Legend Biotech to Showcase CAR-T Cell Therapy Leadership for Multiple Myeloma at ASCO and EHA

Legend Biotech, a global leader in cell therapy, announced the presentation of new and updated clinical data on CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) Hybrid Congress. The data derive from various phases of their CARTITUDE clinical development program, which evaluates CARVYKTI® for multiple myeloma treatment.

CARTITUDE-2: First Disclosure of Cohort D

The Phase 2 CARTITUDE-2 study's Cohort D results will be presented for the first time at ASCO. This cohort investigates the efficacy of a single CARVYKTI® infusion, with or without lenalidomide maintenance, in patients who had suboptimal responses to frontline autologous stem cell transplant (ASCT). An encore presentation will follow at EHA. These results are crucial for understanding CARVYKTI®'s potential benefits in patients who don't achieve complete remission post-ASCT.

CARTITUDE-4: High-Risk Multiple Myeloma Data

Data from the Phase 3 CARTITUDE-4 study will also be showcased at ASCO. This study compares CARVYKTI® to two standard therapy regimens in patients with functional high-risk multiple myeloma who have had one prior line of treatment. A subgroup analysis by cytogenetic risk will be presented at EHA, offering insights into the efficacy of CARVYKTI® across different genetic profiles of the disease.

Key Presentation Details

ASCO Presentations:
1. Abstract #7504: Subgroup analysis comparing CARVYKTI® and standard of care in high-risk multiple myeloma.
- Session: Hematologic Malignancies – Plasma Cell Dyscrasia
- Date: June 3, 2024, 4:12 – 4:24 p.m. CDT
- Location: Hall D1

2. Abstract #7505: Efficacy and safety of CARVYKTI® with or without lenalidomide maintenance in patients with suboptimal responses to ASCT.
- Session: Hematologic Malignancies – Plasma Cell Dyscrasia
- Date: June 3, 2024, 4:24 – 4:36 p.m. CDT
- Location: Hall D1

3. Abstract #7535: Poster on CARVYKTI® in lenalidomide-refractory multiple myeloma.
- Date: June 3, 2024, 9:00 a.m. -12:00 p.m. CDT
- Location: Hall A

EHA Presentations:
1. Abstract #S205: Encore presentation on CARVYKTI® with or without lenalidomide maintenance for suboptimal ASCT response.
- Date: June 15, 2024, 16:30-16:45 CEST
- Location: Hall Picasso

2. Abstract #P959: Poster on CARVYKTI® versus standard care in high-risk myeloma.
- Date: June 14, 2024, 18:00-19:00 CEST
- Location: Hall 7

3. Abstract #P978: Subgroup analysis by cytogenetic risk from CARTITUDE-4.
- Date: June 14, 2024, 18:00-19:00 CEST
- Location: Hall 7

4. Abstract #P967: Effectiveness comparison of CARVYKTI® against real-world therapy choices.
- Date: June 14, 2024, 18:00-19:00 CEST
- Location: Hall 7

5. Abstract #P863: Biomarkers associated with progression-free survival in Chinese patients from the CARTIFAN-1 study.
- Date: June 14, 2024, 18:00-19:00 CEST
- Location: Hall 7

Safety Information on CARVYKTI®

CARVYKTI® has been associated with serious side effects, including cytokine release syndrome (CRS), neurologic toxicities, hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), prolonged and recurrent cytopenia, and secondary hematological malignancies. The drug is available only through a Risk Evaluation and Mitigation Strategy (REMS) program due to these risks.

Key Warnings:
- CRS: Severe or life-threatening reactions can occur. Management includes tocilizumab and corticosteroids.
- Neurologic Toxicities: Potentially fatal, including ICANS and parkinsonism.
- HLH/MAS: Life-threatening and overlaps with CRS.

Conclusion

The new data from the CARTITUDE program underscore the potential of CARVYKTI® in treating multiple myeloma across different patient profiles. Legend Biotech remains committed to advancing treatments and hopes to offer a potential cure for this challenging disease.

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