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Issue 25 - Jun. 24, 2016
  • Stanford, Intermountain and Providence Use Syapse Platform to Integrate Their Data

    Three health systems—Stanford Cancer Institute, Intermountain Healthcare and Providence Health and Services—have agreed to eliminate the electronic barriers between their medical records, tumor registries and genomics databases.

    The three entities said they have started to use a common IT platform to achieve interoperability and guide clinical decision-making.

    That platform is Syapse, a startup that is emerging as an important player in the ongoing conversation on bioinformatics and data sharing in oncology, led by Vice President Joe Biden and the National Cancer Moonshot Initiative.

    • Related Coverage of the Cancer Moonshot

  • Conversation with The Cancer Letter

    Hirsch: I Dropped Out of Stanford to Start Syapse

    Jonathan Hirsch was studying neuroscience at Stanford University when he wandered into two oncology classes and saw an opportunity to change the way health systems handle genomic data.

    “I started getting really immersed in molecular oncology, and the challenges in implementing molecularly guided treatment started coming together with the challenges in utilizing complex data,” Hirsch said to The Cancer Letter.

  • Joint BSA-NCAB Meeting

    The Moonshot’s Metric for Success: Avoiding a Single, Tangible Endpoint

    How will the success of the moonshot be measured? NCI Acting Director Doug Lowy touched on the subject during the joint meeting of the institute’s Board of Scientific Advisors and the National Cancer Advisory Board June 21.

    The moonshots of the 1960s were essentially engineering problems that had tangible goals. Cancer is an evolutionary problem, and the stated goal of the moonshot in cancer research, led by Vice President Joe Biden, is perhaps deliberately vague: to achieve a decade’s worth of progress in just five years.

    “Has there been any discussion of an endpoint that you can point to—like planting the flag on the moon, or sequencing the three-billionth base pair of the genome project?” asked BSA member Lincoln Stein, director of the Informatics and BioComputing Platform at the Ontario Institute for Cancer Research, during the meeting. “Something that looks like an achievable endpoint?”

  • Funding Opportunity

    SU2C, Merck Taking Proposals for Keytruda

    Stand Up To Cancer announced a request for proposals under SU2C Catalyst, a program supporting clinical trials and translational research.

  • In Brief

    • NCI Surgery Branch resumes enrollment in immunotherapy trials
    • Rajesh Garg named president and CEO of Cancer Treatment Centers of America
    • Prostate Cancer Foundation names 24 Young Investigator Award winners
    • Shuanzeng “Sam” Wei and Phillip Pancari join Fox Chase
    • MIT’s Tyler Jacks, Susan Hockfield, and Phillip Sharp publish report on convergence
    • Pancreatic Cancer Action Network lobbies Congress for research funding
    • Leukemia and Lymphoma Society and the American Society of Hematology to collaborate on promoting AML treatment research
Issue 24 - Jun. 17, 2016
  • Moonshot May Play Role in $400 Million Annual Contract to Run NCI’s Frederick Lab

    The contract for operations and technical support at the Frederick National Laboratory for Cancer Research could be accepting proposals as early as next month—but NCI advisors said they are hoping to slow the recompetition process to reform the laboratory’s mission.

    Moreover, NCI should consider how the laboratory could contribute to Vice President Joe Biden’s National Cancer Moonshot Initiative, members of the Frederick National Laboratory Advisory Committee said at a recent meeting.

  • Task Force Adds Tests to Colon Screening Guideline

    The final version of guidelines for colorectal cancer screening by the U.S. Preventive Services Task Force differ substantively from the group’s draft version published last October.

    The final version—unlike the draft—lists CT colonography and FIT-DNA as screening methods that are equal to others.

    It’s unclear whether political pressure had any role in prompting the panel to broaden its list of detection strategies from three to seven in the past six months.

  • Conversation with The Cancer Letter

    Guideline Edits Rooted in Science, Former USPSTF Member Says

    “I don’t see this recommendation as differing in any substantial way from some others that we’ve made, where we suggested that patients talk with their clinicians, and the important messages here is that colorectal cancer screening works, that colorectal cancer screening reduces deaths from colorectal cancer,” said Douglas Owens, a who has rotated off the U.S. Preventive Services Task Force, and was involved in developing the colorectal cancer screening guideline published earlier this week.

  • In Brief

    • President Obama names six appointees to the NCAB
    • Stand Up to Cancer to host fifth-biennial televised fundraiser
    • Kety Duron joins City of Hope as chief human resources officer
    • Miami Cancer Institute takes delivery of 220-ton proton therapy cyclotron
    • Takeda and M2Gen to collaborate on ORIEN genomic data
    • Mayo Clinic and Kiyatec to collaborate on ovarian cancer care
    • St. Jude receives pathology accreditation through College of American Pathologists
  • Drugs and Targets

    • Canadian review agency delivers positive opinion for Opdivo in NSCLC
    • Genomic Health launches Oncotype SEQ Liquid Select biopsy test
ISSUE 23 – June 10, 2016PDF



Biden Designates NCI’s Genomic Data Commons as Foundation of Moonshot 

CHICAGO—Vice President Joe Biden June 6 announced the NCI Genomic Data Commons as part of the National Cancer Moonshot Initiative.

The GDC, a $20 million portal that consolidates NCI’s diverse datasets, contains genomic sequences and analyses of tumors, as well as clinical data on enrollment and treatment.

Biden’s announcement—made hours before his address at the 2016 annual meeting of the American Society of Clinical Oncology—establishes NCI as the leader in a high-stakes debate over who gets to set standards for how health records data should be aggregated and organized.

• Related Coverage of the Cancer Moonshot

ASCO 2016

Biden: “I’d Like to Issue A Challenge to You”

Vice President Joe Biden challenged individual organizations and leading initiatives in oncology bioinformatics to interoperate and share data.

Speaking at the annual meeting of the American Society of Clinical Oncology in Chicago, Biden announced the NCI’s Genomic Data Commons as part of the National Cancer Moonshot Initiative, and urged others to collaborate with NCI.

Cancer Groups, Congress Push for
Dedicated Cancer Center at FDA

The FDA Oncology Center of Excellence—first proposed in the National Moonshot Cancer Initiative—is gaining support from oncology groups as well as in both chambers of Congress.

Earlier this week, 28 oncology professional societies and advocacy organizations sent a letter to FDA Commissioner Robert Califf, describing the organizational structure they’d like to see in the proposed center.

Capitol Hill

Senate Appropriators Propose $2 Billion
Increase for NIH

The Senate Committee on Appropriations marked up a bipartisan spending bill June 9 that gives NIH a $2 billion increase in the 2017 fiscal year.

NCI is to receive a $216 million increase over FY 2016.

Passed on a 29-1 vote, the measure boosts the NIH budget to $34 billion and now moves to consideration by full Senate. Funding for the Centers for Disease Control and Prevention will remain flat.

ASCO 2016

Vose: “Are We Ready To Care For These Patients?

Julie Vose, president of the American Society of Clinical Oncology, addressed the opening session of the society’s annual meeting in Chicago, discussing the themes of her year in office, the coming changes in federal cancer research and Medicare reimbursement, and the progress made over the society’s past 52 years.

Safety Bills on Morcellators,
Essure Introduced in House

Two House measures introduced earlier this week aim to strengthen federal requirements for reporting adverse outcomes caused by medical devices and to increase access to legal recourse for patients harmed by Class III high-risk devices.

• Related Coverage of Power Morcellation

In Brief
  • Former NCI Director Samuel Broder to retire from Intrexon Corp.
  • Yoshinori Ohsumi wins Janssen research prize from Johnson & Johnson

  • Five Pew-Stewart cancer research scholars announced

  • Susan G. Komen names 16 new Komen Scholars

  • American Hospital Dubai joins Mayo Clinic Care Network

  • University of Kentucky joins TriNetX

  • Roswell Park forms for-profit biotechnology company

  • CDC publishes Youth Risk Behavior Survey showing historic low smoking rates

 

20160610 - Jun. 10, 2016
JUNE 6, 2016 

Biden Designates NCI’s Genomic Data Commons As “Foundational Element” of Cancer Moonshot

Vice President Joe Biden June 6 announced the NCI Genomic Data Commons as part of the National Cancer Moonshot Initiative.

The GDC, a $20 million portal that consolidates NCI’s diverse datasets, contains genomic sequences and analyses of tumors, as well as clinical data on enrollment and treatment.

Biden’s announcement—hours before his address at the 2016 annual meeting of the American Society of Clinical Oncology in Chicago—establishes NCI as the leader in a high-stakes debate over who gets to set standards for how health records data should be aggregated and organized.

• Related Coverage of the Cancer Moonshot

    20160606 - Jun. 6, 2016
    ISSUE 22 – June 3, 2016PDF



    Obama and Congress Inadvertently
    Created Obstacles to Data Sharing, Biden Acknowledges—Now What?

    Seven years ago, when Congress sought to jumpstart the U.S. economy, few imagined that one aspect of the $800 billion stimulus program would turn electronic health records into the Tower of Babel.

    Speaking at Memorial Sloan Kettering Cancer Center last week, Vice President Joe Biden took full responsibility for the major bioinformatics snafu triggered by the American Reinvestment and Recovery Act of 2009.

    True, ARRA forced the U.S. medical establishment to digitize records in a hurry. Alas, today, fax machines and legions of data entry technicians are often required to transfer patient records from one hospital to another.

    Biden said the Obama administration didn’t foresee the consequences of mandating the switch to EHRs without developing a standard infrastructure for aggregating data.

    Biden: “You’re All Doing the Same Thing!”

    At a roundtable discussion at Memorial Sloan Kettering Cancer Center, Vice President Joe Biden urged greater efforts to aggregate cancer data.

    “I know MSK is part of Project GENIE and part of data sharing coalitions,” Biden said at the meeting May 26. “But I’ve met also with ORIEN, I’ve met with CancerLinQ.”

    “You’re all doing the same thing! I find it curious. I don’t know if that’s the only way it that can be done.”

    University of Maryland Cancer Center
    Earns NCI Comprehensive Designation

    The University of Maryland Marlene and Stewart Greenebaum Cancer Center has earned a designation as an NCI-designated Comprehensive Cancer Center. The center announced the NCI designation May 31.

    On Aug. 1, when the designation goes in effect, Maryland will become one of the 46 Comprehensive Cancer Centers in the U.S.

    ASCO Updates Value Framework

    The American Society of Clinical Oncology published an updated framework for assessing the relative value of cancer therapies that have been compared in clinical trials.

    The framework defines value as a combination of clinical benefit, side effects, and improvement in patient symptoms or quality of life in the context of cost. The updated framework will be the basis for a software tool that doctors can use to assist shared decision-making with their patients. The update was published in the Journal of Clinical Oncology.

    Study: 70 Cancer Treatments Launched Over 5 Years Pushes Oncology Market to $107 Billion

    A study reviewing trends in oncology found that more than 20 tumor types are being treated with one or more of the 70 cancer treatments that have been launched in the past five years.

    The surge in new therapies drove the global oncology market to $107 billion in 2015, an 11.5 percent increase over the previous year in constant dollars.

     

    Funding Opportunity

    CDMRP Taking Pre-Applications
    For Lung Cancer Concept Award

    Only 40 percent of Americans have a positive overall impression of clinical trials, according to a national survey conducted for Memorial Sloan Kettering Cancer Center.

    The survey, which polled over 2,100 people including nearly 600 physicians, found that 28 percent of doctors considered clinical trials as treatments of last resort.

    Letter to the Editor

    Progress Against Cancer:
    It Comes in Waves and Ripples

    By Silvia Paddock

    In 1916, Albert Einstein predicted the existence of gravitational waves. It took almost 100 years and the construction of the Laser Interferometer Gravitational-Wave Observatory (LIGO) to show that he was right. In 2015, a brilliant team of researchers detected gravitational ripples that had been generated by the collision of two black holes about 1.3 billion years ago.

    In Brief
    • Ralph De Vere White to step down as director of UC Davis Cancer Center
    • FDA publishes two guidances on compassionate use

    • ACCC launches Metastatic Breast Cancer Project

    Drugs and Targets
    • FDA approves cobas EGFR companion blood test for Tarceva

    • FDA approves NETSPOT for neuroendocrine tumors

    • European Commission approves Afinitor, Imbruvica
    • FDA grants orphan designations to Debio 1143 and SUBA-Itraconazole Capsules

    • Mylan launches generic version of Vidaza Injection

    • FDA grants Priority Review of telotristat etiprate in carcinoid syndrome

     

    20160603 - Jun. 3, 2016
    May 2016PDF

     

     Multiple Myeloma

    Study: Combination of ASCT and Bortezomib
    Can Increase Survival

    Early findings from a phase III clinical trial showed that patients with multiple myeloma who received an autologous stem cell transplant survived longer without disease progression than those who received only chemotherapy using novel agents.

    The study was the largest reported aimed at comparing ASCT with a bortezomib-based regimen alone in patients younger than 65, and will be presented at this year’s annual meeting of the American Society of Clinical Oncology, June 3-7 in Chicago.

    “Even in an age of novel therapies, proven approaches can retain their value. This study demonstrated that combining the best of both worlds—initial therapy with a novel agent followed by stem cell transplant—resulted in the best patient outcomes,” said ASCO President Julie Vose in a statement.

     Colorectal Cancer

    Cancers Originating on Left Side of Colon
    Associated with Longer Survival, Study Says

    A retrospective analysis found that the location of the primary tumor within the colon predicts survival and may help inform optimal treatment selection for patients with metastatic colorectal cancer.

    The data show that patients whose primary tumors originate on the left side of the colon—including the descending colon, sigmoid colon and rectum—survive significantly longer than those whose tumors originate on the right side, or the cecum and ascending colon.

    Researchers retrospectively evaluated data from the phase III CALGB/SWOG 80405 clinical trial, a federally funded clinical trial designed to compare Avastin (bevacizumab) and Erbitux (cetuximab) in combination with chemotherapy as initial therapy for metastatic colorectal cancer.

     Drugs and Targets

    FDA Approves Tecentriq, Opdivo, Imbruvica and Lenvima

    FDA granted accelerated approval to Tecentriq (atezolizumab) for urothelial carcinoma, the most common type of bladder cancer. This is the first product in its class of PD-1/PD-L1 inhibitors approved to treat this type of cancer, according to the drug’s sponsor, Genentech.

    Tecentriq is approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has worsened during or following platinum-containing chemotherapy, or within 12 months of receiving platinum-containing chemotherapy, either before or after surgical treatment.

    Also:

    Non-Small Cell Lung Cancer

     Melanoma

    Phase Ib Trial Shows 40 Percent of Patients
    Receiving Keytruda Alive After 36-Month Follow Up

     

    Mesothelioma

    WT1 Vaccine Doubles PFS in Phase II Trial

     

    Breast Cancer

    LEE011 Meets Primary Endpoint, Improves PFS
    in Phase III Trial

     

    Precision Medicine

    Study: Precision Medicine Yields Better
    Outcomes in Phase I Clinical Trials

     

    Palliative Care

    Study: Early Palliative Care Provides Benefits
    for Family Caregivers of Patients

     

    NCI CTEP-Approved Trials for the Month of May
    20160602 - Jun. 2, 2016
    MAY 31, 2016 

    University of Maryland Cancer Center Earns Comprehensive Designation

    The University of Maryland Marlene and Stewart Greenebaum Cancer Center has earned the designation as an NCI-designated Comprehensive Cancer Center.

    The center announced the NCI designation May 31.

    On Aug. 1, when the designation goes in effect, Maryland will become one of the 46 Comprehensive Cancer Centers in the U.S.

      20160531 - May. 31, 2016
      ISSUE 21 – May 27, 2016PDF



      Slamming the Door – Part XIII

      Chair of CPRIT Oversight Committee:

      “Better to Get Them All Out of the Way Now”

      What were Texas politicians and CPRIT officials thinking as they were pounded by blistering letters of resignation?

      Condemnation seemed to be rolling off their backs as they marched toward what they thought was their great triumph.

      Jimmy Mansour, chairman of CPRIT’s oversight committee, mistakenly hit Reply All, sending an especially contemptuous email to a scientist who was announcing his resignation from CPRIT. In the email that came into public view because of his sloppiness, Mansour, a telecommunications entrepreneur, belittles scientists and the peer review process.

      Conversation with The Cancer Letter

      Candace Johnson: A New Vision for Roswell Park

      Since Candace Johnson’s appointment as president and CEO of the Roswell Park Cancer Institute in February 2015, the institute has recruited 22 new faculty members and promoted 19 faculty members into senior leadership positions.

      “I’m a new leader. I have a new style, a new vision of where Roswell Park is going,” Johnson, the Wallace Family Chair in Translational Research, said to The Cancer Letter. “We have new and different challenges, and unless my entire workforce understood these challenges and embraced the changes I’ve been implementing, we wouldn’t have a chance.”

      ASCO Cervical Cancer Guideline Addresses Global Disparities

      The American Society of Clinical Oncology issued its first clinical practice guideline for invasive cervical cancer.

      The guideline provides evidence-based recommendations for four tiers based on available resources for cervical cancer screening and treatment: basic, limited, enhanced and maximal. For each setting, and for each stage of cervical cancer, the guideline recommends optimal therapy and palliative care. The guideline was published in the Journal of Global Oncology and was endorsed by the Society of Gynecologic Oncology.

      Survey: 28 Percent of Doctors See Clinical Trials as Last Resort

      Only 40 percent of Americans have a positive overall impression of clinical trials, according to a national survey conducted for Memorial Sloan Kettering Cancer Center.

      The survey, which polled over 2,100 people including nearly 600 physicians, found that 28 percent of doctors considered clinical trials as treatments of last resort.

      In Brief
      • Northwestern to host 5k coinciding with ASCO’s annual meeting in Chicago
      • The Canadian Cancer Society and Merck to collaborate on New Horizons project

      • American Skin Association presents annual awards

      • Margaret Foti honored by Ovarcome foundation

      • Seattle Children’s and Juno Therapeutics to collaborate on T-cell immunotherapies

      • Memorial Sloan Kettering and Hunter Douglas establish graduate fellowship

      • University of Chicago and Blue Cross and Blue Shield launch oncology medical home

      • Lightpoint Medical signs agreement for Beta Emission Tomography technology from University of Arizona researchers

      Drugs and Targets
      • CHMP issues positive opinion for Kyprolis in multiple myeloma

      • ProNAi Therapeutics and Carna Biosciences to commercialize AS-141

       

      20160527 - May. 27, 2016
      ISSUE 20 – May 20, 2016PDF



      NCI Identifies Moonshot Priorities

      NCI is working to provide five to ten recommendations for Vice President Joe Biden’s cancer moonshot program, officials said at a recent advisory committee meeting.

      At a meeting of the Frederick National Laboratory Advisory Committee May 11, top NCI officials described the mechanisms that will be used to provide recommendations for spending new money that may be directed at cancer research.

      The institute’s Blue Ribbon Panel—consisting of 28 members representing academia, government, industry and patient advocates—has assembled seven working groups.

      Guest Editorial

      Nancy Davidson: Capturing the Moonshot’s Momentum

      Vice President Joe Biden’s National Cancer Moonshot Initiative has touched off an unprecedented national and international dialogue about cancer.

      My presidential year at the American Association for Cancer Research brings the special opportunity to ensure that this momentum is captured and fully utilized to position cancer research as the key to saving more lives from cancer.

      The AACR has been and continues to be a trusted adviser to the vice president on this important initiative.

      Capitol Hill

      House Committee Provides Forum for Opponents of Part B Payment Model

      A Congressional committee earlier this week provided a venue for opponents of a controversial Medicare Part B payment model to argue against its implementation by Centers for Medicaid Services.

      Witnesses at the May 17 hearing of the health subcommittee of the House Committee on Energy and Commerce said the payment model would make it difficult for Medicare patients to obtain care, and one witness likened the model to an unethical clinical trial. Also, in what couldn’t be a coincidence, two witnesses—representing patients with immune deficiencies and rheumatology—submitted written testimony that contained identical paragraphs.

      In Brief
      • James Brink elected chair of American College of Radiology
      • Michael Kaplan named president and CEO of Melanoma Research Alliance

      • Hong-yu Li named Arkansas Research Alliance Scholar and endowed chair

      • CPRIT awards 35 grants totaling $79.2 million

      • Senate marks up FDA tobacco regulation appropriations

      Drugs and Targets
      • FDA grants accelerated approvals to Tecentriq and Opdivo

      • FDA warns doctors about counterfeit BiCNU

       

      20160520 - May. 20, 2016
      ISSUE 19 – May 13, 2016PDF

      art 42-19 showdown

      CMS Drug Payment Experiment Heads Toward Showdown on Capitol Hill

      A demonstration project in which the Centers for Medicare& Medicaid Services hopes to investigate the impact of reimbursement based on Average Sales Prices of drugs is running into strong opposition, as a large number of cancer groups submitted public comments urging the agency to abandon the endeavor.

      The agency’s stated goal for tweaking the ASP-based reimbursement formula is to learn whether it gives physicians the incentive to prescribe the most expensive treatments available.

      Opponents—including oncology professional groups and pharmaceutical companies—say that experimentation with ASP-based reimbursement, which is currently set at ASP plus 4.3 percent, will make it economically unfeasible for oncology practices to treat Medicare patients.

      Agus: $200 Million Interdisciplinary Institute to Focus on Data Modeling

      A few years ago, at dinner with technology entrepreneur Larry Ellison, David Agus, director of the University of Southern California Center for Applied Molecular Medicine, mentioned his dream of opening an interdisciplinary cancer center.

      “I said, it really would be an amazing thing if we could start to get people in one place and have residences, so the greatest physicists, mathematicians, engineers can actually come in and live there and be engrossed in cancer,” said Agus, professor at the Keck School of Medicine of USC and USC Viterbi School of Engineering.

      ““Well, how much would it be to kind of put together such a building and program?” Ellison, Oracle Corporation’s chairman of the board and chief technology officer, said to Agus at the time.

      “You know, about $200 million,” Agus said.

      “Done,” Ellison responded.

      Slamming the Door

      Part XII: Scientists Vote with Their Feet

      In their op-ed piece, Gilman and Sharp stated what it would take to fix CPRIT’s problems. That was the polite version of the Gilman Plan.

      The spoken version was more blunt: get rid of the “assholes” on the oversight board, jettison the administrators, then—maybe—CPRIT’s credibility would be restored.

      NIH Makes Sweeping Changes in Clinical Center Governance

      The NIH Clinical Center will be placed under a new system of governance, similar to that of hospitals.

      Replacing Director John Gallin and the current management structure, NIH has begun “the process of changing the leadership structure of the Clinical Center to model those of world class hospitals in the United States,” institute officials said in a statement.

      ACS Report Assesses Progress in 25-Year Goal Against Mortality

      The American Cancer Society published a report assessing the progress made in its 25-year goal to reduce cancer death rates by 50 percent. The report finds areas where progress was substantial, and others where it was not.

      The report, appearing in the ACS journal CA: A Cancer Journal for Clinicians, said the best improvements were seen in cancers for which prevention, early detection, and treatment tools are available, including cancers of the lung, colon, breast, and prostate.

      In Brief
      • Brigham Does Not Contest Plaintiffs’ Offers of Proof as Morcellation Cases Proceed
      • American Urological Association presents 2016 awards at annual meeting
      • Tom Andrus named chief digital officer at Prostate Cancer Foundation
      • Stand Up to Cancer and Boston College publish nursing training modules in immunotherapy
      • CancerCare publishes report on patient access and engagement
      • Cancer Support Community Benjamin Center presents awards
      • City of Hope receives $2.3 million R01 grant from NCI
      • BioDelivery Sciences International and Collegium Pharmaceutical form collaboration
      • Thomas Jefferson University joins TriNetX research network
      • UCLA and Leica Biosystems to collaborate in digital pathology
      • St. Jude raises $4 million in campaign Univision
      • PhRMA members invested $58.8 billion in R&D in 2015
      Drugs and Targets
      • FDA expands Imbruvica label to include CLL and SLL
      • Health Canada approves Imbruvica in Waldenström’s macroglobulinemia
      • Health Canada grants conditional approval to Ibrance in breast cancer

       

      20160513 - May. 13, 2016
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