ASH 2024: Anito-cel Demonstrates Enhanced Response Rate and Consistent Safety in Phase II Update for Relapsed/Refractory Multiple Myeloma

Response Rate:
Preliminary results from the Phase 2 iMMagine-1 study of anito-cel showed a 97% overall response rate (ORR) and a 62% complete response or stringent complete response rate (CR/sCR) in 86 patients with relapsed or refractory multiple myeloma (RRMM)3.

Safety Profile:
No delayed neurotoxicities, including Parkinsonism, cranial nerve palsies, and Guillain-Barré syndrome, have been observed with anito-cel to date across more than 150 patients dosed in the Phase 1 and iMMagine-1 studies3.

Median Follow-Up:
The median follow-up for the efficacy evaluable population in the Phase 2 iMMagine-1 study was 9.5 months, with patients receiving a median of four prior lines of therapy3.

Progression-Free Survival:
The Phase 1 study of anito-cel demonstrated a 30.2-month median progression-free survival (PFS) with a median follow-up of 38.1 months3.

Commercialization:
Arcellx and Kite, a Gilead Company, are collaborating to co-develop and co-commercialize anito-cel for RRMM, with plans for a global Phase 3 randomized controlled study (iMMagine-3)35.

Clinical Significance:
Analysts view anito-cel's safety profile and efficacy as potentially best-in-class, offering a differentiated treatment option for RRMM patients23.

Sources:

2. https://www.biospace.com/drug-development/gilead-arcellx-tout-best-in-class-potential-for-car-t-therapy-in-multiple-myeloma

3. https://www.biospace.com/press-releases/arcellx-announces-new-positive-data-for-its-immagine-1-study-in-patients-with-relapsed-or-refractory-multiple-myeloma-to-be-presented-during-an-oral-presentation-at-the-66th-ash-annual-meeting-and-exposition

5. https://www.gilead.com/news/news-details/2024/kite-and-arcellx-continue-momentum-with-advances-in-anito-cel-multiple-myeloma-program