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Issue 39 - Oct. 21, 2016
  • Biden Delivers Task Force Report—

    Five Moonshot Goals in Cancer

    Vice President Joe Biden and the National Cancer Moonshot Task Force published their final reports Oct. 17, summarizing the moonshot’s achievements, and outlining five strategic goals and action plans for the years to come.

    The two reports conclude the 2016 National Cancer Moonshot Initiative, and the Obama administration’s efforts to develop a national conversation on cancer research.

  • Obama: The Moonshot, “Architecture and a Framework” for Cancer Research

    President Barack Obama accepted Vice President Joe Biden and the National Cancer Moonshot Task Force’s reports—blueprints for how the federal government should focus on cancer research, oncology bioinformatics, and patient access and care over the next few years.

    “This all comes down to, ‘How does it impact patients?’ And so Joe, I think, has done a great job in engaging people who are going through battling cancer right now, and finding ways that we’re not just coming up with cures, but we’re also making sure that these systems are set up so that they’re easier for people to access,’ Obama said at a press conference Oct. 17.

  • LLS Starts Beat AML Master Trial

    After four decades of few improvements in the treatment for acute myeloid leukemia, the Leukemia and Lymphoma Society has launched a precision medicine trial to identify targeted treatments for patients with AML.

    The society’s trial—called Beat AML Master Trial—was announced by Vice President Joe Biden Oct. 17 at a White House event rolling out Moonshot-related initiatives.

  • Califf, Bach, Jasin, Offit, Venter Among New Members of NAM

    The National Academy of Medicine announced today the election of 70 regular members and nine international members during its annual meeting. 

    The NAM Articles of Organization stipulate that at least one-quarter of the membership is selected from fields outside the health professions.

  • In Brief

    • Fuchs Named Director at Yale
    • Cox Wins Statistics Top Prize
    • David Cella received National Academy of Medicine Gustav O. Lienhard Award
    • Marcio Fagundes and Michael Chuong joined the Miami Cancer Institute at Baptist Health South Florida’s integrated Radiation Oncology Department
    • The Robert H. Lurie Comprehensive Cancer Center announced a partnership that will make Tempus as a preferred partner
    • Leidos Biomedical Research, Inc. awarded ATCC
    • Carol Burke elected president of the American College of Gastroenterology
    • The Pan Mass Challenge raised $47 million
    • The Scripps Research Institute and the California Institute for Biomedical Research announced the signing of a strategic affiliation
  • Drugs and Targets

    • Lartruvo gets accelerated approval for sarcoma
    • Tecentriq approved for a type of NSCLC
    • Venclyxto granted a positive opinion from the European Committee for Medicinal Products for Human Use
    • Onivyde in combination with 5-fluorouracil and leucovorin received marketing authorization from The European Commission
    • CDC recommended 11-to-12-year-olds receive two doses of HPV vaccine
    • IBM Watson Health and Quest Diagnostics launched IBM Watson Genomics from Quest Diagnostics
October 2016PDF

 

 

Non-Small Cell Lung Cancer

Phase III Tecentriq Study Shows Better Survival vs. Chemo Regardless of PD-L1 Status

Genentech said its pivotal phase III OAK study of Tecentriq (atezolizumab) showed a median survival of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 vs. 9.6 months; HR = 0.73, 95% CI: 0.62 – 0.87).

The results were presented at the European Society of Medical Oncology 2016 Annual Meeting in Copenhagen.

The OAK study evaluated people with non-small cell lung cancer whose disease had progressed on or after treatment with one or more platinum-based chemotherapy (second-line and third-line).

 

Melanoma

Yervoy Improved OS in Fully Resected Stage III Patients from Phase III Study

Bristol-Myers Squibb Co. announced superior efficacy for Yervoy 10 mg/kg versus placebo on all survival endpoints in the phase III trial CA184-029 (EORTC 18071) evaluating stage III melanoma patients who are at high risk of recurrence following complete surgical resection.

In the study, Yervoy compared with placebo significantly improved overall survival (OS) (HR=0.72 [95.1% CI: 0.58-0.88; p=0.001]), a secondary endpoint, with five-year OS rates at 65.4% in the Yervoy group and 54.4% in the placebo group.

 

Head and Neck Carcinoma

Opdivo Stabilized Patient-Reported Outcomes in Phase III Study

Bristol-Myers Squibb Co. announced patient-reported quality-of-life data from an exploratory endpoint in the pivotal phase III CheckMate -141 trial evaluating Opdivo in patients with recurrent or metastatic squamous cell carcinoma of the head and neck after platinum therapy compared to investigator’s choice of therapy (methotrexate, docetaxel or cetuximab).

Outcome assessments showed Opdivo stabilized patients’ symptoms and functioning, including physical, role and social functioning across three separate instruments, the company said.

Both PD-L1 expressors and non-expressors treated with investigator’s choice of therapy experienced statistically significant worsening of patient-reported outcomes from baseline to week 15 versus Opdivo.

 

Bladder Cancer

Phase III Trial Confirms ORR in Previously Treated Patients who Received Opdivo

 

Renal Cell Carcinoma

Durable Responses Seen With Opdivo and Yervoy in Updated Analysis

 

Colorectal Cancer

 

Breast Cancer

Novartis’s LEE011 + Letrozole Shows Superior PFS as First-Line Treatment for HR+/HER2- Advanced Breast Cancer

 

Pancreatic Cancer

ONIVYDE Regimen Produced OS, PFS Benefit In Metastatic Disease

 

Multiple Myeloma

Kyprolis Study in Newly Diagnosed Disease Doesn’t Meet Primary Endpoint—PFS

 

Retinoblastoma

Triple-drug Chemo with Topotecan Helps Preserve Vision in Patients

 

NCI CTEP-Approved Trials For the Month of October

 

Regulatory Actions

  • Genentech receives second Breakthrough Therapy Designation from FDA for Alecensa
  • Gamida Cell granted Breakthrough Therapy Designation for NiCord
  • Janssen Research & Development submits supplemental NDA for ibrutinib
  • European Medicines Agency recommends conditional marketing authorization for olaratumab in combination with doxorubicin
  • FDA accepts Array Biopharma’s NDA for binimetinib
CCL Oct 2016 - Oct. 20, 2016
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Issue 38 - Oct. 14, 2016
  • Davidson Moves to Seattle Cancer Consortium

    Nancy Davidson was named executive director of the Fred Hutchinson/University of Washington Cancer Consortium effective Dec. 1. For nearly eight years, Davidson has served as director of the University of Pittsburgh Cancer Institute.

    In the new role, Davidson, will coordinate cancer treatment, clinical and translational research programs of consortium members Fred Hutch, UW School of Medicine, Seattle Children’s and Seattle Cancer Care Alliance, the cancer treatment arm of Fred Hutch, UW Medicine and Seattle Children’s.

  • Where is the FY18 Bypass Budget? 

    Cancer Groups Want to Know

    The NCI Bypass Budget was expected to be made public on Oct. 6.

    Alas, this didn’t happen; why didn’t it?

    America’s top cancer groups would like to know, and theirs is not idle curiosity. The NCI Bypass Budget is an important, unique authority established by the National Cancer Act of 1971. 

  • Guest Editorial

    Goodman: Too Many PD-1 Trials for Adults, Too Few for Children

    Kudos to The Cancer Letter’s report on the 803 PD-1 or PD-L1 trials. As Rick Pazdur noted, that is just too many resources chasing the same idea for adult cancer studies.  

    Alas, as of Friday, Oct. 7, clinicaltrials.gov shows only two open trials for a PD-1 or PD-L1 trial for patients 0 to 17 years of age, and both are monotherapies. There are no listed combination trials that are open and accept kids. There are no PD-L2 trials listed that accept kids.

  • In Brief

    • Adrian Lee named director of the Institute for Precision Medicine
    • Kwok-Kin Wong named chief of hematology and medical oncology at the Perlmutter Cancer Center at NYU Langone Medical Center
    • Yanis Boumber joins the Department of Thoracic Medical Oncology and the Molecular Therapeutics Program at Fox Chase Cancer Center
    • Stanley Marks honored through the establishment of the Stanley M. Marks–OHA Endowed Chair in Hematology/Oncology Leadership
    • Robert Figlin appointed deputy director of the Integrated Oncology Service Line at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute
    • Suresh Ramalingam selected to hold the Roberto C. Goizueta Distinguished Chair for Cancer Research
    • Jacqueline Corrigan-Curay selected as permanent director of FDA Office of Medical Policy at the Center for Drug Evaluation and Research
    • Ann Richmond wins the 2016 William S. Middleton Award
    • Marc Benioff and wife Lynne give $20 million toward construction of the Lawrence J. Ellison Institute for Transformative Medicine of University of Southern California
    • Boris Lushniak named dean of the University of Maryland School of Public Health
    • Southern Research Institute awarded five-year IDIQ contract from NCI
    • Dr. Susan Love Research Foundation receives $3 million NCI grant 
    • NIH expands a five-year funding award to The Scripps Research Institute from $120 million to $207 million
    • Mount Sinai receives a $10 million grant from NCI
    • The University of Michigan Comprehensive Cancer Center and Tempus partner to bring MI-ONCOSEQ to patients and healthcare providers
    • Merck KGaA announces the recipients of the 2016 Grant for Oncology Innovation
    • Research!America announces 2017 Advocacy Award winners
  • Drugs and Targets

    • Genentech receives second Breakthrough Therapy Designation from FDA for Alecensa

    • Gamida Cell says FDA has granted Breakthrough Therapy Designation to NiCord
    • Foundation Medicine, Inc. announces new clinical markers added to FoundationOne and FoundationOne Heme products
    • Abbvie said Health Canada issued a Notice of Compliance with Conditions for Venclexta
    • The US Oncology Network selects Myriad Genetics as its preferred provider laboratory for hereditary cancer testing
  • Funding Opportunities

    Pershing Square Sohn Cancer Research Alliance is accepting applications for its Prize for Young Investigators in Cancer Research.

    The prize of $200,000 per year for up to three years is awarded annually to at least five New York City-based scientists, enabling them to continue to pursue explorative and high-risk/high-reward research at a stage when traditional funding is lacking.