– Updated Results from Phase 2 Pivotal iMMagine-1 Study of Anito-cel for Relapsed/Refractory Multiple Myeloma to be Presented Orally –
– New Findings Reinforce Yescarta’s® Curative Potential as Second-Line Therapy in Patients with Relapsed/Refractory Large B-Cell Lymphoma –
– Next-Generation CAR T-cell Therapies Suggest High Response Rates and Encouraging Durability in B-Cell Malignancies –
November 3, 2025--FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, will present 21 abstracts, including 5 oral presentations, during the 67th American Society of Hematology (ASH) Annual Meeting and Exposition (December 6-9). These data showcase Kite’s continued progress in transforming blood cancer care and expanding the reach and impact of CAR T-cell therapy.
“Kite is dedicated to advancing cell therapy as a path to cures, and our data at ASH will reflect meaningful progress toward this goal,” said Cindy Perettie, Executive Vice President of Kite. “Together with our partner Arcellx, we’ll unveil the updated results from the pivotal Phase 2 iMMagine-1 study. These findings will lay the foundation for our aspiration with anito-cel to deliver a differentiated treatment for relapsed/refractory multiple myeloma with strong potential for community oncology access and reduced burden on patients and caregivers.”
Anito-cel Data Updates
Key presentations for anitocabtagene autoleucel (anito-cel) include updated results from the fully enrolled, ongoing iMMagine-1 Phase 2 pivotal study. No delayed neurotoxicities, including no Parkinsonism, no cranial nerve palsies, no Guillain-Barré syndrome, and no immune-mediated enterocolitis, have been observed to date.
Data on Next-Generation Pipeline
Kite will also share new data on its next-generation bicistronic autologous CAR T-cell therapies, KITE-363 and KITE-753. These therapies are designed to target two antigens (CD19 and CD20) found on cancer cells and use two co-stimulatory domains (CD28 and 4-1 BB) to help the immune system fight cancer more effectively. This dual-targeting approach may lower the chance of the cancer escaping treatment and could also improve safety, making it possible to treat patients outside of a hospital setting.
Survival Outcomes with Yescarta® Based on ASCT Eligibility
A key presentation for Yescarta® (axicabtagene ciloleucel) includes a joint analysis of 4-year follow-up data from ZUMA-7, which evaluated Yescarta as a second-line therapy in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) eligible for autologous stem-cell transplant (ASCT), alongside 2-year follow-up data from ALYCANTE that evaluated patients who were ASCT ineligible. Efficacy, safety, and health-related quality of life patterns were observed to be consistent across both ZUMA-7 and ALYCANTE populations, supporting the use of Yescarta regardless of transplant eligibility and effectively broadening eligibility to this potentially curative, one-time treatment.
About Yescarta
INDICATIONS
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.
About Arcellx and Kite Collaboration
Arcellx and Kite, a Gilead Company, formed a global strategic collaboration to co-develop and co-commercialize anito-cel for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). Anito-cel is currently being developed in a Phase 2 registrational study and a Phase 3 pivotal study for RRMM. Kite and Arcellx will jointly commercialize the anito-cel asset in the United States, and Kite will commercialize the product outside the United States.
About Anitocabtagene autoleucel (anito-cel)
Anitocabtagene autoleucel (anito-cel, previously ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. The small, stable D-Domain binder enables high CAR expression without tonic signalling and is designed to quickly release from the BCMA target. This combination may allow for the effective elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.