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Jun 24, 2016

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.

	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

Jun 17, 2016

ISSUE 24 - June 17, 2016

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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

Jun 10, 2016

ISSUE 23 - June 10, 2016

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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.

	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

Jun 6, 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.

Jun 3, 2016

ISSUE 22 - June 3, 2016

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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

Jun 2, 2016

May 2016

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	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. Also: Retrospective Study Identifies Biomarker for Erbitux Treatment
	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: Health Canada approves Imbruvica, Ibrance, Lynparza EU approves Afinitor and Eribulin, and more
	Non-Small Cell Lung Cancer Alecensa Reduces Death Risk By 66 Percent in Phase III Trial Phase III Patritumab Study in HER3 Stopped Early by IDMC
	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

May 31, 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.

May 27, 2016

ISSUE 21 - May 27, 2016

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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.” RPCI's Recent Recruitments and Promotions
	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

May 20, 2016

ISSUE 20 - May 20, 2016

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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

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