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    Anitocabtagene Autoleucel in RRMM: Efficacy, Safety, and Improving Access With Krina Patel, MD, MSc

    Expert Perspectives

    By Keira Smith

    Published

    BCMA-directed CAR T-cell therapy has reshaped expectations for relapsed/refractory multiple myeloma (RRMM), offering a novel approach that contrasts with continuous, toxicity-accumulating regimens. In this interview, Dr. Krina Patel, Section Chief for Multiple Myeloma and Director of Myeloma Clinical Research at the University of Texas MD Anderson Cancer Center, discusses anitocabtagene autoleucel (anito-cel) and new data from the phase 2 iMMagine-1 study presented at the recent American Society of Hematology (ASH) Annual Meeting, highlighting deepening responses, a favorable safety profile, and the practical importance of moving toward broader (and potentially outpatient) delivery.

    Anitocabtagene Autoleucel and Its Mechanism of Action 

    Compared with other BCMA-targeted therapies, Dr. Patel notes that anito-cel’s differentiator is the binding domain: rather than a traditional single-chain variable fragment (scFv), a small D-Domain protein attaches to the myeloma cells. This design may enable higher CAR loading in T cells, improving CAR T transfection and efficiency and supporting a relatively low administered dose—115 million CAR T-cells—with a product enriched for CAR-positive T cells rather than other bystander cells. She also emphasized a hypothesized kinetic advantage: the D-Domain binder has a fast off-rate from the target, which could be associated with less inflammation and toxicity.

    iMMagine-1 Study

    iMMagine-1 is the phase 2 pivotal study intended to support potential regulatory submission for anito-cel. The trial enrolled 117 patients with relapsed/refractory multiple myeloma, requiring at least three prior lines of therapy (proteasome inhibitor, immunomodulatory drug, and anti-CD38 exposure). After apheresis, patients could receive bridging therapy, followed by lymphodepletion chemotherapy and CAR T infusion. The ASH update included patients with a median follow-up of 15.9 months. 

    Results Presented at ASH

    Dr. Patel characterized the efficacy as “pretty fantastic in that our response rates are deepening.” Reported outcomes included an overall response rate of 96%, with 74% achieving complete response/stringent complete response (CR/sCR) and 88% reaching a very good partial response (VGPR) or better. Measurable residual disease (MRD) data reinforced depth: among 96 evaluable patients, 95% were MRD-undetectable at 10⁻⁵. Importantly, among those with repeat assessments at ≥6 months, 83% maintained MRD undetectability, aligning with the view that sustained MRD can be especially informative in CAR T.

    Safety Results

    On tolerability, Dr. Patel noted that cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS) were minimal, with no emergent safety signals since prior updates. She highlighted the absence of several neurotoxicity and immune-mediated events of concern: no delayed or non-ICANS neurotoxicities, no Parkinsonism or cranial nerve palsies, and no Guillain-Barré or immune effector cell–associated enterocolitis. With the last patient treated over a year ago, she suggested many delayed events would likely have declared themselves. She also referenced durability signals: 18-month progression-free survival (PFS) of 67.4% and 24-month PFS of 61.7%, expressing hope for a future “plateau” as seen with other CAR Ts.

    Comparison With Other BCMA CAR T-Cell Therapies?

    Dr. Patel underscored a clinical priority that goes beyond response rates: quality of life. CAR T is “a one-and-done option,” offering relief from continuous therapy. “I can’t tell you how many patients have said, ‘I feel normal. I feel like I did before I had myeloma.’ That’s pretty powerful” Dr. Patel said. “Most of my patients who get a CAR T, if they relapse, they ask ‘Can I get another CAR T?’ That quality-of-life piece, along with the efficacy, is so important. Compared to other mechanisms of action, CAR T is one of my favorites because of that.” 

    Within the BCMA CAR T class, she pointed to long-term data supporting ciltacabtagene autoleucel (including a reported 33% plateau at five years) and described idecabtagene vicleucel as a strong option for frail and older patients, where risk–benefit considerations differ. For anito-cel, she said, “With the data we have so far, the efficacy looks really good, and the safety looks really good. We just need a few more years’ worth of data to be able to directly compare.” She also emphasized access: if the safety profile supports broader outpatient use, more centers may deliver CAR T closer to patients.

    Lessons in Outpatient Administration

    About 9% of patients in iMMagine-1 received anito-cel as an outpatient infusion, and Dr. Patel reported that those patients did very well, with no increase in toxicities and no safety concerns. She suggested outpatient feasibility may hinge on pre-infusion disease burden and bridging effectiveness. Looking ahead, she raised prophylaxis strategies as a lever to further reduce resource intensity, referencing National Comprehensive Cancer Network (NCCN)–supported tocilizumab prophylaxis for bispecific antibodies and the hope that similar approaches could help CAR T patients stay out of the hospital the whole time, which will dramatically reduce the required resources for CAR T administration. 

    Conclusion

    Dr. Patel closed with optimism about the pace of innovation: “With so much data out there for myeloma, it’s just a wonderful time to be a myeloma doctor and researcher. It’s really going to be about how we use all these therapies to cure our patients. And I do think that anito-cel is going to be one of those options that helps do that.”

    Key Takeaways

    • Distinct construct: anito-cel’s D-Domain BCMA binder may improve transfection efficiency and potentially reduce inflammatory toxicity via a fast off rate.

    • Efficacy signals in IMAGINE-1: ORR 96%, CR/sCR 74%, VGPR+ 88%, with high rates of MRD negativity (10⁻⁵) and encouraging sustained MRD.

    • Safety update: CRS/ICANS described as minimal, with no reported delayed/non-ICANS neurotoxicity signals in the update discussed.

    • Operational implications: early outpatient experience (9%) appeared feasible without increased toxicity; future work may clarify patient selection, bridging goals, and prophylaxis approaches to expand access.

    About Dr. Patel

    Krina Patel, MD, MSc, is the Section Chief for Multiple Myeloma and the Director of Myeloma Clinical Research at the University of Texas MD Anderson Cancer Center. She specializes in the treatment of multiple myeloma and other plasma cell dyscrasias, with a focus on translating immunotherapy discoveries into improved patient outcomes. Dr. Patel’s research centers on biomarker-driven patient selection, immune reconstitution, long-term survivorship, and mechanisms of response and resistance to CAR T-cell therapies and bispecific antibodies. She also leads the US Myeloma Immunotherapy Consortium, a collaborative network of more than 20 institutions producing high-impact real-world evidence and translational data for cellular and immune-based therapies.