Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company focusing on developing innovative immunotherapies for patients with cancer and other incurable diseases, has announced positive data from its phase 2 pivotal immagine-1 study of anitocabtagene autoleucel (anito-cel) for patients with relapsed or refractory multiple myeloma (RRMM).
Preliminary results from the study demonstrated significant improvements with a 97% overall response rate (ORR) and a 62% complete response/stringent complete response (CR/SCR) rate at a median follow-up of 9.5 months. Additionally, the median progression-free survival (MPFS) was reported at 30.2 months with a median overall survival (OS) not reached. The study also highlighted no delayed neurotoxicities, including no parkinsonism, cranial nerve palsies, or guillain-barré syndrome, observed in over 150 patients dosed with anito-cel.
The safety evaluable population showed that 87% of patients were triple refractory, and 42% were penta refractory. Furthermore, the study reported that 93.1% of patients achieved minimal residual disease (MRD) negativity at a minimum of 10-5 sensitivity.
Among the safety evaluable population, 86% had grade ≤1 cytokine release syndrome (CRS), with 17% of patients experiencing no CRS. Moreover, 91% of patients had no immune effector cell-associated neurotoxicity syndrome (ICANS).
The company also highlighted the initiation of the global phase 3 randomized controlled clinical study, immagine-3, designed to compare the efficacy and safety of anito-cel with standard of care in patients with RRMM who have received one to three prior lines of therapy.
Furthermore, Arcellx is set to host a live webcast event with an expert panel of clinicians to discuss the clinical results on December 9, 2024, at 8 p.m. PT.
The company's chairman and chief executive officer, Rami Elghandour, expressed excitement about the milestone reached in the pivotal study and the compelling data presented. Arcellx is also celebrating its 10th anniversary this year.
These positive developments demonstrate the potential of anito-cel as a best-in-class treatment option for patients with RRMM, with the company aiming to position it as a differentiated CAR-T treatment option for the disease.
The announcement also emphasized the collaboration between Arcellx and Kite, a Gilead company, in developing and commercializing anito-cel for patients with RRMM.
The data presented at the 66th American Society of Hematology (ASH) annual meeting and exposition, alongside the initiation of the immagine-3 study, mark significant progress in the development of anito-cel as a potential treatment option for patients with RRMM. Following these announcements, the company's shares moved -1.2%, and are now trading at a price of $83.52. Check out the company's full 8-K submission here.
