ASCO's Multi-Million Big Data Project Aspires to be the "Bedrock" of Oncology

The CancerLinQ database of electronic health records is going through testing at 15 practices, and will be made available for research projects later this year.

The database, launched and operated by the American Society of Clinical Oncology, was designed to pool millions of physician and patient records from practices and hospitals.

Conversation with The Cancer Letter

ASCO CEO Allen Lichter Discusses CancerLinQ

Five years into the making of CancerLinQ, the American Society of Clinical Oncology is poised to become the next big player in oncology bioinformatics.

ASCO has enlisted the help of SAP, a large multinational corporation that specializes in enterprise software, to structure over 170,000 electronic medical records into a growing database that will be launched later this year.

Billed as a “physicians for physicians” product, CancerLinQ is expected to yield high quality data that only quality research proposals can access. 

Funding Opportunity

PhRMA Launches Web Portal For Competitive Grants

The Pharmaceutical Research and Manufacturers of American Foundation launched a platform featuring resources on its competitive research grants and fellowships for young scientists.

The foundation awards more than $3.3 million annually to researchers with support from PhRMA’s member companies. Recent grants have focused on topics such as comparative effectiveness, adherence improvement and health outcomes.

• Theodore Lawrence named director of University of Michigan Cancer Center

• Karen Knudsen named interim director of Sidney Kimmel Cancer Center

• Jonathan Jarow named acting director of FDA's Office of Medical Policy

• AACR names class of 11 AACR Academy fellows

• Varian Medical Systems selected to build proton therapy center in Denmark

Drugs and Targets

• FDA approves Lenvima in thyroid cancer

• FDA expands indication for Revlimid to include multiple myeloma

• Orphan Drug Designation granted to Saposin C

• FDA grants Orphan Drug Designation to Reolysin in pancreatic cancer

• FDA grants Orphan Drug Designation to doxorubicin formulation

• NHS establishes access program for Oncotype DX

Tufts Researchers Say Blood Cancer Drugs Are a Good Value; Kantarjian Disagrees

Even at high cost, blood cancer drugs provide a good value, an analysis by Tufts Medical Center researchers found.

In a paper published online by the American Society of Hematology journal Blood, the Tufts team presents data from a meta-analysis to argue that, even considering their cost of $100,000 or more a year, targeted therapies, as they translate into years and quality of life gained, may justify the prices.

“Given the increased discussion about the high cost of these treatments, we were somewhat surprised to discover that their cost-effectiveness ratios were lower than expected,” Peter Neumann, director of the Center for Evaluation of Value and Risk in Health at Tufts and the senior author of the study, said in a statement.

MD Anderson Pediatrics Chair "Resigned" To Pursue Academic Interests—Or Did She?

According to MD Anderson administration, Eugenie Kleinerman “decided to step down as Head, Division of Pediatrics, and Chair, Department of Pediatrics, effective Feb. 9 in order to pursue her interests in new initiatives in adolescent and young adult cancer.”

This was the version of events promulgated by MD Anderson Provost Ethan Dmitrovsky. 

Leonard Zwelling, a former MD Anderson executive and Kleinerman’s husband, offers another version. 

ACS: Tobacco May Kill More Than Previously Estimated

Cigarette smoking may kill tens of thousands more from diseases that are not currently counted as caused by smoking, according to a decade-long study led by American Cancer Society researchers.

Published in the New England Journal of Medicine, the new study included data from nearly a million U.S. men and women age 55 or older that enrolled in five U.S. cohort studies—the American Cancer Society’s Cancer Prevention Study-II, the Nurses’ Health Study, the Health Professionals Follow-up Study, the Women’s Health Initiative, and the National Institutes of Health-AARP Diet and Health Study.

CMS Announces New Model For Payment & Care Delivery

The Centers for Medicare and Medicaid Services announced the “Oncology Care Model,” a multi-payer payment and care delivery model to support care coordination of cancer care.

BRCA Testing Rates Jump After Angelina Jolie Story

BRCA gene testing rates increased by nearly 40 percent in the week of Angelina Jolie’s 2013 announcement that she carried the BRCA 1 gene mutation and had an elective double mastectomy, according to a new AARP Public Policy Institute study released Feb. 11. 

This is the first report quantifying an increase in BRCA testing rates among women enrolled in a large U.S. health insurance carrier.

• Karl Deisseroth awarded Lurie Prize for cell and tissue imaging

• Douglas Lowy receives Harrington Prize for work on HPV vaccine

• UT Southwestern and a Texas consortium to establish first U.S. heavy ion radiation therapy center

• Wendy Selig to step down as president and CEO of the Melanoma Research Alliance

• Multiple Myeloma Research Foundation and Inflection Biosciences announce collaboration

• Northwestern University to launch Onco-SET precision medicine program

Drugs and Targets

• E.U. expands Velcade label to include mantle cell lymphoma

• FDA ODAC to review talimogene laherparepvec

• Merck to assume full responsibility for Erbitux in Japan from Bristol Myers-Squibb

• FDA grants orphan drug designation to Reolysin

• Roche acquires Signature Diagnostics AG

Conversation with The Cancer Letter

Conti: Don't Count on an 80% Price Drop From the Launch of Neupogen's Biosimilar

Introduction of biosimilar biologics will not bring about the same price drops as introduction of generic small-molecule drugs, said Rena Conti, an economist at the University of Chicago, whose work focuses on drug pricing.

With small-molecule drugs, price drops within two years of patent expiration and the introduction of generics can amount to 80 to 90 percent off the branded price.

The price drop for biologics when biosimilars enter the market will be less dramatic, in part because only a small number of companies have the ability to produce these agents, reducing the competitive pressure that drives down prices. In addition, the costs of manufacturing biosimilar agents is higher than those associated with manufacturing generic small-molecule agents.

Medicare to Begin Coverage Of CT Lung Cancer Screening

Computed tomography screening has become a benefit for Americans covered by Medicare.

The Centers for Medicare and Medicaid Services Feb. 5 published a final decision to cover screening of current and former smokers, provided they meet stringent eligibility criteria.

Beneficiaries will go through counseling, health professionals will be required to provide documentation that “shared decision-making” took place, technical criteria for screening will be met, and data will be collected. CMS has never mandated shared decision-making as a gateway to paying for a service.

• The Cancer Letter's Related Coverage of CT Lung Screening

Obama Proposes $1 Billion Increase for NIH in 2016

NIH would receive a $1 billion funding boost in President Barack Obama’s $4 trillion 2016 budget—a 3 percent increase—should Congress pass his proposal. 

The additional funds would bump the NIH budget to $31.3 billion, which the White House said would support greater research in cancer, Alzheimer’s and other diseases. The proposal provides $38.8 billion in discretionary funding to the Department of Health and Human Services.

The proposal also includes $135 million for NIH’s contribution to the BRAIN Initiative, a research project announced by Obama on April 2, 2013, aimed at accelerating the development and application of innovative technologies to map the human brain.

FDA Commissioner Margaret Hamburg To Step Down Next Month

FDA Commissioner Margaret Hamburg announced that she will be stepping down at the end of March 2015.

In an email to colleagues Feb. 5, Hamburg, 59, reflected on her six-year run in the top job at the agency, and called her decision to leave “not easy.”

“My tenure leading this agency has been the most rewarding of my career, and that is due in no small part to all of you,” she wrote.

Hamburg was nominated by President Barack Obama and confirmed by the Senate in 2009.

World Cancer Day

UICC: Adding $18 Billion a Year Could Drop Cancer Deaths By 30% in Poorer Countries

New data projects that an $18 billion increase in funding per year by the international community could result in a 30 percent reduction in cancer deaths in low- and middle-income countries by 2030.

On World Cancer Day 2015, held annually Feb. 4, public health experts from the Union for International Cancer Control said that millions of lives can be saved through affordable increases in the investment into cancer services throughout the world.

CVS Provided Counseling To 67,000 in Four Months After Halting Sales of Tobacco

A year after it announced its decision to stop tobacco sales, CVS Health released data that shows how its stores are working to deliver the anti-smoking message.

According to CVS, from the launch of the program on Sept. 3, 2014, through December 2014, its pharmacists counseled more than 67,000 patients filling a first prescription for a smoking cessation drug or prescription nicotine replacement therapy.

Funding Opportunity

Crowd Research Initiative Taking Proposals in Myeloma

The Myeloma Crowd Research Initiative is accepting research proposals for high-risk multiple myeloma until the end of February, through the Myeloma Crowd website. The Myeloma Crowd is a division of the CrowdCare Foundation.

• Candace Johnson named president and CEO of Roswell Park Cancer Institute

• Thomas Rutherford named physician director of the Western Connecticut Health Network

• Carolyn Compton to lead Indivumed scientific advisory board

• Eli Lilly donates $1 million to Kenyan health care program

Drugs and Targets

• FDA grants accelerated approval to Ibrance in metastatic breast cancer

• FDA approves Koning Breast CT 3D scanning system

• Yondelis granted priority review in advanced soft tissue sarcoma

• MPDL3280A receives second breakthrough therapy designation

Duke Trial Delayed, But University to Turn Over More Documents

The trial stemming from Duke University’s clinical trials of a fraudulent genomic technology has been delayed, most likely until September.

The attorneys who represent the seven plaintiffs in Aiken vs. Duke initially sought the delay. Struck by the flu, the attorneys, including the lead counsel, were in no condition to deliver opening arguments Jan. 26.

However, even as the principal case has been continued, the judge in Durham County Superior Court Jan. 29 heard an argument over discovery, ordering Duke to turn over additional materials to the plaintiffs.

• The Cancer Letter's Related Coverage of the Duke Scandal

Duke’s Califf to take No. 2 Job at FDA

Robert Califf was named FDA Deputy Commissioner for Medical Products and Tobacco, a de facto No. 2 post at the agency.

Califf, 63, an expert in cardiology, clinical research, and medical economics, is leaving his job as vice chancellor of clinical and translational research at Duke University. He will join the agency in late February.

Califf will oversee the FDA Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products. He will also oversee the Office of Special Medical Programs in the Office of the Commissioner.  

Desequestration? Obama, Congress Seek to Restore Federal Funding

President Barack Obama and several members of Congress announced a slew of initiatives this week aimed at eliminating the effects of sequestration for the government, and for medical research by providing increases for NIH and other federal agencies.

Two bills introduced in Congress would provide sustained increases by boosting funding through direct appropriation and by adjusting caps established in the Budget Control Act.

The American Cures Act, introduced by Sen. Dick Durbin (D-Ill.), would adjust the budget caps to allow for 5 percent annual funding increases over 10 years for NIH, CDC, the Department of Defense Health Program, and the Veterans Medical & Prosthetics Research Program.

Funding Opportunity

SITC and Merck Offering Immunotherapy Fellowship

The Society for Immunotherapy of Cancer, with support from Merck, is providing funding for cancer immunotherapy research through the SITC-Merck Cancer Immunotherapy Clinical Fellowship 

• Scott Strong named chief of GI surgery at Northwestern Memorial Hospital

• James Orr named chair of Florida Board of Medicine

• Columbia University eliminates its mesothelioma center

• BBVA Foundation names winners of Frontiers of Knowledge Award in Biomedicine

• Cancer Treatment Centers of America partners with National Football League Alumni Association 

• MD Anderson begins collaboration with AstraZeneca in gynecologic cancers

• UC San Diego and UC San Francisco to launch Cancer Cell Map Initiative

Drugs and Targets

• FDA adds Waldenström’s macroglobulinemia to Imbruvica label

• FDA grants orphan drug designations to tarextumab in pancreatic cancer and small cell lung cancer

• Health Canada grants device approval to xTAG CYP2D6 Kit v3

• Array BioPharma reaches agreement with Novartis PharmaAG

• Amgen and Onyx Pharmaceuticals submit applications for Kyprolis

News Analysis
Misconduct Expert Dissects Duke Scandal

By C. K. Gunsalus

On Jan. 9, 2015, The Cancer Letter reported that Duke University received information in early 2008 that called into question the validity of the methodology and results published by the Anil Potti research group. Potti, along with his mentor and co-author Joseph Nevins, had galvanized the world of cancer research in 2006 and 2007 with their reports of successful gene expression tests for directing cancer therapy, the “holy grail” of cancer research. The 2008 information came in the form of a letter from a third-year medical student, Brad Perez, who was working in Potti’s lab. The letter, which does not seem to have been given any credence at the time, described with precision the problems that eventually resulted in the termination of clinical trials and the subsequent retractions, beginning in 2011, of at least ten (and counting) papers from major scientific journals. 

• The Cancer Letter's Previous Coverage of the Duke Scandal

Cancer Drug Prices Increased $8,500 Per Year Since 1995

The launch prices of anticancer drugs have increased substantially over time—even when adjusted for inflation and survival benefits—according to a study published by the National Bureau of Economic Research.

State of the Union 2015
Obama Launches Precision Medicine Initiative

President Barack Obama called for innovation in genetic medicine, through the launch of a new initiative, in his State of the Union address Jan. 20.

“Twenty-first century businesses will rely on American science and technology; research and development,” Obama said.

“I want the country that eliminated polio and mapped the human genome to lead a new era of medicine—one that delivers the right treatment at the right time. In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable,” he said.

“So tonight, I’m launching a new precision medicine initiative, to bring us closer to curing diseases like cancer and diabetes, and to give all of us access to the personalized information we need to keep ourselves and our families healthy.”

ASCO Teams with SAP For CancerLinQ Project

The American Society of Clinical Oncology announced Jan. 21 that its CancerLinQ health information technology project will use the SAP HANA platform.

SAP HANA is a flexible, in-memory data management and application platform that provides predictive text analytics, spatial processing and data virtualization. SAP has teamed with medical organizations in Germany and Japan for cancer data analytics and genomic analysis. 

Letter to the Editor
Is $100M in Stock Enough to Make MD Anderson Go Public with its Conflict-of-Interest Management Plan?

By Leonard Zwelling

Last week, it was reported in both The Cancer Letter and the Houston Chronicle that The University of Texas MD Anderson Cancer Center had closed a deal to sublicense intellectual property to two pharmaceutical firms, Intrexon and Ziopharm Oncology. There is nothing terribly unusual about that.

The deals, however, were mostly in exchange for equity, $50 million in stock from each company plus $15-20 million per annum. The technology is chimeric antigen receptor T cells (CAR T) and The Cancer Letter article suggests that the clinical trials testing the technology’s efficacy will be done at MD Anderson, at least in part.

This struck me as odd.

• MD Anderson's Response: Consider the Source and Venue
  

Letter to the Editor
LLS President Responds To "Bad Luck" Cancer Study

By Louis J. DeGennaro

A new study indicates that the risk of developing cancer in some types of tissue is based on the frequency of stem cell divisions, and therefore beyond individuals’ control to minimize their own risks. As the study stated, a majority of these cancers develop due to random mutations of noncancerous stem cells; in other words, it’s just “bad luck.”

• Moffitt's Johnathan Lancaster to join Myriad Genetics

• Sue Biggins receives prize from Genetics Society of America

• Pancreatic Cancer Action Network and NCI's Frederick National Lab award two fellowships

• Caris Life Sciences establishes Caris Centers of Excellence for Precision Medicine Network

• City of Hope and Trovagene Inc. enter into clinical collaboration

• WuXi PharmaTech acquires NextCODE Health

• Medical University of South Carolina location upgrades imaging systems

• Royal Phillips partners with Indica Labs Inc.

• Picador acquires world publishing rights to the debut novel by Paul Goldberg, editor and publisher of The Cancer Letter

Drugs and Targets

• European Medicines Agency's CHMP issues positive opinion on Jakavi for Polycythemia Vera

• Palmetto GBA publishes CMS coverage policy for Decipher prostate cancer classifier

• Ventana Medical Systems submits ALK assay for FDA premarket approval

How the "Bad Luck" Cancer Paper Was Misread by the Press

How much of the potential to develop cancer is due to plain “bad luck”?

A paper published Jan. 1 in Science titled, “Variation in cancer risk among tissues can be explained by the number of cell divisions,” generated a mild controversy when the authors’ use of the term “bad luck” caught on in the press.

Conversation with The Cancer Letter
Kramer: Our Cancer Risk Is Not in the Stars

The stochastic process of stem cell divisions should not be equated with bad luck, said Barnett Kramer, director of the NCI Division of Cancer Prevention, focusing on misinterpretations of the “Bad Luck” paper by Cristian Tomasetti and Bert Vogelstein, of Johns Hopkins University School of Medicine.

AVEO Cuts Workforce by 66%, Ending Research Functions

AVEO Oncology announced plans to cut its workforce by two-thirds, end its internal research functions, and vacate up to 80 percent of its facilities, including laboratory and vivarium locations. The biotechnology company was co-founded by Ronald DePinho, president of MD Anderson Cancer Center.

The restructuring would leave about 20 full-time positions.

FASEB Offers Recommendations To Improve Research Funding

The Federation of American Societies for Experimental Biology called for a re-examination of the way research is funded in the U.S., in a report detailing the challenges facing researchers and the threats to continued progress in the field.

The report, Sustaining Discovery in Biological and Medical Science: A Framework for Discussion, presents a series of recommendations to alleviate them.

Obituary
Dorothy "Dottie" Thomas, 92, "Mother of Bone Marrow Transplantation"

Dorothy “Dottie” Thomas, wife and research partner to 1990 Nobel laureate E. Donnall Thomas, died Jan. 9, at her home near Seattle. She was 92. 

Don Thomas, pioneer of the bone marrow transplant and former director of the Clinical Research Division at Fred Hutchinson Cancer Research Center, preceded her in death on Oct. 20, 2012, also at age 92.

• MD Anderson's Andrew Lee moves to Texas Center for Proton Therapy

• A. Eugene Washington named chancellor for health affairs at Duke University

• Julie Brahmer named director of thoracic oncology at Johns Hopkins Kimmel Cancer Center

• Naiyer Rizvi named director of thoracic oncology at NewYork-Presbyterian/Columbia University Medical Center

• Seton Hall University and Hackensack University Health Network to form four-year, private medical school

• Roche acquires Bina Technologies Inc.

• Karmanos Cancer Institute receives $5 million grant from the Dresner Foundation

• ASCO and College of American Pathologists announce partnership

• Mount Sinai Health System and Valley Health System announce collaboration

• Pelotonia awards six grants to Ohio State

• Genentech and Human Longevity Inc. announce multi-year agreement

• MD Anderson, Intrexon, and Ziopharm announce sublicensing agreement with the University of Minnesota

• Amgen and MD Anderson announce research agreement

The Med Student's Memo

• Bradford Perez Submits His Research Concerns
• Nevins and Potti Respond To Perez's Questions and Worries
• A Timeline of The Duke Scandal
• The Cancer Letter's Previous Coverage

An Appreciation
Joseph McLaughlin, 66, Cancer Epidemiologist

Joseph McLaughlin, an internationally recognized epidemiologist who made numerous contributions towards increasing understanding of the causes of cancer, died unexpectedly Dec. 10, 2014.

He directed key research in the United States and abroad clarifying the roles of tobacco, obesity, diet, occupation and other factors in the etiology of several cancers, especially kidney cancer, for which he was considered among the world’s experts. He led some of the largest studies exploring the etiology of renal cell and renal pelvis cancers, quantifying levels of risk associated with multiple lifestyle and environmental factors.

Obituary
Anthony Murgo, of the FDA Office of Hematology and Oncology Products

Anthony (Tony) J. Murgo, died Dec. 17, 2014 after a courageous year-long battle with cancer. He was a passionate research physician with a kind bedside manner. 

Murgo was a dedicated federal employee for 25 years, serving in multiple capacities at FDA and NCI. As the associate director of regulatory science of the FDA’s Office of Hematology and Oncology Products, Murgo was the liaison between that office and NCI’s Cancer Therapy Evaluation Program. Within OHOP, Murgo also served as a medical reviewer, a team leader and a division director for Division of Oncology Products 1.

Drugs and Targets

• Accelerated Approval Granted to Opdivo in Metastatic Melanoma
• FDA approved a supplemental biologics license application for Gazyva
• FDA approved an updated version of MarginProbe
• FDA granted Fast Track designation to SGX301
• Polaris Group’s lead product candidate, ADI-PEG 20 receives US and EU orphan designations
• Amgen and Kite Pharma entered into a strategic research collaboration
• Taiho Oncology Inc. submits NDA for TAS-102

• Donald Trump named CEO of Inova Cancer Care and Research Institute

• Dario Altieri named CEO of The Wistar Institute

• Sharmila Makhija named chair of the Department of Obstetrics & Gynecology and Women’s Health at Albert Einstein College of Medicine

• Nipun Merchant joins Sylvester Comprehensive Cancer Center

• St. Jude receives $2 million pledge from InfinityQS International Inc.

• NCI Director Harold Varmus addresses NCI staff and grantees with an outlook on the new year

Research Advocates Prepare to Face Republican-led Congress

The 113th Congress staggered through its final spending bill, approving $1.1 trillion in a massive “cromnibus” Dec. 13, keeping most of the federal government funded through September 2015, and locking in a half-percent increase for NIH and NCI in FY2015.

Biomedical research advocates bemoaned the modest increase in funding—$150 million for NIH and $27 million for NCI—and questioned Congress’s commitment to scientific progress. 

Half-Percent NIH, NCI Budget Raise Is Not Enough, Advocates Say

The Cancer Letter asked leaders of science and cancer advocacy groups to comment on the half-percent increases in federal funding for NIH and NCI in fiscal 2015, and on the prospects of science funding when Republicans take control of Congress in January. 

Conversation with The Cancer Letter
Is Republican Control Better Than Two-Party Stalemate?

As Congress goes into recess and Democrats relinquish their eight-year control of the Senate, advocates for biomedical research are rethinking their approaches to a political reality not observed in nearly a decade: a Republican-controlled Congress.

Jennifer Zeitzer, director of legislative relations at the Federation of American Societies for Experimental Biology, a coalition that represents 27 scientific societies and over 120,000 researchers worldwide, says she is optimistic about prospects for science funding in the 114th Congress. 

The reason: both sides have learned that stalemates benefit no one.

ACS President & COO Resigns Unexpectedly; Was Seen as Contender for CEO Position

Gregory Bontrager resigned from his position as chief operating officer and president of the American Cancer Society.

His resignation was announced in an email from ACS Chief Executive Officer John Seffrin Dec. 18. No reason for the departure was cited. 

Bontrager, who became the COO in 2007 and president in 2013, was, in effect, the society’s second-most-powerful official, and one of the engineers of its current move to a centralized structure.

ODAC To Advise FDA on First Biosimilars Application Jan. 7

The FDA Oncologic Drugs Advisory Committee will meet Jan. 7, 2015, to discuss a biologics license application for a proposed biosimilar to Amgen Inc.’s Neupogen (filgrastim).

The biosimilar application, submitted by Sandoz Inc., will be the first such application to be filed and discussed by an FDA advisory committee. 

NCI Advisory Board Approves Three Concepts

At a meeting Dec. 2, the NCI Board of Scientific Advisors approved three concepts during a joint meeting with the National Cancer Advisory Board.

Editorial

A Record-Breaking Year for The Cancer Letter

2014 was a transformative year for The Cancer Letter. 

• We launched a new website that makes our content possible to read online without downloading PDF files. 

• We made the website “responsive,” enabling it to adapt to all screen sizes, including smartphones and tablets. Now, about a third of our readers use these devices. An app will be available shortly.

• Also: The Cancer Letter's Notable Stories of 2014

Regulatory Approvals

• FDA expanded the approved use of Cyramza to include metastatic NSCLC
• FDA approves Somatuline Depot Injection (lanreotide) for metastatic GEP-NETs
• Lynparza (olaparib) and companion diagnostic approved in gBRCAm advanced ovarian cancer
• 510(k) clearance granted to Narrow Band Imaging for bladder cancer patient
• FDA clears Advaxis immunotherapy phase I/II trial IND application
• Genentech submits new drug application for cobimetinibn

• Fabien Calvo named chief scientific officer of Cancer Core Europe

• OSUCCC – James moves into new cancer hospital

• MD Anderson and UnitedHealthcare launch bundled payment program

• Ohio State University names 2014 James Hope Award winners

• Washington University at St. Louis genome center receives $25 million pledge

• George Washington University Cancer Institute receives $150,000 from Center for Advancing Health

• Northwestern University's Lurie Comprehensive Cancer Center enters research agreement with NeoGenomics Inc.

• Oregon Health & Science University and FEI expand Living Lab for Cell Biology agreement

• Cancer Treatment Centers of America select WIRB-Copernicus Group to help expand its clinical research program