Press release | 22nd May 2025

EHA 2025 cell therapy breakthroughs: Rapid manufacturing, unprecedented efficacy, and new standards in CAR-T

The 30^th European Hematology Association (EHA) Congress will take place in Milan, Italy, from 12^th–15^th June 2025, and will heavily feature updates within the CAR-T landscape, platforming emerging key players such as Galapagos as they look to redefine clinical standards, while established brands look to retain market influence. Of the many CAR-T abstracts at this year’s conference, there are several that are of particular interest:

Revolutionising CAR-T: ATALANTA-1 delivers 93% cure rate with one-week and may decentralise Manufacturing in NHL

Low rates of high-grade toxicities with GLPG5101, a Fresh, Stem-Like, Early Memory Phenotype Anti-CD19 CAR T-Cell Therapy in Patients With Non-Hodgkin Lymphoma in the Atalanta-1 Study

Sponsor: Galapagos

In the ATALANTA-1 trial, GLPG5101, a new stem-like CD19 CAR-T, achieved a 93.3% cure rate in R/R non-Hodgkin lymphoma, with most patients receiving therapy within just 7 days and without the need for bridging. The manageable safety profile and rapid, decentralised manufacturing could broaden CAR-T access, reduce time to treatment, and set a new standard for logistics in cell therapy delivery, potentially impacting MM care as this model is adopted more widely. (Abstract #:S281, Presented on: 15^th June 2025).

• The ATLANTA-1 results and Galapagos’ point-of-care manufacturing model positions demonstrate that CAR-Ts, such as GLPG5101, can be produced within a week and without compromising on efficacy or safety, addressing a key bottleneck in current CAR-T logistics
  • The trial’s 93% CR rate in aggressive NHL, coupled with low rates of high-grade cytokine release syndrome and neurotoxicity, highlights both the potency and tolerability of this next-generation CAR-T
• By eliminating the need for interim chemotherapy (bridging) and dramatically shortening vein-to-vein time, this decentralised approach could expand access to cell therapy, especially for patients who cannot wait the typical weeks for manufacturing
• This innovation may set a new standard for CAR-T delivery, with broader implications as similar rapid-production platforms may be adopted in other diseases (including myeloma), potentially improving outcomes through earlier intervention

FastCAR-T GC012F sets new benchmark: 100% response, 95.5% sCR as first-line in high-risk multiple myeloma

Updated Results of a Phase I Open-Label Single-Arm Study of Dual Targeting BCMA and Cd19 FastCAR-T (GC012f/AZD0120) as First-Line Therapy For Transplant-Eligible Newly Diagnosed High-Risk Multiple Myeloma

Sponsor: Gracell Biotechnologies

GC012F, a BCMA/CD19 dual-targeting CAR-T, delivered a 100% ORR and 95.5% sCR in high-risk, transplant-eligible NDMM, with all patients achieving MRD negativity and 85.7% 30-month PFS rate with rapid, deep responses and no severe neurotoxicity. This trial suggests CAR-T could challenge autologous transplant as the frontline standard for high-risk MM, redefining expectations for curative intent. (Abstract #: PS1711, Presented on: 14^th June 2025)

• By targeting two antigens (BCMA and CD19) and utilising a rapid “FastCAR” manufacturing platform, GC012F may set a new efficacy benchmark for newly diagnosed high-risk MM
• In this study, for the first time, a therapy resulted in every patient responding, the majority of whom achieved deep, MRD-negative remissions
  • Notably, no severe neurotoxicity was observed despite the dual targeting, indicating a favourable safety profile
• These results suggest that a CAR-T cell therapy could challenge autologous stem cell transplant as the front-line standard for high-risk patients, delivering potential curative outcomes from the outset
  • If repeated through subsequent trials, GC012F’s may shift treatment paradigms, encouraging clinicians to consider CAR-T at earlier stages of disease while raising expectations for long-term disease control in this challenging population

Carvykti’s five-year milestone: Durable remissions and survival transform myeloma management

Long-Term (≥5 Year) Remission and Survival After Treatment with Ciltacabtagene Autoleucel in Cartitude-1 Patients with Relapsed/Refractory Multiple Myeloma

Sponsor: Janssen Biotech

Carvykti continues to set the bar for durability in R/R MM, with ≥5-year OS benefit and durable remissions. The data supports moving CAR-T earlier in the treatment sequence, potentially as a second-line standard, and reinforce its role as a long-term disease controller rather than a bridge therapy (EHA 2025 Abstract S192).

• Five-year outcomes with Carvykti in heavily pre-treated myeloma showcase survival durations once seen as a stretch target for this setting, with some patients from the pivotal CARTITUDE studies demonstrating prolonged remission, while some even remained alive and disease-free past the five-year mark
  • This long-term efficacy reinforces the idea that BCMA-targeted CAR-T can deliver not just deep initial responses, but also sustained disease control akin to chronic therapy or functional cure
  • These results position Carvykti not just as a last-resort or bridging therapy but as a cornerstone of long-term myeloma management

Redefining CAR-T safety: Anito-cel delivers potent, rapid responses without delayed neurotoxicity in RRMM

Phase 2 Registrational Study of Anitocabtagene Autoleucel for Relapsed and/or Refractory Multiple Myeloma (RRMM): Updated Results from oiMMagine-1

Sponsor: Gilead Sciences, Kite

On the Phase 2 iMMagine-1 trial, anito-cel, a BCMA CAR-T, reported a 97% ORR and 62% CR/sCR in heavily pretreated RRMM, with 93% MRD negativity and no delayed neurotoxicity – a key differentiator from other BCMA CAR-Ts. With rapid, deep responses and a favourable safety profile, anito-cel could become a preferred CAR-T option and may encourage earlier use in the treatment sequence, especially for patients at risk for neurotoxicity (EHA 2025 Abstract S201).

• Anito-cel’s early results position it as a promising CAR-T therapy for relapsed myeloma, pairing highly potent anti-myeloma activity with an improved safety profile
• The numerical strong response rate and CR/sCR frequency in a difficult-to-treat population demonstrates its clinical benefit is comparable to other BCMA CAR-Ts, while the absence of serious or late neurotoxicity is a key differentiator
  • Delayed neurotoxic effects seen with some first-generation products (like movement disorders months post-infusion) were notably absent, and could position anito-cel as a preferred option for patients at higher risk of neurotoxicity or for broader use in older, frailer populations
• If these findings are repeatable in larger studies, anito-cel may expand physicians’ confidence in CAR-T therapy by mitigating safety concerns, potentially supporting its use earlier in the treatment timeline
• Overall, iMMagine-1 demonstrates that engineering and patient selection refinements can drive improvements in both CAR-T efficacy and safety