On Sunday, Arcellx, Inc. ( ACLX ) revealed new data from its Phase 2 pivotal iMMagine-1 study of anitocabtagene autoleucel (anito-cel) in patients with relapsed or refractory multiple myeloma (RRMM).

The data will be presented at the American Society of Hematology (ASH) Annual Meeting and Exposition. Anito-cel is partnered with Kite, a Gilead Science Inc’s company.

Also Read: Arcellx’s Lead Asset Can Potentially Outperform Bristol-Myers Squibb, Johnson & Johnson’s Multiple Myeloma Cell Therapies: Morgan Stanley

The Phase 2 iMMagine-1 data are from an October 31 data cutoff date, with a median follow-up of 9.5 months for the efficacy evaluable population.

At the time of the data cut, 86 patients were evaluable for efficacy based on a follow-up of at least two months after treatment with anito-cel, and 98 patients were evaluable for safety based on a follow-up of at least one month after treatment with anito-cel.

Preliminary results from the Phase 2 iMMagine-1 study demonstrate deep and durable responses with a predictable and manageable safety profile in a high-risk fourth-line or higher RRMM population, including triple- and penta-class refractory disease.

The overall response rate (ORR) was 97% (83/86), with a complete response/stringent complete response (CR/sCR) rate of 62% (53/86) and a very good partial response or higher (>VGPR) rate of 81% (70/86).

Of those evaluable for minimal residual disease (MRD) testing, 93.1% (54/58) achieved MRD negativity at a minimum of 10-5 sensitivity.

Median progression-free survival (mPFS) and overall survival (OS) were not reached, with 6-month PFS and OS rates being 93.3% and 96.5%, respectively, and 12-month PFS and OS rates being 78.5% and 96.5%, respectively.

No delayed or non-ICANS neurotoxicities, including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome, have been observed to date in more than 150 patients dosed with anito-cel. 

Price Action: ACLX stock is up 6.46% at $90.01 during the premarket session at last check Monday.

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