KITE’S CAR T-CELL THERAPY YESCARTA® (AXICABTAGENE CILOLEUCEL) COMPARED WITH BISPECIFICS IN R/R DLBCL IN TWO ANALYSES AT ESMO 2023

KITE’S CAR T-CELL THERAPY YESCARTA^® (AXICABTAGENE CILOLEUCEL) COMPARED WITH BISPECIFICS IN R/R DLBCL IN TWO ANALYSES AT ESMO 2023

Stockley Park, UK – 23 October 2023 – Kite, a Gilead Company, today announced results from two indirect comparative analyses of its CAR T-cell therapy Yescarta^® (axicabtagene ciloleucel) versus bispecific antibodies epcoritamab and glofitamab, respectively, for the treatment of relapsed/refractory (R/R) diffuse large B-Cell lymphoma (DLBCL), during the European Society for Medical Oncology (ESMO) Congress, 20-24 October in Madrid, Spain.

In two separate analyses, a Matching-Adjusted Indirect Comparison (MAIC) was conducted of axicabtagene ciloleucel versus glofitamab and epcoritamab, respectively, using published evidence from clinical studies of R/R DLBCL patients treated after at least two prior systemic therapies. Data from the pivotal axicabtagene ciloleucel study (ZUMA-1) were matched to baseline characteristics of glofitamab and epcoritamab studies, respectively, representing clinically relevant prognostic factors (including disease stage, number of prior lines of therapy, ECOG performance status).

Results showed improved progression-free survival (PFS) versus glofitamab [hazard ratio (HR) 0.62 (95% CI, 0.40-0.96)], and versus epcoritamab [HR 0.51 (95% CI, 0.31-0.85)]. Axicabtagene ciloleucel also improved objective response rate (ORR) versus glofitamab [Odds Ratio (OR) 2.32 (95% CI, 1.01-5.33)], with comparable ORR versus epcoritamab [OR 1.55 (95% CI, 0.65-3.69)]. In both analyses, axicabtagene ciloleucel was associated with higher rates of grade ≥3 cytokine release syndrome [vs glofitamab [OR 4.93 (95% CI, 1.42-17.08)] and vs epcoritamab [OR 5.31 (95% CI, 1.21-23.32)], and with higher rates of neurological events reported versus glofitamab [OR 22.59 (95% CI, 7.25-70.36)]. Neurotoxicity of axicabtagene ciloleucel versus epcoritamab was not analysed as definitions in the studies differed.[1]^,[2]  

“CAR T-cell therapies are changing the treatment landscape for survival in relapsed/refractory diffuse large B-cell lymphoma, which historically has a poor clinical prognosis and limited curative treatment potential,” said Dick Sundh, Vice President, Head of Australia, Canada and Europe (ACE), Kite. “In the absence of randomised controlled clinical trials of CAR T-cell therapies versus bispecific antibodies, treatment comparisons across trials are sometimes necessary to support clinically relevant understanding of these therapies.”

The following Kite spokespeople are available:

• Dick Sundh, Vice President, Head of Australia, Canada and Europe (ACE), Kite
• Dominique Tonelli, Executive Director, Head of Medical Affairs, ACE, Kite

For more information or to arrange an interview contact Cressida Robson on +44 7341 789 204 or cressida.robson@gilead.com.

About Matching-Adjusted Indirect Comparisons (MAIC)

Findings from MAICs need to be considered in context with the overall body of evidence for a therapy, as cross-trial differences can impact the analysis. MAIC is a technique to analyse the comparative effectiveness of treatments, by re-weighting Individual Patient Data (IPD) from one study to the baseline summary statistics of another, to provide adjustment for observed trial differences compared to conventional meta-analytic methods.  The use of MAIC in the absence of direct comparisons between treatments has been increasing across different therapeutic areas, and its acceptability by Health Technology Assessment (HTA) bodies.[3] 

About 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.^[4] 

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 supply 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, COVID-19, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

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 possibility of unfavorable results from ongoing or additional clinical trials involving axicabtagene ciloleucel; Kite’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, including those involving axicabtagene ciloleucel; Kite’s ability to receive regulatory approvals in a timely manner or at all, including additional regulatory approvals of axicabtagene ciloleucel, 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 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 June 30, 2023, 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.

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

[1] Locke, F et al. Matching-Adjusted Indirect Comparison (MAIC) of Axicabtagene Ciloleucel (axi-cel) and Glofitamab (glofit) in Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL) After at Least Two Prior Systemic Therapies (3L+). Presented at the 2023 Annual Meeting of the European Society for Medical Oncology (ESMO). Poster P839.

[2] Oluwole, O et al. Matching-Adjusted Indirect Comparison (MAIC) of Axicabtagene Ciloleucel (axi-cel) and Epcoritamab (epcor) in Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL) After at Least Two Prior Systemic Therapies (3L+). Presented at the 2023 Annual Meeting of the European Society for Medical Oncology (ESMO). Poster P838.

[3] Thom, H et al. Matching Adjusted Indirect Compasrisons to Assess Comparative Effectiveness of Therapies: Usage in Scientific Literature and Health Technology Appraisals. Value in Health. 2016;19 (3);PA100-A101. DOI:https://doi.org/10.1016/j.jval.2016.03.1723

[4] European Medicines Agency. Yescarta^® (axicabtagene ciloleucel) SPC. Available at: https://www.ema.europa.eu/documents/product-information/yescarta-epar-product-information_en.pdf. Accessed October 2023.