The following article features coverage from the American Society of Hematology 2020 meeting. Click here to read more of Hematology Advisor‘s conference coverage.

Idecabtagene vicleucel (ide-cel), a chimeric antigen receptor (CAR) T-cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA), showed clinical benefit and no toxicity concerns in patients with relapsed/refractory multiple myeloma, according to the updated results from the single-arm, phase 1 CRB-401 trial (ClinicalTrials.gov Identifier: NCT02658929).

The trial results were presented at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.


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A total of 62 patients were infused with ide-cel: 21 during the dose-escalation phase and 41 during the dose-expansion phase. Patients were heavily pretreated, having received between 3 and 18 prior lines of therapy (median, 6 prior lines of therapy).

Grade 3 or 4 adverse events that were most frequently seen were neutropenia (89%), leukopenia (61%), anemia (57%), and thrombocytopenia (57%).

Cytokine release syndrome was seen in most patients (76%), with grade 3 or 4 events uncommon (6.5%). Neurotoxicity was seen in 36% of patients, which included only 1 patient with a grade 3 or 4 event.

At a median follow-up of 14.7 months, the study population had a median progression-free survival of 8.8 months and median overall survival of 34.2 months.

The overall response rate was approximately 76%, which included 39% of patients who achieved a complete response (CR) or better and 26% who achieved a very good partial response.

All patients who achieved a CR or better and had an evaluable bone marrow sample were found to be negative for minimal residual disease, as confirmed by next-generation sequencing.

Responses lasted for a median of 10.3 months and appeared to follow a dose-response relationship.

Duration of response did not differ for patients who had worse prognostic features, including receiving bridging therapy, older age, having extramedullary plasmacytoma, or having higher Revised International Staging System scores.

“Not surprisingly, patients who achieve CR or greater response have the longest duration of response,” said the study presenter Yi Lin, MD, PhD, Mayo Clinic, Rochester, Minnesota. “To date, we’re seeing that half of the ongoing responders have duration of response [of] more than 2 years.”

Disclosures: Some of the presenters disclosed financial relationships with the pharmaceutical industry and/or the medical device industry. For a full list of disclosures, please refer to the presentation abstract.

Reference

Lin Y, Raje NS, Berdeja JG, et al. Idecabtagene vicleucel (ide-cel, bb2121), a BCMA-directed CAR T cell therapy, in patients with relapsed and refractory multiple myeloma: Updated results from phase 1 CRB-401 study. Presented at: the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition; December 5-8, 2020. Abstract 131.

This article originally appeared on Cancer Therapy Advisor