Gilead and Kite to present 18‑month anito‑cel and 5‑year Yescarta data at ASH 2026
Gilead Sciences and its cell‑therapy unit Kite will showcase long‑term results for their CAR‑T products at the American Society of Hematology meeting in December 2026. The company will present 18‑month minimum follow‑up from the Phase 2 iMMagine‑1 trial of anito‑cel in heavily pre‑treated multiple myeloma, and five‑year outcomes from the ZUMA‑12 study of Yescarta in first‑line high‑risk large B‑cell lymphoma. The anito‑cel data support a Biologics License Application that the FDA is reviewing with a decision deadline of 23 December 2026. Additional early data on the investigational bispecific antibody gamgertamig for autoimmune blood disorders will also be disclosed.
Why it matters
The FDA decision deadline creates a clear timeline for potential approval of anito‑cel, which could add a new CAR‑T option for relapsed/refractory multiple myeloma. The five‑year Yescarta follow‑up provides durability evidence that may influence reimbursement and adoption in first‑line lymphoma therapy.
Key facts
- 1Gilead and Kite will present 23 abstracts at the 68th ASH Annual Meeting from 12‑15 December 2026. investing.com
- 2The anito‑cel presentation will include 18‑month minimum follow‑up from the Phase 2 iMMagine‑1 study in patients who have received three or more prior therapy lines. investing.com
- 3The anito‑cel data form the basis of a Biologics License Application under FDA review with a PDUFA target decision date of 23 December 2026. investing.com
- 4Yescarta data will feature five‑year follow‑up from the ZUMA‑12 trial in first‑line high‑risk large B‑cell lymphoma patients who remained PET‑positive after two chemo‑immunotherapy cycles. investing.com
- 5Gilead announced early clinical experience with gamgertamig (CM336/OM336), a BCMA×CD3 bispecific T‑cell engager, in Phase 1b studies for relapsed/refractory immune thrombocytopenia and autoimmune hemolytic anemia. investing.com
- 6Anito‑cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the FDA. investing.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.