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Issue 19 - May. 11, 2018
CL44-19 (268 downloads)
Issue 18 - May. 2, 2018
TCL44-18 (253 downloads)

  • Flatiron, BMS form collaboration to curate regulatory-grade real-world data

    Bristol-Myers Squibb and Flatiron Health announced a three-year collaboration to advance methodologies for the curation of real-world data for cancer research and to develop regulatory-grade information.

    BMS will use Flatiron data to analyze real-world evidence across a range of tumors and will collaborate on the development and validation of real-world endpoints within Flatiron’s longitudinal datasets.

  • Conversation with The Cancer Letter

    BMS’s Saha: We’re at the start of defining new endpoints, hypotheses with real-world evidence

    Bristol-Myers Squibb’s three-year collaboration with Flatiron Health will focus on leveraging real-world data to improve the pharmaceutical company’s regulatory submissions, demonstrate the economic value of BMS’s cancer portfolio, and to study the predictive value of biomarkers.

  • Conversation with The Cancer Letter

    Oklahoma’s Stephenson Cancer Center earns coveted NCI Cancer Center designation

    The Stephenson Cancer Center at the University of Oklahoma May 2 announced that it has received Cancer Center designation from NCI.

    This designation brings the total number of NCI designated cancer centers to 70. With Stephenson included, 14 of these centers now have the Cancer Center designation, 49 have the Comprehensive Cancer Center designation, and seven have the Basic Laboratory Cancer Center designation.

     

  • In Brief

    • National Coalition for Cancer Research to cease operations as member groups take on their own education, policy roles
    • Campaign to educate Washington, DC, public about clinical trials

  • Funding Opportunities

    CPRIT announces New Seed Award for early-stage oncology startups

    The Cancer Prevention and Research Institute of Texas is unveiling a new award mechanism targeting early-stage oncology startup companies. Under this program, known as the Seed Award, companies can apply for up to $3 million in nondilutive funding to support development of innovative cancer therapeutics, diagnostics or tools.

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  • New data prompts CDC to examine adequacy of pre-op workup by gynecologists

    In response to a congressional letter and a new study on the prevalence of undiagnosed hidden uterine cancers, officials at the Centers for Disease Control and Prevention are considering launching a review of whether gynecologists are sufficiently thorough in evaluating patients in the preoperative setting, according to insiders with knowledge of the agency’s plans.

  • Clinical Roundup

    • Keytruda meets ORR endpoint in interim analysis of phase III trial in NSCLC

  • Drugs and Targets

    • Novartis’ Kymriah gets second FDA approval—for large B-cell lymphoma
    • FDA approves Tafinlar and Mekinist for BRAF V600-mutant melanoma
    • FDA grants priority review to cemiplimab in advanced cutaneous squamous cell carcinoma
    • Genocea files IND for neoantigen cancer vaccine candidate GEN-009

  • CTEP Protocols

    NCI Trials for May

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

Issue 17 - Apr. 27, 2018
TCL44-17 (737 downloads)
Issue 16 - Apr. 20, 2018
TCL44-16 (820 downloads)

  • Sharpless adds $100 million to NCI’s RPG pool, R01s for young investigators boosted by 25%

    NCI will bump up the budget for its Research Project Grant pool by $100 million in 2018—the largest increase to the institute’s RPG pool since 2003, NCI Director Norman “Ned” Sharpless said at the annual meeting of the American Association for Cancer Research in Chicago.

    “This is possible thanks to increases in the past three years in our congressionally appropriated budget,” Sharpless said in his first public speech as NCI director at the meeting April 16. “While this is not solely for basic science—there are lots of laudable clinical trials and health services research funded from the RPG pool—this is the most straightforward way to assure we continue to fund investigator-initiated basic science.”

  • Piantadosi leaves Cedars-Sinai for Alliance and Harvard

    Steven Piantadosi is moving to Alliance, where he will serve as the associate group chair for strategic initiatives and innovation.

  • In Brief

    • SU2C focuses on precursor conditions in multiple myeloma
    • St. Baldrick’s commits $8 million to SU2C Pediatric Cancer Dream Team
    • Isabella Santos Foundation gives $5 million for rare & solid tumor program at Levine Children’s Hospital
    • MedStar Georgetown offers proton therapy with HYPERSCAN technology for adults and kids with cancer
    • Reprocell and Fox Chase to open biosample repository in India

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  • Clinical Roundup

    • Keytruda combination improved OS regardless of PD-L1 expression, including patients who tested negative for PD-L1
    • Keytruda reduced risk of recurrence or death by over 40% vs. placebo as adjuvant therapy in resected, high-risk stage III melanoma
    • SU2C researchers find treatment strategy for stage I-III NSCLC

  • Drugs and Targets

    • FDA approves Tagrisso for front-line metastatic NSCLC with common EGFR mutations
    • FDA approves Opdivo and Yervoy for front-line advanced RCC
    • FDA approves Tavalisse for ITP
    • FDA issues guidance on investigational in vitro diagnostics in oncology trials

  • CTEP Protocols

    NCI Trials for April

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

Issue 15 - Apr. 13, 2018
TCL44-15 (321 downloads)

  • Sharpless: Expect a big boost to NCI’s RPG pool

    NCI’s Research Project Grant pool is likely to receive the largest increase in funding in 16 years, NCI Director Norman “Ned” Sharpless said at an NCI Town Hall meeting April 10.

    The increase is made possible by a $3 billion raise to NIH’s budget that translates into $275 million in new money for the institute in fiscal year 2018.

  • Whistleblower suit claims McKesson repackaged, sold cancer drug “overfill”

    A whistleblower lawsuit alleges that McKesson Corp. had been repackaging cancer drugs and charging the federal and state governments for “overfill,” extra drug that is routinely put into vials by manufacturers.

  • In Brief

    • Gradishar named chief of hematology and Oncology at Northwestern
    • Cole named chief of pediatric hematology/oncology at Rutgers
    • ACS CAN report examines patient barriers to cancer clinical trial enrollment
    • Woodcock, Shaw and Conway-Welch receive awards from Society for Women’s Health Research
    • Billings appointed chief medical officer at Natera

  • Funding Opportunities

    DOD Ovarian Cancer Research Program Publishes funding opportunities

    FY18 OCRP Program Announcements and General Application Instructions for the following award mechanisms are posted on Grants.gov.

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  • Trials and Tribulations

    Sales Revenues at the Potential Expense of Patient Safety: The Example of You&i TM

    Ibrutinib is a selective and irreversible inhibitor of Bruton’s tyrosine kinase (BTK) that entered phase 1 clinical trials in 2009 based on preclinical efficacy in models of B-cell malignancy and autoimmune disease.[1, 2] The initial phase 1 trial showed clear efficacy in a number of lymphoid malignancies at doses as low as 1.25 mg/kg/d. Furthermore, full receptor occupancy was demonstrated at 2.5 mg/kg/d. Despite these pharmacological and early clinical findings, development of ibrutinib continued at doses of 420 mg qd and 560 mg qd, levels 3-4 fold higher than suggested by the pharmacological data. In addition, the absorption of ibrutinib is enhanced by administration of food, which may explain why even the lowest dose showed efficacy in some patients.

  • Clinical Roundup

    • NCI study revises molecular classification for most common type of lymphoma
    • Updated ASTRO guideline for lung radiation recommends concurrent chemotherapy for some stage III patients
    • Keytruda monotherapy meets OS endpoint in phase III trial
    • Epacadostat plus Keytruda don’t meet PFS endpoint in phase III study in metastatic melanoma
    • Roswell Park, Ohio State researchers identify genes linked to blood and marrow transplant outcomes

  • Drugs and Targets

    • Rucaparib approved for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
    • FDA finalizes guidances to accelerate development of Next Gen sequencing
    • Karyopharm’s Selinexor receive FDA Fast Track designation
    • MD Anderson, Nanobiotix to collaborate on preclinical research combining NBTXR3, nivolumab
Issue 14 - Apr. 6, 2018
TCL44-14 (628 downloads)
Issue 13 - Mar. 30, 2018
TCL44-13 (301 downloads)

  • New players, new strategies, new resolve raise NIH budget to new level

    On March 14, beneath the soaring ceiling of the Andrew W. Mellon Auditorium, Rep. Nancy Pelosi (D-CA) faced a constellation of round tables at the Research!America 2018 Advocacy Awards Dinner.

  • Duke faces tightened NIH grant oversight over handling of past scientific misconduct

    NIH has imposed tighter financial controls on researchers at Duke University, citing “ongoing issues” related to management of grants.

  • Conversation with the Cancer Letter

    University of Michigan gets $150 million to recruit cancer researchers, fund research

    Richard and Susan Rogel gave $150 million to the University of Michigan Comprehensive Cancer Center, which will now be known as the Rogel Cancer Center.

  • AACR announces scientific award winners, new board of directors

    The following cancer researchers and clinicians will be recognized for their scientific achievements during the American Association for Cancer Research annual meeting.

  • An Appreciation

    James Holland, an oncology pioneer, dies at 92

    James Holland became a doctor thanks to what he calls “a series of fortunate mistakes.” The son of a prominent lawyer in Morristown, New Jersey, Holland was raised to go into law, too. But that changed when he took a course in biology at Princeton University and became enthralled with seeing cells under a microscope.

  • In Brief

    • Society of Surgical Oncology gives service award to Wolmark and Fisher
    • NCCN honors contributors to the Improvement of global cancer care
    • City of Hope and Fivepoint partner to bring outpatient center to Orange County
    • Thomas Gallo named ACCC President 2018-2019
    • ONS elects board of directors
    • Cohen joins department of radiation oncology at Fox Chase

  • Funding Opportunities

    DOD publishes funding opportunities for breast and prostate cancer programs

    AACR, AstraZeneca form training partnership

    The American Association for Cancer Research and AstraZeneca formed a partnership to help foster the next generation of cancer research scientists and stimulate innovative research in the areas of DNA Damage Response in cancer and Immuno-Oncology.

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  • Clinical Roundup

    • Sorafenib improves PFS in rare sarcomas, NIH-funded study shows
    • Zejula plus Keytruda shows activity in refractory ovarian cancer
    • Retrospective analysis identifies predictors of dose modification for niraparib

  • Drugs and Targets

    • FDA gives accelerated approval for Blincyto for ALL patients with minimal residual disease
    • Enfortumab vedotin gets breakthrough designation in urothelial cancer
    • FDA approves changes on Hologic’s 3Dimensions Mammography System
    • FDA accepts application for Opdivo plus Yervoy for MSI-H or dMMR metastatic colorectal cancer for priority review

  • CTEP Protocols

    NCI Trials for March

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

Issue 12 - Mar. 23, 2018
TCL44-12 (270 downloads)

  • Right to Try edges closer to becoming federal law

    Libertarians rejoice, but can it solve compassionate use problems?

    Few Washington insiders doubt that a bill that allows terminally ill patients to circumvent FDA as they pursue Hail Mary pass therapies will become the law of the land.

    Collectively known as the “Right to Try” law, the legislation has been passed by both chambers of Congress. The bills, which bear the names of four patients—Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina—are the culmination of years of intense lobbying by conservative groups and patient activists.

  • Conversation with the Cancer Letter

    NYU’s Caplan: Right to Try laws are meaningless, empty hot air, unethical, and utterly ineffective

    The right-to-try bills passed by Congress would remove FDA’s expanded access mandate and leave patients at greater risk, said Arthur Caplan, the Drs. William F. and Virginia Connolly Mitty Professor and founding director of the Division of Medical Ethics at the New York University School of Medicine.

  • Conversation with the Cancer Letter

    Goldwater’s Coleman: Right to Try patients don’t need permission from feds to save their own lives

    Patients and their doctors should be able to make treatment decisions without involvement from the federal government, said Starlee Coleman, senior policy advisor for the Goldwater Institute, a libertarian think tank that lobbied successfully for widespread adoption of right-to-try laws.

  • How CMS intends to pay for next generation sequencing

    Centers for Medicare and Medicaid Services March 16 published the final National Coverage Determination that will pay for next generation sequencing in a broad range of cancers.

  • Congressional omnibus gives NIH a surprisingly hefty $3 billion raise

    Congress March 22 passed a budget that gives a stunning $3 billion increase to NIH and a $275 million boost to NCI.

  • In Brief

    • Robert Redfield to be named CDC director
    • UAMS to offer Arkansas’ first-ever radiation oncology residency program
    • Andrew Aplin named first Kalbach-Newton professor at Thomas Jefferson
    • Jennifer Dorazio named Assistant director for administration at WVU
    • Cofactor Genomics announces collaboration with NCI
    • AbbVie and the International Myeloma Foundation partner to study role of a genetic mutation in multiple myeloma
    • Vanderbilt and Boehringer Ingelheim expand collaboration

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  • Clinical Roundup

    • BioPharma publishes phase III COLUMBUS data of encorafenib and binimetinib
    • AVEO Oncology publishes long-term follow-up results from TIVO-1 Extension Study in TKI refractory RCC
    • Finasteride shown to prevent prostate cancer for up to 16 years
    • Machines see the future of patients diagnosed with brain tumors

  • Drugs and Targets

    • Novartis’s Tasigna approved for children with rare form of leukemia
    • FDA approves Adcetris for adults with previously untreated stage III or IV classical Hodgkin lymphoma
    • University of Maryland certified for CAR T-cell therapy in lymphoma
Issue 11 - Mar. 16, 2018
TCL44-11 (253 downloads)

  • Do patients know best? Industry, NCI committing dollars to studying patient-reported outcomes

    Researchers are coming to the conclusion that cancer patients are the best authority on how therapies affect them.

    Over the past few years, about 20 NCI trials and over 125 industry studies have incorporated direct reports of symptomatic adverse events by cancer patients through an NCI program.

  • Conversation with the Cancer Letter

    Basch: Patient-reported outcomes data can make cancer drugs safer, more tolerable

    Fifteen years ago, when Ethan Basch started developing measures for aggregating patient-reported outcomes, many of his colleagues in oncology saw no promise in this enterprise.

  • Conversation with the Cancer Letter

    Porter: I can’t tell you how the Trump administration gets its budget numbers

    John Edward Porter, a long-time key Congressional appropriator and advocate for biomedical research, received the Research!America Legacy Award at an advocacy awards dinner March 14.

  • In Brief

    • President’s Cancer Panel calls for urgent action on drug prices
    • AACR launches initiative focused on health disparities in African-Americans
    • Aurora Health Care & UTHealth join  Strata Oncology
    • PRIMO Lara named deputy chair of SWOG
    • Fox Chase’s Engstrom receives lifetime achievement award for cancer prevention
    • Bellerjeau gets lifetime achievement award from blood and marrow transplant group

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  • Trials and Tribulations

    Rare Cancers, Common Need

    Cancer immunotherapy, and in particular immune checkpoint blockade, has transformed oncology with the potential for durable responses even in patients with metastatic disease. To date, regulatory approvals and clinical trials have focused on the study of these agents in relatively more common tumor types, such as melanoma, non-small cell lung cancer, bladder cancer, and kidney cancer, amongst others.

  • Clinical Roundup

    • ASTRO issues updated clinical guideline for whole breast radiation therapy
    • Testicular cancer survivors need screening for long-term heart disease risk

  • Drugs and Targets

    • Erdafitinib gets Breakthrough Therapy designation for metastatic urothelial cancer
    • FDA grants priority review to Merck’s sBLA for Keytruda for advanced cervical cancer
Issue 10 - Mar. 9, 2018
TCL44-10 (606 downloads)
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