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Genscript Bio (01548) plunges 4.7% after rising 7.4%
16 Apr 2019
(Infocast News) Genscript Biotech (01548) fell 4.7% to HK$21.3 this afternoon despite a 7.4% rise to HK$24.0 this morning.

Genscript Biotech announced today that according to new data from 17 patients studied at each of Shanghai Ruijin Hospital, Shanghai Changzheng Hospital, and Jiangsu Province People's Hospital involved in the Phase 1/2 LEGEND-2 open-label study (the LEGEND-2 Study) published in the Proceedings of the National Academy of Sciences of the United States of America, treatment with the investigational anti-B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) therapy LCAR-B38M resulted in deep and durable responses, with a manageable and tolerable safety profile, in patients with advanced relapsed or refractory (R/R) multiple myeloma.

A total of 74 patients were enrolled in the LEGEND-2 Study.

Data from the first 11 patients enrolled at the aforesaid hospitals were presented at the 2017 American Society of Hematology (ASH) annual meeting. Results from 57 patients enrolled at the fourth site, The Second Affiliated Hospital of Xi’an Jiaotong University, were previously published in the Journal of Hematology & Oncology and presented at the 2018 ASH annual meeting.

Patients in the LEGEND-2 Study received LCAR-B38M intravenously after lymphodepleting chemotherapy. As of 20 October 2018, of the 17 evaluable patients, the overall response rate was 88.2%, with 13 patients achieving stringent complete response (sCR), two achieving very good partial response (VGPR), and one non-responder. At median follow-up of 14 months, eight patients (47.1%) remained in sCR or VGPR. The progression-free survival was 82.4% at six months and 52.9% at 12 months, and the 12-month overall survival was 82.3%. Adverse events included cytokine release syndrome (CRS) (100%), cytopenia (82.4%), infections (52.9%), and Grade 2 or 3 liver dysfunction (52.9%). Six patients (35.3%) experienced Grade 3 CRS, and one died due to severe CRS and tumor lysis syndrome.

In China, a Phase 2 confirmatory trial (CARTIFAN-1) registered with the Center for Drug Evaluation (CTR20181007, NCT03758417) is currently enrolling patients to further evaluate LCAR-B38M in patients with advanced R/R multiple myeloma.

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