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ISSUE 32 – AUG. 8, 2014PDF



“Wild West” of Molecular Testing?

Caris Engaged in Aggressive Marketing, Improper Medicare Billing, Lawsuit Alleges

It’s possible that molecular testing is doing a lot of good, pinpointing cancer therapies that are most likely (or least likely) to work.

It’s also possible that Medicare is paying for molecular tests that are marketed aggressively despite being based on flimsy evidence.

The latter picture is painted in a suit filed by two former employees of Caris Life Sciences Inc., a company that markets the “Caris Molecular Intelligence” test, a panel of assays previously called “Target Now.”

The whistleblowers allege that their former employer violated the federal anti-kickback statute by routinely waiving some of its fees to induce referrals to federal healthcare programs.

Conversation with The Cancer Letter
Daniel Hayes Leads Tour of Caris Website

Tumor profiling information Caris Life Sciences provides in its reports isn’t backed by sufficient evidence to justify some clinical decisions, said Daniel Hayes, a breast cancer expert at the University of Michigan.

Hayes, the university’s Stuart B. Padnos Professor of Breast Cancer Research and a member of a recent Institute of Medicine committee that issued a report on omics, was clicking through the Caris website as he spoke with Paul Goldberg, editor and publisher of The Cancer Letter.

Caris Officials Respond To Questions Submitted By The Cancer Letter

The Cancer Letter submitted seven questions to Caris Life Sciences regarding their suite of molecular diagnostic tests. 

Questions focused on the costs of the tests, who pays for them, and how much of the information they provide is actionable. 

The Cancer Letter is taking a Summer Break

The next issue will be published Sept. 5.

NCI Launches NCORP with 53 Grants Totaling $465 Million

NCI awarded 53 five-year grants for multi-site clinical trials and care delivery research studies through the NCI Community Oncology Research Program. The program will provide $93 million each year.

photoObituary
Emmanuel Farber, Experimental Pathologist, Dies at Age 95

Emmanuel Farber, a pathologist who made contributions to the understanding of chemical carcinogenesis, died Sunday, Aug. 3. 

photoIn Brief

  • Peter Pisters named CEO of University Health Network in Toronto

  • MD Anderson and Hospital Israelita Albert Einstein form partnership

  • Richard Wahl named head of radiology at Washington University in St. Louis

  • David Espey steps down as acting director of CDC Division of Cancer Prevention and Control

  • Michael Bookman named medical director of US Oncology Research Gynecology Research Program

  • Richard David named professor of urology at UCLA

  • Jennifer Zeitzer named deputy director of FASEB public affairs office

  • Jeffrey Albers named CEO of Blueprint Medicines

  • Conquer Cancer Foundations names Raj Mantena and Aaron Sasson to board of directors

  • Dr. Susan Love Research Foundation receives NIH grant to develop low-cost, portable ultrasound

  • Massachusetts General Hospital receives award from American Hospital Association

  • Association of Community Cancer Centers launches online drug database

  • Bristol-Myers Squibb forms agreement with Leica Biosystems

  • AstraZeneca and Qiagen to collaborate on companion diagnostic

  • Optim Oncology and Urology Centers of Oklahoma join The US Oncology Network

  • FDA and EMA grant orphan designation to AbbVie’s ABT-414

20140808 - Aug. 8, 2014
ISSUE 31 – AUG. 1, 2014PDF



J&J Withdraws Power Morcellators, Citing Risk of Disseminating Cancer

Ethicon, the Johnson & Johnson subsidiary that manufactures nearly three-quarters of laparoscopic power morcellators on the market, has requested a withdrawal of the controversial devices.

“Immediately review inventory to determine if you have any Ethicon Morcellation Devices which are the subject of this market withdrawal,” the company wrote in a letter to hospitals worldwide.

“If you have provided Ethicon Morcellation Devices to any hospital within your system, you are responsible for notifying the appropriate parties immediately,” said the letter dated July 31.

FDA Moves to Regulate Lab-Developed Tests

FDA announced two plans to resolve a cluster of problems that have emerged as impediments to personalized cancer care:

• Targeted drugs will need to be approved simultaneously with companion diagnostics that would determine who should—and shouldn’t—get the drug. 

• At the same time, the agency will begin phasing in oversight of an essentially unregulated terrain: “laboratory-developed tests.” 

Tests that are intended to select therapy for deadly diseases including cancer would be among the first to be subjected to regulation. 

Surgeon General Issues Call To Reduce Skin Cancer Rates

The surgeon general issued a call to action this week, addressing the rising epidemic of skin cancer in the U.S. and around the world. 

Skin cancer is the most commonly diagnosed cancer in the U.S., but is also easily preventable. Billions can be saved on treatment if we adopt new standards and strategies, argued acting Surgeon General Boris Lushniak.

PCORI Approves $54.8 Million For Clinical Effectiveness Research

The Patient-Centered Outcomes Research Institute approved $54.8 million for 33 clinical effectiveness projects.

The projects, approved by the institute’s board of governors July 29, will study ways to improve outcomes for patients with cancer and other diseases, including diabetes, nervous system disorders, cardiovascular diseases, mental health conditions and kidney diseases.

Anonymous $100 Million Gift Moves OHSU Within $82 Million Of Reaching $1 Billion Goal

The Oregon Health & Science University Knight Cancer Institute moved one step closer to meeting a spectacular fundraising goal.

The institution said it received a $100 million gift from an anonymous donor, leaving the institution 17 months to raise the remaining $82 million needed to match the $500 million challenge set by Nike co-founder Phil Knight and his wife, Penny.

photoLetter to the Editor
Expanding the Horizons Of Proton Beam Therapy

By Minesh P. Mehta, Katja Langen and William F. Regine

The Cancer Letter recently published information regarding proton therapy facilities in the U.S., highlighting a contention that 85 percent of patients treated with protons have prostate cancer, the logical implication of which would be that this important resource is utilized minimally for other cancers. In this response, we wish to correct this erroneous impression and also wish to highlight the direction that this technology is moving in.

photoIn Brief

  • IOM Cancer Policy Forum names six at-large members

  • Allyson Kinzel named chief compliance officer at MD Anderson

  • Michael Sapienza receives award from American Society of Colon and Rectal Surgeons

  • Joel Helmke named oncology VP of WellStar Health System

  • W. Michael Alberts receives title of master fellow from American College of Chest Physicians

  • NCI consolidates central communications functions into one office

  • Study: Diagnosing breast cancer is more expensive in the U.S. than Europe

photoFDA News

  • Zydelig approved in three B-cell blood cancers

  • FDA approves Imbruvica in chronic lymphocytic leukemia

  • Avastin granted Priority Review in metastatic cervical cancer

  • FDA issues drug safety communication for docetaxel

  • European committee delivers positive opinion for Imbruvica in two blood cancers

20140801 - Aug. 1, 2014
July 2014PDF

Colorectal Cancer 
Trifluridine and Tipiracil Hydrochloride Increase OS, PFS in Phase III Trial

A phase III trial of trifluridine and tipiracil hydrochloride significantly improved both overall and progression-free survival in refractory metastatic colorectal cancer that had progressed after standard therapies. 

Data from the trial of the oral anticancer combination, also known as TAS-102, were presented at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer in Barcelona, Spain.

The global, randomized, double-blind trial, named RECOURSE, met the primary efficacy endpoint of statistically significant improvement in overall survival versus placebo (HR=0.68, p < 0.0001). TAS-102 reduced the risk of mortality by 32 percent when compared to placebo. 

Melanoma

IDMC Halts Mekinist-Tafinlar Trial Early Due to OS Benefit; Recommends Crossover

An independent data monitoring committee recommended an early stop a phase III trial of Mekinist and Tafinlar in patients with BRAF V600E or V600K mutation-positive unresectable or metastatic cutaneous melanoma, following a demonstrated overall survival benefit.

The randomized, open-label study, named COMBI-v, compared the combination of Mekinist (trametinib) and Tafinlar (dabrafenib) to vemurafenib in subjects with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma. 

Also:
Gastroenteropancreatic Neuroendocrine Tumors
Somatuline Demonstrates 65.1 Percent Of Patients Progression-Free at 96 Weeks

By priming pancreatic ductal adenocarcinomas with a therapeutic vaccine and a low-dose chemotherapy combination prior to surgery, researchers converted PDACs into cancers that may respond to immunotherapy.

Researchers pretreated PDAC patients with the vaccine GVAX and low doses of the chemotherapy cyclophosphamide, which caused the aggregation of immune cells inside the patients’ tumors, and many of these immune cells expressed proteins that may make these cancers amenable to immunotherapies such as PD-1 inhibitors.

The trial was published in Cancer Immunology Research, a journal of the American Association for Cancer Research, produced in collaboration with the Cancer Research Institute).

Acute Myeloid Leukemia
Volasertib and LDAC Doubled Response in Older Patients
Cervical Cancer
Study: Negative HPV Test More Accurate than Negative Pap Test In Predicting Cancer Risk
Proton Therapy
Phase II Study: Proton Therapy Can Have Similar Success Rate, Smaller Level of Risk in Treatment of Hodgkin Lymphoma
NCI CTEP-Approved Trials for the Month of July
FDA Approvals

  • Zydelig tablets approved for three blood cancers

  • Imbruvica approved in chronic lymphocytic leukemia

  • Avastin granted priority review in metastatic cervical cancer

  • Blinatumomab granted breakthrough therapy designation in acute lymphoblastic leukemia

  • CTL019 granted breakthrough therapy designation in adult and pedtiatric ALL

  • European Commission approves Halaven for metastatic breast cancer

  • Mylan Inc. launches generic carboplatin injection in multi-dose vials

  • FDA approves IBA Cone Beam Computed Tomography proton therapy solution

  • FDA issues drug safety communication regarding docetaxel

20140731 - Jul. 31, 2014