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Janssen Enters Immunotherapy Clinical Collaboration with Bristol-Myers Squibb to Evaluate daratumumab (DARZALEX®) in Combination with nivolumab (OPDIVO®)
Phase 1b/Phase 2 studies planned in multiple myeloma and solid tumors
News provided by
Janssen Biotech, Inc.
Jan 05, 2017, 06:59 ET
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HORSHAM, Pa., Jan. 5, 2017 /PRNewswire/ -- Janssen Biotech, Inc. today announced that the company has entered a clinical trial collaboration with Bristol-Myers Squibb Company (BMS) to evaluate the combination of the first CD38-directed cytolytic antibody daratumumab (DARZALEX®) and checkpoint inhibitor nivolumab (OPDIVO®) in Phase 1b/Phase 2 clinical studies in multiple myeloma and several solid tumor types. Nivolumab is developed and commercialized by BMS. Janssen licensed daratumumab from Genmab A/S and is responsible for all global development, marketing and manufacturing.
The multiple myeloma study will evaluate the safety and tolerability of daratumumab in combination with nivolumab with or without pomalidomide and dexamethasone in relapsed/refractory multiple myeloma. The solid tumor studies will evaluate the safety, tolerability and clinical benefit of daratumumab combined with nivolumab in patients with advanced or metastatic tumors, including non-small cell lung, head and neck, pancreatic, colorectal and triple negative breast cancers. Additional tumor types may also be evaluated. Studies are expected to start this year.
"Immunotherapy has vastly changed the way cancer is treated. We are excited to study this novel combination of two potentially synergistic immunotherapies," said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen Research & Development, LLC. "This agreement allows us to extend our footprint in immuno-oncology and will be a significant addition to the growing body of clinical data for daratumumab in combination with other novel agents, in a variety of tumor types."
DARZALEX is the first CD38-directed cytolytic antibody approved anywhere in the world. It was first approved by the U.S. Food and Drug Administration (FDA) in November 2015 as a monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double refractory to a PI and immunomodulatory agent.1 It is also approved in Europe, Canada and several other countries for a similar patient population.
DARZALEX was more recently approved by the FDA in November 2016 for use in combination with lenalidomide (an immunomodulatory agent) and dexamethasone, or bortezomib (a PI) and dexamethasone, in patients with multiple myeloma who have received at least one prior therapy.2 DARZALEX received Breakthrough Therapy Designation from the FDA for this indication in July 2016.3
About DARZALEX® (daratumumab) Injection, for Intravenous Infusion
DARZALEX® (daratumumab) injection for intravenous use is the first CD38-directed cytolytic antibody approved anywhere in the world.1 CD38 is a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.4 Daratumumab is believed to induce tumor cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cellular 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 (MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were decreased by daratumumab.5 DARZALEX is being evaluated in a comprehensive clinical development program that includes five Phase 3 studies across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings.6,7,8,9,10 Additional studies are ongoing or planned to assess its potential for a solid tumor indication and in other malignant and pre-malignant diseases in which CD38 is expressed, such as smoldering myeloma and non-Hodgkin's lymphoma.11,12,13 DARZALEX was the first cytolytic antibody to receive regulatory approval to treat relapsed or refractory multiple myeloma.1
In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize DARZALEX.14 DARZALEX is commercialized in the U.S. by Janssen Biotech, Inc. For more information, visit http://www.DARZALEX.com.
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow.15,16 Refractory cancer occurs when a patient's disease is resistant to treatment or in the case of multiple myeloma, patients progress within 60 days of their last therapy.17,18 Relapsed cancer means the disease has returned after a period of initial partial or complete remission.19 Globally, it is estimated that 124,225 people were diagnosed, and 87,084 died from the disease in 2015.20,21 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone fracture or pain, low red blood counts, fatigue, calcium elevation, kidney problems or infections.22 Patients who relapse after treatment with standard therapies (including PIs or immunomodulatory agents) typically have poor prognoses and few remaining options.16
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS – None
WARNINGS AND PRECAUTIONS
Infusion Reactions – DARZALEX can cause severe infusion reactions. Approximately half of all patients experienced a reaction, most during the first infusion. Infusion reactions can also occur with subsequent infusions. Nearly all reactions occurred during infusion or within 4 hours of completing an infusion. Prior to the introduction of post-infusion medication in clinical trials, infusion reactions occurred up to 48 hours after infusion. Severe reactions have occurred, including bronchospasm, hypoxia, dyspnea, hypertension, laryngeal edema and pulmonary edema. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting and nausea. Less common symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, and hypotension.
Pre-medicate patients with antihistamines, antipyretics, and corticosteroids. Frequently monitor patients during the entire infusion. Interrupt infusion for reactions of any severity and institute medical management as needed. Permanently discontinue therapy for life-threatening (Grade 4) reactions. For patients with Grade 1, 2, or 3 reactions, reduce the infusion rate when re-starting the infusion.
To reduce the risk of delayed infusion reactions, administer oral corticosteroids to all patients following DARZALEX infusions. Patients with a history of chronic obstructive pulmonary disease may require additional post-infusion medications to manage respiratory complications. Consider prescribing short- and long-acting bronchodilators and inhaled corticosteroids for patients with chronic obstructive pulmonary disease.
Interference with Serological Testing - Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab infusion. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted. Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX®. Type and screen patients prior to starting DARZALEX®.
Neutropenia - DARZALEX may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. DARZALEX dose delay may be required to allow recovery of neutrophils. No dose reduction of DARZALEX is recommended. Consider supportive care with growth factors.
Thrombocytopenia - DARZALEX may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. DARZALEX dose delay may be required to allow recovery of platelets. No dose reduction of DARZALEX is recommended. Consider supportive care with transfusions.
Interference with Determination of Complete Response - Daratumumab is a human IgG kappa monoclonal antibody that can be detected on both, the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.
Adverse Reactions – In patients who received DARZALEX in combination with lenalidomide and dexamethasone, the most frequently reported adverse reactions (incidence ≥20%) were: neutropenia (92%), thrombocytopenia (73%), upper respiratory tract infection (65%), infusion reactions (48%), diarrhea (43%), fatigue (35%), cough (30%), muscle spasms (26%), nausea (24%), dyspnea (21%) and pyrexia (20%). The overall incidence of serious adverse reactions was 49%. Serious adverse reactions were pneumonia (12%), upper respiratory tract infection (7%), influenza (3%) and pyrexia (3%).
In patients who received DARZALEX in combination with bortezomib and dexamethasone, the most frequently reported adverse reactions (incidence ≥20%) were: thrombocytopenia (90%), neutropenia (58%), peripheral sensory neuropathy (47%), infusion reactions (45%), upper respiratory tract infection (44%), diarrhea (32%), cough (27%), peripheral edema (22%), and dyspnea (21%). The overall incidence of serious adverse reactions was 42%. Serious adverse reactions were upper respiratory tract infection (5%), diarrhea (2%) and atrial fibrillation (2%).
In patients who received DARZALEX as monotherapy, the most frequently reported adverse reactions (incidence ≥20%) were: neutropenia (60%), thrombocytopenia (48%), infusion reactions (48%), fatigue (39%), nausea (27%), back pain (23%), pyrexia (21%), cough (21%), and upper respiratory tract infection (20%). Serious adverse reactions were reported in 51 (33%) patients. The most frequent serious adverse reactions were pneumonia (6%), general physical health deterioration (3%), and pyrexia (3%).
Effect of Other Drugs on daratumumab: The coadministration of lenalidomide or bortezomib with DARZALEX did not affect the pharmacokinetics of daratumumab.
Effect of Daratumumab on Other Drugs: The coadministration of DARZALEX with bortezomib did not affect the pharmacokinetics of bortezomib.
About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at http://www.janssen.com. Follow us at http://www.twitter.com/JanssenUS and http://www.twitter.com/JanssenGlobal.
Copenhagen, Denmark; February 22, 2017 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today its Annual Report for 2016. Below is a summary of business progress and financial performance for the year, and financial outlook for 2017 from the report. The full report is attached as a PDF file and can be found on the investor section of the company's website, http://www.genmab.com.
Maximize daratumumab progress
• Launch DARZALEX in US and other approved territories - Achieved
• CHMP decision on monotherapy application - Achieved
• Phase III multiple myeloma (MM) interim efficacy analysis in relapsed / refractory MM settings [POLLUX and CASTOR trials] - Achieved
• File for label in relapsed / refractory settings if results of interim analyses are favorable - Achieved
• Start multiple clinical trials in MM and non-MM indications - Achieved
• Report initial clinical data non-MM indications — Clinical data from a non-MM indication for daratumumab is anticipated in 2017.
Optimize ofatumumab value
• Start Phase III subcutaneous autoimmune trials - Achieved
• Regulatory decision for CLL maintenance - Achieved
• File for label in relapsed CLL - Achieved
• Phase III refractory follicular lymphoma (FL) interim efficacy data — Study continued at interim analysis. Full data expected 2017.
Strengthen differentiated product pipeline
• Phase I/II tisotumab vedotin additional data - Achieved
• IND for HuMax-AXL-ADC and start clinical trial - Achieved
• Progress HexaBody-DR5/DR5 program - Achieved
• Progress pre-clinical DuoBody & HexaBody projects - Achieved
Broaden partnership portfolio with next generation technologies
• Sign new / expanded DuoBody & HexaBody collaborations — Goal was to sign two or more commercial collaborations; partially achieved goal with one commercial agreement for DuoBody technology with Gilead Sciences.
• Progress partnered programs - Achieved
• New IND filings — Achieved
Disciplined financial management
• Selectively invest to progress and broaden differentiated product pipeline - Achieved
• Revenue was DKK 1,816 million in 2016 compared to DKK 1,133 million in 2015. The increase of DKK 683 million, or 60%, was mainly driven by higher milestone and royalty revenue under our daratumumab collaboration with Janssen, partly offset by a decrease in our deferred revenue.
• Operating expenses increased by DKK 184 million, or 32%, from DKK 579 million in 2015 to DKK 763 million in 2016 driven by the additional investment in our pipeline of products, including the advancement of tisotumab vedotin, HuMax-AXL-ADC, HexaBody-DR5/DR5, DuoBody-CD3xCD20, and our early stage pre-clinical programs.
• Operating income was DKK 1,053 million in 2016 compared to DKK 730 million in 2015. The improvement of DKK 323 million, or 44%, was driven by higher revenue, which was partly offset by increased operating expenses in 2016 and the one-time reversal of the ofatumumab funding liability of DKK 176 million in 2015.
• 2016 year end cash position of DKK 3,922 million, an increase of DKK 429 million, or 12%, from DKK 3,493 million as of December 31, 2015.
MDKK 2017 Guidance 2016 Actual Result
Revenue 1,950 — 2,150 1,816
Operating expenses (1,000) — (1,100) (763)
Operating income 900 — 1,100 1,053
Cash position at end of year* > 4,500 3,922
*Cash, cash equivalents, and marketable securities
Genmab will hold a conference call in English to discuss the results for the full year 2016 today, February 22, at 6.00 pm CET, 5.00 pm GMT or noon EST. The dial in numbers are:
+1 646 254 3363 (US participants) and ask for the Genmab conference call
+44 20 3427 1912 (international participants) and ask for the Genmab conference call
A live and archived webcast of the call and relevant slides will be available at http://www.genmab.com.
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company has two approved antibodies, DARZALEX® (daratumumab) for the treatment of certain multiple myeloma indications, and Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications. Daratumumab is in clinical development for additional multiple myeloma indications, other blood cancers, and solid tumors. A subcutaneous formulation of ofatumumab is in development for relapsing multiple sclerosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody® platform for generation of bispecific antibodies, and the HexaBody® platform which creates effector function enhanced antibodies. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. For more information visit http://www.genmab.com.
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: firstname.lastname@example.org
This Company Announcement contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on http://www.genmab.com. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements in relation to actual results, unless required by law.
Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo™; the DuoBody logo®; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody® and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates. DARZALEX™ is a trademark of Janssen Biotech, Inc.
Company Announcement no. 06
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
1260 Copenhagen K
Research and technology
© 2017 Genmab A/S
http://www.reuters.com/article/brief-ja ... SFWN1HP01M
http://ir.genmab.com/releasedetail.cfm? ... ID=1021592
Phase II study of tisotumab vedotin in patients with advanced cervical cancer
Study provides opportunity for accelerated approval and is expected to begin in the coming months
Copenhagen, Denmark and Bothell, Washington; October 10, 2017 – Genmab A/S (Nasdaq Copenhagen: GEN) and Seattle Genetics, Inc. (NASDAQ: SGEN) announced today a decision to start a Phase II study of tisotumab vedotin in patients with recurrent and/or metastatic cervical cancer. The study could provide the basis for a regulatory application for approval. Tisotumab vedotin consists of a tissue factor (TF)-targeted antibody linked to the cell-killing agent monomethyl auristatin E (MMAE). TF is a protein expressed on a broad range of solid tumors. The Phase II trial is single arm and includes about 100 patients with recurrent or metastatic cervical cancer who relapsed or progressed after standard of care treatment. The companies plan to start enrolling patients by the first half of 2018.
“We are very pleased to see the clinical development of tisotumab vedotin progress in patients with cervical cancer – an area with a strong unmet medical need. The study provides an opportunity for accelerated registration. We look forward to the continuing development of this promising first-in-class antibody-drug conjugate,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
“Standard therapies for previously treated recurrent and/or metastatic cervical cancer generally result in response rates of less than 15 percent and a median overall survival of six to eight months,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Based on promising data from the Phase I/II clinical trial of tisotumab vedotin in recurrent and/or metastatic cervical cancer and feedback from the Food and Drug Administration (FDA) on the planned trial, we and Genmab are advancing the program into a potentially registrational study for these patients with high unmet medical need.”
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