On April 5, 2019 Janssen Pharmaceutical Companies of Johnson & Johnson reported that the European Medicines Agency (EMA) has granted priority drug status (PRIME) for experimental therapy at the JNJ -68284528 (JNJ-4528) on T cells carrying a chimeric antigen receptor (T-CAR) with B-cell maturation antigen (BCMA) (Press release, Johnson & Johnson, APR 5, 2019, View Source [SID1234535018]). The PRIME program simplifies interactions to optimize development and accelerate the evaluation of breakthrough scientific breakthroughs that address a critical medical need.
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"The PRIME status of this innovative CAR-T BCMA therapy illustrates the importance of regulatory innovation in the European Union," says Sjaak Bot, vice president of regulatory affairs for EMEA at Janssen. Biologics BV "We hope to be able to offer patients this significant breakthrough as quickly as possible. This PRIME status, the first obtained by Janssen, is an essential step towards a possible approval of marketing.
The PRIME status is based on the results of the LEGEND-2 Phase 1/2 study ( NCT03090659 ) evaluating CAR-T cells LCAR-B38M, sponsored by Nanjing Legend Biotech Co., 2 and on the CARTITUDE-1 study of Phase 1b / 2 ( NCT03548207 ) evaluating JNJ-4528, sponsored by Janssen and carried out in collaboration with Legend Biotech USA Inc. 3 The results of the LEGEND-2 study were presented at the 2018 annual conference of the American hematology (ASH) (Free ASH Whitepaper). 4 The results of the CARTITUDE-1 study will be presented shortly.
"CAR-T therapy is a promising therapeutic platform that builds on the patient’s immune system to attack tumor cells," says Sen Zhuang, MD, Ph.D., Janssen’s vice president of clinical oncology development. Research & Development, LLC. "We continue to advance this CAR-T therapy targeting BCMA through international clinical trials. We work tirelessly to be able to offer it to multiple myeloma patients around the world. "
JNJ-4528 is currently being evaluated for the treatment of patients with multiple myeloma who have previously followed at least three therapeutic regimens, containing a proteasome inhibitor, an immunomodulatory agent (IMiD), and an anti-CD38 antibody, and who have presented progression of the disease within 12 months of the start of the most recent therapy, or being dual refractory to IMiD and proteasome inhibitor. 3 Patients have few therapeutic options, and often face an adverse prognosis. 5
In December 2017 , Janssen entered into a worldwide collaboration and license agreement with Legend Biotech to jointly develop and commercialize LCAR-B38M for the treatment of multiple myeloma. 6 In China, CARTIFAN-1 Phase 2 Confirmation Test ( NCT03758417 ), sponsored by Nanjing Legend Biotech Co. Ltd. and registered with the Center for Drug Evaluation (CTR20181007), is in the active recruitment phase to further evaluate LCAR-B38M in patients with relapsed or refractory multiple myeloma. 7
About LEGEND-2
LEGEND-2 ( NCT03090659 ) is an ongoing, open-label, single-group, Phase 1/2 study in four participating hospitals in China to evaluate the efficacy and safety of LCAR-B38M in the treatment of multiple myeloma recurrent or refractory. 2
About CAR-T and BCMA
CAR-T cells are an innovative approach to eradicating cancer cells by harnessing the power of the patient’s immune system. BCMA is a highly expressed protein in myeloma cells. 8 By targeting the BCMA via this approach, CAR-T therapies could redefine the multiple myeloma treatment paradigm.
About multiple myeloma
Multiple myeloma (MM) is an incurable blood cancer that originates in the bone marrow and is characterized by excessive proliferation of plasma cells. 9 In 2018, a diagnosis of MM was made in more than 48,200 people in Europe and more than 30,800 patients died. 10 For nearly 40 percent of patients with multiple myeloma, the survival rate is less than five years. 11
Although treatment may offer remission, recurrence is unfortunately very likely because there is currently no cure. 12 MM is refractory when the disease stops responding or progresses within 60 days of the patient’s last treatment. 13,14 Recurrent myeloma occurs when the disease recurs after a period of initial, partial or complete remission and can not be described as refractory. 15 While some MM patients have no symptoms, most of them are diagnosed because of symptoms that may include bone problems, low blood counts, elevated calcium levels, kidney problems or infections. 16 The prognosis for patients who relapse after treatment with standard therapies, including proteasome inhibitors and immunomodulatory agents, is unfavorable. Few therapeutic options are available. 17