Janssen taking Legend CAR T therapy to clinic
Janssen said FDA cleared an IND for CAR T therapy JNJ-68284528 to treat multiple myeloma. Next half, the unit of Johnson & Johnson expects to start a U.S. and European Phase Ib/II study of Legend Biotech’s therapy targeting BCMA.
At last year’s American Society of Clinical Oncology (ASCO) meeting, Legend reported JNJ-68284528 led to a 100% objective response rate among 19 MM patients in the first phase of the Chinese Phase I/II LEGEND-2 study. No neurotoxicities, which can plague anti-CD19 CAR T therapies, were observed.
In December 2017, Janssen obtained a global license to the therapy from the Legend Biotech USA Inc. and Legend Biotech Ireland Ltd. subsidiaries of Genscript Biotech Corp. The partners are developing JNJ-68284528 jointly worldwide.
The therapy is Janssen’s first in the CAR T space. At the time of the deal, Janssen’s Global Therapeutic Area Head of Oncology Peter Lebowitz told BioCentury BCMA was the first target to meet the company’s safety and efficacy standards for the CAR T modality (see BioCentury, Jan. 5).
Janssen said the primary efficacy endpoint in the Phase II portion of its planned trial to treat relapsed or refractory MM will be overall response rate (ORR) as defined by the International Myeloma Working Group response criteria.