Business Wire

Updated Data from Phase 1/2 Open-Label Study of BCMA-Directed CAR-T Cell Therapy LCAR-B38M Show Tolerable Safety Profile, High Overall Response and MRD Negative Rate in Treatment of Patients with Advanced R/R Multiple Myeloma1

Jaa

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 2018 American Society of Hematology (ASH) Annual Meeting (Abstract #955),1 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 Meeting2 and the 2017 European Hematology Association (EHA) Meeting.3 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.1

“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 pre-treated patients with multiple myeloma, a population that traditionally has been difficult to treat.”

In this study update, 57 patients with advanced R/R multiple myeloma received LCAR-B38M CAR-T cell therapy. The median age of the patients was 54 years (range, 27-72); median number of prior therapies was three (range, 1–9); and 74 percent of patients had Stage III disease by Durie-Salmon staging.1 According to study findings, there was an 88 percent overall response rate (95 percent confidence interval [CI]: 76-95). Complete response (CR) was achieved by 74 percent of patients (95 percent CI, 60-85); very good partial response was achieved by four percent of patients (2/57 patients; 95 percent CI, 0.4-12) and partial response was achieved by 11 percent of patients (95 percent CI, 4-22).4 Notably, among 42 patients with CR, 39 patients (68 percent) were minimal residual disease (MRD) negative in the bone marrow as measured by 8-colour flow cytometry. With a median follow-up of 12 months, the median duration of response was 16 months (95 percent CI: 12-not reached [NR]) and a median progression-free survival (PFS) of 15 months for all patients was observed. Among the patients who achieved an MRD negative CR, the median PFS was 24 months.1

The most common adverse events (AEs) were pyrexia (91 percent), cytokine release syndrome (CRS) (90 percent), thrombocytopenia (49 percent), and leukopenia (47 percent). In patients who experienced Grade ≥3 AEs (65 percent), the most common were leukopenia (30 percent), thrombocytopenia (23 percent) and increased aspartate aminotransferase (21 percent).4 CRS was mostly Grade 1 (47 percent) and 2 (35 percent). However, four patients (7 percent) experienced Grade 3 CRS. The median time to onset of CRS was nine days (range, 1–19). All but one of the CRS events resolved, with a median duration of nine days (range, 3–57). Neurotoxicity was observed in one patient who had Grade 1 aphasia, agitation, and seizure-like activity. Overall, 17 patients died during the study and follow-up period; causes of death were progressive disease (PD; n=14), suicide after PD (n=1), oesophagitis (n=1), and pulmonary embolism and acute coronary syndrome (n=1).1

“Janssen has a long-standing commitment to improving outcomes for patients with multiple myeloma, so these early data are encouraging as to the potential difference this investigational therapy could make to patients with relapsed or refractory disease,” said Dr Catherine Taylor, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag Limited. “We will further explore the safety and efficacy profile of this important BCMA-targeted immunotherapy, with the aim of understanding the potential role it could play as a novel approach for treating patients with multiple myeloma.”

In December 2017, Janssen entered into a worldwide collaboration and licence agreement with Legend Biotech, USA Inc, and Legend Biotech Ireland Limited ("Legend"), subsidiaries of GenScript Biotech Corporation, to jointly develop and commercialise LCAR-B38M in multiple myeloma.5 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.1 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.

While LCAR-B38M identifies the investigational product being studied in China, the investigational product being studied in the US/EU is identified as JNJ-68284528; both terms are representative of the same CAR-T therapy. 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.6 The study is currently enrolling patients following U.S. Food and Drug Administration clearance of an Investigational New Drug application as announced in May 2018.7

#ENDS#

About LEGEND-2

LEGEND-2 (NCT03090659) is an ongoing Phase 1/2, single-arm, open-label programme in China comprised of four independent institutional studies being conducted at participating hospitals evaluating the efficacy and safety of LCAR-B38M for the treatment of patients with R/R multiple myeloma.8

About CAR-T and 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.9 By targeting BCMA via a CAR-T approach, CAR-T therapies may have the potential to redefine the treatment paradigm for multiple myeloma and potentially advance towards cures for patients with the disease.

About Multiple Myeloma

Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.10 More than 45,000 people were diagnosed with MM in Europe in 2016, and more than 29,000 patients died.11 Up to half of newly diagnosed patients do not reach five-year survival,12 and almost 29% of patients with MM will die within one year of diagnosis.13

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.14 Refractory MM is when a patient’s disease progresses within 60 days of their last therapy.15,16 Relapsed cancer is when the disease has returned after a period of initial, partial or complete remission.17 While some patients with MM 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.18 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.19

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com/emea. Follow us at www.twitter.com/janssenEMEA for our latest news.

Cilag GmbH International; Janssen Biotech, Inc.; Janssen Oncology, Inc. and Janssen-Cilag International NV are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

# # #

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of LCAR-B38M and JNJ-68284528. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, Janssen-Cilag Limited, Janssen Biotech, Inc., any of the Janssen Pharmaceutical Companies of Johnson & Johnson and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at  www.sec.gov www.jnj.com  or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

###

References

_________________________

1 Zhao WH, Liu J, Wang BY, et al. Updated analysis of a phase 1, open-label Study of LCAR-B38M, a chimeric antigen receptor T-cell therapy directed against B-cell maturation antigen, in patients with relapsed/refractory multiple myeloma. Presented at 60th Annual Meeting and Exposition of the American Society of Hematology (ASH), San Diego, CA, USA, 1-4 December 2018: Oral presentation.

2 Fan F, Zhao W, Liu J, et al. Durable remissions with BCMA specific chimeric antigen receptor (CAR)-modified T-cells in patients with refractory/relapsed multiple myeloma. J Clin Oncol. 2017;35(Suppl.):abstract LBA3001.

3 Zhang W, Zhao W, Liu J, et al. Phase 1, open-label trial of anti-BCMA chimeric antigen receptor T-cells in patients with relapsed/refractory multiple myeloma. Haematologica. 2017;102(Suppl.2):2-3 (abstract S103).

4 Zhao WH, Liu J, Wang BY, et al. Updated analysis of a phase 1, open-label Study of LCAR-B38M, a chimeric antigen receptor T-cell therapy directed against B-cell maturation antigen, in patients with relapsed/refractory multiple myeloma. Presented at 60th Annual Meeting and Exposition of the American Society of Hematology (ASH), San Diego, CA, USA, 1-4 December 2018: Abstract 955.

5 Johnson & Johnson. Janssen enters worldwide collaboration and license agreement with Chinese company Legend Biotech to develop investigational CAR-T anti-cancer therapy. Press release December 21, 2017. Available at: https://www.jnj.com/media-center/press-releases/janssen-enters-worldwide-collaboration-and-license-agreement-with-chinese-company-legend-biotech-to-develop-investigational-car-t-anti-cancer-therapy Last accessed November 2018.

6 ClinicalTrials.gov. A study of JNJ-68284528, a chimeric antigen receptor T-cell (CAR-T) therapy directed against B-cell maturation antigen (BCMA) in participants with relapsed or refractory multiple myeloma. NCT03548207. Available at: https://clinicaltrials.gov/ct2/show/NCT03548207 Last accessed November 2018.

7 Janssen. Janssen Announces Initiation of Phase 1b/2 Clinical Development Program Evaluating JNJ-68284528 CAR-T Cells for the Treatment of Multiple Myeloma. Available at: https://www.janssen.com/janssen-announces-initiation-phase-1b2-clinical-development-program-evaluating-jnj-68284528-car-t Last accessed November 2018.

8 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 Last accessed November 2018.

9 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.

10 American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: https://www.cancer.net/cancer-types/multiple-myeloma/introduction Last accessed November 2018.

11 Cowan AJ, Allen C, Barac A, et al. Global burden of multiple myeloma: a systematic analysis for the Global Burden of Disease Study 2016. JAMA Oncol. 2018;4:1221-1227 + data supplement.

12 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.

13 Costa LJ, Gonresalves WI, Kumar SK. Early mortality in multiple myeloma. Leukemia. 2015;29:1616-8.

14 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.

15 National Cancer Institute. NCI dictionary of cancer terms: refractory. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=350245 Last accessed November 2018.

16 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.

17 National Cancer Institute. NCI dictionary of cancer terms: relapsed. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=45866 Last accessed November 2018.

18 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 November 2018.

19 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.

PHEM/JAN/1118/0003
December 2018

Contact information

Media Enquiries:
Natalie Buhl
Mobile: +353 (0)85-744-6696
Email: nbuhl@its.jnj.com

Investor Relations:
Christopher DelOrefice
Phone: +1 732-524-2955

Lesley Fishman
Phone: +1 732-524-3922

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

RIBOMIC Announces Positive Top-Line Results from the Phase 1/2a Clinical Trial of RBM-007 (SUSHI Study) in Subjects with Wet Age-Related Macular Degeneration17.6.2019 16:15:00 EESTTiedote

RIBOMIC, Inc., a clinical stage pharmaceutical company specializing in aptamer therapeutics and traded on the Mothers Market of the Tokyo Stock Exchange (Code Number: 4591), today announced positive top-line results from its SUSHI study, Phase 1/2a single ascending dose clinical study of RBM-007, anti-FGF2 aptamer, in nine subjects with wet Age-Related Macular Degeneration (wet AMD). SUSHI study achieved the primary endpoint of safety and tolerability, and also demonstrated efficacy trends in favor of RBM-007. Subjects recruited for the SUSHI Study had wet AMD that was poorly responsive to previous intravitreal anti-VEGF therapy. Through the 56-Day exit visit, excluding one uncompleted case in the last cohort, single dose of RBM-007 demonstrated no dose-limiting toxicities, no systemic or ocular serious adverse events. One subject in Cohort 3 showed anterior inflammation, which was resolved after one day of topical prednisolone treatment. Rescue treatment with anti-VEGF therapy was ava

ECB Chooses SIA And Colt for the Access Network to the Eurosystem’s Payments, Securities and Collateral Infrastructures17.6.2019 16:00:00 EESTTiedote

SIA, in partnership with Colt Technology Services, has won a tender commissioned by the European Central Bank for the provisioning of connectivity services allowing European central and commercial banks, central depositories, automated clearing houses and other payment service providers to connect directly to Eurosystem market infrastructures through a single access interface (Eurosystem Single Market Infrastructure Gateway - ESMIG). Thanks to the concession granted to SIA and Colt as Network Service Providers for the ESMIG, starting from November 2021, all the key organisations in the European financial system will be able to access the platform for the settlement of large-value payments TARGET2, the instant payments settlement service TIPS, the securities settlement platform TARGET2-Securities (T2S), the Eurosystem Collateral Management System (ECMS) and possibly other new services and applications. ESMIG is a fundamental component in the implementation of the TARGET2 and TARGET2-Sec

WPP and iHeartMedia Launch ‘Project Listen’17.6.2019 15:00:00 EESTTiedote

iHeartMedia, America’s leading audio company, and WPP, the creative transformation company, today announced the launch of Project Listen to develop next-generation insights, planning and creative capabilities in audio. The two companies will help brands better engage with consumers and win across all audio platforms: broadcast radio, digital streaming, podcasts, smart speakers and live events. Consumer listening is at an all-time high, according to new iHeartMedia research. The study shows consumers say they are listening to audio content for an average of 17 hours a week, with millennials and younger generations listening the most. This ramp up in listening is the direct result of the rapid growth of digital streaming, podcasts, smart speakers and airpods, on top of the massive and consistent scale of broadcast radio. The new partnership comprises: Creative Audio Studio – Audio will be pushed higher on the agendas of creatives and media strategists with the launch of a new studio at G

GENECAST Launches BRAF Mutation Test Kits with the Highest Detection Sensitivity 0.0001%17.6.2019 15:00:00 EESTTiedote

GENECAST, cancer diagnostics company through liquid biopsy, today announced the launch of ADPSTM BRAF, EGFR, JAK2 mutation test kits with the highest detection sensitivity for Research Use Only (RUO). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190617005007/en/ GENECAST, cancer diagnostics company through liquid biopsy, launched ADPSTM BRAF, EGFR, JAK2 mutation test kits with the highest detection sensitivity for Research Use Only (RUO). ADPS(TM) BRAF Mutation Test Kit (RUO) (Photo: Business Wire) Especially ADPSTM BRAF mutation test kit has 0.0001% detection sensitivity which is 100 times higher than any other products, as well as EGFR and JAK2 mutation kits have the high detection sensitivity of 0.01%. Detection sensitivity is the most important indicator of determining the accuracy of liquid biopsy. According to Butler TM, Spellman PT, Gray J. Circulating-tumor DNA as an early detection and diagnostic tool. Curr Opin G

AB InBev Rolls Out PureDraught™ System to Keep Beer Fresh Longer, Reduce Carbon Footprint17.6.2019 15:00:00 EESTTiedote

AB InBev, through its Global Innovation and Technology Center (GITEC), is introducing PureDraught™, a one-way, polymer keg system that keeps beer fresher up to four times longer than a traditional steel keg and reduces the carbon footprint of shipping beer – all while offering more versatility and variety for bar and restaurant owners. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190617005244/en/ PureDraught™ comes in 6L, 12L and 18L sizes rather than the standard 30L or larger steel keg size, allowing for more flexibility and less wasted product by bar and restaurant owners. The kegs can be stored and dispensed from upright or on their side on a shelf, making them more versatile. (Photo: AB InBev GITEC) While beer delivered in a traditional steel keg is still preferred for beers produced and consumed locally or regionally, it produces a number of costly logistical and environmental issues that are magnified when shipped i

GSMA Debunks False Claims Threatening Future of 5G17.6.2019 14:04:00 EESTTiedote

The GSMA today hit out against false claims that 5G systems will harm other services, such as weather forecasting. The mobile industry has already demonstrated within leading international standards bodies that 5G can be used safely alongside other services, including weather sensing services, commercial satellite, radar and other applications using adjacent airwaves. The GSMA is confident that 5G services and weather sensing services can co-exist, and warns against giving credence to those claiming a negative impact from 5G networks on weather forecasting data. “5G and weather forecasts can and will co-exist – it’s ludicrous to suggest otherwise,” said Brett Tarnutzer, Head of Spectrum, GSMA. “To suggest that our 7-day forecast will go away with 5G is simply fake news. We cannot allow these scare tactics to prevent us from reaping the huge societal and economic benefits of 5G networks. We urge everyone to simply look at the facts and not get drawn in by misleading rhetoric.” The fact

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme