Onco Actu du 30 juin 2016

	3. Prévention
Following prevention guidelines linked to lowered risk for cancer [Reuters] Overall, participants in the 12 studies who followed these guidelines were 10 to 45 percent less likely to be diagnosed with any cancer and up to 61 percent less likely to die of cancer, compared to people who adhered least to the lifestyle guidelines.
	3.3 Prévention - Vaccins
Merck holds parents accountable in new Gardasil ad campaign [FiercePharma] In the TV ad, a young adult man with cancer caused by HPV is shown in a series of pictures that go back in time. He wonders whether his parents just didn’t know about the vaccine that could have protected him when he was 11 or 12. The ad ends with a female voiceover asking, “What will you say?”
	4. Dépistage, diagnostic et pronostic
Tailored health campaigns could help ethnic groups spot cancer symptoms earlier [Cancer Research UK] This is the largest study looking at ethnic differences in public awareness of cancer symptoms and barriers to seeking medical help in England, and the first study to address this using all large ethnic groups living in the country.
	4.10 Dép., diag. & prono. - FDA, EMA, NICE,...
Cancer Genetics, Inc. Expands Its Immuno-Oncology Franchise With The Addition of The FDA-Approved VENTANA PD-L1 (SP142) Assay As A Complementary Diagnostic Test For TECENTRIQ™ [Cancer Genetics] By adding the VENTANA PD-L1 (SP142) assay to its test menu, CGI now offers all the companion and complementary PD-L1 diagnostic tests available on the market for delivering on immuno-oncology therapeutic selection.
	5. Traitements
Leukaemia drug shows potential for rarer type of ovarian cancer [The Institute of Cancer Research] Scientists from The Institute of Cancer Research, London found that ovarian cancer cells in mice stopped growing after they were given a drug called dasatinib.
	5.10 Traitements - Essais
Myriad's myChoice® HRD Test Successfully Identifies Patients that Meet Primary Endpoint in TESARO's Pivotal Phase 3 Ovarian Cancer Study with Niraparib [Myriad] myChoice HRD Increases Eligible Patients by Approximately Twofold.
PARP Inhibitors Come Through [In the Pipeline] So it’s been pretty messy, but the potential of PARP inhibitors has remained in the “unproven” category. Until today, that is.
Tesaro Shares Surge 82% Because Drug Slows Ovarian Cancer [Forbes] It represents the first big proof for a new class of drugs, called PARP inhibitors, that work by breaking the ability of cells to repair their DNA–a function that can damage some cancer cells more than those of healthy people.
Tesaro's ovarian cancer drug shows benefit in late-stage trial [Reuters] Analysts said the data increased the probability of niraparib being used as a first-line treatment for ovarian cancer and BRCA-related breast cancer. "The data was even better than our bullish expectations," Mizuho Securities analyst Eric Criscuolo said.
	5.12 Immunothérapies
EORTC literature review highlights methodology issues in immuno oncology [EORTC] While immune strategies are taking a central role in the spectrum of therapeutic options, current methodologies to define optimal dose and classical activity end-points may not be adapted to the mode of operation of these innovative therapies.
World GI 2016 Press Release: Anti-PD-L1 Immunotherapy Shows Response in Microsatellite-Stable Metastatic Colorectal Cancer in Combination with MEK Inhibition [ESMO] In this phase 1b study, 23 previously-treated patients with metastatic colorectal cancer were treated with escalating doses of MEK inhibitor cobimetinib (20mg, 40mg, and 60mg daily, 21 days on, 7 days off), with an expansion of patients at the highest dose level, and a 800mg dose of intravenous PD-L1 inhibitor atezolizumab every two weeks.
	5.2 Pharma
AbbVie Announces Fourth Breakthrough Therapy Designation Granted by the U.S. Food and Drug Administration (FDA) for Ibrutinib (IMBRUVICA®) for Chronic Graft-Versus-Host-Disease (cGVHD), a Rare Condition with Limited Treatment Options [AbbVie] This latest milestone also highlights the potential benefit of ibrutinib's unique mechanism of action beyond oncology.
	5.2.1 Pharma - Partenariats
Moderna Gets $200M More, Deepens Merck Ties With New Cancer Pact [Xconomy] The deal is industry’s latest vote of confidence in Moderna, the high-flying yet mysterious maker of mRNA drugs. For those unfamiliar with the company, the idea behind Moderna is to inject synthetic mRNA strands into the body so patients’ cells can produce their own therapeutic proteins. It’s a novel way of making drugs that is also completely unproven in humans.
	5.2.2 Pharma - Fusions & Acquisitions
What Tesaro's Cancer Drug Success Means for Medivation [The Street] Sanofi's $52.50 per share takeout offer for Medivation is looking increasingly unappealing.
	5.2.3 Pharma - économie
Syros Cuts Price But Gets $50M in IPO to Fuel Cancer Drug Trials [Xconomy] Syros will use its IPO cash to fund early clinical trials for drug candidates SY-1425 and SY-1365, the first test cases for the discovery work Syros has been doing since its inception in 2011.
	5.3 Traitements - FDA, EMA,...
FDA issues new draft guidelines for ‘appearance’ of conflicts of interest [STAT] Of course, the appearance of a conflict can be nuanced. So the guidance — which, unlike a regulation, is not binding — attempts to describe potentially problematic situations.
US FDA Advisory Subcommittee Weighs in on Pediatric Oncology Candidates and Discusses Treatment Approaches for Fatal Pediatric Brain Tumor – JUN 28-29, 2016 [SAC Tracker] The Pediatric Oncologic Subcommittee of the Oncologic Drugs Advisory Committee (ODAC) considered information pertinent to the formulation of pediatric studies for the following 5 products: (1) VENETOCLAX by AbbVie, Inc.; (2) TAZEMETOSTAT by Epizyme, Inc.; (3) ATEZOLIZUMAB by Roche/Genentech; (4) LOXO-101 by Loxo Oncology, Inc.; and (5) ENTRECTINIB sponsored by Ignyta, Inc.
	5.4 Traitements - Economie
Bristol-Myers Squibb’s Response to ICER’s Draft Scoping Document “Treatment Options for Advanced Non-Small-Cell Lung Cancer” [BMS] Our feedback to ICER on the NSCLC scoping document is intended to contribute our company’s perspective on the value that Immuno-Oncology agents, such as Opdivo, provide to patients impacted by NSCLC. We encourage ICER to incorporate the points we outlined in our response.
	6. Lutte contre les cancers
Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century [The National Academies Press] Optimizing the Nation's Investment in Academic Research reviews the regulatory framework as it currently exists, considers specific regulations that have placed undue and often unanticipated burdens on the research enterprise, and reassesses the process by which these regulations are created, reviewed, and retired.
Interdisciplinary proposals struggle to get funded [Nature News & Comment] Agencies are less likely to fund studies that straddle multiple fields, a study of Australian grants finds.
	6.1 Observation
Heart disease and cancer are responsible for nearly half of all deaths in the U.S., report says [LA Times] Heart disease and cancer have long topped the list of leading causes of death, and each killed a few thousand more people in 2014 than in 2013.
	6.10.1 Politiques (USA)
American Society of Hematology Data Sharing Initiative to Be Featured at National Cancer Moonshot Summit Today [ASH] Society continues to convene multiple myeloma experts from across the globe to contribute to a robust data-sharing infrastructure aimed at advancing curative strategies and personalized medicine.
Significant expansion of data available in the Genomic Data Commons [NIH] The addition of data from 18,000 adult patients with a diverse array of cancers that underwent genomic profiling using FMI’s proprietary comprehensive genomic profiling assay, called FoundationOne, will provide a major boost to the GDC.
Our Moonshot pledge to accelerate research on detecting early signs of cancer [Cancer Research UK] Today, Cancer Research UK is delighted to announce that we’re now the Cancer Moonshot’s first international partner, focusing on an area of huge importance to patients and the public, and one that’s vital to boosting survival: detecting early signs of cancer.
Statement from FDA Commissioner Robert Califf, M.D. announcing the acting director of the FDA Oncology Center of Excellence [FDA] The FDA is honored to be an integral part of the Vice President’s National Cancer Moonshot Initiative (“Cancer Moonshot”), which calls on the agency to leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics and devices to create the Oncology Center of Excellence.
Foundation Medicine On Biden's Cancer Moonshot: A 'Pep Rally' Can't Hurt [Forbes] I do believe that the vice president, as well as the members of the Moonshot team, understand that the reimbursement barriers are some of the greatest obstacles in the advancement of cancer care today. So we believe it will be one of their many priorities, and they can have a meaningful impact just by raising the issue at the national level. That’s something that can facilitate change.
Biden to unveil effort to speed researchers’ access to cancer drugs [STAT] While many of the new efforts are relatively small in scale and come at the tail end of the administration, they are intended to mark “the beginning of a new discussion” on cancer and represent “down payments on actions that we can achieve this year.”
Biden threatens funding cuts for researchers who fail to report clinical trial results [STAT] “Under the law, it says you must report. If you don’t report, the law says you shouldn’t get funding,” Biden said, citing a STAT investigation that found widespread reporting lapses.
The Cancer Moonshot Summit: A Day For Our Nation To Reflect And Commit To What We Can Accomplish To Make This Cancer’s Last Century [Dr. Len's Blog] I personally believe that everyone involved with cancer—those currently under treatment, survivors, those who have lost loved ones, friends and coworkers to cancer, doctors, nurses (who acknowledged with his heart by saying if there are angels in heaven they must be nurses), anyone involved in the cancer sphere—should make every effort to watch that video if they haven’t seen it already.
FDA names Pazdur head of new Oncology Center of Excellence [Reuters] "We are moving into a very complicated area in oncology where drugs and devices and biologics are going to be used in combination or sequentially," Dr. Richard Pazdur, the FDA's cancer drug director, said in an interview.
The Rocket Fuel for Biden’s “Cancer Moonshot”? Big Data [MIT Technology Review] If Vice President Joe Biden’s Cancer Moonshot is really going to double the pace of progress in preventing, diagnosing, and treating cancer, it’s going need a lot more data. That means it’s probably going to need more data-sharing arrangements like one announced at today’s Cancer Moonshot Summit in Washington, D.C., between the National Cancer Institute and Foundation Medicine, a biotech firm selling tests that sequence tumor genomes.
	6.11 Patients
Simple questions predict decline after breast cancer treatment [Reuters] The researchers analyzed data on 184 women 65 to 93 years old and newly diagnosed with breast cancer that had not spread to another area of the body. Each was recruited shortly after her diagnosis but before cancer treatment had begun.
	6.6 Publications
ArXiv preprint server plans multimillion-dollar overhaul [Nature News & Comment] The results of an enormous user survey published this week suggest that researchers are wary of drastic changes to a site that has become an essential part of the infrastructure of modern science.
	6.9 Controverses
U.S. should abandon controversial effort to update human research rules, National Academies panel says [Science] The proposal, which was released last year and has received extensive criticism from science groups, “is marred by omissions, the absence of essential elements, and a lack of clarity,” the report states.
Science academies blast US government’s planned research-ethics reforms [Nature News & Comment] Advisory panel recommends scrapping proposed changes to 'Common Rule' that governs research involving human subjects.