Business Wire

Subcutaneous Formulation of DARZALEX®▼(Daratumumab) Combination Resulted in Deep and Rapid Haematologic Responses and Improved Clinical Outcomes in the Treatment of Patients with Newly Diagnosed Light Chain (AL) Amyloidosis


The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results from the first randomised Phase 3 study investigating the subcutaneous (SC) formulation of DARZALEX®▼ (daratumumab) in the treatment of patients with newly diagnosed light chain (AL) amyloidosis, a rare and potentially fatal disease.1,2 The data demonstrated daratumumab SC in combination with cyclophosphamide, bortezomib, and dexamethasone (D-CyBorD) resulted in a significantly higher haematologic complete response rate (CR), 53 percent vs. 18 percent (P<0.0001), compared to CyBorD.3 Additionally, treatment with D-CyBorD delayed the time to major organ deterioration (MOD), haematologic progression or death (MOD-PFS), and enhanced event-free survival (MOD-EFS) based on MOD-PFS criteria with the time to initiation of next therapy.3 The combination showed a safety profile consistent with daratumumab SC or CyBorD alone.3

The results are being highlighted during a press briefing at the 25th European Hematology Association (EHA) Annual Congress today and will be presented during the late-breaking oral session on Sunday, June 14 at 03:00 p.m. CEST (Abstract LB2604).3

AL amyloidosis is a rare and potentially fatal multi-system disorder that occurs when the bone marrow produces abnormal pieces of antibodies called light chains, which clump together to form an amyloid.1 This amyloid is deposited in tissues and vital organs and interferes with normal organ function.1,2 As the disease progresses, many patients experience gradual deterioration to multiple organs, including the heart, kidneys, liver, nervous system and digestive tract.2 Prognosis is dependent on multiple factors including the pattern and number of organs involved and the treatment regimen.4,5 Patients with AL amyloidosis have a poor prognosis with an estimated median survival ranging from six months to three years depending on the patient population and data used.4 There are currently no therapy options approved by regulatory bodies such as the European Medicines Agency (EMA) or U.S. Food and Drug Administration (FDA) to treat this devastating disease.6,7

“Due to widely varying symptoms of AL amyloidosis, which can be mistaken for more common conditions, patients are often faced with a delayed diagnosis of several years. These delays to diagnosis and treatment impact on emotional wellbeing, and lead to poorer outcomes for patients,” said Giovanni Palladini, M.D., Ph.D., acting director of the Amyloidosis Research and Treatment Center at the University Hospital San Matteo in Pavia, Italy and study investigator*. “Current therapies focus on slowing the production of amyloid protein and managing symptoms, but there is no approved treatment for AL amyloidosis. The results of the ANDROMEDA study have demonstrated the potential of daratumumab for newly diagnosed patients with AL amyloidosis, which could fulfil a great unmet need and alleviate the burden of organ damage for these patients.”

Results from the ANDROMEDA study showed that the primary endpoint, haematologic CR rate, was 53 percent for D-CyBorD and 18 percent for CyBorD (Odds Ratio=5.1; 95 percent confidence interval [CI], 3.2-8.2; P<0.0001).3 In addition, patients receiving D-CyBorD achieved higher rates of overall haematologic response (92 percent vs. 77 percent) and very good partial response or better (≥VGPR; 79 percent vs. 49 percent) than patients receiving CyBorD.3 Among the 195 patients who responded to treatment in the D-CyBorD arm, median time to ≥VGPR/CR was 17/60 days compared to the 193 patients in the CyBorD arm whose median time to ≥VGPR was 25/85 days.3

The six-month organ response rate nearly doubled for patients treated with D-CyBorD versus CyBorD, for both cardiac (42 percent vs. 22 percent; P=0.0029) and renal (54 percent vs. 27 percent; P<0.0001) responses.3 Additionally, MOD-PFS (Hazard Ratio=0.58; 95 percent CI, 0.36-0.93, P=0.0224) and MOD-EFS (Hazard Ratio=0.40; 95 percent CI, 0.28-0.57, P<0.0001) favoured the D-CyBorD arm, demonstrating substantially delayed major organ deterioration, haematologic progression, or death, as well as improved event-free survival.3 In addition, the D-CyBorD arm, which is delivered subcutaneously, helps to limit intravenous fluid overload, an important treatment factor in the setting of cardiac compromised patients.3

“Through the daratumumab development programme, Janssen has deep expertise in diseases where CD38 is highly expressed. Daratumumab’s mode-of-action gives us an opportunity to treat the underlying cause of AL amyloidosis and potentially bring a new therapy option to patients living with this rare disease,” said Patrick Laroche, M.D., Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag. “Since launch daratumumab has treated over 130,000 patients worldwide and has become the foundation of multiple myeloma treatment, and we will continue to investigate its potential in diseases in which CD38 is expressed.”

The most common Grade 3/4 treatment emergent adverse events occurring in more than 5 percent of patients for the D-CyBorD arm compared to the CyBorD arm, included lymphopenia (13 percent vs. 10 percent), pneumonia (8 percent vs. 4 percent), diarrhoea (6 percent vs. 4 percent), cardiac failure (6 percent vs. 5 percent), neutropenia (5 percent vs. 3 percent), syncope (5 percent vs. 6 percent) and peripheral oedema (3 percent vs. 6 percent).3 The study showed daratumumab SC had a low rate of administration-related reactions (ARR).3 Systemic ARRs in the D-CyBorD arm occurred in 14 patients (7 percent), all were Grade 1-2 and most occurred during the initial administration. A total of 56 deaths occurred (D-CyBorD, n=27; CyBorD, n=29).3


In Europe, daratumumab is indicated:8

  • in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant
  • in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant
  • in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy
  • as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy

About the ANDROMEDA Study3,9

ANDROMEDA (NCT03201965) is an ongoing Phase 3, randomised, open-label study investigating the safety and efficacy of daratumumab SC in combination with cyclophosphamide, bortezomib and dexamethasone (CyBorD), compared to CyBorD alone, in the treatment of patients with newly diagnosed light chain (AL) amyloidosis.3,9 The study included 388 patients with newly diagnosed AL amyloidosis with measurable haematologic disease and one or more organs affected. The primary endpoint was overall complete haematologic response rate (intent-to-treat / ITT). Secondary endpoints included major organ deterioration, progression-free survival, event free survival, organ response rate, overall survival, and time to haematologic response, among others.3,9

About AL Amyloidosis

Light chain (AL) amyloidosis is a rare and potentially fatal haematologic disorder that can affect the function of multiple organs.1,2 The disease occurs when bone marrow produces abnormal pieces of antibodies called light chains, which clump together to form a substance called amyloid. These clumps of amyloid are deposited in tissues and vital organs and interfere with normal organ function, eventually causing organ deterioration.1,2 It is the most common type of amyloidosis. AL amyloidosis frequently affects the heart, kidneys, digestive tract, liver and nervous system and is potentially fatal if left untreated.1,2 Diagnosis is often delayed and prognosis is poor due to advanced, multi-organ, particularly cardiac, involvement.1,2 Approximately 30,000 to 45,000 patients in the United States and the European Union have AL amyloidosis.10

About daratumumab and daratumumab SC

Daratumumab is a first-in-class biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma (MM) cells, regardless of disease stage.8,11 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.11 A subset of myeloid derived suppressor cells (CD38+ MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) are decreased by daratumumab-mediated cell lysis.11

In Europe, daratumumab has been approved in five indications, three of which are in the frontline setting, including newly diagnosed MM patients who are transplant eligible and ineligible.8 In June 2020, daratumumab SC (daratumumab and hyaluronidase human-fihj) was approved the European Commission as the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma.12 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.12

Since launch, it is estimated that 130,000 patients have been treated with daratumumab worldwide.13

Daratumumab is being evaluated in a comprehensive clinical development programme across a range of treatment settings in MM, such as in frontline and relapsed settings.14,15,16,17,18,19,20,21 Additional studies are ongoing or planned to assess daratumumab SC’s potential in other malignant and pre-malignant haematologic diseases in which CD38 is expressed, such as smouldering myeloma and in AL amyloidosis.22,23 For more information, please see

For further information on daratumumab, please see the Summary of Product Characteristics at

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.24

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 Follow us at for our latest news. Janssen-Cilag, Janssen Pharmaceutica NV, and Janssen Biotech, Inc. 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, 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.
* Professor Giovanni Palladini has an ongoing contractual relationship with Janssen Pharmaceutica N.V.



1 Desport E, Bridoux F, Sirac C, Delbes S, Bender S, Fernandez B, Quellard N, Lacombe C, Goujon JM, Lavergne D, Abraham J. Al amyloidosis. Orphanet journal of rare diseases. 2012 Dec;7(1):54.
2 Merlini G, Comenzo RL, Seldin DC, Wechalekar A, Gertz MA. Immunoglobulin light chain amyloidosis. Expert review of hematology. 2014 Feb 1;7(1):143-56.
3 Kastritis, E. et al. Subcutaneous Daratumumab + Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis: Primary Results from the Phase 3 ANDROMEDA Study [LBA]. To be presented at European Hematology Association 2020 Annual Congress.
4 McCausland KL, White MK, Guthrie SD, Quock T, Finkel M, Lousada I, Bayliss MS. Light chain (AL) amyloidosis: the journey to diagnosis. The Patient-Patient-Centered Outcomes Research. 2018 Apr 1;11(2):207-16.
5 Quock TP, Yan T, Chang E, Guthrie S, Broder MS. Epidemiology of AL amyloidosis: a real-world study using US claims data. Blood advances. 2018 May 22;2(10):1046-53.
6 European Medicines Agency. EU/3/19/2222 – AL Amyloidosis. Available at: Last accessed: June 2020.
7 Leng S, Bhutani D, Lentzsch S. Amyloid Therapy and Targets. Clinical Lymphoma, Myeloma and Leukemia. 2019 Sep 1;19:S49-52.
8 European Medicines Agency. DARZALEX summary of product characteristics. Available at: Last accessed: June 2020.
9 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. NCT03201965. Available at: Last accessed: June 2020.
10 Lousada I, Comenzo RL, Landau H, Guthrie S, Merlini G. Light chain amyloidosis: patient experience survey from the Amyloidosis Research Consortium. Advances in therapy. 2015 Oct 1;32(10):920-8.
11 Sanchez L, Wang Y, Siegel DS, Wang ML. Daratumumab: a first-in-class CD38 monoclonal antibody for the treatment of multiple myeloma. J Hematol Oncol. 2016;9:51.
12 Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX®▼(daratumumab) Subcutaneous Formulation for all Currently Approved Daratumumab Intravenous Formulation Indications. Press Release June 04, 2020. Available at: Last accessed: June 2020.
13 [Data on file]. DARZALEX: New Patient Starts Launch to Date. RF-124148
14 A study to evaluate daratumumab in transplant eligible participants with previously untreated multiple myeloma (Cassiopeia). NCT02541383. Available at: Last accessed: June 2020 A study comparing daratumumab, lenalidomide, and dexamethasone with lenalidomide and dexamethasone in relapsed or refractory multiple myeloma. NCT02076009. Available at: Last accessed: June 2020.
16 Addition of daratumumab to combination of bortezomib and dexamethasone in participants with relapsed or refractory multiple myeloma. NCT02136134. Available at: Last accessed: June 2020.
17 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. NCT02195479. Available at: Last accessed: June 2020. Study comparing daratumumab, lenalidomide, and dexamethasone with lenalidomide and dexamethasone in participants with previously untreated multiple myeloma. NCT02252172. Available at: Last accessed: June 2020.
19 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). NCT03217812. Available at: Last accessed: June 2020. 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). NCT03180736. Available at: Last accessed: June 2020. Study of carfilzomib, daratumumab and dexamethasone for patients with relapsed and/or refractory multiple myeloma (CANDOR). NCT03158688. Available at: Last accessed: June 2020.
22 A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma. NCT03301220. Available at: Last accessed: June 2020. A Study of Daratumumab Monotherapy in Previously Untreated Patients With Stage 3B Light Chain (AL) Amyloidosis. NCT04131309. Available at: Last accessed: June 2020.
24 Johnson & Johnson. Janssen Biotech announces global license and development agreement for investigational anti-cancer agent daratumumab. Press release August 30, 2012. Available at: Last accessed: June 2020.

June 2020

Contact information

Media contact:
Noah Reymond
Mobile: +31 621 38 5718

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

Jennifer McIntyre
Office: +1 732-524-3922

About Business Wire

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

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

PTC Named Global Manufacturing Partner of the Year in the 2020 Microsoft Partner of the Year Awards14.7.2020 21:35:00 EESTPress release

PTC (NASDAQ: PTC) today announced it has been named the Global Manufacturing Partner of the Year, for the second year in a row, in the Microsoft 2020 Partner of the Year Awards. Honored among a global field of top Microsoft partners, PTC has demonstrated excellence in innovation and implementation of customer solutions based on Microsoft technology. This press release features multimedia. View the full release here: Honored among a global field of top Microsoft partners, PTC has demonstrated excellence in innovation and implementation of customer solutions based on Microsoft technology. “We are pleased to announce that PTC has been recognized by Microsoft as the Global Manufacturing Partner of the Year for the second consecutive year,” said Jim Heppelmann, President and CEO, PTC. “Together, PTC and Microsoft have enabled digital transformation for some of the world’s largest organizations. We look forward to continuing that succ

Spotify Launches in Russia and 12 Additional European Markets14.7.2020 20:30:00 EESTPress release

Spotify (NYSE: SPOT) today launched its service in 13 new markets across Europe including Russia, one of the world’s top 20 largest streaming markets. Already the world’s most popular audio streaming subscription service, with today’s expansion, Spotify now reaches a current total of 92 markets worldwide. Spotify’s 13 new markets include: Albania, Belarus, Bosnia & Herzegovina, Croatia, Kazakhstan, Kosovo, Moldova, Montenegro, North Macedonia, Russia, Serbia, Slovenia, Ukraine. As the leading platform driving music discovery on more types of devices than any other service, Spotify’s expansion in Europe comes as consumers in the region embrace streaming. According to the International Federation of the Phonographic Industry (IFPI), Russia is the 17th-biggest streaming market in the world and on pace to be the 10th-biggest streaming market by 2030. More than 87 percent of fans in Russia now access music through streaming, compared to 61 percent adoption globally, and 68 percent adoption

Pietro Rosa TBM Signs Multi-year Agreement With Boeing to Supply Titanium Forgings14.7.2020 19:08:00 EESTPress release

Pietro Rosa TBM is proud to announce that it has signed a long-term agreement with Boeing to supply forgings for use on the 787 Dreamliner, 777X and 737 MAX airplanes. This press release features multimedia. View the full release here: Left to right: Mauro Fioretti (Pietro Rosa TBM - President & CEO), Antonio De Palmas (Boeing Italy – President) (Photo: Business Wire) The agreement covers a variety of Titanium forgings and represents the first long-term agreement to be placed with Pietro Rosa TBM since the company’s milestone approvals with Boeing in 2018, enhancing Pietro Rosa TBM ability to enact its strategy for the provision of complex forged structural components. The deal with Boeing further reinforces the Pietro Rosa Groups' supply of products in North America. Mauro Fioretti, President and CEO of the Pietro Rosa Group, stated: “This commitment and great trust placed in us by Boeing further underpins our marketplace strat

Kollective Technology to Demonstrate Scalability of Microsoft Teams and Stream Live Events at Microsoft Experience and Technology Centers Worldwide14.7.2020 18:18:00 EESTPress release

Leading Software-Defined Enterprise Content Delivery Network (SD ECDN) provider Kollective Technology today announced that it was selected by Microsoft Corp. (Nasdaq: MSFT) to demonstrate the scalability of Microsoft Teams for live events at Microsoft Experience and Technology Centers worldwide. Designed to create comprehensive and immersive technology experiences for Microsoft customers looking to adopt innovations that accelerate their Digital Transformation initiatives, Microsoft Experience and Technology Centers highlight the latest in Modern Workplace use cases, including live video broadcasts. By selecting Kollective as the certified ECDN of Experience Centers, Microsoft can now easily showcase how Teams can deliver company-wide, global live events with the help of ECDN technology. Kollective’s ECDN platform, utilizing browser-based peering technology, scales Teams live events without the need to install software or invest in additional network infrastructure. Leveraging the Koll

rf IDEAS wins the HP® JetAdvantage 2020 Partner Award for Customer Focus14.7.2020 18:00:00 EESTPress release

rf IDEAS is proud to have received the HP JetAdvantage Partner Award for Customer Focus, presented by HP during its 2020 Partner Conference, held online for participant safety from May 18 to May 22. This press release features multimedia. View the full release here: HP JetAdvantage Partner Award for Customer Focus (Photo: Business Wire) rf IDEAS is a leading manufacturer of credential readers for logical access and authentication. The HP JetAdvantage Partner Program offers services and resources to help solution providers accelerate development, simplify deployment and streamline integration with HP imaging and printing devices. Through the program, HP and rf IDEAS have worked together for more than 12 years to bring contactless authentication and identification to HP enterprise applications and to HP JetAdvantage Solutions Partners worldwide. One quality that sets rf IDEAS apart is the company’s unwavering commitment to custome

Andersen Global Enters Trinidad and Tobago14.7.2020 16:30:00 EESTPress release

Andersen Global continues its expansion in the Caribbean by way of a Collaboration Agreement with full-service tax firm Robley Baynes, marking the organization’s debut in Trinidad and Tobago. Established in 2018, the firm provides a full scope of services including tax and advisory, financial, corporate and management. Led by Partners Kendell Robley and Mikhail Baynes, the dynamic and innovative firm assists clients with value-added solutions focused on business improvement and growth, leveraging their resources and experience across a wide range of client engagements. “We constantly strive to provide best-in-class, client-focused solutions with a high-caliber team of professionals,” Kendell and Mikhail said. “Our collaboration with Andersen Global will allow us to expand our capacity and global footprint, bringing opportunities for broader and more seamless service globally.” “We are delighted to work with Kendall, Mikhail and their team in Trinidad and Tobago. Collaborating with Robl

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom