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ISSUE 18 – MAY 8, 2015PDF

Nascent Group Points to a Way To Validate, Pay for Genomic Tests

How is this for a plan:

Replace the U.S. system for validation and payment for cancer genomic tests with something that actually makes sense.

Dane Dickson, a doctor in Idaho, who until recently had the distinction of being the only oncologist working under the roof of Centers for Medicare and Medicaid Services, would like to do just that—and some important players in cancer research are betting on his success.

Conversation with The Cancer Letter

A Doctor’s Quest to Save Personalized Medicine

Dane Dickson would like to change the U.S. system for validation and coverage of molecular tests, thereby opening the road to development of complex tests and comprehensive genomic assays.

Recently, Dickson formed a nonprofit public-private partnership, called MED-C and published a white paper, which is posted here.

In an interview with Paul Goldberg, editor and publisher of The Cancer Letter, Dickson described his rationale for trying a new approach to solving this fundamental problem in personalized medicine.

Duke Settles with Potti’s Patients; Misconduct Probe Now in Fifth Year

Duke University has settled the suits filed by patients who were enrolled in clinical trials that were testing the technology developed by Anil Potti and his mentor Joseph Nevins.

By settling, Duke avoided having to confront embarrassing revelations about how much the university’s deans knew about the problems in the genomic research organization.

 

Conversation with The Cancer Letter

Gunsalus: Duke’s 4.5 Years is at Extreme End of Spectrum for a Misconduct Probe

The Cancer Letter invited C. K. Gunsalus, an expert on scientific misconduct, to discuss the settlement of the lawsuits against Duke.

Gunsalus is the director of the National Center for Professional and Research Ethics, research professor, Coordinated Science Laboratory, professor emerita, College of Business at the University of Illinois at Urbana-Champaign. She runs a consulting company and is the author of The Young Professional’s Survival Guide (Harvard University Press, 2012) and The College Administrator’s Survival Guide (Harvard University Press, 2006).

In Brief

  • Dan Theodorescu and Seth Lerner named editors-in-chief of Bladder Cancer

  • UW Health, ProHealth Care, and Aurora Health Care agree to co-manage cancer center

  • GW Cancer Institute launches online patient navigation training

  • NIH raises nearly $700,000 for The Children’s Inn
  • Proton Partners selects companies to help supply U.K. proton beam centers
  • Moffitt Cancer Center and Aetna form oncology medical home model
  • Swedish Cancer Institute adopts Syapse software for its precision medicine program
Drugs and Targets

  • FDA grants breakthrough designation to Venetoclax

  • DanDrit Biotech USA forms collaboration with GISCAD Foundation

  • PhRMA report says member companies invested $51.2 billion in R&D

20150508 - May. 8, 2015
ISSUE 17 – MAY 1, 2015PDF

Thumbs Up on Amgen’s T-VEC to Treat Melanoma; Is it Local Therapy for Systemic Disease?

An FDA advisory committee April 29 recommended approval of a metastatic melanoma treatment based on an attenuated Herpes Simplex Virus-1.

In a joint meeting, the agency’s Oncologic Drugs Advisory Committee and its Cellular, Tissue, and Gene Therapies Advisory Committee voted 22 to 1 to recommend full approval for talimogene laherparepvec, sponsored by Amgen Inc.

At the contentious all-day meeting, which ran twice as long as a standard session of ODAC, the unusually large group of advisors summoned by the FDA didn’t get the opportunity to clearly identify the group of patients who stand to benefit from the agent, also called T-VEC, or specify the agent’s place in a sequence of melanoma treatments.

NIH Slated to Receive $10 Billion Increase In Second 21st Century Cures Draft Bill

The House Committee on Energy and Commerce published the second “discussion draft” for a comprehensive bipartisan initiative aimed at streamlining development of drugs and medical devices.

The proposed legislation, called “21st Century Cures,” was launched April 30, 2014, and is led by Rep. Fred Upton (R-Mich.), chairman of the committee, and Rep. Diana DeGette (D-Colo.), chief deputy whip.

In addition to boosting NIH funding by $10 billion over five years and establishing a clinical trial data system for federally funded trials, the discussion draft includes provisions for developing the next line of antibiotics.

Institute of Medicine to Become National Academy of Medicine

The membership of the National Academy of Sciences voted April 28 at its 152nd annual meeting to change the name of the Institute of Medicine to the National Academy of Medicine, effective July 1.

The National Academy of Medicine will continue to be an honorific society and will inherit the more than 1,900 current elected members and foreign associates of the IOM.

 

Letter to the Editor

MD Anderson Administration Behaves as a “Financially Privileged Elitist Group”

To the Editor:

Congratulations on your outstanding article entitled “MD Anderson Execs Get Big Raises In the Midst of Faculty Morale Woes.” As a 35-year faculty member of the MD Anderson Cancer Center, now retired, I am deeply disturbed at the endangered reputation of one of the greatest institutions of its kind in the world. Every other month seems to bring some embarrassing new revelation at the hands of the current leadership.

 

An Appreciation

Mike Katz, 61, Advocate, Educator

By Michael D. Scott

The cancer field is filled with advocates—advocates for research into specific forms of malignancy, advocates for access to care for patients with limited resources, advocates for pediatric cancers—you name it. Many of these people are motivated, passionate, determined, and successful in moving their specific agendas forward in the interests of patients, clinicians, researchers, and others.

In Brief

  • Margaret Kripke to retire as CPRIT chief scientist

  • CPRIT to award two grants

  • ASCO Conquer Cancer Foundation names annual award winners

  • Karmanos Cancer Institute raises $2.8 million at annual dinner
  • IU Simon Cancer Center raises $720,000 at CHUCKSTRONG tailgate gala
  • Dana-Farber, Harvard School of Public Health, and Irish Cancer Society form collaboration
  • St. Jude forms affiliate with Novant Health
  • Geisinger Health System opens precision medicine center
Drugs and Targets

  • FDA grants orphan designation to Reolysin in malignant glioma

  • Paclical receives market authorization in Russian Federation

  • Celgene International II Sarl forms collaboration with MedImmune

20150501 - May. 1, 2015
April 2015PDF

 

Melanoma

Keytruda Meets PFS, OS Endpoints in Phase III Advanced Melanoma Trial

A phase III study investigating Keytruda patients with advanced melanoma met two primary endpoints, demonstrating improvements in progression-free survival and overall survival compared to Yervoy. The study’s independent data monitoring committee recommended stopping the trial early.

In the trial, named KEYNOTE-006, Keytruda (pembrolizumab) improved PFS by 42 percent and extended overall survival by 34 percent compared to Yervoy (ipilimumab).

Investigators from 16 countries enrolled 834 patients with metastatic melanoma in the clinical trial, and patients were randomly assigned to Keytruda and Yervoy. The study was published online in the New England Journal of Medicine, and was presented at the annual meeting of the American Association for Cancer Research. The trial was sponsored by Merck.

 

Prostate Cancer

Three Xtandi Trials Show Positive Results In Castration-Resistant Prostate Cancer

Astellas Pharma Inc. and Medivation Inc. presented an updated overall survival analysis from the placebo-controlled phase III trial of Xtandi in chemotherapy-naive metastatic CRPC.

The companies also published data from two separate phase II head-to-head studies, named STRIVE and TERRAIN, comparing Xtandi (enzalutamide) to Casodex (bicalutamide).

The phase III trial, named PREVAIL, was a randomized, double-blind trial that enrolled 1,717 patients at sites in the U.S., Canada, Europe, Australia, Russia, Israel and Asia, including Japan.

 

Drugs and Targets

FDA Updates Zytiga Label To Include Chemotherapy-Naive Metastatic CRPC Data

FDA approved a label update for Zytiga (abiraterone acetate) plus prednisone to include overall survival results in chemotherapy-naive men with metastatic castration-resistant prostate cancer.

The update was based on the final analysis of the phase III, randomized, double-blind, placebo-controlled COU-AA-302 study, which showed that Zytiga plus prednisone significantly prolonged median overall survival, compared to placebo plus prednisone. 

 

Breast Cancer

Ongoing Phase II Trial Shows Correlation Between Immune Response and Recurrence

 

Lymphoma

Circulating Tumor Cells Can Be Used to Detect DLBCL Recurrence, Researchers Say

 NCI CTEP-Approved Trials for the Month of April 
  
20150430 - Apr. 30, 2015