Legend Biotech to present five-year CARVYKTI data at IMS 2026

Legend Biotech (NASDAQ: LEGN) has confirmed three poster presentations at the 23rd International Myeloma Society Annual Meeting, running 23–26 September 2026 in Glasgow. The presentations centre on updated long-term follow-up from the CARTITUDE-2 Phase 2 study, alongside real-world evidence and a first look at a post-authorisation safety study for ciltacabtagene autoleucel (cilta-cel), marketed as CARVYKTI.

The headline abstract, presented by Adam D. Cohen on 25 September, will report outcomes at five or more years for patients in CARTITUDE-2 Cohort A. That cohort enrolled lenalidomide-refractory patients who had received one to three prior lines of therapy, a notably earlier treatment setting than the heavily pre-treated population studied in CARTITUDE-1. MRD negativity was the primary endpoint for Cohort A, and any updated remission and survival figures will be closely watched as the field debates how early CAR-T should be deployed in routine care.

Real-world evidence and safety data

Two further posters expand the evidence base beyond controlled trials. The eMMpower-CART analysis will present real-world outcomes for cilta-cel used in earlier-line settings, offering a view of how the therapy performs outside the protocol constraints of a clinical study. Separately, first results from a noninterventional, prospective post-authorisation safety study will be presented by Hermann Einsele on 23 September, covering relapsed or refractory multiple myeloma patients treated commercially. Post-authorisation safety studies are increasingly required by regulators as a condition of approval for complex cell therapies, and their early readouts can influence label updates and prescribing guidance.

Interim chief executive Alan Bash said the presentations "reflect our continued commitment to understanding the role of CARVYKTI across the treatment journey and generating evidence that may help inform clinical practice." The quote is representative of the company's broader messaging on the therapy's maturing evidence programme rather than a commentary on specific results, which have not been disclosed ahead of the conference.

Competitive and regulatory context

Cilta-cel competes directly with Bristol Myers Squibb's idecabtagene vicleucel (ide-cel, marketed as Abecma) in the BCMA-directed CAR-T space for multiple myeloma. CARVYKTI holds a generally stronger clinical profile in cross-trial comparisons, though no head-to-head data exist, and ide-cel has been positioned in some markets as a faster-to-manufacture option. The April 2024 FDA approval extending cilta-cel into the second-line setting, for patients refractory to lenalidomide after at least one prior therapy, significantly expanded the addressable patient population and created fresh commercial pressure on standard-of-care triplet regimens.

The IMS presentations follow recent CARTITUDE programme data shown at the Society of Hematologic Oncology annual meeting, suggesting Legend and its collaborator Johnson and Johnson are maintaining a consistent congress cadence as they build the label evidence needed to support broader earlier-line adoption. Real-world data in particular carry weight with payers and health technology assessment bodies in Europe, where value frameworks require evidence of benefit in routine clinical populations rather than trial cohorts alone. The PASS results and eMMpower-CART findings could therefore have direct relevance to market access negotiations in the UK and across the EU.

Multiple myeloma remains an incurable disease. An estimated 35,000 new cases are diagnosed annually in the United States alone, and the treatment landscape continues to evolve rapidly as BCMA-targeting approaches compete with bispecific antibodies such as teclistamab and elranatamab for market share in the relapsed and refractory setting.