Issue 8 - Feb 22, 2019
  • NCI invites scientists to step up competition for $173 million set-aside for commercialization

    NCI would like you to know that it has a pot of money for commercialization projects—please apply.

    Together, the institute’s Small Business Innovation Research and Small Business Technology Transfer programs are giving out $173 million in fiscal 2019. At NIH, these programs gave out $1.145 billion.

  • Conversation with The Cancer Letter

    Caryn Lerman on leading USC Norris: Team science is where breakthroughs emerge

    Caryn Lerman was named director of USC Norris Comprehensive Cancer Center.

    When she reports to work at USC on March 15, Lerman will be the only behavioral scientist to lead an NCI-designated cancer center. She also will hold the position of professor of psychiatry and the behavioral sciences at the Keck School of Medicine of USC.

  • In Brief

    • NCI’s Rosenberg to receive Szent-Györgyi prize
    • Vale named executive director of HHMI Janelia Research Campus
    • Baylor consolidates cancer center clinics on new McNair Campus
    • Merck to acquire Immune Design
    • Doubrava joins Fox Chase
  • Funding Opportunities

    ASCO invites applications for research based on data from CancerLinQ Discovery

    The American Society of Clinical Oncology is inviting applications for research grants for projects that use data from CancerLinQ Discovery, an offering of ASCO’s CancerLinQ initiative, as a source.

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  • Clinical Roundup

    • Guidelines recommend genetic testing for all people with breast cancer
    • Keytruda + Inlyta reduced risk of death by nearly half compared to sunitinib in RCC
    • OS and PFS for Keytruda in hepatocellular carcinoma did not meet statistical significance
    • Merck expands immuno-oncology program with three phase III trials in prostate cancer
    • Opdivo + Yervoy shows response in pre-treated patients with prostate cancer
    • Janssen announces preliminary results from phase II GALAHAD in prostate cancer
    • Roswell Park researchers identify protein that contributes to racial disparities in prostate cancer
    • AVEO Oncology announces TIVO-3 trial topline results 
    • SCLC may respond to combination of immunotherapy and DNA damage repair inhibitors
    • Study finds melanoma brain metastases immunosuppressive with treatment-resistant metabolism
    • Dasatinib enhances response to checkpoint inhibitors, study finds
    • Integrating heart disease and cancer care could reduce overall health care costs
    • CASSINI Trial publishes data on preventing blood clots in cancer patients
  • Drugs & Targets

    • FDA approves Keytruda for adjuvant treatment of melanoma
    • FDA accepts IND for TR1801-ADC, an ADC targeting cMet positive solid tumors
    • FDA grants priority review to Merck’s sBLA for Keytruda monotherapy in SCLC
    • FDA publishes revised draft guidance for investigational tobacco products
Issue 7 - Feb 15, 2019
  • Guest Editorial

    Making the case to double NIH

    The decision to double the budget of the National Institutes of Health should be easy, because it will save lives and save our economy simultaneously. The case for NIH is overwhelming, and there is broad bipartisan congressional support. So why is it so challenging?

  • NCI Director’s Report

    Sharpless: Please stay in oncology, don’t stop sending good research ideas to NCI

    The mathematical concepts underlying the challenge NCI is facing today aren’t difficult to grasp. In fact, a 14-year-old in an algebra class should be able to get it, NCI Director Ned Sharpless said to the National Cancer Advisory Board Feb. 12.

  • In Brief

    • Caryn Lerman named director at USC Norris Comprehensive Cancer Center
    • St. Baldrick’s and ACS form partnership focused on pediatric cancers
    • Report calls on US to accelerate the elimination of cervical cancer worldwide
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  • Clinical Roundup

    • Keytruda + Inlyta improves OS, PFS and ORR vs. Sunitinib in RCC
    • Immunotherapy appears better than chemotherapy for skin cancer
    • Group of lymph nodes to determine prognosis for mesothelioma
    • Phase III ARCHES trial shows Xtandi improved PFS in prostate cancer
    • Opdivo + Yervoy shows continued survival benefit in RCC
    • Immunotherapy effective in recurrent glioblastoma
    • Black-white cancer mortality gap nearly eliminated in some age groups
    • Report calls on US to accelerate the elimination of cervical cancer worldwide
  • Drugs & Targets

    • European Commission approves Sprycel + chemo for pediatric
    • FDA grants Priority Review for Keytruda in head and neck squamous cell carcinoma
    • FDA accepts sBLA and grants Priority Review for Bavencio + Inlyta in RCC
Issue 6 - Feb 8, 2019
  • Guest Editorial

    Two singular men shared an uncommon greatness: Waun Ki Hong and John Mendelsohn

    Waun Ki Hong and John Mendelsohn were singular forces who combined to change the world of oncology and, in the process, the lives of countless trainees, faculty, patients, and families.

  • Conversation with The Cancer Letter

    NYU receives NCI Comprehensive Cancer Center designation

    The Laura and Isaac Perlmutter Cancer Center at NYU Langone Health received the Comprehensive Cancer Center designation from NCI.

  • Trump to dedicate $500M over 10 years to childhood cancer

    In his State of the Union address Feb. 5, President Donald Trump said he plans to ask Congress for $500 million over 10 years to fund pediatric cancer research—an amount Speaker of the House Nancy Pelosi (D-CA) said is insufficient.

  • In Brief

    • Foundation Medicine gets genomic profiling contract from Veterans Affairs
    • Higgins, King, Kilmer, Fitzpatrick to serve as co-chairs of House Cancer Caucus
    • NETRF announces $2.5 million research grants to treat tumors
    • Chien-Chi Lin wins $1.5M grant in pancreatic cancer
    • ADEPT System Cancer Imager wins Illinois Tech’s $1 million Nayar Prize Competition
    • Christiana’s Boman receives $900K grant for stem cell research
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  • Clinical Roundup

    • Study finds HIV+ cancer patients benefit from immunotherapy
    • High-dose radiation therapy improves long-term survival in stage IV cancers
    • Combination of Veyonda/radiotherapy delivers clinical benefits
    • Prolonged time sitting shown to increase risk of colorectal cancer
  • Drugs & Targets

    • FDA approves therapy for adult patients with blood clotting disorder
    • Pfizer given positive CHMP opinion for Vizimpro in NSCLC
    • Genentech submits sBLA for Kadcyla for breast cancer
    • Merck KGaA and GSK to co-develop immunotherapy M7824
    • FDA pursues order to bar some retailers from selling tobacco in efforts to target tobacco use by minors
  • NCI Trials

    NCI Trials for February

    The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month. 

Issue 5 - Feb 1, 2019
  • 20-year follow-up data are in: Prostate cancer prevention works; concerns about high-grade disease dismissed

    Prostate cancer is the most common solid tumor in men. It has been estimated that 60-75 percent of men will have histologic evidence of prostate cancer during their lifetime and that 2-4 percent of men will die of the disease. African American men are at a greater risk of diagnosis and death.

  • Guest Editorial

    The Prostate Cancer Prevention Trial and nine lessons in prostate cancer medicine

    The publication by Ian M. Thompson and colleagues in last week’s New England Journal of Medicine regarding long term follow-up of patients in the NCI-sponsored Prostate Cancer Prevention Trial (PCPT) marks a good opportunity to review and reflect on the history of the trial and the past 30 years of prostate cancer medicine.

  • Real-World Evidence

    Gottlieb: FDA to expand real-world data infrastructure to enhance AI capabilities

    FDA is enhancing its ability to handle real-world evidence by training reviewers in data science via a curriculum on machine learning and artificial intelligence, said FDA Commissioner Scott Gottlieb.

  • Industry a no-show as Sens. Grassley and Wyden hold hearing on drug pricing

    Earlier this week, the Senate Committee on Finance convened what is likely to be the first in a series of hearings focused on the rising costs of prescription drugs, oncology drugs among them.

  • In Brief

    • Califano named physician-in-chief of Moores Cancer Center
    • NYU receives anonymous $75M gift to establish center for blood cancers
    • Ross Mitchell named artificial intelligence officer at Moffitt
    • Sagar Lonial awarded Gray Family Chair in Cancer at Winship
    • Silvia Formenti and Heather McArthur awarded SU2C Laura Ziskin Prize
    • Helen Heslop named by SU2C to lead ‘Dream Team’
    • Robert Prins receives grant to research brain tumor treatments
    • Johns Hopkins Greenberg Bladder Cancer Institute Awards focused on bladder cancer in women
    • ASCO names advance of the year: progress in treating rare cancers
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  • Trials & Tribulations

    Glioblastoma patient is first to receive treatment under Right to Try. Our question is Why?

    University of California, Irvine patient with glioblastoma recently received an experimental cancer vaccine from the U.S. subsidiary of Brussels-based Epitopoietic Research Corp. (ERC-USA). While most cases of patients receiving experimental medical treatment are not particularly newsworthy, this one was.

  • Clinical Roundup

    • Study incorporates patient feedback into better cancer treatments
    • Patients getting placebo allowed to cross to Erleada as TITAN results unblinded
    • Antioxidants may enhance chemotherapy treatment for brain tumor
  • Drugs & Targets

    • Lung-MAP precision medicine trial expands
    • Alimta + Keytruda and platinum chemo for NSCLC gets FDA label expansion
    • Trovagene and PoC Capital agree to fund clinical development of onvansertib in metastatic colorectal cancer
Issue 4 - Jan 25, 2019
Issue 3 - Jan 18, 2019
  • Thomas Jefferson University vying to acquire venerable but troubled Fox Chase Cancer Center

    Thomas Jefferson University is vying to acquire Fox Chase Cancer Center from its current owner, Temple University, the two institutions announced Jan. 10.

  • New MSK rules prohibit service on boards of for-profit entities in healthcare

    An internal task force formed to investigate conflicts of interest at Memorial Sloan Kettering Cancer Center has produced three initial recommendations that codify the moratoria that were put in place after multiple ethics transgressions at the cancer center were revealed by The New York Times and ProPublica last fall.

  • Guest Editorial

    Waun Ki Hong– A Career of Vision

    On Jan. 2, my friend and long-time mentor Waun Ki Hong passed away. In thinking about what Ki did for me personally and the impact he had on the lives and professional careers of so many people, I pulled out a speech I gave at his retirement celebration at MD Anderson on Aug. 15, 2014. I was struck that even in his passing so many of my thoughts ring true today. Perhaps this will give readers of The Cancer Letter a sense of the man.

  • In Brief

    • Wasif Saif, Louis Potters, Matthew Weiss named deputy physicians in chief at Northwell Health Cancer
    • Duke partners with Teen Cancer America, First Citizens Bank to enhance teen and young adult oncology program
    • Adi Gazdar researcher at UT Southwestern, NCI dies at 81
  • Funding Opportunities

    LUNGevity Foundation issues an RFA for 2019 Career Development Awards for Translational Research in Lung Cancer

    LUNGevity has issued a Request for Applications for translational research for Career Development Awards that will be granted in 2019. The RFA is available on the LUNGevity website and is also posted on the proposalCENTRAL website.

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  • Trials and Tribulations

    Giving every patient an opportunity to participate in and benefit from cancer progress

    Last week, the American Cancer Society released its annual Facts and Figures report, showing that we continue to make exceptional progress against cancer, most notably with a 27 percent decline in the death rate across all cancer types over the last 25 years.

  • Clinical Roundup

    • Keytruda reduced risk of death vs. chemo in esophageal carcinoma
    • Array Biopharma announces 15.3 months median overall OS from phase III BEACON CRC trial in colorectal cancer
  • Drugs & Targets

    • FDA approves Cabometyx for previously treated hepatocellular carcinoma
    • European Commission approves Opdivo + low-dose Yervoy in RCC
    • QIAGEN receives approval for EGFR test in lung cancer as companion diagnostic in Japan
    • FDA accepts sBLA for Tecentriq + Abraxane and carboplatin for lung cancer
Issue 2 - Jan 11, 2019
Issue 1 - Jan 4, 2019
  • Real-World Evidence

    Fulfilling 21st Century Cures mandate, FDA lays out philosophy on real-world evidence—and recruits Amy Abernethy for No. 2 job

    FDA has created a framework for evaluating the use of real-world evidence to support additional indications for already approved drugs as well as to satisfy drug post-marketing study requirements.

  • Conversation with The Cancer Letter

    Amy Abernethy to join FDA as principal deputy commissioner

    Amy Abernethy, a thought leader in the field of evidence generation and the development of real-world evidence, was named principal deputy commissioner at FDA.

    Abernethy, who is now the chief medical officer, chief scientific officer and senior vice president of oncology at Flatiron Health, is expected to start at the agency in February 2019 after leaving Flatiron. She will replace Rachel Sherman, who oversees clinical, scientific, regulatory, and operational medical programs and initiatives across the agency. Sherman is retiring after 30 years of service at FDA.

  • An Appreciation

    Waun Ki Hong, Mentor Magnificus

    (Aug. 14, 1942 – Jan. 2, 2019)

    Yesterday, I received a succession of phone calls through the afternoon and evening—from Roy Herbst, chief of medical oncology at the Yale Cancer Center, Marge Foti, president of the American Association for Cancer Research, Patrick Hwu, head of the Division of Cancer Medicine at the MD Anderson Cancer Center (MDACC), and Otis Brawley, professor of oncology at Johns Hopkins University.

  • An Appreciation

    Waun Ki Hong, eminent role model, was always years ahead of the field

    This week, we lost a cancer research pioneer, and friend and mentor to many in the field, with the sudden death of Waun Ki Hong, M.D., a world-renowned clinical researcher who leaves behind a remarkable legacy.

  • An Appreciation

    A general in BATTLE, Waun Ki Hong was a pioneer of precision medicine

    I was heartbroken to learn of the passing of my mentor, colleague, and friend, Waun Ki Hong. Dr. Hong was the quintessential physician scientist who specialized in all aspects of medicine, but most notably patient care, research, and education. This is a devastating loss for the entire oncology community, and especially for all of the patients he cared for and helped.

  • The 25 most-read stories in The Cancer Letter in 2018

    We thought you might want to see what your colleagues in oncology have been reading. So, we went through our analytics to bring you a list of 25 of The Cancer Letter’s most-read stories of 2018.

  • In Brief

    • Lori Pierce elected ASCO president for 2020-2021
    • Community Oncology Alliance elects new officers and board members
    • José Baselga resigns from position of editor-in-chief of Cancer Discovery
    • BMS to acquire Celgene
    • Moffitt recruits five researchers
  • Funding Opportunities

    ACS and MRA fund $4 million in grants on metastasis in melanoma, other cancers

    The American Cancer Society and the Melanoma Research Alliance have partnered to support research by requesting grant applications involving interdisciplinary teams to better understand and manage metastasis of melanoma and other types of cancer.

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  • Clinical Roundup

    • Study finds elevated risk of rare blood cancers after chemo for most solid tumors
    • Study: Methods for reporting toxicities in cancer trials are falling short
    • Astellas, Pfizer announce positive top-line results from trial of XTANDI in mHSPC
    • G1 Therapeutics announces positive topline results from phase II trial of trilaciclib in SCLC
    • JAVELIN Ovarian 100 trial of avelumab fails to support initial hypothesis
  • Drugs & Targets

    • Lynparza gets FDA approval for first-line maintenance in BRCA-mutated advanced ovarian cancer
    • Sprycel approved in combination with chemo pediatric Ph+ ALL
    • Keytuda approved for recurrent locally advanced or metastatic MCC
    • Merck provides update on Keytruda sBLA for KEYNOTE-042 trial
    • Keytruda receives five approvals in Japan
    • FoundationOne CDx receives regulatory approval in Japan
    • FDA approves longer-acting calaspargase pegol-mknl for ALL
    • GRANITE-001 gets FDA Fast Track for colorectal cancer
  • NCI Trials

    NCI Trials for January

    The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month.

    For further information, contact the principal investigator listed.

Issue 46 - Dec 14, 2018
  • An Appreciation

    Howard Ozer died as he lived—on a safari

    Around March, my friend Howard Ozer told me he was heading out on a safari. He did these things often, adding to his collection of trophies.

  • Guest Editorial

    Conflicts have killed trust in the system. Advocates must rebuild it

    Breast cancer research is big business. And the incentives in that business are designed to benefit industry, doctors and institutions, leaving patients behind. In 2018 alone, about $1 billion federal dollars were invested in institutions around the country to fund research.

  • In Brief

    • Anil Rustgi named cancer center director at Columbia, New York-Presbyterian
    • Jasmin Tiro to focus on assessing, meeting cancer needs in Dallas/Fort Worth area
    • Leigh Boehmer named medical director of education at the ACCC
    • Pentecost Foundation gifts $3 million to Moffitt
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  • Clinical Roundup

    • Kadcyla cut risk of disease recurrence vs. Herceptin in HER2-positive early breast cancer with residual disease after neoadjuvant treatment
    • BYL719 + fulvestrant improved PFS in PIK3CA mutated HR+/HER2- advanced breast cancer
    • Data show efficacy, tolerability of Kisqali combination in HR+/HER2- advanced breast cancer with visceral disease
    • Insight Genetics launches test for triple negative breast cancer
    • Biotheranostics presents data on the Breast Cancer Index
    • First-line immunotherapy combination fails to improve OS in lung cancer
    • Amifostine delays onset of acute esophagitis for small cell lung cancer patients
  • Drugs & Targets

    • European Commission adopted positive opinion of rucaparib in platinum-based chemotherapy
    • FDA grants orphan drug designation to Merck’s M7824 in biliary tract cancer
Issue 45 - Dec 7, 2018
  • NCI cuts programs by 5% and non-competing renewals by 3% to maintain paylines in fiscal 2019

    NCI is cutting the budgets of divisions, offices, and centers within the institute by 5 percent to maintain funding for its Research Project Grant pool, which funds a broad range of basic research, as well as clinical trials and health services research.

  • Conversation with The Cancer Letter

    UAB Cancer Center receives $30 million naming gift from O’Neal Industries

    The University of Alabama at Birmingham Comprehensive Cancer Center has received a $30 million gift from O’Neal Industries Inc., a family-owned global business based in Birmingham.

  • In Appreciation

    Lisa Schwartz, expert in overtreatment and pathbreaking educator, dies at 55

    Lisa Schwartz, professor of Medicine and of Community and Family Medicine at Dartmouth Medical School died on November 29 after a seven-year struggle with cancer—a terrible loss to all who knew her.

  • Obituary

    Charles A. Coltman Jr., long-time SWOG chair and co-founder of the San Antonio Breast Cancer Symposium, dies at 88

    Charles A. Coltman Jr., a pioneer of treatment of leukemia and lymphoma, a long-time chair of SWOG, and a co-founder of the San Antonio Breast Cancer Symposium, died after a long illness on Nov. 28. He was 88.

  • In Brief

    • Wafik El-Deiry to lead cancer biology program at Brown 
    • Emory Proton Therapy Center opens
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  • Clinical Roundup

    • Kite announces two-year data for Yescarta in patients with refractory large B-cell lymphoma
    • Kite announces updated data from ZUMA-3 study of KTE-X19 in adult patients with relapsed or refractory ALL 
    • Ibrutinib + rituximab superior to standard treatment for some patients with CLL
    • Data from phase I/II open-label study of BCMA-directed CAR-T cell therapy lcar-b38m show tolerable safety profile, high response and MRD-negative rate in advanced r/r multiple myeloma
    • New long-term data on acalabrutinib in mantle cell lymphoma and CLL
    • Geron announces OS data from IMbark in Imetelstat-treated patients with intermediate or high-risk myelofibrosis and r/r to JAK inhibitor
    • New long-term data on Calquence presented
    • Combination immunotherapy shows high activity against recurrent Hodgkin lymphoma
    • Karyopharm reports positive top-line phase IIb SADAL data for Selinexor in diffuse large B-cell lymphoma
    • Celgene announces initial phase I/II liso-cel data in patients with r/r CLL
  • Drugs & Targets

    • FDA approves Tecentriq + Avastin and carboplatin for initial treatment of specific type of metastatic lung cancer
    • FDA publishes draft guidance on class labeling of in vitro companion diagnostics for classes of drugs in oncology
    • FDA publishes framework document on real-world evidence
  • NCI Trials

    NCI Trials for December

    The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month.

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