欧洲药品管理局(EMA)授予JNJ-68284528(LCAR-B38M)优先药物审评

2019年4月3日

Designation based on clinical research in advanced relapsed or refractory multiple myeloma

Piscataway, NJ, April 3, 2019 – Legend Biotech today announced that the European Medicines Agency has granted a PRIME (PRIority MEdicines) designation to Janssen-Cilag International N.V. (Janssen) for JNJ-68284528 (JNJ-4528), the company’s investigational B cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) therapy, which has been previously identified as LCAR-B38M. The PRIME program focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options. It offers companies enhanced interaction and early dialogue to optimize development plans and speed up the evaluation so that medicines can reach patients earlier. In order to be accepted for PRIME designation, a medicine must show its potential to benefit patients with unmet medical needs based on early clinical data1.

“Despite recent advances, multiple myeloma remains an incurable disease, making the discovery and development of new options critical,” said Yuan Xu, CEO of Legend Biotech. “We’re encouraged that the EMA recognizes the novel nature of JNJ-4528 and its potential to help people faced with advanced relapsed or refractory disease. We look forward to working with Janssen to bring this investigational therapy to market as quickly as possible.”

The PRIME designation is based on results from the Phase 1/2 LEGEND-2 study (NCT03090659) evaluating LCAR-B38M sponsored by Nanjing Legend Biotech Co., and the Phase 1b/2 CARTITUDE-1 study (NCT03548207) evaluating JNJ-4528, sponsored by Janssen and being conducted in collaboration with Legend Biotech USA Inc. Results from the LEGEND-2 study were presented at American Society of Clinical Oncology (ASCO), European Hematology Association (EHA) and American Society of Hematology (ASH) in 2017, and most recently at ASH 2018. Results from the CARTITUDE-1 study will be presented at a future congress.

In December 2017, Legend and Janssen entered into a worldwide collaboration and license agreement to jointly develop and commercialise LCAR-B38M (JNJ-4528) in multiple myeloma. JNJ4528 identifies the investigational product being studied in the US/EU and LCAR-B38M identifies the investigational product in China.

In the US/EU, JNJ-4528 is currently being investigated in the CARTITUDE-1 study for the treatment of patients 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, or are double refractory to an IMiD and PI. In China, the Phase 2 CARTIFAN-1 confirmatory trial (NCT03758417) registered with the Center for Drug Evaluation (CTR20181007), is actively recruiting to further evaluate LCAR-B38M in patients with advanced relapsed or refractory multiple myeloma. These patients have few available treatment options and are often faced with poor outcomes.2

About LEGEND-2
LEGEND-2 (NCT03090659) is an ongoing single-arm, open-label Phase 1/2 study of 74 patients being conducted at four participating hospitals in China evaluating the efficacy and safety of LCAR-B38M for the treatment of relapsed or refractory multiple myeloma.3

About CAR T and B-cell Maturation Antigen (BCMA)
CAR T-cells are an innovative approach to eradicating cancer cells by harnessing the power of a patient’s own immune system. BCMA is a protein that is highly expressed on myeloma cells.4 By targeting BCMA via this approach, CAR-T therapies may have the potential to redefine treatment for multiple myeloma.

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.5 In Europe, more than 48,200 people were diagnosed with multiple myeloma in 2018, and more than 30,800 patients died.6 Almost forty percent of patients with multiple myeloma do not reach five-year survival.7

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.8 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.9,10 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.11 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.12 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.13

About Legend Biotech
Legend Biotech is a clinical stage biopharmaceutical company engaged in the discovery and development of novel cell therapies in hematology/oncology, infectious diseases and auto-immune disorders. Legend is a subsidiary of GenScript Biotech Corporation (HKEx: 1548), which operates in USA, Hong Kong, mainland China and Ireland. Learn more at www.LegendBiotech.com.

Cautions Concerning Forward-Looking Statements
This information constitutes forward-looking statements relating to the business of Legend Biotech USA Inc., Nanjing Legend Biotechnology Co. Ltd., and Legend Biotech Ireland Ltd. (“Legend”), including express or implied discussions regarding potential new products, potential new indications, or regarding potential future revenues from any such products. Such forward-looking statements reflect the current views of Legend’s management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements.

The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any particular revenue levels.

This information was factually accurate on the date it was published. Legend assumes no duty to update the information to reflect subsequent developments. Readers should not rely upon the information on this page as current or accurate after its publication date. In particular, Legend’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays or government regulation generally; Legend’s ability to obtain or maintain patent or other proprietary intellectual property protection, including the uncertainties involved in the US litigation process; competition in general; government, industry, and general public pricing and other
political pressures. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

References

1 European Medicines Agency. PRIME: priority medicines. Available at: https://www.ema.europa.eu/en/human[1]regulatory/research-development/prime-priority-medicines. Accessed March 2019.
2 Castella, M., Fernández de Larrea, C. and Martín-Antonio, B., 2018. Immunotherapy: a novel era of promising treatments for multiple myeloma. International journal of molecular sciences, 19(11), p.3613.
3 ClinicalTrials.gov. LCAR-B38M-02 cells in treating relapsed/refractory (R/R) multiple myeloma (LEGEND-2).NCT03090659. Available at: https://clinicaltrials.gov/ct2/show/NCT03090659 accessed November 2018 4 Cho SF, Anderson KC, Tai YT. Targeting B-cell maturation antigen (BCMA) in multiple myeloma: potential uses of BCMA-based immunotherapy. Front Immunol. 2018;9:18-21.
5 American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: https://www.cancer.net/cancer-types/multiple-myeloma/introduction Last accessed March 2019.
6 GLOBOCAN 2018. Cancer Today Population Factsheets: Europe Region. Available at:
https://gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-sheets.pdf Last accessed February 2019.
7 De Angelis R, Minicozzi P, Sant M, et al. Survival variations by country and age for lymphoid and myeloid malignancies in Europe 2000-2007: results of EUROCARE-5 population-based study. Eur J Cancer. 2015;51:2254-68.
8 Abdi J, Chen G, Chang H, et al. Drug resistance in multiple myeloma: latest findings and new concepts on molecular mechanisms. Oncotarget. 2013;4:2186–2207.
9 National Cancer Institute. NCI dictionary of cancer terms: refractory. Available at:
https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=350245 Last accessed March 2019.
10 Richardson P, Mitsiades C, Schlossman R, et al. The treatment of relapsed and refractory multiple myeloma. Hematology Am Soc Hematol Educ Program. 2007:317-23.
11 National Cancer Institute. NCI dictionary of cancer terms: relapsed. Available at:
https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=45866 Last accessed March 2019.
12 American Cancer Society. Multiple myeloma: early detection, diagnosis and staging. Available at:
https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf Last accessed March 2019.
13 Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012;26:149-57.

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