Dr Bishop on 34-Month Data With Anitocabtagene Autoleucel in R/R Myeloma

“[Anitocabtagene autoleucel was] highly efficacious and safe in the phase 1 study, and the primary end point was safety. The safety profile is very impressive for this drug.”

Michael R. Bishop, MD, professor, medicine, director, Hematopoietic Stem Cell Transplantation Program, The University of Chicago Medicine, discusses 34-month median follow-up data from aphase 1 study of patients with relapsed/refractory multiple myeloma treated with anitocabtagene autoleucel.

The previously reported response rates for this single-arm study were exceptional, highlighting the impressive efficacy of anitocabtagene autoleucel, Bishop begins. Specifically, the overall response rate was 100%, with 92% of patients achieving a very good partial response or better and 79% of patients reaching a complete response or better, he reports. Among patients evaluable for minimal residual disease (MRD; n = 28), 89% achieved MRD negativity.

The focus of this study has now shifted to providing updates on progression-free survival (PFS) and overall survival (OS), Bishop says. The updated data reveal that the median PFS for all patients was30.2 months (95% CI, 16.6-not evaluable [NE]); among complete responders, the median PFS was 34.3 months (95% CI, 24.2-NE), he continues. The median OS for all patients was not reached, emphasizing the durability of these responses, according to Bishop. Although this is a phase 1 study with a limited number of patients, the continued strong response rates and prolonged PFS are particularly noteworthy, Bishop emphasizes.

Additionally, extended follow-up has provided more insights into the safety profile of this CAR T-cell product, he expands. The overall incidence of cytokine release syndrome was approximately 95% but the rate of severe cases was low, Bishop states. Any-grade immune effector cell–associated neurotoxicity syndrome was observed in 18% of patients, with only 1 grade 3 event. Importantly, there were no reports of Parkinson-like syndromes, cranial nerve palsies, or Guillain-Barré syndrome, which are significant safety concerns, Bishop concludes.