J Clin Oncol: Efficacy of Ciltacabtagene autoleucel in adult patients with relapsed or refractory multiple myeloma in our country

Ciltacabtagene autoleucel (Cilta-cel), an autologous chimeric antigen receptor (CAR) T cell therapy that targets B cell maturation antigen (BCMA), is customized using the patient's own T cells, which are collected and genetically modified and then infused back into the
patient.

On February 28, 2022, the U.
S.
FDA approved Cilta-cel for the treatment of adult patients
with relapsed or refractory multiple myeloma (RRMM) who have received ≥ 4-line therapy, including proteasome inhibitors [PI], immunomodulators [IMiD], and anti-CD38 monoclonal antibodies.

The CARTIFAN-1 study was designed to evaluate the efficacy and safety
of Cilta-cel in patients with relapsed/refractory multiple myeloma in China.

This is an open-label phase II flight trial conducted in China to recruit adult RRMM patients
who have received ≥ 3-line therapy.
A single dose of Cilta-cel infusion (target dose 0.
75x106 chimeric antigen receptor-positive T cells/kg)
was given.
The primary endpoint was overall response rate
.
Secondary endpoints included progression-free survival (PFS), overall survival (OS), and incidence and severity
of adverse events.

As of 19 July 2021, a total of 48 patients have received Cilta-cel
infusions.
After a median follow-up of 18 months, the overall response rate was 89.
6% (95% CI 77.
3 to 96.
5), with a median time before the first response of approximately one month; 77.
1% of patients achieved a complete or better response
.
The median duration of response, PFS, and OS were not achieved
.
The 18-month PFS rate and OS rate were 66.
8% and 78.
7%,
respectively.

Common hematologic adverse events included anaemia (100%), neutropenia (97.
9%), lymphopenia (95.
8%), and thrombocytopenia (87.
5%)
.
Cytokine release syndrome occurred in 97.
9% of patients (grade 3 to 4 in 35.
4% of cases), with a median pre-attack time of 7 days and a median duration of 5 days
.
Infection occurred in 85.
4% of patients (grade 3-4 in 37.
5%)
.
Ten patients died after the Cilta-cel infusion, eight of which were associated with
treatment-related adverse events.

In summary, the results of this study show a favorable risk-benefit spectrum of a single infusion of Cilta-cel, which can lead to early, deep, and durable remission in Chinese patients with relapsed or refractory
multiple myeloma who have been treated multiple times in the past.

Original source:

Jian-Qing Mi, et al.
Phase II, Open-Label Study of Ciltacabtagene Autoleucel, an Anti–B-Cell Maturation Antigen Chimeric Antigen Receptor–T-Cell Therapy, in Chinese Patients With Relapsed/Refractory Multiple Myeloma (CARTIFAN-1).
Journal of Clinical Oncology.
October 21, 2022.
https://ascopubs.
org/doi/full/10.
1200/JCO.
22.
00690