Onco Actu du 22 février 2019

	1. BIOLOGIE
Virus linked to cancer takes over ‘cellular mail’ to alter tumor environment [UNC] “Our study shows that Kaposi sarcoma-associated herpes virus uses extracellular vesicles to re-shape the environment near the tumor.”
	2.6 ETIOLOGIE - ENVIRONNEMENT
A New Study About Roundup and Cancer Doesn't Say What You Probably Think It Does [Reason] Is this just another example of epidemiologists torturing the data until they confess to a spurious but headline-grabbing statistical significance?
	3.1 PRÉVENTION - TABAC
Not ready to quit smoking cold turkey? Pfizer offers 'slow turkey' campaign for Chantix [Fierce Pharma] The ad is built around the insight that 95% of smokers who try to quit “cold turkey” are unsuccessful, a Pfizer spokeswoman said in an email. She said Pfizer is “encouraged” by positive feedback from smokers and healthcare providers about the turkey campaign. The work debuted in January on TV and in digital media.
Statement from FDA Commissioner Scott Gottlieb, M.D., on additional steps by the agency to support the development of safe and effective novel nicotine replacement therapies to help smokers quit cigarettes [FDA] While nicotine replacement therapy drug products to date have been developed for smoking cessation, the draft guidance, when finalized, will outline ways sponsors may develop products to reduce the risk of relapse.
	3.3 PRÉVENTION - VACCINS
Two Types of HPV Linked to Cervical Cancer Have Declined in Cervical Precancers Since the Advent of the HPV Vaccine [AACR] Among women who were vaccinated, the proportion of CIN2+ cases that were HPV 16/18-positive declined from 55.2 percent to 33.3 percent. Among unvaccinated women, the proportion of CIN2+ cases that were HPV 16/18-positive declined from 51.0 percent to 47.3 percent, and among those with unknown vaccination status, from 53.7 percent to 45.8 percent.
	3.5 PRÉVENTION - UV
FDA advances new proposed regulation to make sure that sunscreens are safe and effective [FDA] Among its provisions, the proposal addresses sunscreen active ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information.
U.S. FDA proposes new regulations for over-the-counter sunscreens [Reuters] The agency proposed that of the 16 currently used ingredients, only two — zinc oxide and titanium dioxide — are considered safe and effective based on available data.
	4. DÉPISTAGE, DIAGNOSTIC ET PRONOSTIC
Professor Sir Mike Richards launches new drive to improve care and save lives [NHS] Sir Mike, who was the NHS’ first cancer director and is the former CQC chief inspector of hospitals, is leading an independent review of national screening programmes. The review is expected to be published by summer 2019.
	4.10 DÉP., DIAG. & PRONO. - FDA, EMA, NICE,...
Acceptance of Data from Clinical Investigations for Medical Devices [FDA] The FDA requires that data from clinical investigations conducted outside the US that began on or after February 21, 2019, be from investigations conducted in accordance with good clinical practice (GCP), which includes review and approval by an independent ethics committee (IEC) and informed consent from subjects.
	4.12 BIOPSIES LIQUIDES
New method to detect cancer cells faster, potentially improving outcomes [Purdue University] Development of this new test will involve mixing a biological sample, such as cancer cells or blood plasma, with a near-infrared range emitting fluorophore. The protein is allowed to interact with small molecules and then doctors and scientists can measure the intensity of the light produced by the protein binding the small molecule.
	5.10 TRAITEMENTS - ESSAIS
The Imperative For Open Data Access And Sharing: A Progress Report [Bio-IT World] Among the recent advances in creating standardized approaches are the launch of the Vivli platform, the Credit for Data Sharing initiative, the Supporting Open Access to clinical trials data for Researchers (SOAR) initiative, the mandate for data to be shared from all trials receiving National Institutes of Health funding, and European Medicines Agency (EMA) efforts to anonymize clinical trial data.
Lung-MAP Precision Medicine Trial Expands To Include More Patients [Lung-MAP] The trial previously tested treatments for people with advanced stage squamous cell lung cancer. Opening the trial to all types of advanced stage non-small cell lung cancers means that thousands of new patients will be eligible to enroll in this landmark trial and benefit by taking new investigational drugs to fight their cancer.
Lung-MAP Trial Expands to Include All Advanced NSCLC Patients, Plans Liquid Biopsy Screening [Genome Web] Papadimitrakopoulou anticipated that eventually, when the liquid biopsy screening protocol was implemented at scale, it could help increase enrollment into Lung-MAP, since it would open up the study to patients for whom a tissue biopsy is not feasible.
	5.12 IMMUNOTHÉRAPIES
Antibody Therapy Training Phagocytes to Destroy Tumours Now Tested on Patients [University of Turku] Developed by researchers at the University of Turku, an immunotherapeutic antibody therapy re-educates macrophages to activate passivated cytotoxic T cells to kill cancer. The antibody therapy prevented the growth of tumours in several mouse models. The development of the therapy has now progressed to patient testing in a phase I/II clinical trial.
	5.12.10 IMMUNOTHÉRAPIES - FUSIONS ET ACQUISITIONS
Merck moves to buy Immune Design and its cancer vaccines platform for $300M [Fierce Biotech] The synthetic, small-molecule GLAAS platform triggers the production of CD4 helper T cells by the immune system and forms the basis of Immune Design’s lead candidate, G100, for follicular non-Hodgkin’s lymphoma patients who have not responded to at least three previous treatments.
Merck takes a shot on Immune Design [Biopharma Dive] One of the big four vaccine developers, Merck has been on the hunt to explore vaccine-based approaches outside of infectious disease, with cancer being a primary target.
Merck Scooping Up Cancer Drug Developer Immune Design for $300M [Xconomy] The company’s vaccine candidate CMB305 had advanced to Phase 3 testing as a treatment for synovial sarcoma, a rare and aggressive soft tissue cancer. But last October, Immune Design reported that a separate study testing that drug in combination with Roche’s atezolizumab (Tecentriq) showed the treatment was unlikely to improve survival in relapsed synovial sarcoma patients.
Merck to Acquire Immune Design [Merck] Immune Design is a late-stage immunotherapy company employing next-generation in vivo approaches to enable the body's immune system to fight disease. The company's proprietary technologies, GLAAS® and ZVex®, are engineered to activate the immune system's natural ability to generate and/or expand antigen-specific cytotoxic immune cells to fight cancer and other chronic diseases.
	5.12.2 IMMUNOTHÉRAPIES - CAR-T, THÉRAPIES CELLULAIRES
Off-the-shelf CAR-T from stem cells? An early look at UCLA tech — licensed by Gilead [EndPoints] Assuming these cells can be properly tuned with gene editing to go after different tumor types and prevent immune reactions from the patient — a big assumption given the early stage of research — it could represent a big leap from currently available CAR-T therapies that can only be manufactured one at the time, with the patients’ own T cells, to varying efficacy.
	5.2.1 PHARMA - PARTENARIATS
Partnering with Small Business to Advance Innovation in Cancer Research and Care [NCI] We believe these efforts to commercialize cutting-edge cancer science are economically significant, but most importantly, these programs demonstrably provide a means of getting novel technologies from the bench into broad clinical use in a way that will directly help patients with cancer.
	5.3 TRAITEMENTS - FDA, EMA, NICE...
Breakthroughs, Sort of [In The Pipeline] Here are the drugs and indications that have actually made it through approval after being so designated; there are 75. So there’s around a 70% failure rate – grim, but relatively appealing next to the general clinical failure rates that approach 90%.
	5.4 TRAITEMENTS - ECONOMIE
Linking cancer drug prices to treatment success could speed up approvals. But what do patients consider success? [Cancer Research UK] Thanks to input from people affected by cancer, we’re suggesting 4 key measures of a drug’s value, spanning not just its impact on survival, but also how it affects people’s quality of life.
The Financial Toxicity of Illness [NY Times] It sometimes seems baffling to me: I put my life on the line for research to produce a cancer medication that — if and when it is put on the market — I probably could not afford. Its miraculous prolongation of my existence, for which I am ever grateful, deepens my concern about those who will be unable to benefit from it.
	6.10.1 POLITIQUES (USA)
The fighter, the saint, and the odd man out: the executives who will defend pharma before Congress [STAT] On Tuesday, the Senate Finance Committee will poke, prod, and pry the leaders of Merck, Pfizer, AstraZeneca, Johnson & Johnson, AbbVie, Sanofi, and Bristol-Myers Squibb. It’s a televised crucible that arrives amid bipartisan furor over the cost of medicine. Just how those seven executives defend themselves could have sweeping implications for how Washington deals with drug pricing.
	6.11 PATIENTS
I Got A Double Mastectomy After A Genetic Test. Then I Learned The Results Were Wrong. [HuffPost] I sat down with the genetic researcher who was highly regarded for his work in the field, and he told me I had tested positive for the BRCA1 mutation. Because of my family’s history, I wasn’t shocked by the result, but I still couldn’t help but ask him if there was any chance the test was inaccurate. He assured me it wasn’t.
	6.8 COMMUNICATION
The Impact Chain – How to craft an effective impact case study narrative [LSE Impact Blog] Katy McEwan presents the impact chain approach for writing impact case studies. A method, which provides a framework for producing impact narratives and helps authors clearly describe and spotlight the consequences, intended and unintended, of their research.