Lower CRS Enables Outpatient Use of Anito-cel in R/R Multiple Myeloma

Krina K. Patel, MD, MSc, spoke with CancerNetwork® about the feasibility of administering anitocabtagene autoleucel (anito-cel) in the outpatient setting among those with relapsed/refractory multiple myeloma. She discussed these strategies in the context of findings from the phase 2 iMMagine-1 study (NCT05396885) that she presented at the 2025 American Society of Hematology (ASH) Annual Meeting and Exposition, which showed that the investigational cellular therapy elicited an overall response rate of 96% among 117 evaluable patients with relapsed/refractory disease.1,2

Given that 10 patients (9%) in the trial received anito-cel in the outpatient setting, Patel, an associate professor in the Department of Lymphoma/Myeloma of the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, described how the timing and severity of cytokine release syndrome (CRS) may influence outpatient administration. She noted how lower rates of CRS and other toxicities enable the comfort of giving anito-cel in an outpatient context, while current FDA expectations may allow patients to return to their community physicians at 2 weeks after treatment.

Transcript:

Outpatient CAR T-cell therapy in myeloma is dependent on when patients get CRS, and how bad that CRS can be; what grade level [is it]? Most patients on this study either had no CRS or had grade 1 CRS. What we look for is [the potential] to give the cells outpatient, we give the [lymphodepleting] chemotherapy outpatient, and then [if] patients have fevers, we usually have to admit them. Usually, they will be out of the hospital once their fevers are gone in about 3 to 4 days. With anito-cel, the fact that this happens a few days later in terms of when the CRS occurs allows us to do this outpatient, get those patients and treat their fevers if they have them, [and] get them back out. Then, especially with the standard of care now, the FDA says that we can get our patients back out to their community doctors in 2 weeks. That timing works out well; if patients are doing well and they are not having issues, they can go back to their community doctors after that 2-week period. All those logistical things matter, but again, having lower rates of CRS and other toxicities is the main reason why we feel comfortable being able to do this outpatient.

References

1. Patel K, Dhakal B, Kaur G, et al. Phase 2 registrational study of anitocabtagene autoleucel for the treatment of patients with relapsed and/or refractory multiple myeloma: updated results from iMMagine–1. Blood. 2025;146(suppl 1):256. doi:10.1182/blood-2025-256
2. Kite announces new data for pivotal iMMagine-1 study at ASH 2025, highlighting anito-cel’s opportunity in relapsed or refractory multiple myeloma. News release. Kite, a Gilead Company. December 6, 2025. Accessed December 9, 2025. https://tinyurl.com/4nreysw3