Johnson & Johnson's Janssen Pharmaceutical unit presented longer-term results from the Phase Ib/II CARTITUDE-1 study of ciltacabtagene autoleucel (cilta-cel) in patients with relapsed and/or refractory multiple myeloma, with results showing that the BCMA-directed CAR-T therapy continued to demonstrate a very high overall response rate of 97% after a median follow-up of 12.4 months. The data were released at the American Society of Hematology (ASH) meeting.
Cilta-cel, also known as JNJ-4528 and LCAR-B38M, is being co-developed by Johnson & Johnson and Legend Biotech under an agreement signed in 2017. Results from the CARTITUDE-1 study presented earlier this year at the American Society of Clinical Oncology (ASCO) conference showed an overall response rate of 100% in patients with relapsed or refractory multiple myeloma, including 86% with a stringent complete response after a median follow-up of 11.5 months.
The updated results presented at ASH showed that 67% of patients in the trial achieved a stringent complete response, while after a median follow-up of 12.4 months, median duration of response and progression-free survival (PFS) have not been reached. Principal investigator Deepu Madduri, remarked "in the CARTITUDE-1 study, heavily pretreated patients, including those who were triple-class refractory, achieved an impressive response following a single infusion of ciltacabtagene autoleucel."
Further results showed that the median time-to-first response was one month, with responses observed at a low dose of CAR-T cells and were ongoing in 72% of patients. Janssen added that the 12-month PFS rate was 77%, while the 12-month overall survival rate was 89%. "We are encouraged that patients treated with cilta-cel continued to achieve impressive, deep responses," noted Sen Zhuang, vice president of clinical research development at Janssen Research & Development, adding that "the responses also appeared to be durable."
With regards safety, Janssen said that cytokine release syndrome (CRS) was observed in 95% of patients in the CARTITUDE-1 study, with 3% of these cases being grade 3 and 1% each measured at grade 4 and grade 5. Meanwhile, grade 3 or higher neurotoxicity was observed in 10% of patients, including 16 cases of immune effector cell-associated neurotoxicity syndrome (ICANS). The company added that 14 deaths were reported during the trial, with six due to adverse events related to treatment, including sepsis, CRS and neurotoxicity.
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