|The following article features coverage from the 2021 American Society of Hematology Annual Meeting. Click here to read more of Cancer Therapy Advisor’s conference coverage.|
Responses to ciltacabtagene autoleucel (cilta-cel) deepened over time in patients with relapsed/refractory multiple myeloma (MM), according to updated results from the CARTITUDE-1 trial.
“[A]t a median follow-up of approximately 2 years, patients treated with cilta-cel showed durable and deep responses,” said Thomas Martin, MD, of the UCSF Helen Diller Family Comprehensive Cancer Center in San Francisco, California.
Dr Martin presented these results at the 2021 American Society of Hematology (ASH) Annual Meeting.
The CARTITUDE-1 trial (ClinicalTrials.gov Identifier: NCT03548207) included 97 patients with relapsed/refractory MM. They received a single infusion of cilta-cel after lymphodepletion with cyclophosphamide and fludarabine. At baseline, the patients’ median age was 61 years (range, 43-78 years), and 58.8% were men.
Patients had received a median of 6 prior lines of therapy (range, 3-18), including 89.7% who had undergone an autologous stem cell transplant. Nearly all patients (99%) were refractory to their last line of treatment, 87.6% were triple-class refractory, and 42.3% were penta-refractory.
Prior results, at a median follow-up of 12.4 months, showed that cilta-cel produced an overall response rate (ORR) of 97% and a stringent complete response (sCR) rate of 67%. The 12-month progression-free survival (PFS) rate was 77%, and the 12-month overall survival (OS) rate was 89%.
For the current analysis, the median follow-up was about 2 years. The ORR was 98%, and the sCR rate was 83%. The rate of very good partial response or better was 95%, and 92% of patients achieved minimal residual disease negativity.
The median duration of response was not estimable. The median time to first response was 1 month, the median time to complete response or better was 2.9 months.
The median PFS and OS were not reached. The 2-year PFS rate was 60.5%, and the 2-year OS rate was 74.0%.
There were no new safety signals with longer follow-up, including no additional neurotoxicity or treatment-related deaths. During the 2-year follow-up, there were 15 secondary malignancies observed in 11 patients, but these were not considered related to cilta-cel.
“These data are encouraging, and it suggests that cilta-cel will be an important treatment option for patients with multiple myeloma,” Dr Martin said.
Disclosures: This research was supported by Janssen Research & Development, LLC, and Legend Biotech, Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Read more of Cancer Therapy Advisor’s coverage of the ASH 2021 meeting by visiting the conference page.
Martin T, Usmani SZ, Berdeja JG, et al. Updated results from CARTITUDE-1: Phase 1b/2 study of ciltacabtagene autoleucel, a B-cell maturation antigen–directed chimeric antigen receptor T cell therapy, in patients with relapsed/refractory multiple myeloma. Presented at ASH 2021; December 11-14, 2021. Abstract 549.