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ISSUE 32 – SEPT. 4, 2015PDF

UT Chancellor Mandates Unprecedented Shared Governance Structure at MD Anderson

 

After years of turmoil and plunging morale at MD Anderson Cancer Center, the UT System took what observers describe as an unprecedented step—forming a Shared Governance Committee.

The new structure, instituted Sept. 1, disbands the once powerful Executive Committee, thereby changing the cancer center’s top-down power structure.

The new governance committee is designed to incorporate input from the faculty, and serve as the top advisory body to the institution’s president, Ronald DePinho.

 

Editorial

Judge: Amgen Can’t Depose Cancer Letter Reporter (Me)

A federal judge ruled that Amgen Inc. cannot force me to answer questions related to a 2007 story that sparked a class action suit by investors and triggered a change in FDA regulations of erythropoiesis-stimulating agents.

Judge Amit Mehta, of the U.S. District Court for the District of Columbia, quashed a subpoena filed by Amgen that sought information related to my reporting of a story about a critically important clinical trial showing that patients who received Aranesp did worse than patients who did not.

NCI-MATCH Trial Opens

ECOG-ACRIN opened the NCI-MATCH precision medicine trial, the largest, most scientifically rigorous precision medicine trial in cancer to date.

NCI-MATCH seeks to determine whether matching certain drugs or drug combinations to people whose tumors have specific gene abnormalities will effectively treat their cancer, regardless of their cancer type.

ASCO Updates Policy on Genetics and Genomic Testing

The American Society of Clinical Oncology issued an updated policy statement on genetic and genomic testing for cancer susceptibility.

Published in the Journal of Clinical Oncology, the statement reviews the ways in which new technologies are transforming the assessment and identification of inherited cancer susceptibility, and makes a series of recommendations for the optimal deployment of these technologies in oncology practice.

Obituary

UNMC’s Sidney Mirvish, 86

Cancer researcher Sidney Mirvish died at age 86. His research into nitrosamines and carcinogenesis led to changes in the way lunch meats, hot dogs and sausages were made.

Mirvish served as professor emeritus in the Eppley Institute for Research in Cancer and Allied Diseases at the University of Nebraska Medical Center, where he was faculty member for 46 years. Mirvish died due to complications following emergency surgery on Aug. 18.

In Brief

  • Edith Mitchell named president of National Medical Association

  • Robert DiPaola, Stephen Gruber, and Candace Johnson named to AACI Board of Directors
  • NIH Director Francis Collins awarded Leadership in Personalized Medicine Award

  • Massimo Cristofanilli named associate director for precision medicine at Northwestern University Lurie Cancer Center
  • Jeffrey and W. Kimryn Rathmell appointed to leadership roles at Vanderbilt University Medical Center

  • Lois Travis named director of survivorship research program at Indiana University Simon Cancer Center

  • Rachel Humphrey named chief medical officer of CytomX

  • Donald Sheldon appointed regional president at University Hospitals

  • Keith Perry named chief information officer at St. Jude

  • Northwestern Medicine names breast cancer OncoSET program

  • CPRIT awards seven grants, totaling $23 million

Drugs and Targets

  • FDA approves Varubi for CINV

  • European Commission grants authorization to Unituxin for pediatric neuroblastoma
  • FDA grants Orphan Designation to Toca 511 and Toca FC

  • FDA grants Orphan Designation to MTG-20
  • FDA grants Priority Review to MCNA

20150904 - Sep. 4, 2015
August 2015PDF

 

Leukemia

High-Risk Subset of CLL Patients Shows Benefit in Phase II Trial

A statistically significant percentage of chronic lymphocytic leukemia patients in a phase II clinical trial responded to venetoclax therapy.

The open-label study, sponsored by AbbVie, met its primary endpoint, achieving overall response rates in patients with relapsed/refractory or previously untreated CLL with 17p deletion, according to an independent review analysis.

The study enrolled 157 patients, 107 in the main study cohort evaluating efficacy, and 50 patients in the safety expansion cohort.

The primary efficacy endpoint is overall response rate, and the primary safety endpoints are the number and percentage of patients who experienced treatment-related adverse events, changes in physical exam findings, including vital signs, changes in clinical laboratory test results and changes in cardiac assessment findings.

 

Lung Cancer

Atezolizumab Immunotherapy Meets Response Endpoint in Phase II NSCLC Study

A phase II study of atezolizumab immunotherapy met its primary endpoint, shrinking tumors in patients with locally advanced or metastatic non-small cell lung cancer whose disease expressed PD-L1.

The study showed the amount of PD-L1 expressed by a person’s cancer correlated with their response to the medicine.

The study, BIRCH, is an open-label, multicenter, single-arm study that evaluated the safety and efficacy of atezolizumab in 667 people. Results from the study will be presented at an upcoming medical meeting, according to the drug’s sponsor, Genentech, a member of the Roche Group.

Also:

 

Drugs and Targets

European Commission Approves Unituxin in Pediatric High-Risk Neuroblastoma

The European Commission granted a marketing authorization for Unituxin (dinutuximab) for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation.

Unituxin is administered in combination with granulocyte-macrophage colony-stimulating factor, interleukin-2, and isotretinoin.

The European approval was based on demonstration of improved event-free survival and overall survival in a multicenter, open-label, randomized trial (ANBL0032) sponsored by NCI under a Cooperative Research and Development Agreement with the drug’s sponsor, United Therapeutics Corp., and conducted by the Children’s Oncology Group.

 

Liver Cancer

ThermoDox plus RFA Increase OS By 58 Percent in HEAT Study

 

Carcinoid Syndrome

Oral Telotristat Etiprate Trial Meets Phase III Primary Endpoint

 

NCI CTEP-Approved Trials for the Month of August

20150831 - Aug. 31, 2015
SPECIAL REPORT – AUG. 14, 2015 

 

MD Anderson Moves from Top-Down Structure

to “Shared Governance” with Faculty Senate

 

MD Anderson Cancer Center was instructed to institute a “shared governance” structure, disbanding its powerful Executive Committee effective Sept. 1.

After years of turmoil and plunging morale, the UT System has instructed the Houston-based cancer center to form a Shared Governance Committee, which would incorporate input from the faculty. The move appears to change the institution’s structure from a strong top-down flow of authority to an unusually democratic system.

The new governance committee will serve as the top advisory body to the institution’s president, Ronald DePinho, and will include all division heads; the chair, chair-elect, and immediate past chair of the Faculty Senate; and senior executives.

The decision was announced Aug. 14, in a faculty-wide email from DePinho and Gary Whitman, chair of the Faculty Senate.

20150814 - Aug. 14, 2015
ISSUE 31 – AUG. 7, 2015PDF

Conversation with The Cancer Letter

AstraZeneca Exec Discusses Iressa’s Future in the U.S.

 

After a decade of near-absence from the U.S. market, the AstraZeneca drug Iressa (gefitinib) is back.

The drug, which stayed on the market between 2003 and 2005, when it was pulled because clinical trials in a general population of patients failed to demonstrate a survival advantage, has returned. Now it is accompanied by a diagnostic tests that selects patients.

The Cancer Letter asked Andrew Coop, vice president of US medical affairs in oncology at AstraZeneca, to discuss the company’s plans for the future of Iressa in the US, and lessons that have been learned.

 

Report: Part D Drug Prices “Needlessly High”

Medicare’s Part D program paid significantly higher prices for drugs than either Medicaid or the Veterans Health Administration, a study by Carleton University and Public Citizen found.

Prices paid by Medicare Part D were also above those in 30 other countries.

The price is caused by congressional restrictions on the federal government’s ability to negotiate with the pharmaceutical industry, the study said.

Obituary

Carolyn Kaelin, 54, Dana-Farber Surgical Oncologist and Researcher

Carolyn Mary Kaelin, a surgical oncologist in the Women’s Cancers Program at Dana-Farber and director of the Breast Clinic at Brigham and Women’s Hospital, died July 28, surrounded by loved ones. Kaelin was 54.

FDA News

In Brief

  • Lehigh Valley Health Network joins MSK Cancer Alliance

  • Siteman Cancer Center receives “exceptional” rating from NCI
  • John Cunningham named chairman of pediatrics department at the University of Chicago

  • Jinhgui Zhang named first chair of Department of Computational Biology at St. Jude
  • Stephen Lessnick named director of childhood cancer center at Research Institute at Nationwide Children’s Hospital

  • GI Chair Lopa Mishra to leave MD Anderson Cancer Center

  • Leukemia & Lymphoma Society receives donation from Bristol Myers Squibb

  • Commission on Cancer names Outstanding Achievement Award winners

  • California Dept. of Public Health launches big data collaboration with St. Joseph’s Health

  • Pan-Mass Challenge raises $33.5 million over weekend bike ride for Dana-Farber

 Drugs and Targets

  • Health Canada approves Imbruvica in MCL

  • EMA grants orphan designation to synthetic hypericin
  • AstraZeneca and Heptares Therapeutics enter licensing agreement

  • Mirati Therapeutics and MedImmune launch clinical trial collaboration
 

The Cancer Letter will be taking a short publication break, and will return Friday, Sept. 4.

20150807 - Aug. 7, 2015
July 2015PDF

 

Lymphoma

Phase II Trial Shows Benefit with Imbruvica In Activated B-cell-like Subtype of DLBCL

A phase II clinical trial identified patients with a specific molecular subtype of diffuse large B-cell lymphoma that are more likely to respond to Imbruvica (ibrutinib) treatment.

In the trial, patients with the activated B-cell-like subtype of DLBCL were more likely to respond to Imbruvica than patients with the germinal center B-cell-like subtype. The trial was jointly conducted by NCI and Pharmacyclics Inc., and was published in Nature Medicine.

 

Drugs and Targets

FDA Approves Odomzo in Advanced BCC, Kyprolis Combination in Multiple Myeloma

FDA approved Odomzo (sonidegib) capsules for the treatment of patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. Odomzo is marketed by Novartis Pharmaceuticals Corp.

The approval was based on demonstration of a durable objective response rate in an international, multi-center, double-blind, randomized, two-arm, non-comparative trial in patients with locally advanced basal cell carcinoma not amenable to local therapy or metastatic basal cell carcinoma.

 

Prostate Cancer

Researchers: As Many as 40% of Patients Could be Receiving Overtreatment

As many as 40 percent of patients with lower-risk prostate cancers may be currently receiving overtreatment, according to researchers that examined common treatment practices.

Monitoring men with very low- and low-risk prostate cancers using watchful waiting or active surveillance, or expectant management, is a useful approach for a large number of men with localized tumors and could spare them the debilitating side effects of aggressive treatments that are too often unnecessarily used in this patient population, according to a study led by researchers at UCLA.

 

Colorectal Cancer

Vectibix Improves OS in Phase III Trial of mCRC

 

Liver Cancer

Cyramza Trial Fails OS Endpoint; Subgroup Data to Form New Study

 

Leukemia

Pracinostat/Vidaza Combination Shows Response in Phase II Trial

 

Bladder Cancer

Study: Robotic Surgery Shows Long-term Results Similar to Traditional Open Surgery

 

NCI CTEP-Approved Trials for the Month of July

20150804 - Aug. 4, 2015
ISSUE 30 – JULY 31, 2015PDF

Pharma Industry Critics

Seek Grassroots Support

 

Many people are studying the rising prices of cancer drugs. A growing group of oncologists want to do something different: they want to give them a downward push.

Last week, a group of 118 oncologists signed an editorial published in the Mayo Clinic Proceedings in which they laid out seven specific actions that they argue would moderate drug prices.

 

Conversation with The Cancer Letter

The War on Cancer (Drug Prices): Political Education of Hagop Kantarjian

Here is what Hagop Kantarjian has learned over the past two years of his campaign to lower the prices of cancer drugs:

People would rather avoid disputing you head-on.

Instead, they seek to draw you into a process. And as this process drags on, things remain as they are.

Kantarjian, chair of the Department of Leukemia at MD Anderson Cancer Center, is too savvy and too impatient to get sucked into chasing elusive solutions.

Baylor Earns Comprehensive Designation;

Tisch Institute Becomes NCI Cancer Center

The Dan L. Duncan Cancer Center at Baylor College of Medicine and the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai received NCI designations this week.

The Duncan Cancer Center—which was named an NCI-designated cancer center in 2007—was awarded the Comprehensive Cancer Center designation, which includes a $14.56 million, five-year grant. 

Guest Editorial

Kids v Cancer: Laws Need to Catch up to the Science

By Nancy Goodman

Kids with cancer are the last, not the first, to get on trials of promising new drugs. And, when drug companies abandon their unapproved cancer drugs, as they do 95 percent of the time for all sorts of reasons, the chance to study those drugs for kids with cancer goes away forever.

Drugs and Targets

Lenvima Receives FDA Breakthrough Designation

In Brief

  • Thomas Lynch Jr. to step down as director of Yale Cancer Center

  • Peter Schulam to serve as interim center director
  • Karen Reckamp named medical director for clinical research at City of Hope

  • Timothy Lash named leader of cancer prevention program at Winship Institute
  • Ontario Institute for Cancer Research and Centre for Drug Research and Development announces call for pre-proposals for early-stage research

20150730 - Jul. 30, 2015
ISSUE 29 – JULY 24, 2015PDF

MD Anderson No. 1 (Again)

In Rankings by U.S. News & World Report

 

MD Anderson Cancer Center has once again assumed its place at the top of the influential U.S. News & World Report rankings for 2015-2016.
The Houston-based center edged out New York’s Memorial Sloan-Kettering Cancer Center.

As MD Anderson returns to the paramount position it has held 11 times over the past 14 years, it does so despite turmoil between its faculty and administration (The Cancer Letter, July 13).

 

 

FDA & NCI Create Unique Jobs Combining Regulatory Science with Clinical Expertise

NCI and FDA are recruiting three medical oncologists who would divide their time between clinical and regulatory duties—half at the FDA Office of Oncology and Hematology Products, and half at the NCI Center for Cancer Research.

These clinician-scientists would serve as associate directors for clinical research at the OHOP, and as independent, tenure-track principal investigators at the CCR.

    In Brief

    • Charles Roberts named director of St. Jude Comprehensive Cancer Center

    • Eric Rohren named chair of radiology at Baylor College of Medicine

    • Carrie Kitko joins Monroe Carell Jr. Children’s Hospital at Vanderbilt
    • Bruce Quinn joins FaegreBD Consulting

    • Children’s Hospital of Philadelphia opens Buerger Center for Advanced Pediatric Care

    Odomzo Approved in Basal Cell Carcinoma

    FDA approved Odomzo (sonidegib) capsules for the treatment of patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. Odomzo is marketed by Novartis Pharmaceuticals Corp.

     

    Kyprolis Combination Approved in Relapsed Multiple Myeloma

    FDA approved Kyprolis (carfilzomib) in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. Kyprolis is sponsored by Onyx Pharmaceuticals Inc., an Amgen subsidiary.

       Drugs and Targets

      • FDA grants orphan drug designation to Anisina in neuroblastoma

      • Amgen submits sNDA for Kyprolis for Injection

      • IriSys awarded five-year contact by NCI

      20150724 - Jul. 24, 2015
      ISSUE 27 – JULY 17, 2015PDF

      MD Anderson Faculty White Paper Calls for Executive Pay Freeze, Elimination of “Two-Class System”

       

      MD Anderson Cancer Center’s faculty has asked the UT System to freeze the salaries of Ronald DePinho and members of his executive team until they reach a level of parity with faculty salaries, according to a white paper presented to UT System Chancellor Bill McRaven June 14.

      The white paper—authored by the Executive Committee of the Faculty Senate and distributed confidentially to the faculty July 10—is arguably the most comprehensive representation of the faculty’s cumulative dissatisfaction with DePinho and his administration’s performance and handling of personnel matters over the past three years.

       

      Iressa Returns to U.S. Market— Now with Companion Diagnostic

      FDA approved Iressa (gefitinib) for patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

      The drug is being approved concurrently with the therascreen EGFR RGQ PCR Kit as a companion diagnostic.

        NCCS: Covering End-of-Life Planning is a Step Toward Delivering Patient-Centered Care

        Last week, the Centers for Medicare & Medicaid Services announced plans to support Medicare beneficiaries by reimbursing doctors for advance care planning beginning in January 2016.

        The proposed codes would reimburse for discussions about an individual’s wishes, should he or she becomes too ill to make decisions, and for the completion of an advance directive.

        Funding Opportunity

        DoD Taking Applications for $75,000 Horizon Grant

        The Department of Defense is taking applications for its Horizon Award, which offers up to $75,000 in funding to support junior-level scientists to conduct impactful research with the mentorship of an experienced cancer researcher.

        The award is for principal investigators, both pre-doctoral candidates and postdoctoral fellows are eligible, and mentors that have a strong record of funding and publications. The PI and mentor must be from the same organization.

           In Brief

          • Georgetown Lombardi and John Theurer Cancer Center to form research consortium

          • City of Hope establishes professorship with $1.5 million grant

          • Maryann Roefaro named co-chair of COA administrator network

          • Synexus opens three clinical trial research centers in Eastern Europe

          • ACT for NIH appoints seven members to its advisory committee

          Drugs and Targets

          • EU approves Imbruvica in Waldenstrom’s macroglobulinemia

          • FDA grants orphan drug designation to ImMucin in multiple myeloma

          • Cleave Biosciences’s CB-5083 receives FDA orphan drug designation

          • FDA grants fast track designation to Toca 511 and Toca FC

          • FDA grants priority review to MM-398 in pancreatic cancer

          • Eli Lilly and Immunocore launch clinical trial collaboration

          20150717 - Jul. 17, 2015
          SPECIAL REPORT – JULY 13, 2015 

          MD Anderson Faculty White Paper to UT Chancellor Calls for Executive Pay Freeze, Elimination of “Two-Class System”

          MD Anderson Cancer Center’s faculty has asked the UT System to freeze the salaries of Ronald DePinho and members of his executive team until they reach a level of parity with faculty salaries, according to a white paper presented to UT System Chancellor Bill McRaven June 14.

          The white paper—authored by the Executive Committee of the Faculty Senate and distributed confidentially to the faculty July 10—is arguably the most comprehensive representation of the faculty’s cumulative dissatisfaction with DePinho and his administration’s performance and handling of personnel matters over the past three years.

          20150713 - Jul. 13, 2015
          ISSUE 27 – JULY 10, 2015PDF

          Lilly Drug to Change Squamous NSCLC,

          But ODAC’s Opinion is Nuanced

           

          The FDA Oncologic Drugs Advisory Committee July 9 appears to have recommended approval for the Eli Lilly and Co. agent necitumumab.

          Yes, the word “appears” has indeed appeared in the previous sentence.

          It had to because, in breaking with a long-standing tradition, the agency asked ODAC members to “discuss” the key questions of risk vs. benefit of the experimental therapy instead of reducing their answers to a yea or nay vote.

          No vote was taken, but The Cancer Letter’s analysis of ODAC’s discussion suggests that, had a vote been taken, necitumumab would have received an overwhelming 11:1 vote in favor of approval.

           

          Do-It-Yourself Guide to ODAC

          Circle One: Yes, No, Maybe

          FDA has often asked ODAC members to discuss broad scientific questions. However, the approval questions have, without an exception, been shoehorned into the up-or-down dichotomy.

          What is ODAC without a vote on approval questions?

          Here, The Cancer Letter has combined a transcript of the ODAC discussion with a coding scale that may provide a clue about how the vote on necitumumab would have gone.

            Huntsman, UNM Cancer Center, and UT Southwestern Receive NCI Comprehensive Designations

            Three cancer centers have been awarded comprehensive status from NCI, the highest designation possible: the Huntsman Cancer Institute at the University of Utah, UT Southwestern’s Harold C. Simmons Cancer Center, and the University of New Mexico Cancer Center.

            A fourth, the Dan L. Duncan Cancer Center at Baylor College of Medicine, is also expected to receive the comprehensive designation, sources said. This will bring the total number of comprehensive centers to 45.

            House Passes 21st Century Cures Act

            The U.S. House of Representatives July 10 passed H.R. 6, The 21st Century Cures Act without amendments by a 344 to 77 vote.

            The bill—designed to modernize clinical trials and streamline the drug approval process—would boost NIH funding by $1.75 billion in mandatory funding a year over the next five years, for a total of $8.75 billion, and FDA’s budget by a total of $550 million.

              ORIEN Partners with Three Cancer Research Centers

              The Oncology Research Information Exchange Network July 9 announced the addition of three cancer institutions to its precision cancer research partnership, bring the total number of partners to nine.

              The new members are the Rutgers Cancer Institute of New Jersey, the University of Southern California Norris Comprehensive Cancer Center, and Morehouse School of Medicine.

                In Brief

                • Carolyn Britten named director of Hematology/Oncology at the Medical University of South Carolina

                • Marcia McNutt nominated to be president of the National Academy of Sciences

                • Kevin Fitzpatrick named CEO of CancerLinQ LLC

                • Memorial Sloan Kettering Cancer Center to open new lung cancer research center

                • American College of Radiology launches Commission on Patient Experience

                • The Association of Community Cancer Centers launches the Institute for Clinical Immuno-Oncology

                20150710 - Jul. 10, 2015