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Issue 31 - Aug. 4, 2017
  • AACR’s Project GENIE about to release second dataset, creating the largest publicly available genomic database

    Project GENIE, a publicly available genomic data repository created and run by the American Association for Cancer Research, has amassed 18,804 de-identified records, and is on track to release another large dataset early this fall.

    Launched in 2015, Project GENIE, short for the AACR Project Genomics Evidence Neoplasia Information Exchange, is a multi-phase, multi-year international data-sharing initiative that seeks to catalyze precision oncology through the development of a regulatory-grade registry.

  • Conversation with The Cancer Letter

    Charles Sawyers: Project GENIE demonstrates what a coalition of willing institutions is able to do

    When former Vice President Joe Biden sought to convene and cajole cancer organizations into breaking down silos as part of the Cancer Moonshot, he frequently expressed frustration about reluctance on the part of cancer organizations to share data.

    “You’re not going to like this, but imagine if you all worked together,” Biden said at the 2016 annual meeting of the American Society of Clinical Oncology. “I’m not joking! Imagine if you all worked together.” (The Cancer Letter, June 10, 2016).

  • Ned Sharpless set to leave UNC job Aug 4; Starting date as NCI director not publicly known

    Norman “Ned” Sharpless, the scientist slated to be the next NCI director, is departing from his current job, that of director of UNC Lineberger Comprehensive Cancer Center, sources said.

    While it’s confirmed that Aug. 4 is Sharpless’s last day at Lineberger, it’s less clear what his first day at NCI would be, though insiders say he would likely report to work at the institute by the end of August.

  • Conversation with The Cancer Letter

    More than three million life-years added over 60 years as a result of SWOG clinical trials

    A SWOG study estimates that implementation of findings from that group’s clinical trials has added 3.34 million years to the lives of cancer patients in the 60 years since its founding in 1956.

    The primary question the researchers sought to answer was: “How have the NCI–sponsored network cooperative cancer research groups benefited patients with cancer in the general population?”

  • Guest Editorial

    Senate passes a “right to try” bill; Harm to patients comes next

    Patients for whom there are no existing treatments watch with desperation as a potentially helpful new drug spends years working its way from a lab bench, through clinical trials, and finally to the FDA, where reviewers consider it for approval.

    To help those who don’t qualify for clinical trials but wish to try experimental drugs as a last treatment option, the FDA allows patients’ physicians to apply for “compassionate use” of experimental medications through its expanded access program, which allows seriously ill patients without other treatment options to access investigational, unapproved drugs and devices outside of a clinical trial.

  • In Brief

    • Ramon Parsons named director of Tisch Cancer Institute at Mt. Sinai
    • ASTRO names 23 members to 2017 class of “fellows”
    • Emmanuel Quien joins the Fox Chase Cancer Center Department of Hematology/Oncology
  • Drugs and Targets

    • Enasidenib, companion diagnostic get FDA approval for relapsed or refractory AML
    • Vyxeos gets FDA approval for first treatment for types of poor-prognosis AML
    • Opdivo gets FDA accelerated approval for MSI-H/dMMR colorectal cancer
    • FDA expands ibrutinib indications to chronic GVHD
    • Amgen, Allergan submit biosimilar application for ABP 980 to FDA
    • Kite files the first CAR-T application in Europe for axicabtagene ciloleucel
    • BMS to acquire IFM Therapeutics to focus on innate immunity
    • BMS, Clovis form collaboration to evaluate Opdivo and Rubraca
    • Loxo Oncology acquires highly selective, reversible BTK inhibitor
    • MedStar Health partners with Indivumed to advance precision oncology research
  • Funding Opportunities

    • NETRF announces grants for neuroendocrine cancer research
July 2017PDF

 

Hematologic Malignancies

Oral enasidenib demonstrates durable CRs in IDH2 mutant relapsed, refractory AML

Agios Pharmaceuticals Inc. published efficacy and safety data from the ongoing phase I/II dose-escalation and expansion study evaluating investigational oral Idhifa (enasidenib) in patients with relapsed or refractory acute myeloid leukemia and an isocitrate dehydrogenase-2 mutation.

 

Lung cancer

First-line immunotherapy treatment can improve survival for subset of lung cancer patients

Findings from a phase III clinical trial for advanced lung cancer patients could help oncologists better predict which patients are likely to receive the most benefit from immunotherapy as a first-line treatment based on the unique molecular characteristics of their tumor, according to a new study reported by a global team led by David Carbone of Ohio State University Comprehensive Cancer–Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.

 

Colon Cancer

UW study links insurance coverage to higher rates of colorectal cancer screenings

Researchers at the University of Wisconsin School of Medicine and Public Health determined that people with a certain type of insurance policy were more likely to be screened for colorectal cancer.  

 

Gastric Cancer

Differences in subtypes may determine prognosis and response to treatment

 

Pancreatic Cancer

Combined molecular biology test can identify patients with benign pancreatic abnormalities

 

Breast Cancer

Nipple-sparing mastectomy has low rate of breast cancer recurrence

 

Melanoma

Delaying lymph node biopsy after diagnosis doesn’t affect survival

 

Brain tumors

Experimental “enhancer” may boost conventional therapies for pediatric disease

 

NCI CTEP-Approved Trials for July

 

Regulatory actions

FDA approves treatment to reduce risk of breast cancer returning

  
CCL July 2017 - Aug. 3, 2017
Issue 30 - Jul. 28, 2017
  • Pediatric MATCH starts to accrue children with recurrent and refractory cancers

    NCI and the Children’s Oncology Group opened enrollment in Pediatric Molecular Analysis for Therapy Choice—Pediatric MATCH—a long-awaited precision medicine trial.

    Pediatric MATCH, a series of single-arm phase II trials, will seek to screen between 200 and 300 patients per year, with the goal of screening 1,000 patients over four years, assigning children to therapies that target genomic characteristics of their diseases.

  • Conversation with The Cancer Letter

    Will Parsons: This is a fantastic opportunity to test precision oncology for pediatric patients in a large-scale way

    Though NCI-MATCH and Pediatric MATCH are similar in structure, they represent different approaches to oncology.

    While a small minority of adult cancer patients in the U.S. get treated on-protocol, in pediatric oncology only a small proportion of patients receive care off-protocol. Altogether 90 percent of childhood cancer patients are treated at institutions that are part of Children’s Oncology Group.

  • Conversation with The Cancer Letter

    Rita Redberg: FDA proposal to delay reporting of device malfunctions “should be tossed”

    A recent proposal to delay reporting of device malfunctions to FDA will weaken the already inadequate medical device reporting system at the agency, said Rita Redberg, a professor of medicine and cardiologist at the University of California San Francisco.

    Redberg, editor of JAMA Internal Medicine, has been studying adverse event reporting and medical device surveillance issues for over a decade. She often opines on recommendations of U.S. Preventive Services Task Force, and in 2014, as chair of an advisory committee for the Centers for Medicare and Medicaid Services, Redberg presided over the panel that expressed low confidence in low-dose CT screening for lung cancer (The Cancer Letter, May 9, 2014).

  • In Brief

    • Carlos Arteaga to head UT Southwestern Simmons Comprehensive Cancer Center
    • Larry Copeland appointed president of GOG Foundation
    • Edith Mitchell receives 2017 ASTRO Honorary Membership
    • SU2C-Lustgarten Foundation team aims to apply CAR T-cell therapy to pancreatic cancer
    • Andrew Baschnagel wins UW Carbone Cancer Center award for lung cancer study
    • Cancer groups release statement on health disparities research
    • Report shows cancer patients struggle to afford treatment
    • Christiana Care Gene Editing Institute, NovellusDx form personalized medicine partnership
  • Drugs and Targets

    • FDA expands approval of Yervoy to include pediatric patients 12 years and older with unresectable or metastatic melanoma
    • FDA accepts BMS applications for Opdivo four-week dosing schedule across approved indications
    • Novartis receives positive CHMP opinion for Rydapt for newly diagnosed FLT3-mutated AML, three types of advanced systemic mastocytosis
    • AstraZeneca and Merck from oncology collaboration
    • CHMP issues positive opinion for avelumab for metastatic Merkel cell carcinoma