JNJ-68284528 (LCAR-B38M) is an autologous CAR-T therapy that targets B-Cell Maturation Antigen (BCMA), a molecule expressed on the surface of mature B lymphocytes and malignant plasma cells. The investigational therapy expresses an identical CAR protein as Legend's LCAR-B38M CAR-T product, which was evaluated in a first-in-human clinical study (Legend-2) conducted in multiple sites by Legend Biotech in China.
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The following is a listing of clinical trials for patients with multiple myeloma who have received one to two prior lines of therapy.
The following is a listing of clinical trials for patients with multiple myeloma who have received three or more prior lines of therapy.
December 03, 2018
As of June 25, 2018, 57 pts have been infused with LCAR-B38M CAR T cells. The median age was 54 years (range, 27–72), median number of prior therapies was 3 (range, 1–9), and 74% of pts had stage III disease by Durie-Salmon staging. The median duration of follow-up for all pts was 12 months (range, 0.7–25).
The overall response rate (partial response [PR] or better) was 88% (95% confidence interval [CI], 76–95). Complete response (CR) was achieved by 42 pts (74%; 95% CI, 60–85), very good partial response was achieved by 2 pts (4%; 95% CI, 0.4–12), and PR was achieved by 6 pts (11%; 95% CI, 4–22; Figure 1B). Among pts with CR, 39/42 were minimal residual disease (MRD) negative by 8-color flow cytometry. The median time to initial response was 1 month (range, 0.4–4). No clear relationship between LCAR-B38M CAR T cell dose and response was observed (Figure 1C). BCMA expression did not correlate with clinical response.
The median duration of response (DOR) was 16 months (95% CI, 12–not reached [NR]). The median DOR for pts who achieved a CR was 22 months (95% CI, 14–NR). At data cutoff, 18 pts (36%) who achieved PR or better progressed. The median progression-free survival (PFS) for all treated pts was 15 months (95% CI, 11–NR); median PFS for pts who achieved CR was 24 months (95% CI, 15–NR). The median overall survival was not reached. Overall, 17 pts died during the study and follow-up period; causes of death were progressive disease (PD; n=14), suicide after PD (n=1), esophagitis (n=1), and pulmonary embolism and acute coronary syndrome (n=1).