Onco Actu du 7 novembre 2017

	2. Etiologie
Acid reflux drugs linked to increased stomach cancer risk [NHS Choices] This type of study can't prove PPIs caused the increased risk of cancer. The increased risk could be down to other factors.
	4.10 Dép., diag. & prono. - FDA, EMA, NICE,...
FDA Announces Streamlined Review Pathway for DTC Genetic Tests [RAPS] FDA is proposing a model similar to a pilot for digital health products, by which companies can be pre-certified to market low-risk software-based devices following an assessment of their systems for software design, validation and maintenance.
FDA clears the way for more consumer genetic health tests to hit the market [STAT] Since then, the FDA has generally been approving tests one by one before they hit the market. The new proposed regulations will instead allow genetic carrier screening tests — those taken by prospective parents — and genetic health tests to enter the market without prior review.
Statement from FDA Commissioner Scott Gottlieb, M.D., on implementation of agency’s streamlined development and review pathway for consumer tests that evaluate genetic health risks [FDA] The accelerated development of these innovative DTC genetic risk tests paired with the known safety considerations presents unique challenges to FDA regulation, as these technologies don’t fit squarely into our traditional risk-based approach to device regulation.
	4.11 Dép., diag. & prono. - Ovaire
Levels of Immune Cells within Ovarian Tumors Linked to Survival for Some Patients [NCI] “One of the messages of this study is that the more immune cells you have in your tumor, the better,” said study coauthor Martin Koebel, M.D., of the University of Calgary, who was among the dozens of investigators from 70 institutions worldwide who conducted the research.
	4.12 Biopsies liquides
Liquid biopsy spots aggressive pediatric brainstem cancer earlier without surgery [Children's National] Sensitive, specific analysis counts individual tumor DNA molecules left in blood and fluids.
New techniques give blood biopsies greater promise [Broad Institute] Reporting in Nature Communications, the team demonstrates that nearly 90 percent of a tumor’s genetic features can be detected in blood samples using whole-exome sequencing, and that the method can be effectively applied in up to 49 percent of patients with advanced cancer — a number likely to increase as sequencing becomes cheaper.
	4.9 Dép., diag. & prono. - Sein
Hologic and Tromp Medical to provide all mammography systems for the Dutch Breast Cancer Screening Program [HealthCareBusiness] Under the tender, Hologic's new, state-of-the-art 3DimensionsTM mammography systems will be installed in mobile and stationary screening facilities across the country, starting in 2018.
	5. Traitements
Could AstraZeneca’s ovarian cancer drug also treat glioblastoma? [FierceBiotech] Due to the positive results from their initial glioblastoma trial, the U.K. research team is now planning two additional trials of the Lynparza-chemo combo. Those trials will recruit newly diagnosed glioblastoma patients and will test the drug cocktail along with radiotherapy.
	5.12.2 Immunothérapies - CAR-T
FDA Lifts Clinical Hold on Cellectis Phase 1 Clinical Trials with UCART123 in AML and BPDCN [Cellectis] Cellectis is currently working with the investigators and clinical sites to obtain IRB’s approval on the revised protocols and resume patient enrollment.
FDA gives Cellectis a green light to relaunch off-the-shelf CAR-T studies — with several strings attached [EndPoints] Enrollment has to be staggered, with a 28-day gap between enrollment of 2 patients in the 2 studies, evidently to better control how many patients are exposed to risk.
	5.12.4 Immunothérapies - Essais
AVEO Oncology and EUSA Pharma Announce Promising Phase 1 Results from the Phase 1/2 TiNivo Study of Tivozanib and Nivolumab in Renal Cell Carcinoma [Aveo] Oral Presentation Delivered at the 16th International Kidney Cancer Symposium.
Opdivo (nivolumab) Demonstrates Superior Three-Year Survival Benefit for Patients with Previously Treated Advanced Renal Cell Carcinoma (RCC) [BMS] The three-year OS rate was 39% for Opdivo and 30% for everolimus. The safety profile of Opdivo was consistent with that of previous reports.
	5.12.7 Immunothérapies - vaccins
NousCom bags €42M to trial off-the-shelf cancer vaccine [FierceBiotech] Basel, Switzerland-based NousCom’s near-term prospects rest on programs based on Exovax. The Exovax platform uses single adenovirus vectors that can encode for 100 or more neoantigens to create vaccines that induce development and expansion of T-cell populations, including effector memory T cells.
	5.2 Pharma
Merck, Pfizer launch Bavencio for rare skin cancer [PharmaTimes] It is thought that there are around 50 new cases of mMCC annually in the UK, but data show that the incidence rising, possibly because of an ageing population or increased UV exposure, the firms note.
Speedy review for Jazz’ high-risk AML chemo [PharmaTimes] Vyxeos (daunorubicin and cytarabine) has also been awarded Promising Innovative Medicine (PIM) designation from the UK’s Medicines and Healthcare.
Amgen is shaking up R&D (again), chopping 200 as Genentech targets 130 layoffs [EndPoints] That move comes 8 months after Amgen CEO Bob Bradway turned up at the White House boasting to President Donald Trump that the company will hire 1,600 staffers this year. The job cuts were not part of that forecast.
	5.3 Traitements - FDA, EMA, NICE...
Should we accept higher p values than 0.05 for new cancer drugs? [BMJ] The current regulatory system already tolerates a tremendous amount of uncertainty regarding cancer drugs in the real world and does not need more.
	5.3.4 Traitements - AMM (FDA, EMA)
FDA approves Zelboraf (vemurafenib) for Erdheim-Chester disease with BRAF V600 mutation [Roche] Approval based on data from a basket study, which enrolls participants across multiple diseases based predominantly on genetic profile.
FDA approves Roche’s Alecensa (alectinib) as first-line treatment for people with specific type of lung cancer [Roche] Approval based on phase III results that showed Alecensa extended the average time that people lived without their disease worsening compared to crizotinib.
FDA Approves New BTK-Targeted Therapeutic for Non-Hodgkin Lymphoma [Cancer Research Catalyst] Given that the approval of acalabrutinib is based on overall response rate rather than overall survival data, the FDA requires AstraZeneca to conduct additional clinical trials to confirm that the new molecularly targeted therapeutic improves survival.
FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancer [FDA] Erdheim-Chester Disease is estimated to affect 600 to 700 patients worldwide. Approximately 54 percent of patients with ECD have the BRAF V600 mutation.
FDA approves Roche drugs for rare types of blood, lung cancers [Reuters] The Food and Drug Administration approved Zelboraf to treat patients with Erdheim-Chester Disease whose cancer cells have a genetic mutation known as BRAF V600. It is the first FDA-approved treatment for the disease.
	6.1 Observation
Fertility preservation with hormone stimulation did not increase risk of breast cancer relapse [Karolinska Institutet] The results could influence the clinical practice for young cancer patients wishing to pursue fertility preservation.
Eating more fiber tied to lower mortality with colon cancer [Reuters] Chan and colleagues examined data on 1,575 adults diagnosed with colon cancer who completed diet surveys detailing how much fiber they ate. They followed half of the participants for at least 8 years. During that period, 773 people died, including 174 who died of colon and rectal tumors.
	6.6 Publications
Court demands that search engines and internet service providers block Sci-Hub [Science] American Chemical Society awarded $4.8 million in damages from site with millions of illegal journal papers.
	6.7 DMP, Big Data & applis
Tailored treatment for prostate cancer could save men from devastating side-effects [The Telegraph] Artificial intelligence could be used to tailor treatment for prostate cancer, and save men from devastating side-effects, new research suggests.
NCRI 2017: Big data analysis predicts risk of radiotherapy effects [Institute of Cancer Research] Researchers at The Institute of Cancer Research, London, have, for the first time, applied big data analytics to information from more than 700 men given radiotherapy to treat their prostate cancer. This included medical history, genetics, radiotherapy dose, and reported side effects.
NIH awards to test ways to store, access, share, and compute on biomedical data in the cloud [NIH] Twelve awards totaling $9 million in Fiscal Year 2017 will launch a National Institutes of Health Data Commons Pilot Phase. A data commons is a shared virtual space where scientists can work with the digital objects of biomedical research, such as data and analytical tools.