Onco Actu du 24 août 2018

	1. Biologie
Dana-Farber Lab Finds Misguided Gene Regulator at Fault in Prostate Cancer [Dana-Farber Cancer Institute] The discovery of BAF’s role in prostate cancer suggests potential new targeted therapeutic strategies for this disease, say Kadoch and colleagues at Dana-Farber and the Broad Institute of MIT and Harvard, who published their findings in Molecular Cell.
	2.10 Etiologie - Alcool
Early-life Alcohol Intake May Increase the Odds of High-grade Prostate Cancer Later in Life [AACR] Compared with non-drinkers, men who consumed at least seven drinks per week during adolescence (ages 15-19) had three times the odds of being diagnosed with clinically significant prostate cancer, according to results published in Cancer Prevention Research.
The risks of alcohol (again) [Medium] In spite of the Lancet’s own guidelines for meta-analyses saying "For risk changes or effect sizes, give absolute values rather than relative changes", the paper did not report any absolute risks, meaning that readers couldn’t tell how dangerous drinking alcohol really was for them.
No healthy level of alcohol consumption, says major study [The Guardian] “There is strong support here for the guideline published by the Chief Medical Officer of the UK who found that there is ‘no safe level of alcohol consumption’.”
	2.11 Etiologie - Alimentation
The Challenge of Reforming Nutritional Epidemiologic Research [JAMA] Some nutrition scientists and much of the public often consider epidemiologic associations of nutritional factors to represent causal effects that can inform public health policy and guidelines. However, the emerging picture of nutritional epidemiology is difficult to reconcile with good scientific principles. The field needs radical reform.
	2.6 Etiologie - Environnement
Bayer's Monsanto faces 8,000 lawsuits on glyphosate [Reuters] When asked whether Bayer would consider settling cases out of court, he said: “We will vigorously defend this case and all upcoming cases.” Bayer executives on the call stressed that demand for glyphosate and seeds for crops that tolerate the broad-spectrum herbicide had not been affected by the verdict.
	3.1.1 Prévention - Tabac - e-cigs
Companies cease sales of e-liquids with labeling or advertising that resembled kid-friendly foods following FDA, FTC warnings [FDA] The warning letters – many in partnership with the Federal Trade Commission – are part of ongoing efforts to protect youth from the dangers of nicotine and tobacco products. Several of the companies that received warning letters had also been cited for illegally selling the products to minors.
	3.3 Prévention - Vaccins
HPV-related cancer rates are rising. So are vaccine rates — just not fast enough. [Washingtom Post] Outside experts welcomed the increased HPV vaccination rates but said much more improvement is needed. Larry Copeland, a gynecologic oncologist at The James, The Ohio State University Comprehensive Cancer Center, agreed, saying it was “not satisfactory at all” that more than 50 percent of adolescents have not completed the HPV vaccine series.
	4. Dépistage, diagnostic et pronostic
How we label life experiences can lead to overdiagnosis [BMJ] Helen Macdonald wraps up some final thoughts from the last day of Preventing Overdiagnosis.
Big people, big data, and big problems [BMJ] Helen Macdonald discusses the key points from the 2nd day of Preventing Overdiagnosis.
	4.2 Dép., diag. & prono. - Génome
How scientists are trying to predict your future with your genes [Vox] But with any new scientific tool, there are some serious limits to what GWAS, and the genetic risk profiles generated from these studies, can tell us. And critics argue that the predictive ability of these tests is quickly hitting a ceiling and will not necessarily be useful for most individuals seeking to understand their genetic fate.
	5.12.1 Immunothérapies - partenariats
Bluebird Bio Turns to Gritstone’s A.I. to Find TCR Cancer Targets [Xconomy] The agreement calls for Gritstone to provide Bluebird with 10 tumor-specific targets across several tumor types. In certain cases, Gritstone will provide the TCR cells that are directed to those targets.
bluebird bio and Gritstone Oncology Announce Strategic Collaboration to Develop Novel Cancer Cell Therapies [bluebird bio] With its lentiviral-based gene therapies, T cell immunotherapy expertise and gene editing capabilities, bluebird bio has built a pipeline with broad potential application in severe genetic diseases and cancer.
Newly partnered with bluebird, Gritstone seeks $80M IPO in final dash for clinic [EndPoints] Zeroing in on common solid tumors like metastatic non-small cell lung cancer and gastroesophageal, bladder and colorectal cancers, these trials will be the first tests of Gritstone’s theory that targeting rare mutations can boost the efficacy of checkpoint inhibitors provided by Bristol-Myers Squibb.
	5.12.2 Immunothérapies - CAR-T, thérapies cellulaires
Is It “Gene Therapy”? [Journal of Law and the Biosciences] Here, we review older attempts to define ‘gene therapy’ and find them lacking in the face of recent developments in biotechnology, such as CAR-T and CRISPR. We propose defining ‘gene therapy’ as the intentional, expected to be permanent, and specific alteration of the DNA sequence of the cellular genome, for a clinical purpose.
	5.2 Pharma
Novartis’ PI3K drug hits goal in phase 3 breast cancer trial, laying groundwork for talks with regulators [FierceBiotech] Drugmakers have continued to pursue PI3K inhibitors against this backdrop, resulting in signs the field may be in recovery. Roche linked its alpha-specific PI3K inhibitor taselisib to a small PFS gain in a phase 3 breast cancer trial in June. And now Novartis has shared a superficially upbeat look at data from its rival candidate, BYL719.
SOLAR-1 trial of Novartis investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) meets primary endpoint in HR+/HER2- advanced breast cancer with PIK3CA mutation [Novartis] SOLAR-1 evaluated BYL719 plus fulvestrant vs. fulvestrant alone in HR+/HER2- advanced breast cancer patients with PIK3CA mutations who progressed on or following treatment with an aromatase inhibitor with or without a CDK4/6 inhibitor.
U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma [BMS] Application based on results from Phase 2 ELOQUENT-3 study.
	5.2.1 Pharma - Partenariats
Pfizer, Astellas speed up 2 Xtandi studies in market duel with Johnson & Johnson [FiercePharma] The companies now expect the phase 3 Arches trial, which is testing Xtandi plus androgen deprivation therapy (ADT) versus ADT alone in metastatic HSPC patients, to wrap up at the end of the year, instead of in April 2020 as previously expected.
	5.3 Traitements - FDA, EMA, NICE...
Need a placebo control group for your next cancer drug study? Only in certain circumstances, says FDA [EndPoints] In terms of the practical and ethical concerns related to using placebos in some oncology trials, the FDA notes that in many cases, because of the toxicity of the active treatment, patients and investigators may know if they are receiving a placebo treatment.
Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development [FDA] Given the challenges of using a placebo in randomized controlled clinical trials for therapies to treat hematologic malignancy and oncologic disease, FDA recommends that a sponsor use a placebo-controlled design only in selected circumstances (e.g., where surveillance is standard of care), or with certain trial design features (e.g. if the trial uses an add-on design, when the endpoint intended to support a labeling claim has a high degree of subjectivity, such as patient-reported outcomes.
	5.3.4 Traitements - AMM (FDA, EMA,...)
Eisai and Merck Announce European Commission Grants Marketing Authorization for LENVIMA® (lenvatinib) as First-Line Treatment in Adults with Advanced or Unresectable Hepatocellular Carcinoma [Merck] First new, first-line treatment option for advanced or unresectable HCC approved in Europe in a decade.
	5.4 Traitements - Economie
Cabozantinib for untreated locally advanced or metastatic renal cell carcinoma [NICE] Cabozantinib is recommended, within its marketing authorisation, for adults with untreated advanced renal cell carcinoma that is intermediate- or poor-risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria. It is recommended only if the company provides cabozantinib according to the commercial arrangement.
	6.1 Observation
AACR Project GENIE: More Data, More Participants, and More Progress [Cancer Research Catalyst] AACR Project GENIE is an international cancer registry of real-world data assembled through data sharing between 19 of the leading cancer centers in the world.
Enhancements to NCI’s SEER Program Creating New Research Opportunities [NCI] SEER now covers 34% of the US population, covering 19 different geographic areas. With this expansion, SEER is collecting data on approximately 550,000 new individual cancer cases (without any personally identifying information) each year.
	6.10 Politiques
UK calls for extra six weeks of Brexit drug stockpiles [Reuters] In a bid to limit future difficulties, the UK government also said on Thursday it would take a pragmatic approach to future drug monitoring by recognizing and using products that have been licensed and tested in the EU.
	6.7 DMP, Big Data & applis
23andMe will no longer let app developers read your DNA data [CNBC] The company works with pharmaceutical developers aiming to use genetic information to identify new drugs, and with academic researchers on genetics studies.