The Janssen Pharmaceutical Companies of Johnson & Johnson reported today updated results from Legend Biotech Inc.’s LEGEND-2 Phase 1/2 open-label study, which evaluated the investigational chimeric antigen receptor T-cell (CAR-T) therapy LCAR-B38M in the treatment of patients with advanced relapsed or refractory (R/R) multiple myeloma. The findings, featured in an oral presentation at the 60th American Society of Hematology (ASH) Annual Meeting (Abstract #955), build upon the data from one of four independent institutional studies, the Second Affiliated Hospital of Xi’an Jiaotong University, which were initially presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting and 2017 European Hematology Association (EHA) Meeting. These updated results showed that the B-cell maturation antigen (BCMA) directed CAR-T cell therapy LCAR-B38M achieved deep and durable responses, with a manageable and tolerable safety profile in patients who failed a median of three prior therapies.
In December 2017, Janssen entered into a worldwide collaboration and license agreement with Legend Biotech, USA Inc. and Legend Biotech Ireland Limited (“Legend”), subsidiaries of GenScript Biotech Corporation, to jointly develop and commercialize LCAR-B38M in multiple myeloma. LCAR-B38M is a CAR-T cell therapy directed against two distinct BCMA epitopes, which confers high avidity and affinity binding of the compound to the BCMA-expressing cells. In China, a Phase 2 confirmatory trial registered with the Center for Drug Evaluation (CTR20181007) is currently being planned to further evaluate LCAR-B38M in patients with advanced R/R multiple myeloma. Globally, Janssen, together with Legend, is advancing a Phase 1b/2 trial (NCT03548207) of JNJ-68284528 to evaluate its efficacy and safety in adults with advanced R/R multiple myeloma. The study is currently enrolling patients following the U.S. Food and Drug Administration clearance of an Investigational New Drug application as announced in May 2018.
LCAR-B38M identifies the investigational product being studied in China and JNJ-68284528 identifies the investigational product being studied in the U.S./EU, both of which are representative of the same CAR-T therapy.
“CAR-T science has led to the approval of much-needed therapeutic interventions for certain blood cancers, and it is our hope that the results we are seeing in multiple myeloma will yield another much needed option for patients,” said Wan-Hong Zhao, M.D., Ph.D., Associate Director of Hematology at the Second Affiliated Hospital of Xi’an Jiaotong University in Xi’an, China, and lead study investigator. “We are excited about these data and the fact that they demonstrated notable responses in heavily pretreated patients with multiple myeloma, a population that traditionally has been difficult to treat.”
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