucel was consistent with previous clinical and real-world studies.  

 

Abstract P1191

Updated Trends in Real-World Outpatient (OP) Administration of Axicabtagene Ciloleucel (Axi-Cel) and Brexucabtagene Autoleucel (Brexu-Cel) in Relapsed/Refractory (R/R) Non-Hodgkin Lymphoma (NHL)

 

A real-world outpatient study assessed trends in safety and hospitalisation for patients with R/R Non-Hodgkin lymphoma (NHL) who received axicabtagene ciloleucel and brexucabtagene autoleucel at Mayo Clinic.⁵ Safety endpoints included cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) and hospitalisation rates.⁵ Analysis of safety trends reported that outpatient administration of axicabtagene ciloleucel and brexucabtagene autoleucel was possible without added toxicity.⁵

 

About ZUMA-7

ZUMA-7 is an ongoing, randomised, open-label, global, multicentre (US, Australia, Canada, Europe, Israel) Phase 3 study of 359 patients at 77 centres, evaluating the safety and efficacy of a single-infusion of axicabtagene ciloleucel versus current standard of care (SOC) for second-line therapy (platinum-based salvage combination chemotherapy regimen followed by high-dose chemotherapy and autologous stem cell transplant in those who respond to salvage chemotherapy) in adult patients with relapsed or refractory LBCL within 12 months of first-line therapy. The primary endpoint is event free survival (EFS). Key secondary endpoints include objective response rate (ORR) and overall survival (OS). Additional secondary endpoints include patient reported outcomes (PROs) and safety.³

 

About Large B-Cell Lymphoma

Globally and in Europe, large B-cell lymphoma (LBCL) is the most common type of non-Hodgkin lymphoma (NHL), representing around 30% of all cases.⁶ In Europe, it is estimated that up to 37,000 new cases of LBCL were diagnosed in 2020.⁷ Although first-line treatment can be effective in around 60% of cases, up to half of these will relapse (return).^8,9 For people who relapse, or who do not respond to first-line treatment, outcomes are often poor.¹⁰ Most patients with refractory (no response) LBCL have no curative treatment options.1¹

 

About Yescarta (Axicabtagene Ciloleucel)

Axicabtagene ciloleucel is a CD19-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy, approved by the European Commission (EC) for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) who relapse within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy; adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy; adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.¹²

About Tecartus (Brexucabtagene Autoleucel)

In December 2020, the European Commission (EC) granted conditional Marketing Authorisation for brexucabtagene autoleucel, the first CAR T-cell therapy approved in Europe for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. In August 2022, the EC approved brexucabtagene autoleucel for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia.¹³

 

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 acquired Kite in 2017.

 

Forward-Looking Statements

Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavourable results from ongoing or additional clinical trials involving axicabtagene ciloleucel; Gilead and Kite’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, including those involving axicabtagene ciloleucel and brexucabtagene autoleucel; Gilead and Kite’s ability to receive regulatory approvals in a timely manner or at all, including additional regulatory approvals of axicabtagene ciloleucel and brexucabtagene autoleucel, and the risk that any such approvals may be subject to significant limitations on use; the risk that physicians may not see the benefits of prescribing axicabtagene ciloleucel and brexucabtagene autoleucel; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended 31 March 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Kite and Gilead, and Kite and Gilead assume no obligation and disclaim any intent to update any such forward-looking statements.

 

Yescarta, Tecartus, Gilead, the Gilead logo, Kite and the Kite logo are trademarks of Gilead Sciences, Inc., or its related companies.