On June 12, 2015 Novartis reported data from the Phase III COMPLEMENT 2 study showing that treatment with Arzerra (ofatumumab) plus fludarabine and cyclophosphamide significantly improved median progression-free survival (PFS) by 54% compared to treatment with fludarabine and cyclophosphamide alone (28.9 months vs 18.8 months, respectively; p=0.0032) in patients with relapsed chronic lymphocytic leukemia (CLL) (Press release, Novartis, JUN 12, 2015, View Source [SID:1234505400]). Results are being presented at the 20th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Vienna. Schedule your 30 min Free 1stOncology Demo! "There are limited treatment options for patients who have stopped responding to current CLL treatments, which happens in many patients with this disease over time," said Tadeusz Robak, Professor of Hematology, Department of Hematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz, Poland. "These data showed that the addition of ofatumumab to fludarabine and cyclophosphamide extended the amount of time before a patient’s CLL progressed, and further add to the body of evidence supporting the potential use of ofatumumab for these patients."
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The most commonly diagnosed adult leukemia in Western countries, CLL accounts for approximately 1 in 4 cases of leukemia[1],[2]. Most CLL patients experience disease progression despite initial response to therapy and may require additional treatment[3].
In this clinical study, median PFS was improved by 54% in patients receiving Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide (n=183) compared to those receiving fludarabine and cyclophosphamide alone (28.9 months vs 18.8 months, respectively; HR 0.67 [95% CI: 0.51, 0.88]; p=0.0032). Additionally, patients receiving ofatumumab in combination with fludarabine and cyclophosphamide had a higher overall response rate (ORR) compared to those receiving fludarabine and cyclophosphamide alone (84% vs 68% of patients, respectively; p=0.0003), with a better complete response (CR) rate (27% vs 7% of patients, respectively), compared to those receiving fludarabine and cyclophosphamide alone (n=182). Median overall survival (OS) was 56.4 months for patients receiving ofatumumab in combination compared to 45.8 months for patients receiving fludarabine and cyclophosphamide alone (HR 0.78 [95% CI: 0.56, 1.09]; p=0.1410). The safety profile observed in this trial was consistent with other trials of ofatumumab and no new safety signals were observed. The most common AEs (>=5%) reported were neutropenia, thrombocytopenia, anemia, nausea, leukopenia, vomiting, pyrexia, rash, fatigue, and pneumonia.
"The results from the COMPLEMENT 2 study validate the benefit of Arzerra treatment in combination with fludarabine and cyclophosphamide in certain patients with CLL," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "We look forward to sharing the data with regulatory authorities."
About COMPLEMENT 2
COMPLEMENT 2 (NCT00824265) is an open-label, two-arm, randomized, Phase III study, which included 365 patients with relapsed CLL in 18 countries. Patients in the study were randomized 1:1 to receive treatment with up to six cycles of Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide or up to six cycles with fludarabine and cyclophosphamide alone.
The primary endpoint of the study was PFS as assessed by an Independent Review Committee (IRC) according to the International Workshop for Chronic Lymphocytic Leukaemia (iwCLL) updated 2008 National Cancer Institute-sponsored Working Group (NCIWG) guidelines[4]. Secondary endpoints included ORR, CR, OS, patient reported outcomes, time to response, duration of response (DoR), time to progression, time to next therapy (TTNT), safety assessments, and quality of life.
Results from additional secondary endpoints showed that DoR was 29.6 months vs 24.9 months, respectively (HR 0.77 [95% CI: 0.56, 1.05]; p=0.0878) for the patients receiving ofatumumab in combination compared to those receiving fludarabine and cyclophosphamide alone. Time to progression was 42.1 months in those receiving ofatumumab in combination compared to 26.8 months in those receiving fludarabine and cyclophosphamide alone (HR 0.63 [95% CI: 0.45, 0.87]; p=0.0036).
More patients receiving ofatumumab in combination (74%) experienced grade 3 or greater adverse events (AEs) compared to those receiving fludarabine and cyclophosphamide alone (69%). A higher incidence of Grade >=3 neutropenia was observed in patients receiving ofatumumab with fludarabine and cyclophosphamide compared with those receiving fludarabine and cyclophosphamide alone (53% vs 39%, respectively) but a substantially higher rate of infection was not reported. Grade 3/4 infusion-related reactions (IRRs) were reported in 4% of patients receiving ofatumumab in combination with fludarabine and cyclophosphamide. IRRs led to discontinuation of study treatment in <1% of patients receiving ofatumumab in combination with fludarabine and cyclophosphamide. No fatal IRRs were reported.
Arzerra is not approved in combination with fludarabine and cyclophosphamide for relapsed CLL. Novartis will further analyze data from the COMPLEMENT 2 study and plans to share the results with regulatory agencies to evaluate the potential for future regulatory filings.
About Arzerra
Arzerra (ofatumumab) is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes.
In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate. In the European Union, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. Arzerra is also approved for first-line use in Russia, Iceland, Norway, Luxembourg and Brazil.
In more than 50 countries worldwide, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab.
Arzerra is marketed under a co-development and collaboration agreement between Genmab and Novartis, as successor in interest to GSK.
Important Safety Information for Arzerra (ofatumumab)
Treatment with Arzerra may cause side effects, some of which are serious and life-threatening.
Treatment with Arzerra may cause a side effect called an infusion reaction, which may be serious. Before treatment with Arzerra, doctors will prescribe 3 types of medicine to their patients to help reduce the risk of an infusion reaction, including a steroid (to reduce swelling and other symptoms of inflammation), a pain reliever, and an antihistamine (to reduce allergic reactions). Even though patients receive these medicines, they may still have an infusion reaction. If an infusion reaction occurs, the doctor will stop their patient’s treatment with Arzerra so the infusion reaction can be treated. Patients should tell their doctor or seek medical treatment right away if they have any of these symptoms while receiving Arzerra or within 24 hours after receiving Arzerra: fever, chills, rash, hives, chest pain, back pain, stomach pain, swelling, dizziness, blurred vision, drowsiness, headache, cough, wheezing, or trouble breathing.
Treatment with Arzerra may cause hepatitis B virus (HBV) infection to reoccur, which may cause serious liver problems and death. Patients who are newly exposed to HBV during or following treatment with Arzerra may experience serious liver problems and death. Patients should tell their doctor if they have had HBV infection or are a carrier of HBV. Before starting Arzerra, doctors will do a blood test to check for HBV infection. In some patients, additional blood tests may be done during and several months after treatment. Patients should call their doctor right away if they feel more tired than usual or notice a yellowing of the skin or eyes. These may be symptoms of hepatitis.
Progressive multifocal leukoencephalopathy (PML) is a rare brain infection that can occur with treatment with Arzerra. PML causes severe disability and can lead to death. Patients should call their doctor right away if they notice new medical problems or problems that are getting worse, such as confusion, dizziness or loss of balance, difficulty talking or walking, or strength, vision or other problems that have lasted over several days.
Tumor lysis syndrome (TLS), including the need for a hospital stay, can occur with treatment with Arzerra. TLS is caused by the fast breakdown of cancer cells, which then release their contents into the blood. This may lead to serious problems, including kidney failure or an abnormal heartbeat. Doctors may do a blood test to check their patients for TLS and may give medicines before starting treatment with Arzerra to help prevent TLS.
Arzerra can cause low blood cell counts (white blood cells, platelets, and red blood cells). These low blood cell counts can be severe and, in some cases, lead to death. Low white blood cells counts (neutropenia), can happen during treatment. Neutropenia can occur 42 days or longer after the end of treatment with Arzerra and may also last between 24 and 42 days after the last treatment dose. Doctors should regularly check their patient’s blood to see if they have low blood cell counts. Patients should call their doctor right away if they have any bleeding, bruising, red or purple spots on their skin, paleness, worsening weakness, tiredness, cough that will not go away, fever, chills, congestion, or any flu-like symptoms while receiving Arzerra.
After a patient receives Arzerra, they should not receive live vaccines until the doctor who prescribed Arzerra has told them that they may do so.
The most common side effects with Arzerra include infusion reactions, feeling tired, low white blood cell count, shortness of breath, pneumonia, rash, fever, nausea, cough, bronchitis, diarrhea, upper respiratory tract infection, and low red blood cell count.
Treatment with Arzerra can increase patients’ chances for getting infections. Some infections, such as pneumonia, bronchitis, and sepsis (a blood infection), can be serious, and in some cases, life-threatening. Patients should call their doctor right away if they have a cough that will not go away, fever, chills, congestion, or any flu-like symptoms while receiving Arzerra. These symptoms may be signs of a serious infection.
Cyclenium Pharma and McGill University Collaborate to Identify Novel Macrocyclic Modulators for Pharmacological Targets in
Multiple Therapeutic Areas
On June 11, 2015 Cyclenium Pharma Inc., an emerging pharmaceutical company specializing in the discovery and development of novel drug candidates based on proprietary macrocyclic chemistry and McGill University, one of the world’s leading post-secondary institutions, have entered into multiple research agreements designed to discover novel modulators for promising biological targets of pharmacological interest (Press release, Cyclenium, JUN 11, 2015, View Source [SID1234517246]). Involving investigators from the Rosalind and Morris Goodman Cancer Research Centre (GCRC), the Departments of Biochemistry and Physiology, and the McGill High Throughput Screening (HTS) facility, these collaborations will provide McGill researchers with immediate access to Cyclenium’s proprietary QUEST Library of next generation macrocyclic molecules and associated optimization capabilities. The initial objective of these exploratory efforts is to identify macrocyclic compounds capable of interacting with specific therapeutic targets, including several involving protein-protein interactions, being studied in the various McGill laboratories, thereby providing tools to improve the understanding of their involvement in various disease states, with the longer term goal of discovering novel pharmacological or diagnostic agents acting at these targets.
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"We have been greatly impressed with the nature and quality of the research being pursued within McGill’s laboratories and feel strongly that our macrocyclic compounds will be of significant assistance in advancing their studies," stated Helmut Thomas, Ph.D., President & Chief Executive Officer of Cyclenium. "Coupling the cutting-edge efforts and the world class expertise of their investigators with our CMRT Technology and proven development success in the macrocycle arena offers an excellent opportunity for synergy in the discovery and development of novel therapeutic and diagnostic agents against important, but difficult, pharmacological targets."
"We are excited about our collaboration with Cyclenium," said Dr. Morag Park, Director of the Rosalind and Goodman Cancer Research Centre, McGill University, "as it will continue to create new opportunities to accelerate the translation of basic research and our mechanistic understanding of cancer biology into potential therapies for cancer patients."
"The partnership with Cyclenium will provide our researchers access to new chemical probes with which we can query the mechanics of life at the molecular level," said Dr. Albert Berghuis, Chair of the Biochemistry Department, McGill University. "There is no doubt that the basic insights gained will lead to new avenues for therapy development for a host of diseases. This is therefore a win-win-win scenario for McGill, Cyclenium, and ultimately patients."
"This collaborative venture is a prime example of harnessing the biomedical expertise of publicly funded university researchers with the technical prowess and resources of the biopharmaceutical industry to enhance drug discovery and disease treatment," said Dr. John Orlowski, Chair of the Department of Physiology, McGill University. "Such relationships will ultimately benefit not only the healthcare of Canadians but also individuals world-wide."
Targovax and Oncos Therapeutics join forces to create a Nordic leader within immuno-oncology
On June 11, 2015 Targovax AS ("Targovax" or the "Company") reported that it has entered into an agreement with the shareholders of Oncos Therapeutics Oy ("Oncos") to acquire the shares of Oncos with settlement in Targovax shares (the "Transaction") (Press release, Oncos Therapeutics, JUN 11, 2015, View Source [SID:1234512624]). The combined company with multiple assets in research and development will be a Nordic leader within immuno-oncology. The new company will have a strong senior management team and be financially backed by reputable institutional investors with sector specialist HealthCap as the largest shareholder. After the Transaction, the shareholders of Oncos will own 50 per cent of Targovax.
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To fund the combined company, Targovax contemplates to raise NOK 125-150 million through a private placement directed towards Norwegian and international investors (the "Private Placement") and has already received indications from leading institutional investors for a substantial amount, including but not limited to a NOK 26 million commitment from HealthCap, NOK 25 million from Datum Invest AS and NOK 5 million from the Norwegian Radium Hospital Research Foundation. In addition, the Private Placement is directed towards the 24 employees of Targovax and Oncos and their respective subsidiaries, and companies controlled by any such employees ("Eligible Employees").
Rationale for the Transaction
Targovax and Oncos—based in Oslo and Helsinki, respectively—are both clinical-stage biotechnology companies with broad pipelines addressing the immuno-oncology market, which currently is quite modest, but is expected to grow to USD 30-35 billion over the next decade.
By combining Targovax and Oncos, a larger and more visible Nordic immuno-oncology player with a more extensive portfolio will be created. Furthermore, the combination of two highly competent and complementary organizations will promote more efficient execution and accelerate the development of ongoing and future programs.
Clinical results to date confirm the safety and the mechanisms of action for both technology platforms. Safety data from Targovax and Oncos programs have been collected on approximately 250 and 290 patients, respectively. Both companies have completed Phase I and are now in Phase II development, or about to enter Phase II development, with broad pipelines, and both utilize an immuno-oncology approach that is highly suitable for combination therapies. Clinical programs in several indications will provide increased opportunities for newsflow over the next 18 months.
"The combination of Targovax and Oncos creates a major Nordic player within immuno-oncology. We will have a wide array of programs in the pipeline and multiple shots at goal. The companies’ complementary technologies will provide a unique platform for the development of cutting-edge immunotherapies, and we will have a higher chance of success, thus offering investors an even more compelling opportunity. I am excited to lead an organization of highly skilled professionals with deep industry experience", said Gunnar Gårdemyr, Chief Executive Officer of Targovax.
Senior Executives and Board of Directors
After the Transaction, the highly experienced senior management team will consist of the following members:
Gunnar Gårdemyr (Chief Executive Officer) has more than 30 years of international experience in the pharmaceutical and biotech industry from companies such as Nycomed and Takeda
Dr. Magnus Jäderberg (Chief Medical Officer) has more than 25 years of experience from R&D functions and was previously CMO at Bristol-Myers Squibb (Europe)
Øystein Soug (Chief Financial Officer) has prior experience as the Chief Financial Officer of Algeta and in positions with the Orkla Group
Jon Amund Eriksen (Chief Operating Officer) was the co-founder of Targovax and has 35 years of R&D experience in the pharmaceutical and biotech industry, of which 25 years were within immuno-oncology
After the Transaction, the proposed Board of Directors will consist of the following members:
Jónas Einarsson (Chairman of the Board of Directors), Chief Executive Officer of the Norwegian Radium Hospital Research Foundation
Johan Christenson (Board Member), Partner at HealthCap
Per Samuelsson (Board Member), Partner at HealthCap
Lars Lund-Roland (Board Member), CEO of Bringwell, with more than 25 years of experience from various executive positions within Merck
Bente-Lill Romøren (Board Member), Board Member of the Norwegian Radium Hospital Research Foundation and Chairman of Farmastat and Photocure
Robert Burns (Board Member), Chairman of Haemostatix, previously CEO of 4-Antibody, Affitech, and Celldex Therapeutics, all three being early companies in the immuno-oncology space
BIND Therapeutics and Macrophage Therapeutics Announce Collaboration to Engineer CD206 Targeted Accurin™ Nanoparticle Using Manocept™ Macrophage Targeting Platform
On June 11, 2015 BIND Therapeutics, a subsidiary of Navidea Biopharmaceuticals reported they have entered into a research collaboration to engineer Accurins with the Manocept targeting platform that enables selective, efficient binding to CD206 positive disease-associated macrophages (Press release, Navidea Biopharmaceuticals, JUN 11, 2015, View Source;p=RssLanding&cat=news&id=2058494 [SID:1234505428]). Upon achievement of proof-of-concept, the companies anticipate expanding the collaboration to develop Manocept-linked Accurins as a novel, potent approach to impact the tumor microenvironment which, in many forms of cancer, is a barrier to immune effector cells.
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This Smart News Release features multimedia. View the full release here: View Source
"This collaboration represents a potentially significant advance in the evolution of our platform as we develop Accurins with novel targeting ligands," said Andrew Hirsch, president and chief executive officer of BIND Therapeutics. "The modular nature of our platform offers multiple therapeutic possibilities, and our collaboration with Macrophage Therapeutics may enable the development of Accurins that target activated macrophages, which in cancer, help create an immunosuppressive microenvironment. We believe the clinically validated Manocept platform, with its unique ability to seek out activated macrophages, fits into our vision to engineer Accurins that have a profound impact on the treatment of diseases, including our current focus in cancer."
Disease-associated macrophages generally play a pro-tumoral role and are immunosuppressive, preventing the immune system from mounting an attack on tumor cells. Based on the expression of CD206 mannose receptors on disease-associated macrophages, BIND and Macrophage plan to conduct joint research to develop a CD206 targeted Accurin nanoparticle that is capable of concentrating various therapeutic payloads to the tumor microenvironment.
"We are pleased to work with BIND Therapeutics to explore the therapeutic potential of our two complementary technology platforms," said Michael M. Goldberg, M.D., CEO of Macrophage Therapeutics and Director of Navidea. "The Manocept platform is the basis for the FDA-approved CD206 targeted sentinel lymph node detection agent, Lymphoseek (technetium Tc 99m tilmanocept) injection. Coupled with BIND’s specifically engineered Accurins that concentrate therapeutic payloads to extracellular and intracellular compartments, with a tunable controlled-release profile, we are optimistic that we can create a wide range of therapeutic applications."
"It is well-established that macrophages play an important role in many disease states but it has proven difficult to selectively target and alter macrophages that play a key role in disease progression," said Hagop Youssoufian, M.Sc., M.D., chief medical officer at BIND Therapeutics. "By coupling Accurins with Macrophage’s well-credentialed CD206 targeting ligand, we may be able to treat macrophage-mediated diseases through increased uptake, and concentration, of targeted therapeutic payloads in the tumor microenvironment. BIND’s Medicinal Nanoengineering platform is able to combine multiple molecular components into a targeted, long-circulating Accurin. An Accurin nanoparticle that binds to CD206 positive macrophages could be a valuable asset in the armament against multiple cancers and disease states."
"The collaboration furthers our vision to develop therapeutic applications of the Manocept platform through strategic partnerships," said Rick Gonzalez, president and CEO of Navidea. "In collaborating with BIND, we will be able to leverage their accomplished R&D team who has strong track record for advancing targeted nanoparticles from concept into the clinic."
About Accurins
Accurins, a new class of targeted therapeutics developed using BIND’s Medicinal Nanoengineering platform, are nanoparticles engineered to have a profound impact on the treatment of disease. The elegant and novel design of Accurins allow for prolonged circulation, controlled and tunable release and selective targeting of a therapeutic payload to diseased tissue or cells while avoiding immune surveillance detection and systemic toxicities.
Accurins can be engineered for multiple therapeutic applications and have the potential to integrate numerous payloads, including highly potent drugs with mechanism-based toxicities that limit therapeutic benefit, DNA, RNA, proteins and immunotherapy agents. This attribute enables Accurins to target multiple diseases, including cancer, inflammatory, vascular, and infectious disease.
About Manocept CD206 Targeting Platform for Therapeutics Development
Manocept CD206 Targeting Platform is a proprietary mannose-containing, receptor-directed technology platform designed to engineer novel, synthetic receptor targeted imaging agents and therapeutics for cancer and other diseases. Manocept’s unique structural and molecular properties enable the design of novel immuno-constructs that selectively target and bind to CD206 (mannose receptor) and other C-type Lectins found on activated, disease-associated macrophages and tumor associated macrophages (TAMs). The Manocept CD206 Targeting Platform provides a novel and valuable approach to the design of drug molecules targeting CD206 disease-associated macrophages for therapeutic purposes.
About Lymphoseek
Lymphoseek (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.
Accurate diagnostic evaluation of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 235,000 new cases of breast cancer, 76,000 new cases of melanoma and 45,000 new cases of head and neck/oral cancer in the U.S., and approximately 367,000 new cases of breast cancer, 83,000 new cases of melanoma and 55,000 new cases of head and neck/oral cancer diagnosed in Europe annually.
Lymphoseek Indication and Important Safety Information
Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:
Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
Important Safety Information
In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).
Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.
Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers.
In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).
TG Therapeutics to Present Clinical Data on TG-1101 and TGR-1202 at the 20th Congress of the European Hematology Association and the 13th International Congress on Malignant Lymphoma
On June 11, 2015 TG Therapeutics reported that clinical data for TG-1101 (ublituximab), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, and TGR-1202, the Company’s once-daily PI3K delta inhibitor, will be presented at the 20th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), being held from June 11 – June 14, 2015 in Vienna, Austria as well as at the 13th International Congress on Malignant Lymphoma (ICML), being held from June 17 – June 20, 2015 in Lugano, Switzerland (Press release, TG Therapeutics, JUN 11, 2015, View Source [SID:1234505398]).
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The Company and its study investigators will present data from the following clinical studies:
TGR-1202 as a single agent in relapsed/refractory B-cell malignancies
TGR-1202 in combination with TG-1101 ("1303 combination") in CLL and NHL
TGR-1202 + TG-1101 + ibrutinib in B-cell malignancies
TG-1101 in combination with ibrutinib in patients with relapsed/refractory CLL
Additional information on the presentations can be found below:
20th Congress of EHA (Free EHA Whitepaper) (Vienna):
Date/Time: Friday, June 12, 2015, 17:15 – 18:45 CEST
Abstract Number: P327 (Poster)
Presentation Title: UBLITUXIMAB + TGR-1202 DEMONSTRATES ACTIVITY AND FAVORABLE SAFETY PROFILE IN RELAPSED/REFRACTORY B-CELL NHL AND HIGH-RISK CLL
Presenter: Matthew Lunning, DO, University of Nebraska, Omaha, NE
Date/Time: Saturday, June 13, 2015, 11:45 – 12:00 CEST
Abstract Number: S432 (Oral Presentation)
Presentation Title: TGR-1202, A NOVEL ONCE DAILY PI3K-DELTA INHIBITOR, DEMONSTRATES CLINICAL ACTIVITY WITH A FAVORABLE SAFETY PROFILE, LACKING HEPATOTOXICITY, IN PATIENTS WITH CLL AND B-CELL LYMPHOMA
Presenter: Owen A. O’Connor, MD, PhD, Columbia Presbyterian Lymphoma Center, New York, NY
ICML Meeting (Lugano):
Date/Time: Wednesday, June 17, 2015, 17:45 CEST
Abstract Number: 038 (Oral Presentation)
Presentation Title: TGR-1202, A NOVEL ONCE DAILY PI3K δ INHIBITOR, DEMONSTRATES CLINICAL ACTIVITY WITH A FAVORABLE SAFETY PROFILE, LACKING HEPATOTOXICITY IN PATIENTS WITH CLL AND B-CELL LYMPHOMA
Presenter: Owen A. O’Connor, MD, PhD, Columbia Presbyterian Lymphoma Center, New York, NY
Date/Time: Thursday, June 18, 2015, 17:15 CEST
Abstract Number: 105 (Oral Presentation)
Presentation Title: UBLITUXIMAB (TG-1101), A NOVEL GLYCOENGINEERED ANTI-CD20 MAB, IN COMBINATION WITH IBRUTINIB ACHIEVES 95% ORR IN PATIENTS WITH HIGHRISK RELAPSED/REFRACTORY CLL
Presenter: John Burke, MD, Rocky Mountain Cancer Center/US Oncology, Aurora, CO
Date/Time: Thursday, June 18, 2015, 17:25 CEST
Abstract Number: 106 (Oral Presentation)
Presentation Title: THE CHEMOTHERAPY-FREE TRIPLET OF UBLITUXIMAB, TGR-1202, AND IBRUTINIB IS SAFE AND HIGHLY ACTIVE IN RELAPSED B-CELL MALIGNANCIES
Presenter: Loretta Nastoupil, MD, MD Anderson Cancer Center, Houston, TX
Date/Time: Thursday, June 18, 2015
Abstract Number: 284 (Poster)
Presentation Title: UBLITUXIMAB + TGR-1202 DEMONSTRATES ACTIVITY AND FAVORABLE SAFETY PROFILE IN RELAPSED/REFRACTORY B-CELL NHL AND HIGH-RISK CLL
Presenter: Matthew Lunning, DO, University of Nebraska, Omaha, NE