Arcellx, a biotechnology company, announced positive Phase 2 iMMagine-1 study data for anitocabtagene autoleucel (anito-cel), a CAR T-cell therapy for relapsed or refractory multiple myeloma (RRMM). The study, with a median follow-up of 9.5 months, showed a 97% overall response rate (ORR) and a 62% complete response/stringent complete response (CR/sCR) rate in 86 efficacy-evaluable patients. Importantly, no delayed neurotoxicities were observed.

This news is significant for Arcellx, its partner Kite (a Gilead Company), and the field of multiple myeloma treatment. Current treatment options for RRMM, particularly for patients with triple or penta-refractory disease, often have limited efficacy and can be associated with significant side effects, including neurotoxicity. Anito-cel’s high response rates and manageable safety profile, especially the absence of delayed neurotoxicity, suggest it could become a valuable new treatment option for these patients.

The iMMagine-1 study enrolled a high-risk patient population, with 87% being triple-refractory and 42% penta-refractory. Patients had received a median of four prior lines of therapy. Beyond the high ORR and CR/sCR rates, 81% of patients achieved a very good partial response or higher, and 93.1% of those evaluable for minimal residual disease (MRD) testing achieved MRD negativity. While median progression-free survival (mPFS) and overall survival (OS) were not reached, the 6- and 12-month PFS rates were 93.3%/78.5% and OS rates were 96.5%/96.5%, respectively. Safety data were also encouraging, with low rates of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and notably, no delayed neurotoxicities observed across more than 150 patients dosed with anito-cel in Phase 1 and iMMagine-1 studies.

These preliminary results suggest that anito-cel holds considerable promise for patients with RRMM. The high response rates, coupled with the manageable safety profile, particularly the lack of delayed neurotoxicity, position anito-cel as a potential best-in-class therapy. Further data from the ongoing iMMagine-1 study and the Phase 3 iMMagine-3 study, which is evaluating anito-cel in earlier lines of therapy, will be crucial in confirming these findings and establishing the long-term efficacy and safety of anito-cel. The positive data generated thus far suggest a potential paradigm shift in the treatment of RRMM, offering new hope for patients who have limited effective options. This also strengthens Arcellx’s position in the competitive CAR T-cell therapy landscape. The results create anticipation for the potential regulatory approval and subsequent commercialization of anito-cel, which could significantly impact the treatment algorithm for RRMM.

Source link: http://www.businesswire.com/news/home/20241208772135/en/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

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.