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ISSUE 23 – JUNE 12, 2015PDF

NCI Frederick Laboratory’s $400 Million Per Year Contract Up for Re-Competition

NCI is opening up its contract for operations and technical support at the Frederick National Laboratory for Cancer Research for re-competition—a process that officials said will take up to two years.

The institute is broadening the statement of work for the contract to maximize new opportunities in cancer research, which involves fostering interactions with academia. Bidders can include universities, consortia of universities, other nonprofit institutions and for-profit companies.

The contract, which was awarded in 2008, is scheduled to end in September 2018. Leidos Biomedical Research Inc. received $400.2 million to run the lab in fiscal 2014. It is not publicly known how much NCI is budgeting for the 2018 contract.

    21st Century Cures Heads for House Floor Vote

    The 21st Century Cures Act cleared the House Committee on Energy & Commerce and is heading for floor vote.

    The legislation, H.R. 6, is designed to expedite drug development, modernize clinical trials, and accelerate approval of drugs and medical devices. Capitol Hill insiders say the floor vote may occur within two weeks.

    Guest Commentary

    Obamacare was Undermined from the Outset

    By Leonard Zwelling

    Could the Supreme Court functionally end Obamacare before the end of June?

    It could if the court determines that subsidies paid to those individuals eligible for the payments who gained health insurance on the federal exchanges are inconsistent with the Affordable Care Act as written.

    Pediatrician Charged With Child Porn Possession Resigns From MD Anderson

    A pediatric oncologist at MD Anderson Cancer Center is facing federal charges of one count of receiving and possessing child pornography.

    Dennis Hughes, an associate professor of pediatrics, was arrested at his home June 5 after the Federal Bureau of Investigation found a thumb drive containing 8,200 downloaded files, the majority of which appeared to contain child pornography.

      In Brief

      • Karen Knudsen named director of Sidney Kimmel Cancer Center at Thomas Jefferson University

      • Roberto Pili joins IU Melvin and Bren Simon Cancer Center

      • Mary Beckerle appointed to board of Johnson & Johnson

      • Pew Charitable Trusts name 27 biomedical research scholars

      • The Cancer Genome Atlas Research Network publishes study on molecular classification of diffuse gliomas

      • AACR and Bayer partner to expand research fellowship program

      • Scripps Mercy O’Toole Breast Care Center opens in San Diego

      • ASCO Publishes Practical Tips for Oncology Practice 

      • Chris4Life Colon Cancer Foundation and Smart Patients launch DATABLUE

      • The Cancer Letter receives first place award from the Society of Professional Journalists for its coverage of power morcellation

       Drugs and Targets

      • Lenvatinib launches in U.K. for advanced thyroid cancer

      • Keytruda authorized for sale by Health Canada

      • FDA grants orphan designation to APTO-253

      • Janssen initiates rolling submission for daratumumab in multiple myeloma

      • MD Anderson and Nektar Therapeutics announce collaboration

      20150612 - Jun. 12, 2015
      ISSUE 22 – JUNE 5, 2015PDF

      NCI-MATCH to Bring in Public, Private Funds, Giving NCI New Urgent Scientific Agenda

      ECOG-ACRIN Cancer Research Group is starting enrollment in NCI-MATCH, the most ambitious of NCI’s new generation of clinical trials.

      In addition to being the centerpiece of the institute’s recently formed National Clinical Trials Network, NCI-MATCH—the name is an acronym for Molecular Analysis for Therapy Choice—provides a strong case for garnering Congressional support for the White House precision medicine initiative.

      The $215 million program proposed by Obama as part of appropriations for fiscal 2016 hasn’t translated into congressional appropriations. The PMI budget request includes $70 million for NCI to scale up efforts to identify genomic drivers in cancer and apply that knowledge to develop more effective approaches to cancer treatment. Similarly, the new-generation trials would boost the NCI case in pursuit of a share of another potential windfall: the 21st Century Cures.

      See also:

      Conversation with The Cancer Letter

      Doroshow: NCI-MATCH is an Example of What Smart Public-Private Partnerships Can Do

      The NCI-MATCH phase II study is intended to allow the institute and its clinical trials groups catapult to the premier role in cancer research.

      In a conversation with The Cancer Letter, James Doroshow, director of the NCI Division of Cancer Treatment and Diagnosis, said NCI-MATCH established the institute as a trusted party in a complex, multi-agent trial intended to produce leads for government-funded investigators and pharma companies would be able to follow.

      ASCO CEO Lichter to Step Down in June 2016

      Allen Lichter, CEO of the American Society of Clinical Oncology and the Conquer Cancer Foundation of ASCO, announced June 1 that he would step down June 30, 2016.

      Lichter has led ASCO since 2006.

      Melanoma Drugs Could be Used to Treat Lung, Liver, Head-Neck and Colorectal Cancers

      Three immunotherapy drugs approved for the treatment of melanoma may be used to treat advanced lung, liver, head and neck, and colorectal cancers, according to clinical trial results presented at the 2015 American Society of Clinical Oncology annual meeting in Chicago.

      These drugs—Keytruda (pembrolizumab) by Merck, and Opdivo (nivolumab) and Yervoy (ipilimumab) by Bristol-Myers Squibb—are called checkpoint inhibitors because they release the molecular checkpoints that keep the immune system from attacking tumors.

        ESMO Scale Stratifies Magnitude of Benefit of Cancer Drugs

        The European Society for Medical Oncology May 30 published the ESMO Magnitude of Clinical Benefit Scale, a tool to assist oncology clinicians in evaluating the most effective anti-cancer medicines for their patients.

        According to the society, the ESMO-MCBS offers a “rational, structured and consistent approach to stratify a drug’s clinically meaningful benefit”—a scale that can be used in public policy decision-making, to develop or improve clinical guidelines, in day-to-day clinical situations.

          Canadian Judge Orders Tobacco Companies to Pay $12 Billion to About One Million Quebec Citizens

          A Quebec court ordered three major tobacco companies to pay US$12 billion, over 15 billion Canadian dollars, in damages in a landmark class action lawsuit.

          On June 1, Quebec Superior Court Judge Brian Riordan instructed Canadian tobacco companies JTI-Macdonald, Imperial Tobacco, and Rothmans, Benson & Hedges to pay punitive and moral damages to two groups of Quebecois plaintiffs. The lawsuit was filed in fall 1998, and legal proceedings began in 2012.

            ASCO President Peter Paul Yu’s 2015 Presidential Address

            A transcript of ASCO President Peter Paul Yu’s address at the 2015 ASCO Annual Meeting.

              Amgen Seeks to Depose Reporter, TCL Invokes First Amendment Shield

              Amgen Inc. is seeking to depose The Cancer Letter editor and publisher Paul Goldberg in connection with a shareholders suit stemming from his 2007 story about the results of a Danish trial of Aranesp.

              The Cancer Letter is contesting the subpoena, asserting first amendment protection and its rights to protect confidentiality of sources.


                Wally Sampson, 85, Challenged Alternative Remedies

                Wallace Ira Sampson, a longtime “quackbuster,” emeritus clinical professor of medicine at Stanford University, and former director of oncology at the Santa Clara Valley Medical Center, died May 25 following a three-month hospital stay for complications following cardiac surgery. He was 85.

                Sampson was one of a group of scientists and physicians who focused on the growing influence of alternative medicine, said Stephen Barrett, a fellow quackbuster.

                  In Brief

                  • Nicole Robinson named VP of Industry Relations at Fred Hutch

                  • The Department of Defense appropriations bill includes an additional $12 million for lung cancer research

                  • The Community Oncology Alliance announces nine practices received oncology medical home designation

                  20150605 - Jun. 5, 2015
                  May 2015PDF


                  NCI MATCH Trial to Begin Patient Enrollment in July

                  CHICAGO—NCI’s long-planned, large scale precision medicine trial will open to patient enrollment in July, investigators announced June 1 at the annual meeting of the American Society of Clinical Oncology.

                  NCI-MATCH: Molecular Analysis for Therapy Choice will assign patients to therapies based on molecular profiles of their tumors, rather than the organ site where their cancer began. The purpose is to determine whether targeted therapies for people whose tumors have specific gene mutations will be effective regardless of their cancer type.

                  The phase II trial will incorporate more than 20 different study drugs or drug combinations, each targeting a specific gene mutation, to match each patient with a therapy that targets a molecular abnormality in their tumor.


                  ASCO to Launch its First Clinical Trial: TAPUR

                  CHICAGO—The American Society of Clinical Oncology announced June 1 that it will move forward with its first-ever clinical trial, a study designed to offer patients with advanced cancer access to molecularly-targeted cancer drugs and to collect data on clinical outcomes to learn the best uses of these drugs outside of FDA-approved indications.

                  The Targeted Agent and Profiling Utilization Registry, or TAPUR, is a prospective, non-randomized clinical trial that will collect information on the anti-tumor activity and toxicity of commercially available, targeted cancer drugs in a range of cancer types, including any advanced solid tumor, multiple myeloma, or non-Hodgkin lymphoma with a genomic variation known to be a drug target.


                  Pancreatic Cancer

                  IMM-101 Combination Improves OS in Metastatic Disease in Phase II Trial

                  Updated long-term survival results from IMAGE 1, a phase II clinical trial evaluating a combination of IMM-101 and gemcitabine as first-line treatment for advanced pancreatic cancer, found that, in patients with metastatic disease, IMM-101 was associated with improving the probability of survival at 12 months to 24 percent, compared to 11.5 percent in patients receiving gemcitabine alone.

                  This difference was amplified at 18 months to 18.3 percent for IMM-101-treated patients compared to 2.3 percent in the control group. At 24 months the corresponding survival probabilities were 11 percent and 0 percent, respectively. This is in addition to the previously reported consistent and significant improvements in overall survival and progression free survival in patients with metastatic pancreatic cancer.


                  Non-Small Cell Lung Cancer

                  MPDL3280A Immunotherapy Doubles OS in Patients with Highest Levels of PD-L1


                  Kidney Cancer

                  Study: Statins Can Improve Survival in Renal Cell Carcinoma


                  Stomach Cancer

                  Avastin Combination Improves Survival in Phase II Study


                  Endometrial Cancer

                  Phase III ZoptEC Trial to Continue Following Interim Analysis



                  APD403 Demonstrates Control Of Nausea and Vomiting After Highly Emetogenic Treatments


                  Drugs and Targets

                  FDA Grants Orphan Designation For Reolysin in Malignant Glioma

                   NCI CTEP-Approved Trials for the Month of May 
                  20150601 - Jun. 1, 2015