[ad_1]
Business Announcement
- The main data from the randomized phase II study GRIFFIN in newly diagnosed, treatment-eligible multiple myeloma patients treated with daratumumab in combination with lenalidomide, bortezomib, and dexamethasone have shown that the primary endpoint is the study was a higher percentage of strict complete response in the daratumumab arm compared with patients treated with lenalidomide, bortezomib and dexamethasone alone
Copenhagen, Denmark; July 8, 2019 – Genmab A / S (Nasdaq Copenhagen: GEN) today announced that baseline data from the GRIFFIN Phase II study (MMY2004) on newly diagnosed patients with multiple myeloma and eligible for chemotherapy at baseline. high dose and autologous stem cell transplantation (ASCT), were treated with daratumumab in combination with lenalidomide, bortezomib and dexamethasone (VRd) met its primary endpoint, demonstrating a higher percentage complete, rigorous responses than patients who received VRd alone. Specifically, baseline data showed that 42.4% of patients treated with daratumumab in combination with VRd achieved a SSC, compared to 32.0% of patients who received VRd alone, with a odds ratio of 1 , 57 (95% CI: 0.87 – 2.82, p = 0.1359, exceeding statistical significance at the pre-defined bilateral alpha level of 0.2). The secondary endpoints, including the results of the minimal residual disease (MRD) badysis, corroborated the primary endpoint for daratumumab in combination with VRd.
Overall, the safety profile of daratumumab in combination with VRd was consistent with the safety profile of each treatment separately, which has been reported in previous studies of the dosing regimen. VRd as well as in previous studies on daratumumab.
Janssen Biotech, Inc., which licensed daratumumab from Genmab in 2012, plans to submit additional data for submission at a future medical conference.
"GRIFFIN Phase II Trial Data Highlights the Potential of Daratumumab when Used in Combination with VRd and Supports Janssen's Decision to Initiate Phase III PERSEUS and CEPHEUS Studies of Daratumumab in Combination with VRd for some indications of first-line multiple myeloma, "said Jan van de Winkel, Ph.D., chief executive of Genmab. "These data are also based on data on the efficacy and safety of daratumumab as first-line therapy for multiple myeloma patients eligible for transplantation, as shown in the Phase 2 study. CASSIOPEIA III in which newly diagnosed patients with multiple myeloma and ASCT candidates were treated with daratumumab. with an immunomodulatory drug and a proteasome inhibitor. "
About the GRIFFIN study (MMY2004)
This phase II study (NCT02874742) is a randomized, parallel-badignment study in which 223 patients with newly diagnosed multiple myeloma eligible for high-dose chemotherapy and autologous stem cell therapy participated. Patients were randomized to receive either daratumumab plus lenalidomide, bortezomib and dexamethasone, lenalidomide, bortezomib and dexamethasone alone. The primary endpoint of the study is the number of patients who achieved SSC before the end of consolidation therapy.
About multiple myeloma
Multiple myeloma is an incurable blood cancer that originates in the bone marrow and is characterized by excessive proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the United States after leukemia and lymphoma.2 Approximately 26,000 new patients are expected to be diagnosed with multiple myeloma and an estimated 13,650 people will die from the disease in the United States in 2018.3 Globally, an estimated 160,000 people have been diagnosed and 106,000 have died from the disease in 2018.4 Although some patients with multiple myeloma have no symptoms, most patients are diagnosed with symptoms that may include bone problems, low blood counts, elevated calcium levels, kidney problems, or infections.5
About DARZALEX® (Daratumumab)
DARZALEX® (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation ; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as monotherapy for the treatment of patients with multiple myeloma who have received at least three prior treatment lines, including an IP and an immunomodulatory agent, or who are refractory to PI and an immunomodulatory agent.6 DARZALEX is the first monoclonal antibody (MAb) approved by the US Food and Drug Administration (FDA) for the treatment of multiple myeloma. DARZALEX is indicated in Europe in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation; to be used 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; and as monotherapy for the treatment of adult patients with recurrent and refractory multiple myeloma whose previous therapy included PI and an immunomodulatory agent and who had demonstrated progression of the disease during the last course of treatment. The option to split the first injection of DARZALEX on two consecutive days has been approved in Europe and the United States. In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma. DARZALEX is the first human monoclonal antibody CD38 to be marketed. For more information, visit www.DARZALEX.com.
Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab causes the person's immune system to attack cancer cells, resulting in rapid death of tumor cells through multiple mechanisms of immune action and immunomodulatory effects, as well as direct death of tumor cells by apoptosis (programmed cell death).6,7,8,9,10
Daratumumab is developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and market Genmab daratumumab. A comprehensive clinical development program for daratumumab is underway and includes numerous phase III studies on smoldering, recurrent and first-line multiple myeloma, as well as amyloidosis. Additional studies are underway or planned to evaluate the potential of daratumumab in other precancerous and malignant diseases, such as NKT cell lymphoma, B-cell and T-cell LAL. Daratumumab has received two designations of US FDA's novel therapy for multiple myeloma, both as monotherapy and in combination with other therapies.
About Genmab
Genmab is a publicly traded international biotechnology company specializing in the creation and development of differentiated antibody therapies for the treatment of cancer. Founded in 1999, the company has two approved antibodies, DARZALEX.® (daratumumab) for the treatment of certain indications of multiple myeloma, and Arzerra® (ofatumumab) for the treatment of certain indications of chronic lymphocytic leukemia. Daratumumab is under clinical development for the treatment of other indications for multiple myeloma, other blood cancers and amyloidosis. A subcutaneous formulation of ofatumumab is being developed for the treatment of relapsing multiple sclerosis. Genmab also has a broad portfolio of clinical and preclinical products. Genmab's technological base includes validated and proprietary new generation antibody technologies: DuoBody.® platform for the generation of bispecific antibodies, the HexaBody® platform, which creates antibodies that improve effector function and HexElect® platform, which combines two HexaBody molecules acting in a co-dependent manner to introduce selectivity while maximizing therapeutic potency. The company intends to leverage these technologies to create full or future co-ownership opportunities for future products. Genmab has formed alliances with major pharmaceutical and biotechnology companies. For more information, visit www.genmab.com.
Contact:
Marisol Peron, Vice President, Communications and Investor Relations
T: +1 609 524 0065; E: [email protected]
For investor relations:
Andrew Carlsen, Senior Director, Investor Relations
T: +45 3377 9558; E: [email protected]
This company announcement contains forward-looking statements. The words "believe", "expect", "anticipate", "intend" and "plan", as well as similar expressions, refer to forward-looking statements. Actual results or performance may differ materially from future results or performance expressed or implied in such statements. Significant factors that could materially differ from our actual results or performance include, but are not limited to, the risks badociated with the preclinical and clinical development of the products, the uncertainties related to the results and the conduct of the clinical trials, including the problems unforeseen security uncertainties related to products. manufacturing, the lack of acceptance of our products in the market, our inability to manage growth, the competitive environment relative to our industry and markets, our inability to attract and retain qualified personnel, the inapplicability or lack of protection of our patents and our rights of ownership rights, our relationships with affiliated entities, technological changes and developments that may render our products obsolete, as well as other factors. For a more detailed discussion of these risks, please refer to the risk management sections of Genmab's latest financial reports, available at: www.genmab.com. Genmab badumes no obligation to update or revise the forward-looking statements contained in this Company Announcement or to confirm such statements to reflect events or circumstances subsequent to the date of publication or actual results, unless required by law.
Genmab A / S and / or its subsidiaries own the following brands: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in badociation with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®. Arzerra® is a trademark of Novartis AG or its subsidiaries. DARZALEX® is a trademark of Janssen Pharmaceutica NV.
1 American Cancer Society. "Overview of multiple myeloma." Available at http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myelomaAccessed in June 2016.
2 National Cancer Institute. "A snapshot of myeloma." Available at www.cancer.gov/research/progress/snapshots/myeloma. Accessed June 2016.
3 Globocan 2018. Fact Sheet on the United States of America. Available at http://gco.iarc.fr/today/data/factsheets/840-united-states-of-america-fact-sheets.pdf.Accès March 2019
4 Globocan 2018. World Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf. Accessed December 2018.
5 American Cancer Society. "How is myeloma diagnosed?" http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diagnosis. Accessed June 2016.
1 DARZALEX Dose Information, June 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036s020lbl.pdf Last accessed June 2019
7 From Weers, M et al. Daratumumab, a new human therapeutic monoclonal antibody CD38, induces the destruction of multiple myeloma and other hematologic tumors. The journal of immunology. 2011; 186: 1840-1848.
8 Overdijk, MB et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015; 7: 311-21.
9 Krejcik, MD et al. Daratumumab depletes CD38 + immunoregulatory cells, promotes T-cell expansion, and biases the T-cell repertoire in multiple myeloma. Some blood. 2016 128: 384-94.
ten Jansen, JH et al. Daratumumab, a human CD38 antibody, induces apoptosis of myeloma tumor cells via cross-linking mediated by the Fc receptor. Some blood. 2012; 120 (21): summary 2974.
Business Announcement no. 31
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A / S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
Source link
