BioCentury This Week Ep. 351 - Gilead's Arcellx Buy. Plus: ctDNA as Surrogate Endpoint
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Feb 24, 2026 Steve Usdin, Washington editor covering policy and FDA moves. Lauren Martz, oncology biomarker and cell therapy development expert. Paul Benanos, dealmaking and cell therapy commercialization analyst. They discuss Gilead’s $7.8B acquisition of Arcellx and its implications. They explore ctDNA as a potential surrogate endpoint and the validation, standardization and trial hurdles that remain.
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Gilead Bought Arcellx To Control A High-Performing BCMA CAR-T
- Gilead bought Arcellx mainly to secure AnitoCell and its BCMA CAR-T advantages.
- Arcellx shows 96% objective response, 83% two-year survival, and claims shorter manufacturing turnaround using Kite infrastructure.
Acquisition Brings Next Generation Programs And Expanded Indications
- The deal includes more than one program beyond the lead CAR-T, expanding Gilead's options.
- Gilead exercised options on ACLX001 and gains other Arcellx programs plus non-oncology rights.
Run Prospective Early-Stage Trials To Validate ctDNA
- Validate ctDNA as a surrogate endpoint with prospective trials in earlier-stage cancers rather than relying solely on retrospective advanced-cancer data.
- Prioritize trials with complete data capture to link ctDNA reduction to survival outcomes.