Nanjing Legend Biotech Adds More Patient Data for BCMA CAR-T

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BCMA expression did not correlate with clinical response.
BCMA expression did not correlate with clinical response.
The following article features coverage from the American Society of Hematology (ASH) 2018 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.

More data on an anti-B-cell maturation antigen chimeric antigen receptor T-cell therapy (anti-BCMA CAR-T) was released at the 2018 American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, California.1

This particular antimyeloma cellular therapy, LCAR-B38M, is a little different than some of the other BCMA CAR-T therapies in that it actually targets 2 separate BCMA epitopes (2 binding domains) at once.

Although the researchers listed 74 total participants in the trial, all of the data are not new — some of them were first presented at 3 prior cancer meetings.  And, some of the slides reported statistics out of a sample size of 74, while other slides included 57 patients, which was the number of patients seen at the Xi'an site in China as of June 25, 2018.

In the current study, overall response rate was 88%, with a complete response of 34%. The duration of response was 22 months. Forty-two patients (74%) saw a minimal residual disease (MRD)-negative complete response (CR). Twelve-month progression-free survival was 61%, while 12-month overall survival was 75%. There were 17 deaths, 14 of which were due to progressive disease.

The key objectives of the study were to test the safety of LCAR-B38M CAR-T cells and gauge their antimyeloma activity based on IMWG criteria.

Patients had a median of 3 prior lines of therapy (range, 1-9); of these prior medications, the largest proportion of patients had received a prior immunomodulatory imide (86%).

At least 20% of all patients saw adverse events; 90% of patients experienced cytokine release syndrome (CRS) of any grade, and 91% of patients had pyrexia of any grade. Other adverse effects included thrombocytopenia, leukopenia, increased AST, anemia, hypotension, and neurotoxicity. One patient died as a result of PE/ACS before resolution of grade 2 CRS.

The researchers concluded that the MRD-negative CRs were durable, and responses were achieved with low CAR-positive T-cell doses. They determined BCMA expression did not correlate with clinical response. “A phase 1b/2 study with JNJ-68284528 is ongoing in the US (ClinicalTrials.gov Identifier: NCT03548207) and a phase 2 study will be initiated in China (CTR20181007) in 2019.”

Read more of Cancer Therapy Advisor's coverage of the ASH 2018 meeting by visiting the conference page.

Reference

  1. Zhao W-H, Liu J, Wang B-Y, et al. Updated analysis of a phase 1, open-label study of LCAR-B38M, a chimeric antigen receptor T cell therapy directed against B-Cell maturation antigen, in patients with relapsed/refractory multiple myeloma. Oral presentation at: American Society of Hematology 60th Annual Meeting & Exposition; December 1-4, 2018; San Diego, California. Abstract 955.

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