Issue 23 - Jun 8, 2018
  • Big takeaway from ASCO: 70 percent of women with early breast cancer don’t benefit from adjuvant chemotherapy

    An NCI-sponsored trial showed that up to 70 percent of women with hormone receptor-positive, HER2-negative, axillary lymph node-negative breast cancer would not benefit from chemotherapy.

  • Conversation with The Cancer Letter

    Abrams: Only about 20-30 percent of the group might benefit from chemotherapy

    The practice-changing TAILORx trial was brought to you by publicly funded cancer clinical trials system, pointing to its continuing relevance, said Jeff Abrams, NCI acting director for clinical research and associate director of the Cancer Therapy Evaluation Program.

  • Sharpless: NCI adds $10 million for NCTN and NCORP trials

    NCI is providing an additional $10 million to support trials run with the National Clinical Trials Network and the NCI Community Oncology Research Program, Norman “Ned” Sharpless said in his first appearance as NCI director at the annual meeting of the American Society of Clinical Oncology in Chicago. “NCI’s major efforts with regards to large clinical trials are largely supported through our clinical trials networks like the National Clinical Trials Network,” Sharpless said in his June 2 talk at ASCO. “One of the major challenges for these networks over the past few years, however, has been a rapid increase in the per-patient costs for patients on trials.

  • In Brief

    • J&J Innovation and Boston University form lung cancer research alliance
    • Kochevar to retire from Colorado Cancer Center
  • Funding Opportunities

    Addario, Van Auken foundations announce 2018 Young Innovators Team Award

    The Bonnie J. Addario Lung Cancer Foundation, in collaboration with the Van Auken Private Foundation, announced the 2018 Young Innovators Team Award to fund and support teams of young investigators conducting innovative research with a potential of delivering meaningful and measurable results in the field of lung cancer.

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  • Trials and Tribulations

    Searching for Breast Cancer’s “Extreme Survivors” 

    I remember the day I met Margaret “Peg” Geisler, who has now been living with breast cancer for 40 years, and with metastatic disease for 36 of those years.

  • Clinical Roundup

    • New treatment combination improves outcomes for some patients with colorectal cancer
    • Exact Sciences, Mayo Clinic identify blood-based DNA biomarkers to diagnose hepatocellular carcinoma
    • Opdivo demonstrates superior RFS vs. Yervoy for patients with resected stage III or IV melanoma
    • Opdivo plus Yervoy provide QOL improvements in RCC
Issue 22 - Jun 1, 2018
Issue 21 - May 25, 2018
Issue 20 - May 18, 2018
Issue 19 - May 11, 2018
Issue 18 - May 2, 2018
  • 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
Issue 16 - Apr 20, 2018
  • 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
  • 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
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