On December 5, 2017 AbbVie (NYSE: ABBV), a global biopharmaceutical company, reported the Phase 3 iNNOVATE (PCYC-1127) trial evaluating IMBRUVICA (ibrutinib) in combination with rituximab in patients with treatment-naïve and previously-treated Waldenström’s macroglobulinemia (WM) successfully met its primary endpoint and demonstrated improvement of progression-free survival (PFS) compared to rituximab alone (Press release, AbbVie, DEC 5, 2017, View Source [SID1234522376]). The Independent Data Monitoring Committee (IDMC) recommended that the study be unblinded based on the positive outcome from the pre-specified interim analysis data. IMBRUVICA, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.

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"IMBRUVICA is the first and only treatment approved in Waldenström’s macroglobulinemia. We continue to be committed to exploring the full potential of IMBRUVICA, and are pleased to add the results of iNNOVATE to our growing scientific understanding of its use as a combination therapy in WM and other blood cancers," said Thorsten Graef, M.D., Ph.D., Head of Clinical Development at Pharmacyclics LLC, an AbbVie company.

Pharmacyclics and Janssen are planning to share the interim analysis data from the study with regulatory authorities and plan to present the data in a future publication or medical congress. In January 2015, the U.S. FDA granted approval for IMBRUVICA for adult patients with WM. The approval was supported by the FDA’s Breakthrough Therapy Designation.

"This is a first-of-its-kind prospective randomized trial in Waldenström’s macroglobulinemia," said Meletios A. Dimopoulos, M.D., Professor and Chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine. "The full report of this study will be of important clinical significance regarding the benefits of the combination of ibrutinib with rituximab in patients with WM."

WM is a rare form of non-Hodgkin’s lymphoma, and roughly 1,000 to 1,500 people are diagnosed each year in the U.S.1

On December 5, 2017 Delcath Systems, Inc. (OTCQB:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announces that results of a multi-center retrospective analysis of Delcath’s PHP Therapy have been accepted for publication in the peer-reviewed Journal of Surgical Oncology (Press release, Delcath Systems, DEC 5, 2017, View Source;p=RssLanding&cat=news&id=2321097 [SID1234522379]). The study, Percutaneous Hepatic Perfusion with Melphalan in Uveal Melanoma: A Safe and Effective Treatment Modality in an Orphan Disease, was conducted by researchers from Moffitt Cancer Center in Tampa, FL and the University Hospital Southampton in the United Kingdom. The publication of the data is expected in an upcoming edition of the Journal. An abstract of this study was presented at the 12th Annual Regional Therapies International Symposium in Snowbird, Utah in February 2017.

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Commenting on the announcement, Jennifer K. Simpson, Ph.D., President and CEO of Delcath Systems, said, "this study represents the largest data set outside of a controlled clinical trial on the use of PHP Therapy in the treatment of uveal melanoma metastatic to the liver. Preliminary results of the study presented at the Regional Therapies conference earlier this year showed data indicating tumor response and overall survival benefit with PHP Therapy beyond the 6-8 months seen with other therapies in this patient population. The most common serious side effects following treatment were anemia, thrombocytopenia and neutropenia; these were expected and the majority managed with supportive care. The preliminary data provide confidence that our Phase 3 clinical trial in ocular melanoma liver metastases can provide the evidence necessary to support an application for a labeled indication in this tumor type, and we look forward to the publication of the full study results."

PHP Therapy with Melphalan/HDS was developed by Delcath Systems as a targeted, whole organ therapy for the liver. It is commercially available as a device in Europe, where it is marketed as CHEMOSAT. The system has not been approved by the U.S. Food and Drug Administration, and is undergoing Phase 3 clinical testing in the U.S. as an investigational product.

On December 5, 2017 At the American Society of Hematology (ASH) (Free ASH Whitepaper)’s 59th Annual Meeting and Exposition in Atlanta, Georgia, researcher Gustavo Milone, MD, and his team reported that will present a study that investigates the post-marketing trends of Novex, a biosimilar rituximab that has been approved in Argentina for the same indications as the reference product (MabThera, Rituxan) (Press release, mAbxience, DEC 5, 2017, View Source [SID1234594760]).1 Since Novex’s commercial launch, the first national pharmacovigilance plan for a biosimilar monoclonal antibody has been implemented, and data from this post-marketing surveillance show that, in terms of tolerability, this biosimilar has a similar safety profile to that of the reference product.

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In order to determine deviations from expected frequencies of adverse events (AEs), a prospective treatment registry for the biosimilar was implemented from the start of its commercialization on November 26, 2014. Data in the study are reported until June 30, 2017. Physicians, 180 in total, tracked age, gender, indication, dose, dose frequency, and date of treatment initiation and finalization for each patient receiving the biosimilar.

The study comprised the records of 525 patients who had at least 1 follow-up. The majority of patients were female (52%), the mean age was 63.3 years (range, 10-90), and most patients received the biosimilar rituximab for hematological disease (91.2% of cases). The treatment duration ranged from 154 to 309 days, with the number of treatment cycles varying from 1 to 12. Individual Case Safety Reports (ICSRs) were collected from 24 patients with 29 AEs.

The most frequently reported AEs were:

Acute infusion-related reaction (14)
Arrhythmia (3)
Pneumonia (2)
Stroke (2)
The researchers noted that 41 treatments with rituximab were initiated before the launch of the product; assuming treatment began with MabThera, these 41 treatments imply switching to the biosimilar from the reference.

Researchers investigating data from the post-marketing surveillance found a similar incidence of AEs after the use of rituximab biosimilar when compared to the published data of the reference product. Thus, in terms of tolerability, the biosimilar has a similar safety profile compared with its reference.

On December 5, 2017 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, will present clinical data from the Phase 3 DUO study evaluating the efficacy and safety of duvelisib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) at a Research and Development reception at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2017 Annual Meeting (Press release, Verastem, DEC 5, 2017, View Source;p=RssLanding&cat=news&id=2321050 [SID1234522395]). The event will take place on Sunday, December 10, 2017 in Atlanta.

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The event, which follows the oral presentation of the DUO data results at ASH (Free ASH Whitepaper), will feature a slide presentation and moderated panel discussion with recognized experts in the treatment of hematologic malignancies, including CLL/SLL, and a live Q&A session. Speakers will include Ian Flinn, MD, PhD, Sarah Cannon Research Institute, who will present results from the Phase 3 DUO study, and Steven Horwitz, MD, Memorial Sloan Kettering Cancer Center, who will provide an update on duvelisib for the treatment of Peripheral T-Cell Lymphoma (PTCL). In addition, Lori Kunkel, MD, Verastem Clinical and Scientific Advisory Board, and Steven Bloom, Verastem Chief Strategy Officer, will participate in the discussion panel and Q&A session, which will be moderated by Robert Forrester, Verastem President and Chief Executive Officer.

The event will take place during the ASH (Free ASH Whitepaper) 2017 Annual Meeting and is open to analysts and institutional investors. Interested parties can access a live webcast of the event beginning Sunday, December 10, 2017 at 8:15 p.m. ET on the "Presentations" page of the company’s website View Source;p=irol-calendar. A replay of the webcast will be archived on the company’s website for 90 days following the event. For more information or to RSVP, please contact Maeve Conneighton at [email protected].
Duvelisib is Verastem’s first in class oral dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma which is currently being developed for the treatment of CLL/SLL, peripheral T cell lymphoma (PTCL), and other hematologic malignancies.

On December 5, 2017 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center ("MD Anderson"), reported the physician-sponsored Investigational New Drug ("IND") application for a Phase I trial of Moleculin’s drug WP1066 in patients with recurrent malignant glioma and brain metastasis from melanoma has been allowed by the US Food and Drug Administration ("FDA") (Press release, Moleculin, DEC 5, 2017, View Source [SID1234522382]).

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"We are so pleased to now have a second drug enter the clinical stage," commented Walter Klemp, Chairman and CEO of Moleculin. "We believe WP1066 represents a new class of anticancer drugs able to fight tumors on two fronts by directly inhibiting cell signaling supporting tumor activity, and independently stimulating a natural immune response. This constitutes a new approach to treating brain tumors and tumor metastasis to the brain.

Mr. Klemp concluded, "Since the discovery of WP1066 at MD Anderson by Prof. Waldemar Priebe, it has now been studied by many independent groups and is widely recognized as a potent inhibitor of the activated form of a protein called STAT3, which has been implicated in many difficult to treat tumors, including brain tumors. Animal studies have shown that inhibition of STAT3 directly blocks tumor proliferation and its survival, while most importantly boosting the immune system’s ability to fight cancer. We finally have our first opportunity for a clinical proof of concept and confirmation of promising preclinical activity."
This IND was sponsored by Dr. Amy Heimberger, who will serve as the principal investigator for the Phase I trial at MD Anderson Cancer Center to evaluate safety and efficacy. Details about the trial can be viewed on www.clinicaltrials.gov.