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ISSUE 19 – MAY 9, 2014PDF

Oregon Center Launching $1 Billion Program To Identify Lethal Cancers Before They Kill

Brian Druker has some awesome jobs to fill.

As many as 30 scientists and their teams will get to focus on cancer research without having to worry about applying for grants.

“It’s about bringing 20 to 30 people together, giving them sufficient funding—almost like [Howard Hughes Medical Institute] level funding,” Druker said to The Cancer Letter. “If you have 20 to 30 people who are focused on science, working as a team to solve a problem, judged on progress toward the goal, as opposed to how many grants and publications do you have, we think we can make a more rapid contribution in this area.

photoCMS Advisors Express Low Confidence In Low-Dose CT Screening for Lung Cancer

An advisory panel for the Centers for Medicare and Medicaid Services expressed low confidence in low-dose computed tomography as a method for screening for lung cancer in the Medicare population.

Evidence is inadequate to ensure that benefits of the procedure would outweigh harms, the Medicare Evidence Development & Coverage Advisory Committee said at the hearing April 30.

photoBach: LCA Center Certification Untrustworthy; CISNET Models Don’t Match

When it appeared that CT screening for lung cancer was a shoo-in for Medicare coverage, the Lung Cancer Alliance, an advocacy group, started to certify “screening centers of excellence.”

Centers all over the country received this designation from LCA and were listed on the group’s website.

However, as he prepared for a recent Medicare advisory committee meeting, Peter Bach, a pulmonologist and health systems researcher at the Memorial Sloan-Kettering Cancer Center, checked the list of LCA-certified centers.

photoSteven Woolf: Why CMS Should Not Cover LDCT

National coverage for low-dose computed tomography may result in more harm than benefit to the Medicare population at this time, said Steven Woolf, a member of the Medicare Evidence Development & Coverage Advisory Committee.

Speaking at the April 30 MEDCAC hearing, Woolf said coverage would run into many implementation challenges and adherence problems—it would be unlikely that all practices would observe the strict criteria set by the U.S. Preventive Services Task Force and the National Lung Screening Trial, he said.

photoGrowth of the Cost of Drugs Slows to 5.4 Percent per Year; 21 Therapies Launched in 2 Years

The growth of global spending on oncology medicines has slowed over the past five years, according to a report by the IMS Institute for Healthcare Informatics.

Spending on cancer drugs, including those used for supportive care, increased at a compound annual growth rate of 5.4 percent during the past five years, reaching $91 billion in 2013, compared with 14.2 percent from 2003 to 2008. 

photoWomen’s Health Initiative Trial Produced $37.1 Billion in Returns

The overall economic return from the Women’s Health Initiative estrogen plus progestin trial indicates that the changes in practice it produced provided a net economic return of $37.1 billion over 10 years.

photoFDA Oncology Unit Fastest in Approvals Despite Having Highest Workload

A study by a conservative think tank found large differences in performance of the FDA divisions, with oncology demonstrating the agency’s fastest time from application submission to approval.

Paradoxically, the Manhattan Institute found that the oncology division’s staff members had the agency’s highest workload—measured in INDs per staff member at the division.

photoIn Brief

  • David Cole named president of The Medical University of South Carolina

  • Peter Bach’s account of his wife’s death from breast cancer

  • MD Anderson honors 16 junior faculty members

  • US Oncology and Community Oncology Alliance speak to Congress

  • Athena Breast Health Network adopts ASCO’s HL7 Guide for EMRs

  • Eli Lilly & Co. sign agreement with Prasco Laboratories

  • Johns Hopkins receives $10 million from Under Armour 

  • Melanoma Research Alliance and L’Oreal Paris begin campaign

  • Kristin Darby named chief information officer of Cancer Treatment Centers of America

Drug Approvals

  • Zykadia granted accelerated approval for ALK+ NSCLC

  • ADXS-HPV grated orphan drug designation

20140509 - May. 9, 2014
ISSUE 18 – MAY 2, 2014PDF

NCI Officials Open to Fine-tuning Group Budgets
As Advocates Chip Away at NCTN’s Façade

NCI officials said they plan to hold a series of meetings with clinical trials group chairs and group financial officers in order to fine-tune the new National Clinical Trials Network.

“We are in the midst of one-on-one meetings with the group chairs and their financial people and their statistical leadership, [meeting] group-by-group [to] look at the numbers as they exist, and try to understand from both sides what that research budget will support and what it won’t support,” said James Doroshow, director of the NCI Division of Cancer Treatment and Diagnosis. 

“Without seeing, from the group perspective, what the resources can and can’t support, it’s hard to know from a system-wide perspective how we will move forward.”

In a telephone conference the institute convened to respond to concern from advocates, Doroshow said, in effect, that the budgets sent to the groups recently didn’t represent fait accompli, and that flexibility was an option.

photoOn Biomedical Malthusianism
Varmus, et al. Propose a Strategy For Saving Biomedical Research

The assumption that growth in research funding would be sustained indefinitely has created an “unsustainable hypercompetitive system” heading toward “long-term decline,” a group of scientists, including NCI Director Harold Varmus, wrote in a paper published in the April 22 edition of the Proceedings of the National Academy of Sciences. 

photoIn Brief

  • CFO Dwain Morris to leave MD Anderson Cancer Center

  • National Academy of Sciences elects new members

  • Dept. of Defense taking applications for $25 million in research grants

20140502 - May. 2, 2014
April 2014PDF

 

Drug Approvals

FDA Approves Cyramza for Stomach Cancer;
Zykadia in NSCLC; Lipiodol for HCC Imaging;
And Cobas HPV Test for Primary Screening

FDA approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma. 

Cyramza is an angiogenesis inhibitor that blocks the blood supply to tumors. It is intended for unresectable or metastatic cancers that have been treated with a fluoropyrimidine- or platinum-containing therapy. 

Cyramza’s safety and effectiveness were evaluated in a clinical trial of 355 participants with unresectable or metastatic stomach or gastroesophageal junction cancer. Two-thirds of trial participants received Cyramza while the remaining participants received a placebo. 

Prostate Cancer 
Phase III Custirsen/Docetaxel/Prednisone Trial Fails Primary Endpoint of Overall Survival

Top-line results from a phase III trial evaluating the addition of custirsen to standard first-line docetaxel/prednisone therapy did not meet its primary endpoint of a statistically significant improvement in overall survival in men with metastatic castrate-resistant prostate cancer when compared to docetaxel/prednisone alone.

Custirsen is an experimental drug that is designed to block the production of the protein clusterin, which may play a fundamental role in cancer cell survival and treatment resistance.

Thyroid Cancer
Oral Sorafenib Trial Published in The Lancet; Tablets Extend PFS in Metastatic Disease

Last year, a phase III trial demonstrated Nexavar (sorafenib) tablets significantly extended progression-free survival in locally recurrent or metastatic, progressive, differentiated thyroid carcinoma that is refractory to radioactive iodine treatment.

Results from the trial, named DECISION, were recently published in The Lancet. Based on these data, Nexavar was approved by FDA in November 2013.

Melanoma
Phase III Trial Fails to Extend OS After Meeting Primary Endpoint Of Durable Response Rate
Breast Cancer

 

Non-Small Cell Lung Cancer
LDK378 Demonstrates 58 Percent Overall Response Rate in Phase I
Survivorship
ASCO Releases Three Guidelines For Cancer Survivorship Care
NCI Approved Trials for the Month of April
More Drug Approvals

  • FDA approves sBLA for Arzerra in CLL
  • FDA and European Commission grant orphan status to volasertib in AML
  • CHMP issues positive opinion for Mekinist in metastatic melanoma
  • sNDA submitted for Imbruvica in CLL and SML based on phase III data
20140501 - May. 1, 2014
ISSUE 17 – APRIL 25, 2014PDF


No Justification Provided
DePinho’s Nixing of Tenure Renewals
May Bring Censure to MD Anderson

A year before Kapil Mehta’s tenure term expired last August, the 11-member Promotions and Tenure Committee at MD Anderson Cancer Center had unanimously recommended renewal.

“I’ve done everything I’m supposed to do during my tenure,” Mehta said to The Cancer Letter. “I’ve done publications, organized international meetings, service, teaching—everything.” 

Mehta’s application was personally rejected by MD Anderson President Ronald DePinho, who overruled the PTC recommendation in May 2012.

Mehta appealed, and a second committee—the Faculty Appeals Panel—endorsed the PTC’s recommendation to renew Mehta’s tenure. However, the administration wasn’t swayed. DePinho’s decision stood.

photoItri Pays Fine, Agrees Not to Serve As Company Officer for Five Years

The Securities and Exchange Commission earlier this week said it has settled insider-trading charges against a prominent cancer researcher who was also an executive of a now-defunct company. 

photoASCO Releases Three Guidelines For Survivorship Care

The American Society of Clinical Oncology published three clinical practice guidelines for the prevention and management of neuropathy, fatigue, depression, and anxiety. 

photoIn Brief

  • Gareth Morgan named director of UAMS myeloma institute

  • Michael Gordon named medical director of Virginia G. Piper Cancer Center Clinical Trials

  • Clinical Research Forum names its Top Ten achievement awards

  • Conquer Cancer Foundation names 2014 Merit Award winners

photoFDA Approvals

  • Cobas HPV Test approved for primary cervical cancer screening

  • Arzerra sBLA approved for previously untreated CLL

  • Cyramza approved for advanced stomach cancer

20140425 - Apr. 25, 2014
ISSUE 16 – APRIL 18, 2014PDF

 

The Walgreens Connection
ACS Calls on Drug Stores to Stop Tobacco Sales

 

Last week, a blistering opinion piece on The New York Times editorial page focused on the coziness of the relationship between the American Cancer Society and Walgreens.

The piece initially triggered criticism by ACS officials, but then—with no fanfare whatsoever—the society’s CEO called on the drug store chain, as well as others, to stop selling tobacco products.

 

photoConversation with The Cancer Letter
Youle: ACS Stance on Tobacco Sales is Clear

The American Cancer Society prefers to avoid public confrontation with corporate donors, even those who make money by selling tobacco products.

“We have come to the conclusion that in the case of Walgreens, CVS, and other business partners, the best strategy is to work with them rather than against them,” said Robert Youle, vice chair of the board of the American Cancer Society and an attorney with the Denver firm Sherman & Howard.

photoIn a Change of Heart, LCA Endorses NLST

Almost one decade ago, Laurie Fenton-Ambrose, president and CEO of the Lung Cancer Alliance, described the National Lung Screening Trial as “failed” and “outdated.”

photoFunding Opportunity
Defense Department Offering $30.5 Mil In Lung, Ovarian Cancer Research Grants

The Department of Defense announced the availability of several grants through its Ovarian Cancer Research Program and its Lung Cancer Research Program.

20140418_1 - Apr. 18, 2014
ISSUE 15 – APRIL 11, 2014PDF


Varmus Pledges No Funding Gap for NCORP, Blames Snafu on “Unclear Communication”

Following an explosion of criticism, NCI said funding for community oncology clinics would not be interrupted.

In “an open letter to the cancer community” April 10, NCI Director Harold Varmus assured researchers that funding for the NCI Community Clinical Oncology Program sites would continue as it morphs into the NCI Community Oncology Research Program.

photoWhat the Physician Pay Report Won’t Tell You

For a good time, go to the Medicare database and key in the name of your physician friend, foe, or whatever, and presto!—you will see how much that person had billed Medicare in 2012.

This will make for hours of guilty pleasure, especially if you are willing to set aside concerns about—not just privacy—but accuracy.

photoPresident Obama Signs Law Authorizing $126 Million for Pediatric Research over the Next 10 Years

President Obama signed a bill authorizing $126 million for pediatric medical research over the next 10 years, following a rare showing of bipartisanship on Capitol Hill.

photoAACR Presents Awards, Arteaga Becomes President at Annual Meeting

The American Association for Cancer Research presented its 2014 awards at its annual meeting, held April 5-9 in San Diego. The AACR also inaugurated its officers for the next year during its annual business meeting. Carlos Arteaga was named president of the organization. 

photoIn Brief

  • Patricia Goldsmith named CEO of CancerCare

  • Becky DeKay named president of the Association of Community Cancer Centers

  • MD Anderson Cancer Center partners with GlaxoSmithKline

  • AACR taking applications for SU2C-Cancer Research UK Fellowship

20140411 - Apr. 11, 2014
ISSUE 14 – APRIL 4, 2014PDF


Group Chairs: Research in “Crisis”

 

The chairs of the adult clinical trials groups that make up the NCI National Clinical Trials Network said in a letter that recent budget cuts have triggered a “crisis” in clinical research.

Simultaneously, a statement by the president of the American Society of Clinical Oncology, Clifford Hudis, amplified the concerns of the group chairs, and pointed to a separate problem in NCI’s transition to the new structure of clinical research: a three-month gap in funding for community oncology clinics engaged in institute-funded research.

photoAACR, ASCO Publish Reports Criticizing Current State of U.S. Cancer Care

Cancer research remains underfunded, and the U.S. cancer care system as a whole may be unprepared to handle an aging population, according to two separate reports from the American Association for Cancer Research and the American Society of Clinical Oncology.

photoOncologists Tell Congress Community Practices Are Not Adequately Reimbursed

Current Medicare policies do not adequately reimburse cancer care provided in the community setting, the Community Oncology Alliance and the U.S. Oncology Network said in a joint, open letter to members of Congress.

photoAACR Academy Names 2014 Class of Fellows

The American Association for Cancer Research named its 2014 class of elected fellows of the AACR Academy. The fellows will be inducted at the association’s annual meeting in San Diego, April 5-9.

photoIn Brief

  • PCORI Forms Clinical Trials Advisory Panel

  • Samuel Broder named executive VP at Intrexon Corporation

  • Marion Couch named chair of IU Head and Neck Surgery

  • John Powderly II honored by ACCC

  • Two foundations offer $300,000 for neuroendocrine tumor lines

  • Fred Hutch honors thirteen graduate students

  • Community Oncology Alliance publishes IV Fluid Shortage Survey

  • NCCN Updates colorectal assessment guidelines

20140404 - Apr. 4, 2014
March 2014PDF

Metastatic Melanoma

Phase III Trial Retrospective Analysis Finds Talimogene Laherparepvec Reduced Tumors

A retrospective analysis of a phase III study found that talimogene laherparepvec reduced the size of injected tumors and non-injected metastatic melanoma tumors that had metastasized to other parts of the body.

The study evaluated talimogene laherparepvec in patients with injectable unresected stage IIIB, IIIC or IV melanoma compared to granulocyte-macrophage colony-stimulating factor. Full results were presented during an oral session at the Society of Surgical Oncology Annual Cancer Symposium in Phoenix.

Ovarian Cancer 
Avastin-Zybrestat Combination Increases Progression-Free Survival in Phase II Trial

A phase II study evaluating Avastin in combination with Zybrestat demonstrated increased progression-free survival in recurrent ovarian cancer. 

The study, known as Gynecologic Oncology Group protocol 186I, met its primary endpoint of a statistically significant increase in progression-free survival (p < 0.05; HR=0.685) for the combination compared to Avastin alone.

The study is the first and currently only randomized trial to test an antiangiogenic therapeutic agent combined with a vascular disrupting agent, without including any cytotoxic chemotherapy.

Non-Small Cell Lung Cancer
IDMC Recommends Halting Phase III Trial Of Onartuzumab in MET-Positive NSCLC

An independent data monitoring committee recommended that the phase III METLung study be stopped due to a lack of clinically meaningful efficacy, following an interim analysis.

Also:

Palliative Care
Study: End-of-Life Chemotherapy Leads to More Deaths in Hospital
Metastases
Y-90 Radioembolization Stabilizes Liver Metastases in 98.5 Percent Of Breast Cancer Patients in Study
Prostate Cancer
Robotic-Assisted Surgery Offers Better Cancer Control, Study Says
NCI Approved Trials for the Month of March
Drug Approvals

  • European Commission approves subcutaneous MabThera

  • Japan approves Lonsurf combination tablet

  • UK’s National Institute for Health and Care Excellence recommends Pixuvri

  • FDA Microbiology Devices Panel recommends cobas HPV test for approval

  • FDA revises prescribing information for Thyrogen

  • And more…

20140331 - Mar. 31, 2014
ISSUE 13 – MARCH 28, 2014PDF


FDA Advisory Panel Unanimously Favors New Stool DNA Colorectal Screening Test

 

The FDA Molecular and Clinical Genetics Panel voted 10-0 to recommend approval of Cologuard—a noninvasive, multitarget stool DNA screening test for colorectal cancer.

Sponsored by Exact Sciences Corp., Cologuard outperformed a standard fecal immunochemical test in a study published March 19 in the New England Journal of Medicine.

photoRising Costs at NCI Threaten to Overtake
Slim Increases In Budget Appropriations

Sometimes a funding increase can be no increase at all.

NCI’s budget was increased by 2.8 percent for the current 2014 fiscal year, or about $134 million, restoring about 53 percent of previous cuts made by sequestration. The institute’s total budget stands at $4.9 billion.

photoIn Brief

  • Caplan Receives NSB Public Service Award

  • Fazio and Kantarjian Receive Lifetime Achievement Awards

  • Pienta named director of Johns Hopkins Prostate Cancer Program

  • American Society of Hematology awards 15 bridge grants

  • Stewart named incoming president of Patient Advocate Foundation

  • Ohio State signs agreement with MedVax Technologies Inc.

  • UC San Francisco signs agreement with Advaxis Inc.

  • Georgia Regents receives CEO Gold Standard accreditation

  • The winners of the Research!America Advocacy Awards

  • European Commission approves MabThera SC

  • Japan approves LonSurf combination tablet

20140328 - Mar. 28, 2014
ISSUE 12 – MARCH 21, 2014PDF


Does a B from USPSTF Guarantee Coverage? Lung Screening will Define Medicare Stance

 

The Centers for Medicare and Medicaid Services is facing the formidable challenge of deciding what kinds of patients should be screened for lung cancer. 

The agency’s Medicare Evidence Development & Coverage Advisory Committee will meet April 30 to decide how the positive findings of a large randomized trial and the recommendation the U.S. Preventive Services Task Force should be translated into policy.

The controversy over screening for lung cancer will demonstrate how scientific findings influence the standard of care in the new healthcare system. Under the Affordable Care Act, USPSTF grades translate into coverage mandates for private insurers.

photoConversation with The Cancer Letter
Kazerooni: The Case for Broad Coverage

The Cancer Letter asked Ella Kazerooni, a professor of radiology at the University of Michigan, chair of the American College of Radiology Committee on Lung Screening, and vice chair of the lung screening panel of the National Comprehensive Cancer Network, to lay out the rationale for a proposal for broad coverage for lung screening.

photoIn Brief

  • Alan Ashford named center director at UCSF

  • Edith Perez receives Claude Jacquillat Award

  • NCI announces 2013 Cancer Center Clinical Investigator Team Leadership Awards

  • Chad Ellis named associate director at UNC Lineberger

  • Tripathy joins MD Anderson as breast medical oncology chair

  • Thayer named chief of surgical oncology at University of Nebraska

  • Bayer Pharma and Ventana enter agreement

  • MD Anderson signs three-year agreement with MedImmune

20140321 - Mar. 21, 2014