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Data from the APOLLO Study Show Clinically Meaningful Response with DARZALEX®▼ (daratumumab) Subcutaneous Formulation Regimen After First or Subsequent Relapse in Multiple Myeloma

Results featured at ASH 2020 represent the first and only subcutaneous anti-CD38 in combination with pomalidomide and dexamethasone

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The Janssen Pharmaceutical Companies of Johnson & Johnson announced results of the Phase 3 APOLLO study showing that the addition of DARZALEX®▼ (daratumumab) subcutaneous (SC) formulation to pomalidomide and dexamethasone (D-Pd) significantly reduced the risk of progression or death by 37 percent, compared to Pd alone in patients with multiple myeloma (MM) after the first or subsequent relapse of disease.1 The APOLLO results, which will be presented on Sunday, December 6 at 9:00 p.m. CET during the American Society of Hematology (ASH) 2020 Annual Meeting and featured in the ASH press briefing (Abstract #112), add to the body of evidence supporting treatment with daratumumab SC-based regimens for patients with relapsed MM.

These data were the basis for recent regulatory submissions in Europe and the United States (U.S.) seeking approval for daratumumab SC in combination with Pd for the treatment of patients with relapsed or refractory MM, with two or more prior lines of therapy, including lenalidomide and a proteasome inhibitor (PI).2

“For patients with multiple myeloma who relapse, it is important that efficacious treatments significantly reduce the risk of progression. The data presented at ASH makes D-Pd a compelling treatment option for early relapsed or lenalidomide refractory patients,” said Meletios A. Dimopoulos, M.D.,* Professor and Chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine, Athens, Greece, and principal investigator. “The APOLLO study also highlights the potential benefits of the subcutaneous formulation of daratumumab, which offers patients and physicians a three- to five-minute injection experience and the potential to reduce infusion-related reactions compared to intravenous administration of daratumumab.”

Key Findings from the APOLLO Oral Presentation (Abstract #412):

  • The study met its primary endpoint of improved progression-free survival (PFS).1 When added to Pd, daratumumab SC significantly reduced the risk of progression or death by 37 percent, compared to Pd alone (hazard ratio, 0.63; 95 percent confidence interval, 0.47-0.85; P=0.0018).1 The median PFS for the D-Pd vs. Pd arms was 12.4 vs. 6.9 months, respectively.1
  • Response rates were significantly higher with D-Pd compared to Pd alone, including rates of overall response (69 percent vs. 46 percent), rates of very good partial response (VGPR) or better (51 percent vs. 20 percent), over six times the rate of complete response (CR) (25 percent vs. 4 percent) and over four times the rate of minimal residual disease-negativity (9 percent vs. 2 percent).1
  • The rate of infusion-related reactions with daratumumab SC was 5 percent (all Grade 1/2), and 2 percent of patients had local injection-site reactions (all Grade 1). Median duration of administration was five minutes.1 Both of these parameters are in line with what has previously been reported for daratumumab SC.
  • The rates of study treatment discontinuation due to treatment emergent adverse events were similar for D-Pd vs. Pd (2 percent vs. 3 percent).1

The safety profile of D-Pd is consistent with known profiles of daratumumab SC and Pd. The most common Grade 3/4 treatment-emergent adverse events (TEAEs) were neutropenia (68% vs. 51%), anaemia (17% vs. 21%), thrombocytopenia (17% vs. 18%), and leukopenia (17% vs. 5%). The most common serious TEAEs were pneumonia (13% vs. 7%) and lower respiratory tract infection (11% vs. 9%).1

“Despite much progress over the last decade, multiple myeloma remains a disease with considerable unmet need, with many patients progressing or relapsing on their initial treatment,” said Dr Catherine Taylor, VP, Medical Affairs Therapeutic Area Strategy, Europe, Middle East and Africa (EMEA), Janssen-Cilag Ltd., Middle East. “At Janssen, we continually strive to address the complex needs of these patients and are devoted to pursuing new treatment formulations, such as daratumumab SC, as part of different treatment regimens.”

“We are encouraged by the efficacy of this combination with daratumumab SC, which has improved outcomes over pomalidomide-dexamethasone, a widely used regimen for patients with relapsed or refractory myeloma who have received prior treatment with lenalidomide,” said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Janssen Research & Development, LLC. “Together with the reduced infusion time for patients receiving daratumumab SC as compared to the intravenous formulation, the APOLLO study results further solidify this differentiated anti-CD38 monoclonal antibody as a foundational treatment in multiple myeloma for patients who are in need of additional treatment options.”

*Meletios A. Dimopoulos is lead investigator of the APOLLO study and was not compensated for any media work

#ENDS#

About the APOLLO Study3

APOLLO (NCT01960348) is an ongoing multicentre, Phase 3, randomised, open-label study comparing daratumumab SC, pomalidomide and low-dose dexamethasone with pomalidomide and low-dose dexamethasone alone in patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen with both lenalidomide and a proteasome inhibitor and have demonstrated disease progression. The study, which was conducted in collaboration with the European Myeloma Network, enrolled 304 participants.

The primary endpoint is progression-free survival (PFS) between treatment arms. Secondary endpoints include rates of overall response rate (ORR), very good partial response (VGPR) or better, complete response (CR) or better and duration of response, among others. The study reinforces findings from the Phase 1b EQUULEUS (MMY1001) trial, which formed the grounds for U.S. Food and Drug Administration (FDA) approval of intravenous D-Pd in 2017 for the treatment of relapsed and refractory multiple myeloma. In November 2020, Janssen submitted regulatory applications to the U.S. FDA and European Medicines Agency (EMA) seeking approval of the combination of D-Pd for the treatment of patients with relapsed or refractory multiple myeloma with ≥2 prior lines of therapy, including lenalidomide and a PI.

About daratumumab and daratumumab SC

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialise daratumumab. Since launch, it is estimated that more than 150,000 patients have been treated with daratumumab worldwide.4 Daratumumab is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma. Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.5

CD38 is a surface protein that is highly expressed across multiple myeloma cells, regardless of the stage of disease. Daratumumab SC binds to CD38 and induces myeloma 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.6

Data across nine Phase 3 clinical trials in multiple myeloma and light chain (AL) amyloidosis, in both the frontline and relapsed settings, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival.7,8,9,10,11,12,13,14,15 Additional studies have been designed to assess the efficacy and safety of daratumumab SC in the treatment of other malignant and pre-malignant haematologic diseases in which CD38 is expressed, including smouldering myeloma.16

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

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.17 In Europe, more than 48,200 people were diagnosed with MM in 2018, and more than 30,800 patients died.18 Around 50 percent of newly diagnosed patients do not reach five-year survival,19,20 and almost 29 percent of patients with multiple myeloma will die within one year of diagnosis.21

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.22 Relapsed and refractory myeloma is defined as disease that is nonresponsive while on salvage therapy, or progresses within 60 days of last therapy in patients who have achieved minimal response (MR) or better at some point previously before then progressing in their disease course.23 While some patients with MM have no symptoms at all, others are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.24 Patients who relapse after treatment with standard therapies, including proteasome inhibitors and immunomodulatory agents, have poor prognoses and require new therapies for continued disease control.25

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 Research & Development, LLC, Janssen Biotech, Inc., and Janssen-Cilag Ltd., Middle East 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 and projections of 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 29, 2019, 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. 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.

ENHANZE® is a registered trademark of Halozyme.

References

1 Dimopoulos, MA et al. APOLLO: Phase 3 Randomized Study of Subcutaneous Daratumumab Plus Pomalidomide and Dexamethasone (D-Pd) Versus Pomalidomide and Dexamethasone (Pd) Alone in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM). Abstract #412. Oral presentation, to be presented at 2020 American Society of Hematology Annual Meeting.

2 Janssen Submits Applications in the EU and U.S. Seeking Approval of DARZALEX®▼ (daratumumab) Subcutaneous Formulation in Combination With Pomalidomide and Dexamethasone for Patients With Relapsed or Refractory Multiple Myeloma. Janssen EMEA, 12 Nov. 2020. https://www.janssen.com/emea/sites/www_janssen_com_emea/files/janssen_submits_applications_in_the_eu_and_u.s._seeking_approval_of_darzalex_daratumumab_subcutaneous_formulation_in_combination_with_pomalidomide_and_dexamethasone.pdf. Last accessed: December 2020.

3 Comparison of Pomalidomide and Dexamethasone With or Without Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Previously Treated With Lenalidomide and a Proteasome Inhibitor Daratumumab/Pomalidomide/Dexamethasone vs Pomalidomide/Dexamethasone (EMN14). Available at: https://clinicaltrials.gov/ct2/show/record/NCT03180736. Last accessed: December 2020.

4 Janssen [data on file]. Number of patients treated with DARZALEX worldwide as of October 2020. RF-145436.

5 Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX®▼(Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: www.businesswire.com/news/home/20200604005487/en/European-Commission-Grants-Marketing-Authorisation-for-DARZALEX%C2%AE%E2%96%BC-daratumumab-Subcutaneous-Formulation-for-all-Currently-Approved-Daratumumab-Intravenous-Formulation-Indications. Last accessed: December 2020.

6 European Medicines Agency. DARZALEX Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf Last accessed: December 2020.

7 Janssen Research & Development, LLC. A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02076009?term=mmy3003&rank=1 Identifier: NCT02136134. Last accessed: December 2020.

8 Janssen Research & Development, LLC. Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02136134?term=mmy3004&rank=1 Identifier: NCT02076009. Last accessed: December 2020.

9 Janssen Research & Development, LLC. A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma (Cassiopeia). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02541383?term=mmy3006 Identifier: NCT02541383. Last accessed: December 2020.

10 Janssen Research & Development, LLC. A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02195479?term=mmy3007&rank=1 Identifier: NCT02195479. Last accessed: December 2020.

11 Janssen Research & Development, LLC. Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT02252172?term=mmy3008&rank=1 Identifier: NCT02252172. Last accessed: December 2020.

12 Janssen Research & Development, LLC. A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24]. Available at: https://clinicaltrials.gov/ct2/show/NCT03217812?term=MMY3011&rank=1 Identifier: NCT03217812. Last accessed: December 2020.

13 European Myeloma Network. Compare Progression Free Survival Btw Daratumumab/Pomalidomide/Dexamethasone vs Pomalidomide/Dexamethasone (EMN14). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24] Available at: https://clinicaltrials.gov/ct2/show/NCT03180736?term=MMY3013&rank=2 Identifier: NCT03180736. Last accessed: December 2020.

14 Amgen. Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma. (CANDOR). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2018 July 24] Available at: https://clinicaltrials.gov/ct2/show/NCT03158688?term=NCT03158688&rank=1 Identifier: NCT03158688. Last accessed: December 2020.

15 ClinicalTrials.Gov. A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis. Available at: https://clinicaltrials.gov/ct2/show/NCT03201965 Last accessed: December 2020.

16 ClinicalTrials.Gov. A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma. Available at: https://clinicaltrials.gov/ct2/show/NCT03301220 Last accessed: December 2020.

17 American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: https://www.cancer.net/cancer-types/multiple-myeloma/introduction Last accessed: December 2020.

18 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: December 2020.

19 American Society of Clinical Oncology. Multiple Myeloma: Statistics. Available at: https://www.cancer.net/cancer-types/multiple-myeloma/statistics Last accessed: December 2020.

20 Cancer Research UK. Myeloma statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/myeloma Last accessed November 2020.

21 Costa LJ, Gonsalves WI, Kumar SK. Early mortality in multiple myeloma. Leukemia. 2015;29:16168.

22 Abdi J, Chen G, Chang H, et al. Drug resistance in multiple myeloma: latest findings and new concepts on molecular mechanisms. Oncotarget. 2013;4:2186–207.

23 Rajkumar SV, Harousseau JL, Durie B, Anderson KC, Dimopoulos M, Kyle R, Blade J, Richardson P, Orlowski R, Siegel D, Jagannath S. Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1. Blood, The Journal of the American Society of Hematology. 2011 May 5;117(18):4691-5

24 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 2020.

25 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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December 2020

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