Genscript Biotech Corporation (1548.HK), a leading China-based Contract Development and Manufacturing Organization (CDMO), has announced the publication of long-term follow-up data from the Phase 1b/2 study, CARTITUDE-1. The study, conducted in partnership with Janssen Pharmaceutical, focuses on the chimeric antigen receptor (CAR)-cell therapy JNJ-4528 for the treatment of recurrent or refractory multiple myeloma (MM). With a median follow-up of 11.5 months, the study enrolled 29 patients who exhibited a remarkable response rate to the treatment, achieving a 100% total effective rate. Notably, this included an 85% strict complete remission and a 95% very good partial remission (VGPR) or better, with only a 3% partial remission rate.
The study also reported common adverse reactions, with neutropenia affecting 100% of patients and cytokine release syndrome (CRS) impacting 93%. The Phase 1b study segment experienced three patient deaths attributed to CRS, acute myeloid leukemia (unrelated to treatment), and disease progression. The long-term follow-up trial’s findings are scheduled for presentation at the American Society of Clinical Oncology (ASCO) annual meeting.
JNJ-4528, a novel CAR-T therapy, boasts a new structure that enables higher antibody affinity due to its 4-1BB costimulatory domain and two BCMA-targeted single domain antibodies. Developed by Genscript’s subsidiary, Legend Biological Technology Co., Ltd, JNJ-4528 was out-licensed to Janssen in 2017, granting them exclusive rights to the drug’s development and commercialization. The therapy has received clinical approvals in both China and the US and was awarded orphan drug designation (ODD) and Breakthrough Therapeutic Designation (BTD) in February and December 2019, respectively. Additionally, it was prioritized for review by the European Medicine Agency (EMA) in April 2019.
