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Issue 35 - Sep. 23, 2016
  • No Moonshot Funds In House & Senate FY17 Appropriations Bills

    The National Cancer Moonshot Initiative is not slated to receive funding in fiscal 2017—neither the House nor Senate appropriations bill includes the $680 million the White House proposed for Vice President Joe Biden’s project.

    Despite great bipartisan breast-beating in support of boosting the NCI and NIH budgets, Congress has not set aside funding for the moonshot, a broad scientific and public health effort focused on improving clinical trials, data sharing, and streamlining regulatory processes for oncology products at FDA.

  • Obituary

    Sargent, Mayo Biostatistician and Clinical Trialist, Dies Unexpectedly at 46

    Dan Sargent, one of the world’s foremost experts in oncology clinical trials, died unexpectedly on Sept. 2. Sargent died from an acute illness, Mayo officials said. He was 46.

    “This is a tremendous loss to Mayo Clinic as well as the national and international cancer research community. Dan has given so much to so many,” said Robert Diasio, director of the Mayo Clinic Cancer Center. “We are deeply saddened by his passing. Our thoughts and prayers are with his wife and family.”

  • Conversation with The Cancer Letter

    OHSU Seeks to Raise another $1 Billion; Keith Todd Describes the Strategy

    After raising $1 billion for Knight Cancer Institute, the Oregon Health and Science University fundraising team set out to raise another $1 billion over five years—before 2020.

    Some of the money—at least $200 million—would go to cancer, but the rest is slated to support research and patient care in other areas of medicine, including neuroscience, HIV, heart disease, blindness, and child health.

  • In Brief

    • American Association for Cancer Research releases 2016 Cancer Progress Report
    • 90 cancer groups and centers urge CMS to rescind proposed lung cancer screening reimbursement cuts
    • Rep. Michael Burgess (R-TX) receives ASCO Congressional Leadership Award
    • Spectrum Pharmaceuticals Inc. under investigation for potential securities fraud
    • Columbia University and New York-Presbyterian rename shared medical campus for donors Herbert and Florence Irving
    • Shirley Johnson named senior vice president of Nursing & Patient Care Services of Roswell Park Cancer Institute
    • Falk Medical Research Trust awards $485,000 for uveal melanoma research
    • American Brain Tumor Association awards 16 brain tumor research grants
  • Drugs and Targets

    • Dignity Health and Catholic Health Initiatives launch Precision Medicine Alliance
    • EMA recommends conditional marketing authorization for olaratumab
    • Golden Meditech and MD Anderson announce creation of Cellenkos Inc.
    • St. Jude Children’s Research Hospital and Wellcome Trust Sanger Institute agree to exchange cancer mutation data
    • ORIEN and HudsonAlpha announce new research collaboration
August/September 2016PDF

 

 

Non-Small Cell Lung Cancer

Tecentriq Demonstrates Increase In Overall NSCLC Survival in Phase III Study

Genentech announced positive results for Tecentriq (atezolizumab) from the Phase III study OAK. The study met its co-primary endpoints and showed a statistically significant and clinically meaningful improvement in overall survival compared with docetaxel chemotherapy in people with locally advanced or metastatic non-small cell lung cancer whose disease progressed on or after treatment with platinum-based chemotherapy.

Adverse events were consistent with what has been previously observed for Tecentriq. Genentech, a member of the Roche Group, will present full results at an upcoming medical meeting in 2016.

Also:

 

Lymphoma

Adcetris Improves ORR4 in Phase III Trial

Takeda Pharmaceutical Co. Ltd. and Seattle Genetics Inc. said that the phase III ALCANZA clinical trial evaluating Adcetris (brentuximab vedotin) in cutaneous T-cell lymphoma met its primary endpoint, demonstrating a highly statistically significant improvement in the rate of objective response lasting at least four months (ORR4).

This randomized trial, which received a Special Protocol Assessment from FDA and scientific advice from the European Medicines Agency, compared the use of single-agent Adcetris to a control arm of investigator’s choice of standard therapies, methotrexate or bexarotene, in 131 patients with CD30-expressing CTCL who received prior systemic or radiation therapy.

 

Breast Cancer

Abemaciclib Phase III Trial Continues After Interim Efficacy Criteria Not Met

Eli Lilly and Co. said that following a pre-planned interim analysis of the MONARCH 2 trial, an independent data monitoring committee provided the recommendation to continue the study without modification as the interim efficacy criteria were not met.

The phase III trial compares abemaciclib plus fulvestrant versus placebo with fulvestrant in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer.

 

Prostate Cancer

Custirsen Trial Fails to Show Improvement in Survival

 

Melanoma

Two-drug Immunotherapy May Produce Better Survival in Advanced Melanoma

 

Hepatocellular Carcinoma

Study Confirms Association Between RFA Burn Time, OS In Patients Receiving ThermoDox

 

Kidney Cancer

Study Finds HIF-2 Inhibitors More Effective Than Sunitinib

 

Regulatory Actions

Novartis, MEI Pharma. Receive Breakthrough Therapy Designations

 

NCI CTEP-Approved Trials for the Months of August and September

 

Screening

FDA Warns Against Ovarian Cancer Screening

CCL 39-08 - Sep. 22, 2016
Issue 34 - Sep. 16, 2016
  • ODAC Slams Spectrum for Massaging Data From Two Bladder Cancer Trials

    A brief consult with an undergraduate earning a B or above in Statistics 101 might have acquainted Spectrum Pharmaceuticals executives with all the science that would have saved them from a devastating encounter with an FDA advisory committee.

    Yet, there they were, black suits and all, at a suburban Maryland conference center, watching the Oncologic Drugs Advisory Committee vote unanimously against approval of Spectrum’s bladder cancer therapy Qapzola (apaziquone). 

    During the Sept. 14 meeting, FDA officials said repeatedly that taking apaziquone, a drug chemically related to mitomycin, to ODAC wasn’t their idea.

  • White House: New Moonshot Initiatives On Clinical Trials Will Improve Speed, Access

    Vice President Joe Biden Sept. 16 announced a series of initiatives to improve the safety, accessibility, and impact of clinical research—one of the central goals of the National Cancer Moonshot Initiative.

    The programs, which span four federal entities—NCI, FDA, the Department of Health and Human Services, and NIH—would make existing clinical trial search sites more user-friendly, and ensure that results of clinical trials are shared in a timely fashion.

  • NCI Director’s Report

    Lowy: RPG Funding Increased by $100M From 2013 to 2015—150 More Grants Funded

    Research Project Grant funding at NCI has increased 25 percent, from $400 million in 2013 to $500 million in 2015, NCI Acting Director Douglas Lowy said to the National Cancer Advisory Board Sept. 7.

    NCI’s fiscal 2016 budget is $5.21 billion, an increase of $260.5 million over fiscal 2015. This represents the  first time in about three years that funding for the institute has recovered to above pre-sequestration levels.

  • Abcodia Suspends Sale of Ovarian Cancer Screening Test After FDA Communication

    Abcodia Inc., a British company that manufactures a controversial ovarian cancer screening test, said it will temporarily suspend the availability of the product in the United States.

    ROCA, also known as the Risk of Ovarian Cancer Algorithm, uses a blood test called CA-125 and patients’ history to determine their risk for developing ovarian cancer.

  • Obituary

    John Bailar, Epidemiologist and Critic of War on Cancer, Dies at 83

    John Christian Bailar III, an epidemiologist and biostatistician known for his criticism of NCI’s emphasis on treatment, died Sept. 6. He was 83.

    Bailar riffed on the bellicose language of President Richard Nixon’s “War on Cancer” to suggest that the war in question was being lost. Researchers have focused too much on treatment and not enough on prevention, he argued.

  • Obituary

    Hopkins Biologist Saul Sharkis Dies at 72; Studied Blood Stem Cells’ Role in BMT

    Saul Sharkis, a scientist who studied the biology of blood stem cells and how they could be used to treat cancer through bone marrow transplantation, died Sept. 4. He was 72.

    Sharkis was a professor of oncology at the Johns Hopkins University School of Medicine and a faculty member in the Johns Hopkins Kimmel Cancer Center for more than 40 years.

  • In Brief

    • Eric Fearon named director of the University of Michigan Comprehensive Cancer Center
    • William Kaelin, Peter Ratcliffe, and Gregg Semenza receive 2016 Lasker Award for basic medical research
    • NCI publishes full list of FY2016 SPORE grantees
    • NCCN collaborates with New Century Health to integrate Imaging Appropriate Use Criteria
    • Levi Garraway succeeds Richard Gaynor as Lilly Oncology senior vice president, Global Development & Medical Affairs
    • Brian Goldstein named chief health system officer of UW Medicine and vice president for medical affairs at the University of Washington
    • Ashani Weeratna named Ira Brind Associate Professor at the Wistar Institute
    • Thomas Imperiale named inaugural Lawrence Lumeng Professor in Gastroenterology and Hepatology at Indiana University School of Medicine
    • The Terry Fox Foundation awards $27.3 million to six Canadian research teams
    • FDA issues first warning letters for selling e-cigarettes, e-liquids and cigars to minors
    • FDA modifies dosage regimen for nivolumab (Opdivo) for the currently approved indications
    • The European Commission issues marketing authorization for lenvatinib (Kisplyx) in combination with everolimus