CHMP Grants Positive Opinion for Expanded Use of Janssen’s Darzalex®▼(daratumumab) for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended broadening the existing marketing authorisation for Darzalex^® (daratumumab) to include the use of daratumumab in combination with lenalidomide and dexamethasone (DRd) for patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT).

“As multiple myeloma can become more complex with each relapse, it is important that patients receive the latest treatment options with the goal of extending their first remission period,” said Professor Thierry Facon, M.D., Service des Maladies du Sang, Hôpital Claude Huriez, Lille, France, and principal investigator of the MAIA study. “For newly diagnosed patients who are transplant ineligible, this regimen could be an important frontline therapy option and reinforces the consistent clinical profile of daratumumab.”

This Positive Opinion is based on results from the Phase 3 MAIA (MMY3008) study, published in The New England Journal of Medicine, ¹ and presented at the 2018 American Society of Hematology (ASH) Annual Meeting.

Additional information about the MAIA study can be found at www.ClinicalTrials.gov (NCT02252172).

“This recommendation marks an important step towards realising our ambition to improve outcomes for patients with multiple myeloma, right from diagnosis, especially for the majority of patients who are not eligible for transplant,” said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC.

“Daratumumab has been used to treat more than 100,000 patients worldwide and we look forward to working with regulatory authorities to bring this important therapy to even more patients with multiple myeloma,” adds Dr Patrick Laroche, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag France.

This Opinion will now be reviewed by the European Commission (EC), which has the authority to grant final approval of the indications.

Professor Thierry Facon was the principal investigator in the MAIA study. He was not compensated for any media work.

#ENDS#

About the MAIA (NCT02252172) Trial²
The randomised, open-label, multicentre Phase 3 study included 737 NDMM patients ineligible for high-dose chemotherapy and ASCT aged 45-90 years old (median age of 73 years). Patients were randomised to receive either daratumumab-Rd or Rd alone in 28-day Cycles. In the daratumumab-Rd treatment arm, patients received daratumumab 16 (mg/kg) IV weekly for Cycles 1 – 2, every two weeks for Cycles 3 – 6 and every 4 weeks for Cycle 7 and thereafter. The primary endpoint was Progression-Free Survival (PFS), defined as the time from date of randomisation to either progressive disease (PD), or death, whichever occurred first. Patients in the daratumumab-Rd and Rd treatment arm received 25 mg of lenalidomide on Days 1 – 21 of each 28-day Cycle, and dexamethasone at 40 mg once a week for each Cycle. Patients in both treatment arms continued until disease progression or unacceptable toxicity.

About daratumumab
Daratumumab is a first-in-class³ biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.⁴ Daratumumab is believed to induce tumour cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.⁵ A subset of myeloid derived suppressor cells (CD38+ MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were decreased by daratumumab.⁵ Since launch, it is estimated that 100,000 patients have been treated with daratumumab worldwide.⁶ Daratumumab is being evaluated in a comprehensive clinical development programme across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings.^{7,8,9,10,11,12,13,14} Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant haematologic diseases in which CD38 is expressed, such as smouldering myeloma.^15,16 For more information, please see www.clinicaltrials.gov.

The most frequent adverse reactions seen with daratumumab include infusion reactions, fatigue, nausea, diarrhoea, muscle spasms, pyrexia, cough, neutropenia, thrombocytopenia, anaemia, peripheral sensory neuropathy and upper respiratory tract infection.⁵

For further information on daratumumab, please see the Summary of Product Characteristics at https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex.

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive licence to develop, manufacture and commercialise daratumumab.¹⁷

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.¹⁸ In Europe, more than 48,200 people were diagnosed with MM in 2018, and more than 30,800 patients died.¹⁹ Almost 60 percent of patients with MM do not survive more than five years after diagnosis.²⁰

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.²¹ Refractory MM is when a patient’s disease progresses within 60 days of their last therapy.^22,23 Relapsed cancer is when the disease has returned after a period of initial, partial or complete remission.²⁴ 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.²⁵ Patients who relapse after treatment with standard therapies, including proteasome inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.²⁶

About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com/emea. Follow us at www.twitter.com/janssenEMEA for our latest news. Janssen-Cilag, Janssen Biotech, Inc. and Janssen Research & Development, LLC 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 the benefits of daratumumab for the treatment of patients with multiple myeloma. 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 of the Janssen Pharmaceutical Companies 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 30, 2018, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent 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. Neither the Janssen Pharmaceutical Companies of Johnson & Johnson nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

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References

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CP-110013
October 2019

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