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Issue 45 - Dec. 8, 2017
  • Building a “hybrid” center by the Beltway, Trump pursues vision of a new national research network

    As he goes about the task of building a cancer center, Donald “Skip” Trump has to align the money, the real estate, the recruitment—all the customary components of an institution.

    Sure, all of this is more complex because Trump is building the Inova Schar Cancer Institute in hyper-competitive and wealthy Northern Virginia, literally by the outer loop of the Beltway.

  • FDA considers using data from approved indications to support regular approvals of sNDAs based on intermediate endpoints

    FDA officials are floating a proposal for a review process informally dubbed “reverse accelerated approval.”

    This mechanism would come into play in situations where the data that have already been provided to the agency may justify approval of supplemental indications.

  • Guest Editorial

    Tobacco companies finally have to say smoking causes cancer

    These statements may not be breaking news for oncologists and other physicians, who should have been aware of the lethal nature of cigarette smoking at least since the publication of the first Surgeon General’s report on Smoking and Health more than half a century ago.

  • In Brief

    • William Oh named deputy director of Tisch Cancer Institute
    • Pisters embarks on “listening tour” at MD Anderson
    • Viviane Tabar named chair of the department of neurosurgery at MSK
    • Aradhana Ghosh named vice president of oncology at Syapse
    • NCI awards $16 million grant to PHSU and Moffitt to strengthen tissue bank, reduce health disparities
    • New national clinical trial investigated link between diabetes and pancreatic cancer
    • Mount Sinai’s Sundar Jagannath wins MMRF award
    • AACR urges Congress to reach bipartisan budget agreement
  • Drugs and Targets

    • FDA grants Avastin full approval for glioblastoma
November 2017PDF

 

Hematologic malignancies

CD22 CAR-T therapy shows results in leukemia study

A new type of CAR-T therapy that targets the protein CD22 helped achieve remission in nearly 60 percent of leukemia patients who had failed or relapsed on other treatments, according to a paper published in Nature Medicine.

 

Immunotherapy

Mount Sinai researchers develop first mathematical model for predicting patient response to immunotherapy

Researchers at the Icahn School of Medicine at Mount Sinai have created the first mathematical model that can predict how a cancer patient will benefit from certain immunotherapies, according to a study published in Nature.

 

Lung cancer

Phase III study shows Tecentriq and Avastin plus chemo reduced risk of disease progression or death in advanced lung cancer

Genentech said the phase III IMpower150 study met its co-primary endpoint of progression-free survival and demonstrated that the combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) plus chemotherapy (paclitaxel and carboplatin) provided a statistically significant and clinically meaningful reduction in the risk of disease worsening or death compared to Avastin plus chemotherapy in the first-line treatment of people with advanced non-squamous non-small cell lung cancer.

 

Breast Cancer

Novartis reports positive results from phase III trial of Kisqali for advanced or metastatic breast cancer

 

Genitourinary cancers

Clinical data for CXCR4 inhibitor, Inlyta showa 29% ORR in clear cell renal cell carcinoma

 

Brain tumors

Ziopharm announces positive updated results of Ad-RTS-hIL-12 study in brain cancer

 

NCI CTEP-Approved Trials for November

 

Regulatory actions

FDA approves adjuvant indication for Sutent in renal cell carcinoma

  
CCL Nov 2017 - Dec. 7, 2017
Issue 44 - Nov. 28, 2017
  • Caligiuri named president of City of Hope National Medical Center

    Michael Caligiuri was named physician-in-chief of City of Hope and president of City of Hope National Medical Center.

    Caligiuri recently stepped down as director of The Ohio State University Comprehensive Cancer Center and as CEO of the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.

    He will join City of Hope in this newly created position next February. The appointment was announced on Nov. 28.

  • Conversation with the Cancer Letter

    Caligiuri: It was time for me to hit the refresh button on my career

    After 20 years at Ohio State University, Michael Caligiuri is moving on.

    Caligiuri was named physician-in-chief of City of Hope and president of City of Hope National Medical Center on Nov. 28. He stepped down as director of The Ohio State University Comprehensive Cancer Center and as CEO of the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute earlier this month.

  • NCI Director’s Report

    Sharpless lists initial priorities for NCI: Big Data, cell therapy, and more trials at the NIH Clinical Center

    NCI needs to focus on developing a structured approach to Big Data initiatives to ensure optimal use of the institute’s limited resources, said NCI Director Norman “Ned” Sharpless at his first joint meeting of the National Cancer Advisory Board and the Board of Scientific Advisors.

  • FDA approves Foundation Medicine’s genomic profiling test for all solid tumors; CMS proposes coverage

    FDA has approved the FoundationOne CDx, the first breakthrough-designated, next generation sequencing-based in vitro diagnostic test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type.

    The Centers for Medicare & Medicaid Services—at the same time—proposed coverage of the F1CDx, a laboratory-developed test sponsored by Foundation Medicine.

  • In Brief

    • FDA’s Pazdur named to Bloomberg 50 list
    • National Academies report calls for government negotiation of drug prices
    • Antonio Wolff named chair of ECOG-ACRIN Breast Cancer Committee
    • Louis Weiner to lead MedStar Georgetown Cancer Institute
    • LLS awards $5 million grant to team led by Sylvester’s Stephen Nimer
    • Ronda Henry-Tillman named to Kohn Chair in breast surgical oncology UAMS
    • NCCN, in collaboration with Pfizer, awards nine grants for quality improvement in breast cancer
    • Ronald Maier elected president of American College of Surgeons
    • Leigh Neumayer elected chair of the ACS board of regents
  • Drugs and Targets

    • FDA approves Ogivri, first biosimilar for treating breast and stomach cancers
    • Tesaro receives European approval of Zejula for recurrent ovarian cancer
    • G1 Therapeutics and AstraZeneca enter clinical trials collaboration in NSCLC
    • ITUS Corp. Moffitt enter into CRADA to develop CAR-T technology
Issue 43 - Nov. 17, 2017
  • Defining the next level for Inova

    In 2010, John Knox Singleton, the CEO of the Inova Health System, had several meetings with John Niederhuber, a surgeon and scientist who had just been replaced as NCI director.

    At the time, Niederhuber still had a lab at NIH, but was plotting the next step in his career. Singleton had been Inova’s CEO since 1984.

  • Caligiuri resigns as CEO of the James after stepping down as director of OSUCCC

    Michael Caligiuri, who over the past 14 years demonstrated virtuosity in recruitment, lobbying, and fundraising, building the third-largest cancer hospital in the U.S., has stepped down as director of The Ohio State University Comprehensive Cancer Center and as CEO of the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.

  • An Appreciation

    Hail to “The Chief” Donald S. Coffey, a scientist, a mentor, a wit, dies at 85

    Donald S. Coffey, Ph.D., cancer warrior, humanist, mentor to hundreds of researchers and physicians, friend to countless people, was filled with a burning curiosity to understand the world and to know personally everyone he came in contact with.

    Everyone has the story—“I met Don at a meeting and he sat me down and he asked me to tell him my life story—and I was forever changed.”

  • In Brief

    • De la Chapelle receives lifetime achievement award from colorectal cancer group
    • Gallagher named vice president and head of Global Oncology Development at AbbVie 
    • Sylvester geneticist Shiekhattar receives NIH “Pioneer Award” 
    • WPI’s Mattson receives $1.7-million NIH award to develop molecular methods
    • LUNGevity partners with ALK Positive Patient Group to fund research
  • Drugs and Targets

    • FDA approves adjuvant indication for Sutent in renal cell carcinoma
    • FDA approves obinutuzumab for previously untreated follicular lymphoma
    • FDA approves Sprycel for pediatric patients with CML
    • FDA approves Genentech’s Hemlibra to prevent bleeding in hemophilia A
    • FDA authorized MSKCC’s tumor profiling tests
Issue 42 - Nov. 10, 2017
  • Skip Trump builds a cancer center by the Beltway

     Should Donald “Skip” Trump look up while talking to you on the phone, he might see deer roaming in the pine forest outside his office window.

    Trump might let his gaze skim the brown granite skin of the building of his cancer center—the Inova Schar Cancer Institute—and watch the proton beam and radiation therapy center take shape.

  • Conversation with the Cancer Letter

    Trump’s plans for Inova reach across the Washington Beltway, through Virginia—and beyond

    Trying to build a cancer center in the middle of a saturated market should be difficult enough.

    Yet, preparing to face the competition from other established cancer centers across the Potomac is just one of the challenges Donald “Skip” Trump faces as CEO and executive director of the Inova Schar Cancer Institute.

  • CMS plan to slash $1.6 billion from 340B program will reduce discounts on cancer drugs

    Hospitals enrolled in the 340B program stand to lose up to $1.6 billion in Medicare Part B reimbursements through upcoming cuts to the drug pricing program, according to a final rule by the Centers for Medicare and Medicaid Services.

  • In Brief

    • WUSTL’s DiPersio receives $6 million for leukemia research
    • Hopkins researchers launch interdisciplinary effort for breast cancer
    • Gad Getz, Chuan He, and Aviv Regev win Paul Marks Prize
    • Neuroblastoma foundation awards grant to Harvard’s Malgorzata Krajewska
    • Sanford Health wins ACCC David King Award
    • Ohio State receives Press Ganey Guardian of Excellence Award
    • NCI grant will support UA research in “lung cancer stigma”
    • NCCN publishes guidelines for cancer treatment in sub-Saharan Africa
  • Drugs and Targets

    • Alecensa gets FDA approval for ALK-positive metastatic NSCLC
    • FDA approves first treatment for Erdheim-Chester Disease
    • FDA approves Adcetris for cutaneous anaplastic large cell lymphoma
    • Seattle Genetics submits sBLA for Adcetris in Hodgkin lymphoma
October 2017PDF

 

Lung cancer

Researchers confirm IASLC proposed characterization of uncertain R Status R(un), prognosis between R0 and R1

A recent study confirmed the International Association for the Study of Lung Cancer’s proposed criteria for uncertain resection margin status, R(un), in residual tumor (R) classification.

 

Breast cancer

Trastuzumab for HER-2-expressing tumors needn’t delay breast reconstruction

Treatment with trastuzumab (Herceptin/Genentech) of breast cancers that express the HER-2 protein does not increase the risk for complications at the surgical site for women who undergo immediate breast reconstruction after mastectomy.

 

Brain Cancer

Local radiation provides comparable control of brain metastases compared to surgery

An analysis led by researchers at Fox Chase Cancer Center in collaboration with the European Organization for the Research and Treatment of Cancer found that treating cancer that has metastasized to the brain with focal, high-dose radiation yields improved early results compared with surgical removal.

 

Melanoma

Cleveland Clinic study: timing of melanoma diagnosis, treatment critical to survival

 

Prostate Cancer

Pfizer, Astellas report positive results from trial of Xtandi in non-metastatic castration-resistant disease

 

Kidney Cancer

Argos Therapeutics reports interim analysis of phase III ADAPT trial

 

NCI CTEP-Approved Trials for October

 

Regulatory actions

FDA approves Kite’s CAR-T cell therapy; another win for NCI’s intramural program

  
CCL Oct 2017 - Nov. 8, 2017
Issue 41 - Nov. 3, 2017
  • Conversation with the Cancer Letter

    Peter Pisters reflects on the upcoming challenge: leading MD Anderson

    With a month to go before his Dec. 1 start date as president of MD Anderson Cancer Center, Peter Pisters reflected on the challenges that await him in Houston.

  • House appropriators push back on Trump proposal to cap NIH facilities and administrative costs at 10%

    The Trump administration should consider NIH and the biomedical research enterprise as a component of the nation’s “defense” when making budgetary decisions, said Rep. Tom Cole (R-OK), chairman of the House Appropriations Subcommittee for Labor-HHS, Education, and Related Agencies.

  • In Brief

    • Kelly McMasters named editor of Annals of Surgical Oncology
    • Focused Ultrasound Foundation receives transformative $10 million pledge
    • Cancer imaging archive at UAMS bolstered by $8.3 million NCI grant
    • Wistar, Man’s Best Friend Therapeutics collaborate on veterinary vaccine
    • Bryant Gumbel named 2017 NFL Players Association Georgetown Lombardi Award Recipient
    • Colon Cancer Alliance changes name to Colorectal Cancer Alliance
  • Drugs and Targets

    • FDA approves AstraZeneca’s Calquence for mantle cell lymphoma
    • Consortium aims to accelerate preclinical cancer drug discovery
  • Funding Opportunities

    • The FY17 Defense Appropriations Act provides $10 million to the Department of Defense Kidney Cancer Research Program to support United States Army Medical Research Acquisition Activity 
Issue 40 - Oct. 27, 2017
  • Redefining “normal”: IU’s Komen Tissue Bank shows how race and abnormalities correlate with development of disease

    When two women—a patient advocate and a scientist—embarked on a mission to collect “normal” breast tissue for comparative purposes, colleagues in oncology dismissed their idea as wild.

    In the early 2000s, Connie Rufenbarger, a breast cancer patient advocate, and Anna Maria Storniolo, a professor of clinical medicine at the Indiana University School of Medicine and a member of the Vera Bradley Foundation for Breast Cancer Research Laboratories, were attending a meeting in Indianapolis when they realized that oncologists had no source of “true normal” breast tissue to use as control in studies.

  • Conversation with the Cancer Letter

    Storniolo: The Komen Tissue Bank fills the gap in understanding of “normal”

    Ten years ago, the formation of the Komen Tissue Bank at the Indiana University Melvin and Bren Simon Cancer Center was met with skepticism.

    Critics questioned the ethics of collecting “normal” breast tissue from healthy women who otherwise would have no other reason to undergo biopsies.

    Anna Maria Storniolo, a founder of the tissue bank and now its director, was one of those skeptics—before she started work on the bank in 2005.

  • ACS: Access and socioeconomic factors affect racial disparities in breast cancer mortality rates

    The disparity in survival outcomes between black and white women with breast cancer—the result of a complex interaction of biologic and nonbiologic factors—can be reduced by increasing access to health care in all U.S. states, researchers from the American Cancer Society concluded in a recent study.

  • Dmitrovsky named president of Leidos Biomedical and director of Frederick Lab

    Ethan Dmitrovsky was appointed president Leidos Biomedical Research, Inc. and Laboratory director of the Frederick National Laboratory for Cancer Research.

    Dmitrovsky will succeed the current president, David Heimbrook, who will retire.

    FNLCR is operated by Leidos Biomedical under an operations and technical support contract from NCI worth up to $400 million-a-year.

  • Help Wanted: MD Anderson seeks chief academic officer; Draetta named to the job in the interim

    MD Anderson has begun a search for a chief academic officer.

    Giulio Draetta will serve as CAO ad interim. Draetta is the Sewell Family Chair of Genomic Medicine, senior vice president, discovery and platforms and co-leader of the MD Anderson Moon Shots Program. Until now, Stephen Hahn, deputy president and chief operating officer, also served as interim chief academic officer.

  • In Brief

    • Pat Coyne and Meg Gaines receive NCCS Stovall Award for advancing patient-centered care
    • SU2C launches four teams on “cancer interception” to detect and treat cancer
    • SU2C launches 10 clinical trial projects combining cancer treatments
    • Barbara McAneny receives ACCC award
    • NCCN has one million registered users accessing the guidelines and related content
    • Fox Chase Cancer Center Opens Satellite Office in East Norriton
    • Xiongbin Lu named Vera Bradley Foundation professor of breast cancer innovation at IU
    • The GW Cancer Center announces new mobile mammography van
  • Drugs and Targets

    • FDA accepts Genentech’s application for Avastin for advanced ovarian cancer
    • G100 receives Orphan Drug Designation from EMA for follicular non-Hodgkin’s lymphoma
Issue 39 - Oct. 20, 2017
Issue 38 - Oct. 13, 2017