Johnson & Johnson's Janssen Pharmaceutical Companies today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of a type II variant for CARVYKTI ® ▼ (ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of relapsed and refractory multiple myeloma (RRMM). The recommended indication for cilta-cel is the treatment of adult patients with RRMM who have received at least one prior treatment, including an immunomodulatory agent (IMiD) and a proteasome inhibitor (PI), have demonstrated disease progression with the latter. treatment and are refractory to lenalidomide. 2  Cilta-cel is the first chimeric antigen receptor T cell (CAR-T) treatment that has received a positive opinion from the CHMP for the treatment of this patient population, already after the first relapse. Cilta-cel is an innovative CAR-T treatment directed against B cell maturation antigen (BCMA), 3,4  a protein highly expressed on myeloma cells. 5

"Early resistance to standard treatments is increasingly common in patients with lenalidomide-refractory multiple myeloma, highlighting the need for new options at an earlier stage of treatment," said Edmond Chan, Ph.D. Medical Research, Senior Director and Head of Hematology Therapeutics Area EMEA at Janssen-Cilag Limited, a Johnson & Johnson company. 'Today's CHMP recommendation recognizes the potential of cilta-cel to significantly improve outcomes for eligible patients with relapsed and refractory multiple myeloma, starting after the first relapse.'

The CHMP recommendation of cilta-cel is based on data from the CARTITUDE-4 study ( NCT04181827 ), the first randomized phase 3 study evaluating the efficacy and safety profile of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma who have received between one and three previous lines of treatment. 2.6

“We are committed to the development of cilta-cel and other immunotherapies as we aim to improve outcomes for patients and redefine the paradigm of multiple myeloma treatment,” said Sen Zhuang, MD, vice president of Clinical Research and Development. from Johnson & Johnson Innovative Medicine. "Today's milestone represents an important step forward in the treatment of this complex disease and in our ultimate goal of one day achieving a cure."

Cilta-cel is currently approved under conditional marketing authorization (CCA) for the treatment of adults with RRMM after three prior lines of treatment. 3 The positive news is that the CHMP has now recommended converting the CCA into a standard marketing authorisation, as the obligations of the conditional authorization have been met. 2

About ciltacabtagene autoleucel (cilta-cel)

Cilta-cel  received  conditional marketing authorization from the European Commission in May 2022 for the treatment of adults with relapsed and refractory multiple myeloma who have received at least three prior treatments, including an IMiD , a PI and an anti-CD38 antibody, and who have shown disease progression with the latest treatment. 3,7  In February 2022, the US Food and Drug Administration (FDA)  approved  cilta-cel for the treatment of adults with relapsed and refractory multiple myeloma after four or more prior lines of treatment, including a PI, an IMiD and an anti-CD38 monoclonal antibody. 8,9  For a complete list of adverse events and information on dosage, administration, contraindications and other precautions when using cilta-cel, see the Summary of Product Characteristics. 3  In line with EMA regulations for new medicines and for those granted conditional approval, cilta-cel is subject to additional monitoring. 3

Cilta-cel is a genetically modified autogenous T cell immunotherapy, targeting B cell maturation antigens (BCMA), which involves reprogramming the patient's own T cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. 10  BCMA is mainly expressed on the surface of B-lineage cells of malignant multiple myeloma, as well as on advanced-stage B lymphocytes and plasma cells. 11,12  The cilta-cel CAR protein features two single-scope antibodies targeting BCMA, designed to transmit high avidity against human BCMA. 10  Modified CAR T cells express antigen receptor fusion proteins against tumor-associated surface antigens and T cell activation domains and, by binding to BCMA-expressing cells, redirect the effect of T cells and increase immunosurveillance specific for the tumor. 13

In December 2017, Janssen Biotech, Inc., a Johnson & Johnson company, entered into a global licensing and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialize cilta-cel. 14

About multiple myeloma

Multiple myeloma is an incurable hematological cancer that affects a type of white blood cells called plasma cells, found in the bone marrow. 15,16  In multiple myeloma, these malignant plasma cells continue to proliferate, accumulate in the body and displace normal blood cells, often causing bone breakdown and other serious complications. 16  In the European Union, it is estimated that in 2022 more than 35,000 people will be diagnosed with multiple myeloma and more than 22,700 patients will die. 17  While some patients with multiple myeloma have no symptoms initially, others may have frequent symptoms of the disease, which may include broken bones or pain, anemia, fatigue, hypercalcemia, infections, or kidney failure. 18

About Johnson & Johnson's Janssen Pharmaceutical Companies

At Janssen, we are creating a future where disease is a thing of the past. We, the Pharmaceutical Companies of Johnson & Johnson, are working tirelessly to make that future a reality for patients around the world, fighting disease with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: oncology, immunology, neuroscience, cardiovascular medicine, pulmonary hypertension and retina. 19

More information at  www.janssen.com/emea . Follow us at  www.linkedin.com/janssenEMEA  for the latest news. Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc. and Janssen Research & Development, LLC are part of Johnson & Johnson.

Cautions Regarding Forward-Looking Statements

This press release contains “forward-looking statements” as defined by the Private Litigation Reform Act of 1995 regarding product development and the potential benefits and impact of cilta-cel treatment. The reader is cautioned not to rely on these forward-looking statements. Such projections are based on current expectations of future events. If underlying assumptions prove inaccurate, or known or unknown risks or uncertainties materialize, actual results may vary materially from the expectations and projections of Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., Janssen Research & Development, LLC and/or Johnson & Johnson. These risks and uncertainties include, but are not limited to: challenges and uncertainties inherent to product research and development, including the uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents obtained by competitors; patent oppositions; changes in the behavior and spending patterns of purchasers of health products and services; changes to existing laws and regulations, including comprehensive healthcare reforms; and trends toward reducing health costs. 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, 2023, included in the sections subtitled "Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson'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  http://www.sec.gov/ ,  http://www.jnj.com/  or upon request from Johnson & Johnson. Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., Janssen Research & Development, LLC and Johnson & Johnson undertake no obligation to update forward-looking statements as a result of new information or future events or developments.

References

1  San-Miguel J. et al. Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma. New England Journal of Medicine. July 27, 2023; 389(4): 335-347.
2  European Medicines Agency. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2024. Available at:  https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human -use-chmp-19-22-february-2024 . Last consulted on: February 2024.
3  European Medicines Agency. CARVYKTI (Ciltacabtagén autoleucel) Summary of product characteristics. Available at:  https://www.ema.europa.eu/en/documents/product-information/carvykti-epar-product-information_en.pdf . Last accessed: February 2024.
4  De Novellis D. et al. Innovative Anti-CD38 and Anti-BCMA Targeted Therapies in Multiple Myeloma: Mechanisms of Action and Resistance. International Journal of Molecular Sciences. 2023; 24: 645.
5  Novak AJ, Darce JR et al. Expression of BCMA, TACI, and BAFF-R in MM: a mechanism for growth and survival. Blood. 2004; 103: 689-694.
6  ClinicalTrials.gov. A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4). Available at:  https://clinicaltrials.gov/study/NCT04181827 . Last accessed: February 2024.
7  Janssen.com. European Commission Grants Conditional Approval of CARVYKTI ®  (Ciltacabtagene Autoleucel), Janssen's First Cell Therapy, for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma. Available at:  https://www.janssen.com/emea/sites/www_janssen_com_emea/files/carvykti_ec_approval_press_release.pdf . Last accessed: February 2024.
8  JnJ.com US FDA Approves CARVYKTI™ (ciltacabtagene autoleucel), Janssen's First Cell Therapy, a BCMA-Directed CAR-T Immunotherapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma. Available at:  https://www.jnj.com/us-fda-approves-carvykti-ciltacabtagene-autoleucel-janssens-first-cell-therapy-a-bcma-directed-car-t-immunotherapy-for-the-treatment -of-patients-with-relapsed-or-refractory-multiple-myeloma . Last accessed: February 2024.
9  CARVYKTI ®  Prescribing Information. Horsham, PA: Janssen Biotech, Inc. Available at:  https://www.fda.gov/media/156560/download . Last accessed: February 2024.
10 Martin T. et al. Ciltacabtagene Autoleucel, an Anti–B-cell Maturation Antigen Chimeric Antigen Receptor T-Cell Therapy, for Relapsed/Refractory Multiple Myeloma: CARTITUDE-1 2-Year Follow-Up. Journal of Clinical Oncology. 2022; 41: 1265-1274.
11 Frerichs K. A. et al. Preclinical Activity of JNJ-7957, a Novel BCMA×CD3 Bispecific Antibody for the Treatment of Multiple Myeloma, Is Potentiated by Daratumumab. Clinical Cancer Research. 2020; 26(9): 2203-2215.
12 Cho S. F. et al. Targeting B Cell Maturation Antigen (BCMA) in Multiple Myeloma: Potential Uses of BCMA-Based Immunotherapy. Frontiers in Immunology. 2018; 10(9): 1821.
13 Tai Y. T. y Anderson K. C. Targeting B-cell maturation antigen in multiple myeloma. Immunotherapy. 2015; 7(11): 1187-1199.
14 JnJ.com Janssen Enters Worldwide Collaboration and License Agreement with Chinese Company Legend Biotech to Develop Investigational CAR-T Anti-Cancer Therapy. Disponible en: 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. Consultado por última vez en: febrero de 2024.
15 Abdi J. et al. Drug resistance in multiple myeloma: latest findings on molecular mechanisms. Oncotarget. 2013; 4(12): 2186-2207.
16 Sociedad Estadounidense de Oncología Clínica. Multiple myeloma: introduction. Disponible en: https://www.cancer.net/cancer-types/multiple-myeloma/introduction. Consultado por última vez en: febrero de 2024.
17 Sistema Europeo de Información sobre el Cáncer (ECIS). Estimates of cancer incidence and mortality in 2022, by country. Multiple myeloma. Disponible en: https://ecis.jrc.ec.europa.eu/explorer.php?$0-0$1-All$2-All$4-1,2$3-51$6-0,85$5-2022,2022$7-7$CEstByCountry$X0_8-3$X0_19-AE27$X0_20-No$CEstBySexByCountry$X1_8-3$X1_19-AE27$X1_-1-1$CEstByIndiByCountry$X2_8-3$X2_19-AE27$X2_20-No$CEstRelative$X3_8-3$X3_9-AE27$X3_19-AE27$CEstByCountryTable$X4_19-AE27. Consultado por última vez en: febrero de 2024.
18 Sociedad Estadounidense contra el Cáncer. Multiple myeloma: early detection, diagnosis and staging. Disponible en: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Consultado por última vez en: febrero de 2024.
19 Janssen.com. Janssen is now Johnson & Johnson Innovative Medicine. Disponible en: https://www.janssen.com/emea/johnson-johnson-innovative-medicine. Consultado por última vez en: febrero de 2024.

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