Gilead and Arcellx Highlight Promising CAR T Therapy for Multiple Myeloma with Enhanced Safety Profile

Anito-cel Efficacy:
Preliminary findings from the Phase II iMMagine-1 trial show that anito-cel, a CAR T therapy developed by Gilead and Arcellx, achieved a 95% overall response rate and a 62% complete response or stringent complete response rate in patients with relapsed or refractory multiple myeloma.

Safety Profile:
Anito-cel demonstrated a favorable safety profile with no delayed neurotoxicities such as Guillain-Barré syndrome, Parkinson’s-like symptoms, or cranial nerve palsies. However, three patients died due to side effects including cytokine release syndrome, fungal infection, and retroperitoneal hemorrhage.

Clinical Trials:
The Phase 3 iMMagine-3 trial is expected to start in the second half of 2024, comparing the efficacy and safety of anito-cel against the standard of care in patients with relapsed and/or refractory multiple myeloma who have received one to three prior lines of therapy.

Competitive Advantage:
Analysts suggest that anito-cel’s safety profile could differentiate it from competitors like Legend Biotech and J&J’s Carvykti, potentially making it a more appealing therapeutic option and suitable for outpatient treatment settings.

Data Presentation:
Gilead and Arcellx will present detailed findings from the Phase 1 and Phase 2 iMMagine-1 studies at the 2024 Annual Meeting of the American Society of Hematology (ASH 2024).