Johnson & Johnson’s Janssen has announced the granting of a PRIME (PRIority MEdicines) designation for its CAR-T therapy JNJ-68284528 (JNJ-4528) in multiple myeloma.
The European Medicines Agency (EMA) gave the investigational B-cell maturation antigen (BCMA) the designation based on results from the Phase I/II LEGEND-2 study (NCT03090659) evaluating LCAR-B38M CAR-T cells, and the Phase Ib/II CARTITUDE-1 study (NCT03548207) evaluating JNJ-4528.
The clinical study results evaluated the safety and efficacy of the novel therapy, and found that there was an 88% overall response rate in the treatment of patients with advanced relapsed or refractory multiple myeloma.
“CAR-T therapy is an exciting therapeutic platform that harnesses the patient’s immune system to attack tumour cells,” said Sen Zhuang, vice president, Oncology Clinical Development, Janssen Research & Development, LLC. “We continue to advance this novel BCMA targeted CAR-T therapy through clinical studies globally as we strive to bring it to the patients with multiple myeloma around the world.”
The drug is currently being tested for patients have few available treatment options and are who faced with poor outcomes, such as those with multiple myeloma who have received at least three prior regimens, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody, and have documented disease progression within 12 months of starting the most recent therapy.
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells. There is still massive unmet need for treatment, as in Europe alone more than 48,200 people were diagnosed with multiple myeloma in 2018, and more than 30,800 patients died.