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Issue 2 - Jan. 12, 2018
Issue 1 - Jan. 5, 2018
  • ASCO forms collaboration with two Big Data firms to grow CancerLinQ

    The ten-year collaboration, announced Dec. 21, gives Tempus and PH.AI access to de-identified data from over a growing database of more than a million records contained in CancerLinQ.

    ASCO and its new commercial partners will continue to expand CancerLinQ and, at the same time, look for better ways to aggregate and mine the data. The data could be used in drug development as well as scientific projects and quality initiatives.

  • Conversation with the Cancer Letter

    Hudis: ASCO needed collaborators to help CancerLinQ deliver faster on its mission

    “This is a licensure and a strategic collaboration. This leverages the expertise of several organizations to allow us to deliver real value to our members and subscribers faster than we would have been able to otherwise.”

  • Conversation with the Cancer Letter

    Lefkofsky: CancerLinQ has value in ushering in an era of precision medicine

    “This gets a bit into Tempus’s business model and at least how we view the world. This data has some commercial applicability today. But the real value in this data is in how do you build much larger, much more comprehensive datasets that actually can be used to usher in an era of precision medicine.”

  • Introducing the clinical section of The Cancer Letter

    Today’s issue of The Cancer Letter contains a new section devoted to clinical news.

    As part of our new format, stories that have immediate clinical significance will appear in every issue, much like a sports or business section in a newspaper.

  • An Appreciation

    Jimmie Holland, founder of psycho-oncology, dies at 89

    Jimmie C. Holland, internationally recognized as the founder of the field of psycho-oncology, died suddenly on Dec. 24, 2017, at the age of 89.

  • An Appreciation

    Gerald Hanks, pioneering radiation oncologist, dies at 83

    Gerald E. Hanks was a giant in the world of radiation oncology and oncology in general. It isn’t often that we can say this and probably understate a person’s significance and influence, but Jerry was one of those people.  He died on Dec. 20, 2017, at the age of 83.

  • In Brief

    • Howard “Skip” Burris elected ASCO president for 2019-2020
    • Hochster named associate director, clinical research, and chief of GI med/onc at Rutgers
    • Whitten named president of Taiho Oncology
    • Purdue Center for Cancer Research receives $10 million from Walther Cancer Foundation
    • METAvivor announces 2017 grant awards for metastatic cancer research
    • JAX starts canine cancer initiative to find predictors, treatments for humans, dog
  • TCCL Logo

  • Trials and Tribulations

    Cabozantinib in first-line treatment of metastatic renal cell carcinoma

    Systemic therapies for metastatic renal cell carcinoma (mRCC) have expanded dramatically over the past 3 years.

  • Clinical Roundup

    • CAP publishes guideline to ensure accurate HPV testing in head and neck cancers
    • CAR-T therapy cancer study published in the New England Journal of Medicine
    • Cancer mortality in the U.S. continues decades-long drop
  • Drugs and Targets

    • FDA approves Perjeta in adjuvant breast cancer
    • FDA approves Cabometyx for previously untreated advanced renal cell carcinoma
    • FDA approves Pfizer’s Bosulif (bosutinib) for newly-diagnosed Ph+ CML
    • FDA approves Xgeva for prevention of skeletal-related events in multiple myeloma
    • Kisqali receives breakthrough designation for HR+/HER2- breast cancer
    • FDA accepts sBLA, grants priority review for Adcetris
    • FDA grants breakthrough designation for Avelumab in combination with Inlyta in RCC
    • FDA grants orphan drug designation to Aptose Biosciences for CG’806 in AML
    • FDA accepts regulatory submission for Tagrisso in 1st-line EGFR-mutated NSCLC
    • FDA grants priority review for Apalutamide in non-metastatic castration-resistant prostate cancer
    • Janssen and Legend Biotech enter deal to develop CAR-T therapy
December 2017PDF

 

Breast Cancer

Pfizer’s talazoparib extends PFS in phase III trial in metastatic breast cancer

The phase III EMBRACA trial in patients with germline BRCA1/2-positive locally advanced and/or metastatic breast cancer demonstrated superior progression-free survival in patients treated with talazoparib, compared to patients who received physician’s choice standard of care chemotherapy.

 

Lymphoma

Juno Therapeutics and Celgene release additional data from TRANSCEND trial

Juno Therapeutics Inc., a biopharmaceutical company developing cellular immunotherapies for the treatment of cancer, released additional data from the TRANSCEND study of JCAR017 (lisocabtagene maraleucel; liso-cel) in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma in a presentation at the 59th American Society of Hematology Annual Meeting and Exposition.

 

Leukemia

Phase III study of venetoclax in combination with rituximab meets primary endpoint

MURANO, a randomized phase III study sponsored by Abbvie, showed that patients with relapsed or refractory chronic lymphocytic leukemia achieved significantly prolonged median progression-free survival with Venclexta/Venclyxto (venetoclax) in combination with Rituxan (rituximab) [median PFS, not reached], compared with bendamustine in combination with Rituxan [median PFS, 17.0 months; hazard ratio, 0.17; 95% CI, 0.11–0.25; P<0.0001].

 

Kidney Cancer

Genentech’s Tecentriq and Avastin reduce the risk of disease worsening or death from RCC

 

Skin Cancer

PD-1 antibody cemiplimab demonstrates 46.3% ORR in advanced cutaneous squamous cell carcinoma

 

Head and Neck Cancer

Galera Therapeutics reports statistically significant results in a 223-patient phase IIb trial of GC4419 for oral mucositis in head and neck cancer

 

Lung Cancer

Aggressive surgery is best treatment option for early stage lung cancer

 

Side Effects

Daily oral edoxaban met primary endpoint in Hokusai-VTE cancer study

 

Liquid Biopsy

Liquid biopsy results differed substantially between two providers in a study

 

NCI CTEP-Approved Trials for December

  
CCL Dec 2017 - Dec. 29, 2017
Issue 46 - Dec. 15, 2017
  • “We’re gonna free the data,” Sharpless pledges at NCI Town Hall

    In his first talk to  NCI staff, director Norman “Ned” Sharpless presented himself as an institute insider—highlighting his career-long relationships with NCI and its “legends,” demonstrating his grasp of the institute’s agenda and research portfolio.

  • Five health systems join Strata Oncology network to sequence and match patients to targeted therapy trials

    Five health care systems have joined a precision oncology network that sequences patients’ tumors at no cost and matches patients to clinical trials.

  • As FDA, AHRQ spar over incidence estimates for uterine sarcomas, FDA reiterates recommendation to restrict power morcellation

    About one in 225 to one in 580 women who undergo surgery for fibroids may have hidden uterine cancers, FDA concluded in a recent review of medical studies published over the past four years.

    The updated estimate is generally consistent with one contained in the agency’s 2014 review, FDA officials said in a statement Dec. 14. Three years ago,  the agency estimated that  one in 350 women undergoing such surgery may have a previously undiagnosed sarcoma.

  • Anticipating fundamental change in oncology

    In 2017, The Cancer Letter’s readership grew by over 40 percent and the number of page views has nearly doubled from the 2016 level.

    On an average day in 2017, our website got over 1,700 visits and over 12,500 page views. By way of comparison, in 2016, we gauged 1,200 visits and 6,800 page views. We are losing the right to call ourselves a small publication.

  • In Brief

    • AACR urges House-Senate conference to remove tax bill provisions penalizing future scientists, patients, survivors
    • 2017 AACR-Bayer Innovation and Discovery Grants recipients announced
    • USPSTF recommends against hormone therapy for preventing chronic conditions 
    • Jason Incorvati joins hem/onc department at New Fox Chase East Norriton Campus
  • Drugs and Targets

    • Fate Therapeutics completes technology transfer and starts IND-enabling manufacture of FT500
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
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