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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

 

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
Issue 29 - Jul. 21, 2017
Issue 28 - Jul. 14, 2017
  • ODAC unanimously recommends approval for CAR T-cell therapy for relapsed and refractory B-cell ALL in kids and young adults

    “If you want to see what a cure looks like, you already have,” said Tom Whitehead as his daughter Emily joined him at the lectern at the public hearing of the FDA Oncologic Drugs Advisory Committee July 12.

    “She’s standing right beside me.”

  • Removed from U.S. market in 2011, Pfizer’s Mylotarg slated to return following results of a French study that tested a new regimen

    The FDA Oncologic Drugs Advisory Committee July 11 voted to approve Pfizer’s Mylotarg (gemtuzumab ozogamicin, GO), a CD33-directed antibody-drug conjugate for the indication of “combination therapy with daunorubicin and cytarabine for the treatment of adult patients with previously untreated, de novo CD33-positive acute myeloid leukemia.

    The committee voted 6-1 in favor of approval.

  • FY18 health budget battle begins: House appropriators slate $1.1 billion increase for NIH while defunding ACA, Title X

    The House Subcommittee on Appropriations for Labor-HHS marked up the fiscal 2018 spending bill—voting 9-6 along party lines on legislation that would prohibit the use of any new discretionary funding in connection with the Affordable Care Act.

    The bill includes $156 billion in discretionary spending, which is $5 billion below the fiscal 2017 enacted level. Nevertheless, this amount is $5 billion above the fiscal 2018 sequestration cap enacted under the Budget Control Act of 2011. The sequester will automatically activate unless a deal—much like the Bipartisan Budget Act of 2013 achieved by Rep. Paul Ryan (R-WI) and Sen. Patty Murray (D-WA)—is reached.

  • In Brief

    • Steven Piantadosi steps down at Cedars-Sinai to focus on clinical trial design
    • Edus Warren named leader of Fred Hutch Global Oncology program
    • Interdisciplinary program at NYU Langone targets pancreatic cancer
    • Fox Chase Cancer Center creates a fellowship
  • Drugs and Targets

    • FDA converts accelerated approval of Amgen’s Blincyto to full approval in ALL
    • FDA places clinical hold on Merck’s three Keytruda multiple myeloma studies
Issue 27 - Jul. 7, 2017
  • NCI-MATCH keeps enrolling—Targeted mutations are proving to be less common than estimated

    The NCI-MATCH trial has met its goal of screening 6,000 patients, but it will not stop there.

    The landmark precision medicine trial, which is essentially a collection of single-arm phase II studies, recently cleared four laboratories to identify patients who are getting tested as part of their care. If actionable mutations are found, these patients could become eligible for NCI-MATCH.

  • Conversation with The Cancer Letter

    Keith Flaherty: We will certainly stop if we enroll all subprotocols

    NCI and ECOG-ACRIN officials said the NCI-MATCH trial will keep going, continuing to match patients with treatment arms based primarily on their molecular characteristics.

    The institute will no longer pay for genotyping—which it has done to biopsy and genotype nearly 6,000 patients—but it will make use of genomic sequencing that’s being done by commercial labs and at some cancer centers to guide clinical care.

  • Conversation with The Cancer Letter

    Barbara Conley: Learning from first broad foray into precision medicine

    The first step in the NCI-MATCH trial—deciding how many patients to screen—was a guess.

    At first, NCI and ECOG-ACRIN thought genotyping 3,000 patients may be sufficient. Then the sample was upped to 6,000, which also proved to be insufficient to fill the trial’s arms.

  • James Doroshow: NCI-MATCH tests ability to integrate next generation sequencing

    The new iteration of the NCI-MATCH trial will test the ability on the part of cancer researchers to integrate exchanges of genomic information between academic institutions and commercial vendors, said James Doroshow, NCI deputy director for clinical and translational research and director of the Division of Cancer Treatment and Diagnosis

    “I think this is a very important test of how we can, or if we can, utilize resources across the entire country,” Doroshow said at the June 20 meeting of the NCI National Cancer advisory Board and the Board of Scientific Advisors.

  • In Brief

    • Steven Leach named director at Dartmouth Norris Cotton Cancer Center
    • Chi Van Dang appointed professor at Wistar Institute
    • Patricia Ganz named editor in chief of Journal of the National Cancer Institute
  • Drugs and Targets

    • FDA clears cooling cap treatment in solid tumor chemotherapy
    • FDA granted marketing approval to the Praxis Extended RAS Panel
    • FDA approves Endari for patients with sickle cell disease
  • Funding Opportunities

    • Call for applications – Society for Translational Oncology Fellow’s Forum
June 2017PDF

 

Lymphoma

Takeda, Seattle Genetics announce data of ADCETRIS for CD30-positive cutaneous T-cell lymphoma

Takeda Pharmaceutical Co. Ltd. and Seattle Genetics Inc. announced that data from the randomized phase III Alcanza clinical trial evaluating Adcetris (brentuximab vedotin) in patients with cutaneous T-cell lymphoma was published in Lancet.

 

Hepatocellular carcinoma

Lenvatinib shows positive results vs sorafenib in unresectable hepatocellular carcinoma

Eisai Inc. announced results from the REFLECT study, a phase III trial evaluating lenvatinib (Lenvima), the company’s multiple receptor tyrosine kinase inhibitor (including fibroblast growth factor receptors, for the first-line treatment of patients with unresectable hepatocellular carcinoma.

 

Breast cancer

Study: surgery prior to drug treatment not beneficial in metastasized breast cancer

A study from the Austrian Breast & Colorectal Cancer Study Group indicates that women with metastasized breast cancer do not benefit from surgery performed prior to drug treatment. This could cause a paradigm shift in treatment of the disease.

 

Ovarian cancer

Clovis Oncology’s rucaparib improved survival in ovarian cancer patients

Clovis Oncology Inc. announced topline data from the confirmatory phase III ARIEL3 trial of rucaparib, which successfully achieved the primary endpoint of improved progression-free survival by investigator review in each of the three populations studied.

 

Lung cancer

Breast cancer drug ineffective in treating squamous non-small cell lung cancer

 

Head and neck cancer

Study provides better understanding of how brain tumors “feed”

 

Bladder cancer

Combined modality treatment could be first course for muscle-invasive bladder cancer

 

Pancreatic cancer

Strategy for pancreatic cancer uses engineered exosomes targeting mutated KRAS gene

 

Glioblastoma

Efficacy results for ONC201 in recurrent glioblastoma published

 

Appendix cancer

Review of appendix cancer cases finds overdiagnosis

 

Colon cancer

Web calculator to more accurately predict bowel cancer survival

 

Beyond disease sites

Roswell Park-OmniSeq tool reflects response to checkpoint inhibition

 

Health services research

Fred Hutch study finds many cancer patients’ ER visits preventable

 

Sequelae

Balance, gait negatively impacted after chemotherapy

 

Regulatory actions

FDA approves Vectibix for use in wild-type ras metastatic colorectal cancer

  
CCL June 2017 - Jul. 6, 2017
Issue 26 - Jun. 30, 2017
  • Biden’s cancer nonprofit gets going

    The Bidens are now official players in the realm of oncopolitics.

    Former Vice President Joe Biden and wife Jill Biden announced the formation of the Biden Cancer Initiative, becoming the first U.S. vice president and second lady to establish and lead a cancer advocacy organization.

  • BSA, NCAB approve nine Cancer Moonshot concepts based on Blue Ribbon Panel recommendations

    The NCI Board of Scientific Advisors and the National Cancer Advisory Board unanimously approved nine Cancer Moonshot-related funding opportunity announcements.

    The approvals bring the total number of NCI Cancer Moonshot FOAs to 33, of which 11 have been closed. The FOAs are aligned with the NCI Blue Ribbon Panel scientific recommendations, which were presented to the White House less than a year ago.

  • House appropriations bill to allow NIH to move moonshot money to FDA

    Under the House version of the agriculture funding bill for fiscal 2018, NIH would be allowed to transfer Cancer Moonshot money to FDA.

    This provision of the Agriculture, Rural Development, FDA and Related Agencies bill recognizes the unintended consequences of the 21st Century Cures bill, which authorized $75 million over five years to be spent on the FDA Oncology Center of Excellence as part of the federal moonshot program. However, NIH was designated to serve as a conduit for these new funds.

  • Buchholz, Dmitrovsky and Fontaine lose authority at MD Anderson as executive vice president positions are eliminated

    MD Anderson has simplified its power structure, eliminating the three executive vice president positions and flattening out the box diagram, with six vice presidents and senior vice presidents reporting directly to the president.

    “These changes create a more diverse leadership team, built of leaders who know the institution and its needs,” the institution said in a press release. “No new hires or additional costs are needed to support the new structure.”

  • In Brief

    • Ruben Mesa new director of UT Health San Antonio
    • Claire Verschraegen to lead medical oncology division at Ohio State
    • Gideon Blumenthal named acting deputy director of FDA Office of Hematology & Oncology Products
    • Robert Haile to join Samuel Oschin Comprehensive Cancer Institute
    • Alexander Kutikov named chief of Division of Urologic Oncology at Fox Chase
    • San Diego nonprofits set to receive 2017 ASTRO Survivor Circle grants
    • ACS and Melanoma Research Alliance to fund pilot research projects
    • Michael Joiner to receive Lifetime Achievement Award from European Society of Radiotherapy and Oncology
  • Drugs and Targets

    • FDA approves Vectibix for use in wild-type ras metastatic colorectal cancer
    • FDA approves flow cytometry test for leukemias and lymphomas
    • Novartis Kisqali receives positive CHMP opinion for HR+/HER2- locally advanced or metastatic breast cancer
    • Novartis receives EU approval for Zykadia in ALK-positive advanced non-small cell lung cancer
    • FDA unveils plan to eliminate orphan designation backlog
Issue 25 - Jun. 23, 2017
  • Senate appropriations subcommittee members vow to resist Trump proposal to cut NIH budget

    If the June 22 Senate appropriations hearing is an indication, President Donald Trump will encounter considerable difficulty in accomplishing his stated goal of cutting the NIH budget by 21 percent in fiscal 2018. 

    As their congressional colleagues were ramping up partisan warfare over replacement of the Affordable Care Act, members the Subcommittee on Labor, HHS, Education and Related Agencies expressed bipartisan support for providing sustained increases for biomedical research.

  • Douglas Lowy to remain deputy director of NCI as Sharpless takes over

    NCI Acting Director Douglas Lowy will continue to serve as deputy director of the institute after Norman “Ned” Sharpless, director of the UNC Lineberger Comprehensive Cancer Center and the Wellcome Distinguished Professor in Cancer Research, is sworn in as the next NCI director.

    Sharpless’s appointment was announced June 9. It is not publicly known when Sharpless will be starting in his new role.

  • NCI funds research proposals based on recommendations from the Cancer Moonshot’s Blue Ribbon Panel

    Less than a year after the Cancer Moonshot’s NCI Blue Ribbon Panel identified 10 opportunities in cancer research, NCI has published 24 funding opportunity announcements to conduct research based on the panel’s scientific recommendations.

    The institute has received over 500 applications for the FOAs, said Dinah Singer, director of the NCI Division of Cancer Biology.

  • In Brief

    • CancerCare establishes Patient Values Initiative
    • National accreditation program for rectal cancer accepting applications from hospitals
  • Drugs and Targets

    • FDA approves Rituxan Hycela for DLBL and CLL
    • FDA approves Tafinlar and Mekinist for NSCLC with BRAF V600E mutation
    • FDA approves first companion diagnostic test to screen for multiple NSCLC therapies
    • FDA rejects Pfizer’s marketing application for Epogen biosimilar
    • FDA approves betrixaban for the prophylaxis of venous thromboembolism in adult patients
    • FDA accepts Amgen’s application to expand indication for Xgeva
Issue 24 - Jun. 16, 2017
  • Ned Sharpless, Trump’s choice for NCI director, described as erudite scientist whose expertise spans basic, clinical research

    President Donald Trump announced his intention to name Norman “Ned” Sharpless to serve as the next NCI director. The appointment was announced late on June 9.

    Sharpless, director of the UNC Lineberger Comprehensive Cancer Center and the Wellcome Distinguished Professor in Cancer Research, will replace Douglas Lowy, who has served as acting director at the institute since Harold Varmus stepped down as director in March 2015.

  • Sandoz prevails over Amgen in Supreme Court case on marketing biosimilars

    Resolving a three-year-long court fight, the U.S. Supreme Court June 12 ruled that Sandoz can commence marketing of its biosimilar white blood cell growth factor immediately after getting FDA approval.

    Amgen Inc., the sponsor of the reference agent, was seeking to make Sandoz wait for six-months after approval.

  • NIH plans to set aside up to $1.1 billion a year to fund more young investigators

    NIH is revamping its grant funding process to provide additional support to meritorious early-stage and mid-career investigators by freeing up funds from NIH’s base budget.

    The policy, called the Next Generation Researchers Initiative, would set aside about $210 million this year and ramp up that amount to $1.1 billion a year after five years—pending availability of funds.

  • In Brief

    • Immunology expert Robert Ferris named director of UPMC Hillman Cancer Center
    • Warren Kibbe to lead translational biomedical informatics at Duke
    • Tuya Pal to lead Vanderbilt’s cancer health disparities program
    • GW Cancer Center Opens Supportive Oncodermatology Clinic
    • Longnecker named Siteman Cancer Center vice president, oncology services
    • Hopkins Medicine expands collaboration with Allegheny Health Network and Highmark
    • McKesson and USON expand agreement with NCCN, adding five disease states to NCCN Value Pathways
    • ASTRO issues guideline for use of stereotactic radiation in early-stage lung cancer
  • Drugs and Targets

    • FDA approves Darzalex as combination therapy for multiple myeloma
    • FDA approves aminolevulinic acid hydrochloride as imaging agent for gliomas
    • OncoSec granted orphan drug designation for unresectable metastatic melanoma
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