BEERSE, Belgium, June 2, 2015 /PRNewswire/ --
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Results from the Phase 2 MMY2002 trial (Abstract LBA8512) featured in the official press programme of the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO)
Data from the international, multi-centre, open-label two part, single arm Phase 2 MMY2002 (SIRIUS) trial show treatment with single-agent daratumumab - an investigational, human anti-CD38 monoclonal antibody - achieved an overall response rate (ORR) of 29.2 percent (95% CI, 20.8-38.9), as assessed by an independent review committee, in heavily pre-treated patients with multiple myeloma.[1] The ORR was consistent among the pre-specified subgroups based on age, prior lines of therapy, type of myeloma and baseline renal function.
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Median duration of response was 7.4 months (95% CI, 5.5-not estimable).[1] Ninety-five percent of patients in the study were double refractory to a proteasome inhibitor (PI) and immunomodulatory drug (IMiD). Patients received a median of five prior lines of therapy, including a PI and an IMiD. No patients discontinued treatment due to infusion-related reactions (IRRs) and 4.7 percent of patients discontinued treatment due to adverse events (AEs), none of which were considered drug-related.
Janssen-Cilag International NV (Janssen) announced the data, which will be included during the official press programme at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. These data will be presented today in full during the myeloma oral abstract session at 11:21 CT (18:21 CET) by lead investigator Sagar Lonial, M.D., Chief Medical Officer, Winship Cancer Institute of Emory University and Professor and Executive Vice Chair, Department of Hematology and Medical Oncology, Emory University School of Medicine. In addition, the data will be presented as an encore at Europe's most prestigious haematology specialist congress - the European Hematology Association Annual Meeting - taking place 11-14 June, 2015 in Vienna, Austria.
"It is particularly noteworthy to see this level of response with a single agent in a heavily pre-treated population. Ninety-seven percent of the people in this study were refractory to their last line of therapy, and 95 percent were double refractory to both a PI and an IMiD" said Dr. Lonial. "These findings speak to the potential of daratumumab for people with multiple myeloma who have exhausted currently available treatment options."
In part one of this ongoing international, multi-centre, open-label, two-part, single-arm study, 34 patients were randomised to receive either 8 mg/kg of daratumumab once every four weeks (Q4W) or 16 mg/kg once a week (QW) for eight weeks, then once every two weeks (Q2W) for 16 weeks and once every four weeks (Q4W) following, until disease progression or unacceptable toxicity. In part two, 90 additional patients were enrolled to receive 16 mg/kg of daratumumab on the same dosing schedule as in part one. Results are reported for all patients in parts one and two treated with 16 mg/kg of daratumumab (n=106). Very good partial response (VGPR) or better was achieved in 12 percent (95% CI, 7-20) of patients, with three stringent complete responses (sCR) (95% CI, 0.6-8.0) and 10 very good partial responses (VGPR) (95% CI, 4.6-16.7) reported.[1] Median overall survival (OS) has not been reached, and the estimated one-year overall survival rate is 65 percent.[1] The median progression-free survival was 3.7 months. After a median follow up of 9.4 months, 45.2 percent of responders remain on therapy.[1]
"Janssen's commitment in oncology is stronger than ever, and the promising results of the MMY2002 study are an exciting step towards furthering our understanding of multiple myeloma and its treatment," said Thomas Stark, Vice President Medical Affairs, Janssen EMEA. "We are working tirelessly to develop new, innovative treatment options for the treatment of multiple myeloma, and are looking forward to the results from future studies investigating this compound, to truly address the significant unmet clinical needs in this disease area."
Serious adverse events (SAEs) occurred in 30 percent of patients. The most common AEs were fatigue (39.6 percent), anaemia (33 percent), nausea (29.2 percent), thrombocytopenia (25.5 percent), neutropenia (22.6 percent), back pain (22.6 percent) and cough (20.8 percent). Five patients (4.7 percent) discontinued treatment due to AEs, none of which were considered drug-related. Infusion-related reactions (IRR) were reported in 42.5 percent of patients and were predominantly grade 1 or 2 (4.7 percent grade 3; no grade 4 reported). These occurred mainly during the first infusion. The most common IRRs included nasal congestion (12 percent), throat irritation (7 percent), cough, dyspnoea, chills, and vomiting (6 percent each) - all of which were treated with standard of care and slower infusion rates.[1]
Daratumumab was granted Orphan Drug Status by the European Medicines Agency in July 2013 for the treatment of plasma cell myeloma.[2] On 20 May 2015, Janssen announced plans to submit a Biologics License Application (BLA) to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for daratumumab this year, based on these MMY2002 data.
In August 2012, Janssen Biotech, Inc. and Genmab entered an agreement which granted Janssen an exclusive license to develop, manufacture, and commercialise daratumumab. Janssen is currently the sponsor of all but one study globally.
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.[3] MM is the second most common form of blood cancer, with around 39,000 new cases in Europe in 2012.[4] MM most commonly affects people over the age of 65 and is more common in men than in women.[5] Across Europe, five-year survival rates are 23 percent to 47 percent of people diagnosed.[6] 25 percent of patients with MM will die within one year of diagnosis.[7],[8] Although treatment may result in remission, unfortunately patients will most likely relapse as there is currently no cure. While some patients with MM have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.[5]
About Daratumumab
Daratumumab is an investigational human IgG1K monoclonal antibody (mAb) that binds with high affinity to CD38 on the surface of multiple myeloma cells, inducing rapid tumour cell death through diverse mechanisms of action.[9] Daratumumab is in Phase 3 clinical development for multiple myeloma.
About Janssen
The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g. multiple myeloma and prostate cancer), immunology (e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain), infectious disease (e.g. HIV/AIDS, hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g. diabetes). Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. More information can be found on http://www.janssen-emea.com. Follow us on http://www.twitter.com/janssenEMEA for our latest news.
Janssen Pharmaceutical NV, Janssen Research & Development, LLC, Janssen Biotech, Inc., and Janssen-Cilag International NV are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Janssen in Oncology
In oncology, our goal is to fundamentally alter the way cancer is understood, diagnosed and managed, reinforcing our commitment to the patients who inspire us. In looking to find innovative ways to address the cancer challenge, our primary efforts focus on several treatment and prevention solutions. These include a focus on hematologic malignancies, prostate cancer and lung cancer; cancer interception with the goal of developing products that interrupt the carcinogenic process; biomarkers that may help guide targeted, individualised use of our therapies; as well as safe and effective identification and treatment of early changes in the tumour microenvironment.
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development. 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 any of the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in new product development, including the uncertainty of clinical success and of obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and description 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 28, 2014, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments.
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May 2015
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