Onco Actu du 2 novembre 2017

	2.6 Etiologie - Environnement
Exclusive: Congressional committee questions operation of WHO cancer agency [Reuters] The Congressional committee letters cited these Reuters investigations as well as other media reports, saying they revealed “troubling evidence” about the way IARC operates.
	3.1 Prévention - Tabac
Tobacco firms using 'clever tactics' to target poorest smokers, study finds [The Guardian] Cheaper brands, price-marking and smaller pack sizes are thwarting attempts to reduce UK smoking rates, researchers say.
	3.2 Prévention - Obésité
Recommendations from ASCO Summit Promotes Multi-disciplinary Collaboration to Focus on Obesity Prevention and Treatment [ASCO] The recommendations cover four key areas in response to the current issues providers face in addressing obesity prevention and treatment and its impact on morbidity and mortality in the United States.
	3.4.1 Chimioprévention - aspirine
An aspirin a day keeps many cancers away, study suggests [The Telegraph] Chinese researchers followed the progress of more than 600,000 people in the largest study to date looking at the link between cancer and aspirin.
	4. Dépistage, diagnostic et pronostic
Is there a conflict of interest behind your cancer diagnosis? [STAT] Many people have looked up their internist or surgeon in the Open Payments database. My guess is that few have looked up their pathologist. A study that I recently carried out with several colleagues suggests that they should.
	4.11 Dép., diag. & prono. - Ovaire
New Blood Test Developed to Diagnose Ovarian Cancer [Dana-Farber Cancer Institute] Non-invasive diagnostic tool being developed to measure circulating microRNAs to predict ovarian cancer with specificity.
	4.2 Dép., diag. & prono. - Génome
3 Lessons From An Alarming Case Of Mistaken Cancer Gene Test Results And Surgery [Forbes] Elisha Cooke-Moore underwent a prophylactic total hysterectomy and bilateral mastectomy, with nipple-sparing reconstruction and implants, after medical practitioners informed her she had cancer-causing genes. Only later, she learned she didn’t have the abnormality about which she’d been informed. There’s a lawsuit.
Genomic studies track early hints of cancer [Nature] Pilot projects aim to pinpoint how benign tumours turn into lung, breast, prostate and pancreatic cancers.
	4.9 Dép., diag. & prono. - Sein
TMIST Trial Aims to Provide Clarity on Breast Cancer Screening Approaches [NCI] Led by the ECOG-ACRIN Cancer Research Group, TMIST will be the first large randomized clinical trial of screening mammography in decades. It will also be the first to directly compare the current standard technology for breast cancer screening, 2D digital mammography, against tomosynthesis.
EndoPredict (EPclin) Shown in Second Study to be More Effective than Oncotype DX® (RS) in Women with Intermediate Risk of Breast Cancer Recurrence [Myriad] The first study was published in the Journal of the National Cancer Institute (JNCI) in July 2016.
The Mammography Quality Standards Act – a 25-year Public Health Success Story [FDA Voice] Today the nation’s 8,700 -plus mammography facilities are inspected every year, an immense task that is accomplished by both FDA inspectors and our state contracting partners.
Uruguay’s mandatory breast cancer screening is challenged [BMJ Blogs] In July 2016 the Uruguayan Court, taking account of the Constitution and related laws, ruled that human rights override health policies. This meant that I, personally, was exempted from mandatory screening mammograms. I finally obtained a health card for two years.
	5. Traitements
Watch Your Covalent Drugs Carefully [In the Pipeline] Importantly, if you just screen osimertinib against cathepsin C in vitro, it doesn’t look like there would be a problem at all. It’s not that reactive under normal assay conditions, but in the cell, when the compound piles up in the lysosomes, things are different.
	5.1 Traitements - Pré-clinique
Researchers find fatal flaw in childhood tumors [Science] The researchers also found that to survive, a cell that makes lots of PGBD5 needs to be able to repair its DNA, possibly because the protein triggers mutations than can kill the cell. Block this repair, the researchers reasoned, and you should be able to stop the tumor in its tracks.
Sight Unseen [Harvard Medical School] Gene expression study reveals “hidden” variability in how cancer cells respond to drugs.
	5.12.1 Immunothérapies - partenariats
PhIII dealmaking frenzy in i/o continues as AstraZeneca follows PACIFIC with a new Incyte IDO1 combo [EndPoints] For AstraZeneca, this is a chance to follow up on its PACIFIC study after unveiling some (very badly needed) positive data in September for inoperable, locally advanced stage 3 lung cancer where the cancer had not advanced after chemo.
AstraZeneca and Incyte enter clinical trial collaboration in early lung cancer [AstraZeneca] Phase III trial evaluating Imfinzi and epacadostat in patients with locally-advanced, unresectable non-small cell lung cancer is expected to begin in the first half of 2018.
	5.12.2 Immunothérapies - CAR-T
Novartis submits application to FDA for KymriahTM (tisagenlecleucel) in adult patients with r/r DLBCL, seeking second indication for first-ever FDA approved CAR-T therapy [Novartis] Submission based on updated analyses from global, multi-center Phase II JULIET study, which met primary endpoint, including 6-month data to be presented at ASH 2017.
Novartis asks FDA to expand Kymriah's use against blood cancer [Reuters] As it adds indications, Novartis expects Kymriah to eventually top annual sales of $1 billion, but the drug has rivals in the DLBCL setting.
	5.12.3 Immunothérapies-combinaisons
Boehringer Ingelheim expands collaboration with Sarah Cannon Research Institute to investigate novel immuno-oncology combination therapy [Boehringer Ingelheim] Expanded partnership will evaluate SMAC mimetic alone and in combination with anti-PD-1 immunotherapy for the treatment of solid tumours.
	5.12.5 Immunothérapies - Pharma
Bristol-Myers Squibb could double patient numbers for Opdivo in kidney cancer [FiercePharma] Its move into a larger kidney cancer market will be central to that equation.
European Medicines Agency Validates Bristol-Myers Squibb’s Type II Variation Application for Opdivo (nivolumab) for Treatment of Patients with Resected High-Risk Advanced Melanoma [BMS] The type II variation submitted is based on data from CheckMate -238, an ongoing phase 3, randomized double-blind study of Opdivo 3 mg/kg versus Yervoy (ipilimumab) 10 mg/kg in patients who have undergone complete resection of stage IIIb/c or stage IV melanoma, in which Opdivo met its primary endpoint of recurrence-free survival.
Merck Has Good Reasons for Its Keytruda Delay [Bloomberg] The delay may slow sales growth and make it likelier that Merck has to share more of the lung market with rivals. But the company deserves some credit for sticking to its cautious guns.
Merck Keytruda sales soar, but European application pulled [Reuters] The drugmaker said nearly one in three new lung cancer patients in the United States were starting with Keytruda and that the launch in bladder cancer was going well. Lung cancer is by far the most lucrative oncology market.
Merck Provides Update on European Application for KEYTRUDA® (pembrolizumab) in Combination with Pemetrexed and Carboplatin for First-Line Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC) [Merck] The application was based on findings from KEYNOTE-021, Cohort G. Merck is confident in the clinical data from this rigorously conducted trial, which demonstrated significant improvements in overall response rate (ORR) and progression-free survival (PFS) for the KEYTRUDA combination regimen compared to chemotherapy alone.
	5.12.8 Immunothérapies - Economie
UK's NICE gives Roche drug green light for bladder cancer [Reuters] The green light comes under the Cancer Drugs Fund, which offers an alternative source of funding and is designed to provide access to promising treatments. Roche is offering a special deal on the medicine, the details of which have not been disclosed.
	5.2 Pharma
Seattle Genetics Submits Supplemental Biologics License Application to FDA for ADCETRIS® (Brentuximab Vedotin) in Frontline Advanced Hodgkin Lymphoma [Seattle Genetics] Submission Based on Positive Results from the Phase 3 ECHELON-1 Clinical Trial.
GSK’s investigational BCMA antibody-drug conjugate receives Breakthrough Therapy Designation from US FDA for relapsed and refractory multiple myeloma [GSK] The PRIME and Breakthrough Therapy Designations are based on results from a phase 1 open-label, dose escalation and expansion study in patients with relapsed/refractory multiple myeloma, irrespective of BCMA expression.
	5.2.1 Pharma - Partenariats
Public-private consortium aims to cut preclinical cancer drug discovery from six years to just one [GSK] Lawrence Livermore National Laboratory, Frederick National Laboratory for Cancer Research, GSK, and University of California San Francisco will combine vast data stores, supercomputing, and scientific expertise to reinvent discovery process for cancer medicines.
	5.2.2 Pharma - Fusions & Acquisitions
Novartis snags blockbuster hopeful Lutathera in $3.9B deal for Advanced Accelerator [FiercePharma] NetSpot is AAA's only product that's now approved in the U.S., so most of its sales now derive from European markets. The company posted 2016 sales of €109 million.
Novartis Looks to Buy French Firm to Bolster Cancer Portfolio [NY Times] The acquisition comes amid a slowdown in the value of deals in the pharmaceutical sector this year.
Novartis announces the planned acquisition of Advanced Accelerator Applications to strengthen oncology portfolio [Novartis] Acquisition would add Lutathera®, a first-in-class RadioLigand Therapy (RLT) approved in Europe and under review in the US for neuroendocrine tumors (NETs).
Novartis builds cancer pipeline with a new platform/drug buyout, bagging Advanced Accelerator Applications for $3.9B [EndPoints] Novartis has just bought itself a new cancer therapy as well as a new tech platform for $3.9 billion in cash, bagging the French biotech Advanced Accelerator Applications.
In a switch, Merck CEO signals he’s in a deal-making frame of mind [EndPoints] Major new deals were put on the back burner, until recently. But now the company is changing its tune, and there could be significant implications for the industry.
	5.2.3 Pharma - économie
Roche pulls cancer drug from Greece in fight over government cost cuts [FiercePharma] The drugmaker took the step in a fight over a 25% rebate Greece recently imposed on branded drugs as part of its bailout plan with lenders. The market withdrawal of cobimetinib was immediately denounced by authorities there.
	5.3 Traitements - FDA, EMA, NICE...
EU-US mutual recognition of inspections of medicines manufacturers enters operational phase [EMA] Major milestone is a testimony to mutual trust.
	5.3.4 Traitements - AMM (FDA, EMA)
US FDA approves AstraZeneca’s Calquence (acalabrutinib) for adult patients with previously-treated mantle cell lymphoma [AstraZeneca] Accelerated approval of the selective Bruton tyrosine kinase (BTK) inhibitor in MCL marks AstraZeneca’s entry into the treatment of blood cancers
FDA approves new treatment for adults with mantle cell lymphoma [FDA] Today’s approval of Calquence was based on data from a single-arm trial that included 124 patients with mantle cell lymphoma who had received at least one prior treatment.
Eagle Pharmaceuticals Receives Tentative FDA Approval for PEMFEXY (Pemetrexed Injection) Ready-to-Dilute [Eagle] Our formulation does not require reconstitution, reducing the potential for dosing errors during mixing as well as the hazards of inhaling cytotoxic vapors that can occur when handling the powder form of the drug during preparation.
Eagle Pharma gets tentative FDA approval for Lilly's Alimta version [Reuters] The drug, Pemfexy, aims to treat patients with advanced stage of non-small cell lung cancer and mesothelioma, a rare type of tumor often caused by asbestos. The company expects to capture about 25 percent or a third of the market, Chief Executive Scott Tarriff said in an interview.
AstraZeneca wins early U.S. approval for blood cancer drug [Reuters] AstraZeneca acquired acalabrutinib when it bought a majority stake in Acerta Pharma in 2015. It paid $2.5 billion upfront at the time, with a further $1.5 billion due on first regulatory approval of the medicine.
	5.4 Traitements - Economie
Value-Based Contracting for Oncology Drugs: A NEHI White Paper [NEHI] NEHI white paper calls for a series of regulatory steps and other actions to enable new payment arrangements for high cost cancer drugs.
Rapid flurry of new drug pricing leaves no room for public debate [The Hill] In these cases, pharmaceutical manufacturers are packaging publicly funded science, and being paid handsomely for their efforts.
	5.8.2 ASH - Pharma
ImmunoGen to Present New Data on Novel Antibody-Drug Conjugates at 59th ASH Annual Meeting [ImmunoGen] IMGN779 is a CD33-targeted ADC for the treatment of acute myeloid leukemia (AML) currently in Phase 1 testing. IMGN632 is a CD123-targeted ADC for hematological malignancies, including AML and blastic plasmacytoid dendritic cell neoplasm (BPDCN)
Seattle Genetics to Present Data from Broad ADCETRIS® (Brentuximab Vedotin) Development Program at ASH 2017 [Seattle Genetics] Positive Phase 3 ECHELON-1 Clinical Trial Results to be Featured in the Plenary Scientific Session on Sunday, December 10th.
Juno Therapeutics to Highlight New Advances in CD19- and BCMA-Targeted CAR T Therapy at ASH [Juno] 15 abstracts to be presented at upcoming ASH Conference.
ASH 2017: Janssen to Present 40 Abstracts, Including 8 Oral Presentations, with New Data on DARZALEX® (daratumumab), IMBRUVICA® (ibrutinib) and Other Compounds from Robust Portfolio [Janssen] Includes early data evaluating the subcutaneous delivery of DARZALEX in relapsed or refractory multiple myeloma and new Phase 2 data for single-agent DARZALEX in smoldering multiple myeloma.
Genmab Announces Data to be Presented at 2017 ASH Annual Meeting [Genmab] Over 25 abstracts on Genmab partnered programs scheduled for presentation at ASH.
Roche to present new data across a range of blood diseases at the American Society of Hematology (ASH) 2017 Annual Meeting [Roche] New data for polatuzumab vedotin in a difficult-to-treat blood cancer, which led to FDA Breakthrough Therapy and EMA PRIME Designations, to be presented.
	5.8.4 ASH - CAR T
ASH Sneak Peeks: Novartis, Juno Update CAR-T Lymphoma Competition [Xconomy] The upshot is that for NHL, Juno has excellent three-month durability data in a very small number of patients, while Novartis is starting to fill in the durability picture at six months. Meanwhile, Gilead and Kite are keeping a few laps ahead of their would-be competitors. They will unveil a year’s worth of durability data for Yescarta at ASH.
Servier and Pfizer Announce Preliminary Results of the First-in-Human Trials of UCART19 Will Be Presented at the 59th American Society of Hematology (ASH) Annual Meeting [Cellectis] The CALM study is an open label, dose-escalation study designed to evaluate safety, tolerability and antileukemic activity of UCART19 in patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL). The study was initiated in the UK in August 2016.
Cellectis Announces Two Oral Presentations and One Poster Presentation at the 2017 ASH Annual Meeting [Cellectis] Abstracts regarding the Company's allogeneic, off-the-shelf, CAR T product candidates have been accepted for presentation at the 59th American Society of Hematology (ASH) Annual Meeting and Exposition.
#ASH17: Novartis’ 6-month Kymriah data in DLBCL sets up a head-to-head fight with Gilead [EndPoints] The latest data puts Novartis on a short track to going head-to-head with Gilead, which paid close to $12 billion to land Kite and its newly approved CAR-T drug Yescarta.
#ASH17: The big loser in CAR-T, Juno is making a bid to seize the fast lane to frontrunner status [EndPoints] Investors liked what they were seeing, driving up Juno’s shares by 10% this morning.
	5.9 AACR
Number of Seamless Clinical Trials in Oncology Has Risen Recently [AACR] “Seamless trials are combined studies where, instead of conducting the conventional phases I, II, and III, the trial adapts and expands based on the results of interim data.”
NCI-MATCH Reaches Central Patient-screening Goal [AACR] Eighteen percent of the tumors successfully sequenced harbored a mutation that matched the patient to one of the 30 treatment arms in NCI-MATCH. Of these 998 patients, 69 percent enrolled in the treatment arm to which they were matched.
	5.9.10 AACR - colorectal
New Colorectal Cancer Test Could Detect Early Cancer-causing Genetic Biomarkers with High Degree of Sensitivity [AACR] The ColoScape assay uses xenonucleic acid (XNA) molecular clamping technology to detect multigene mutation biomarkers in colorectal cancer.
Colorectal Cancers May Mutate to Escape Immune System Detection in Many Ways [AACR] Grasso and colleagues used colorectal tumor exome data from 592 cases from The Cancer Genome Atlas (TCGA), and 619 cases from the Nurses’ Health Study and the Health Professionals Follow-up Study to examine immunoediting in MSI-H (179 cases) and MSS (1,032 cases) tumors.
	5.9.11 AACR - SNC
Safety of gene therapy for brain tumours tested in early trial [Cancer Research UK] Out of the 56 patients, 23 were eligible to enter the next phase of the clinical trial. Of these, 5 patients had their tumours disappear and in a further 5 the treatment prevented their disease from worsening. The average survival within this group of patients was 14.4 months.
Gene Therapy Shows Early Efficacy Against Recurrent Brain Cancer [AACR] “Given the deadly nature of this disease, three-year survival is rarely reported in the recurrent setting. It is notable that the survival benefit was seen across a range of patients and not just limited to patients with specific genetic mutations."
	5.9.7 AACR - divers
Tazemetostat Shows Early Promise for Children with Certain Relapsed or Refractory Solid Tumors [AACR] Chi and colleagues enrolled patients from 6 months to 21 years old with INI-1 negative tumors in this multicenter phase I study. Patients received one of the seven dose levels of tazemetostat as an oral suspension twice daily. The investigators assessed objective responses every eight weeks.
	5.9.9 AACR - immunothérapies
Computer programme could predict if immunotherapy will work [Cancer Research UK] “It’s still early days and the work needs careful validation in other centres and with bigger groups of patients,” said Glennie.
A Non-invasive Computational Imaging Approach May Help Predict Response to Immunotherapy [AACR] Sun and colleagues used radiomics to estimate the abundance of immune-cell infiltration in tumors and assess their potential to predict response to anti-PD1/PDL1 therapies. The team developed a radiomics-based model of tumor-infiltrating effector T cells (Teff) using data from the head and neck, liver, lung, and bladder cohorts of The Cancer Imaging Archive.
	6. Lutte contre les cancers
It is Time for a Concerted European Approach to Defeat Cancer [ESMO] ESMO President, Fortunato Ciardiello, has contributed an editorial on the priorities for future cancer research, to The Lancet Oncology (1) with Josep Tabernero, ESMO President-Elect as co-author.
U.S. experts set research agenda to meet 'Cancer Moonshot' goals [Reuters] In a report published in Lancet Oncology, cancer researchers outlined a new model for cancer drug discovery and development focused on increased data sharing and collaboration, as well as a major focus on expanding patient access to clinical trials.
	6.1 Observation
Infertility in women could be sign of increased cancer risk, study finds [The Telegraph] In the first analysis of its kind, researchers discovered infertile women have a 10 per cent higher chance of dying prematurely than those able to conceive and are 45 per cent more likely to die from breast cancer.
Heartburn Drugs Tied to Stomach Cancer Risk [NY Times] A new study suggests that one reason may be the long-term use of proton pump inhibitors, or P.P.I.s, acid-reducing medicines sold under brand names such as Prilosec and Prevacid.
	6.11 Patients
She said she had cancer, and neighbors opened their wallets. Then a stranger’s email raised questions [STAT] The email also put him in a bind. If Deokaran was lying when she said she had cancer, Wootten’s whole community had essentially been robbed. If she did have cancer, though, and Wootten mistakenly accused her of fraud, he could ruin what little time she had left to live.
The responses to the “cancer drugs scandal” must fully involve patients—an essay by Tessa Richards [BMJ] After finding that most new cancer drugs appear to confer little clinical benefit, The BMJ’s Tessa Richards reflects on her cancer journey and argues that decision making in cancer must improve, to involve patients at every level.
I was meant to be dead by 40 – but I’m still here, living in cancer limbo [The Guardian] My body no longer has signs of terminal disease, yet it could return and quickly kill me. All I can do is live in the moment.
	6.4 Médico-éco
I’ve been a cancer nurse for over 30 years – things have never been so bad [The Guardian] Understaffed wards are full of exhausted nurses; meanwhile cancer has changed and the NHS isn’t catching up with it.
Cancer competition drives robot surgery, clinic closures in UK [Reuters] At the start of the study period, there were 65 centers offering radical prostatectomy, including 12 that performed robotic surgery. By the end, 10 centers had closed, and 39 of the remaining 55 centers, or 71%, offered robotic surgery.
	6.5 Médecines alternatives
Alternative cancer therapies: the potential impact on survival [Cancer Research UK] Now, a researcher in the US has taken a step towards collecting robust evidence to measure the harm of alternative therapy. And the numbers he has calculated have helped put an estimate on the negative impact alternative therapies might be having on survival.
FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer [FDA] The FDA issued warning letters to four companies – Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC – citing unsubstantiated claims related to more than 25 different products spanning multiple product webpages, online stores and social media websites.
Cancer charity hires 'fake news' nurse to warn patients off bogus cures [The Telegraph] Macmillan Cancer Support has hired a digital nurse specialist amid concern that patients are increasingly turning to websites promoting bogus cures and false information.
F.D.A. Warns Companies Against Claims That Marijuana Cures Diseases [NY Times] Four companies selling those and dozens of other marijuana-derived dietary supplements have been warned by the F.D.A. to stop pitching their products as cures for cancer, a common but unproven claim in the industry.
	6.7 DMP, Big Data & applis
Johns Hopkins Partnering with Other Institutions to Create a National Center for Health Data [Johns Hopkins] Team awarded five-year, $25 million cooperative agreement from National Center for Advancing Translational Science.
The Evolution of Patient Diagnosis [JAMA] There should be a new compact between patients and the health system, such that captured data and biospecimen by-products of the care delivery system should be aggregated and linked to build a clinical information commons (CIC) to aid diagnosis.
	6.8 Communication
Breast Cancer Is Serious. Pink Is Not. [NY Times] The phrase suggests that pink doesn’t tell the whole story of breast cancer. I would take that statement further, arguing that it insults breast cancer patients to conjoin our femininity and this frightening disease.
	6.9 Controverses
Plans to promote German research excellence come under fire [Nature] Critics say selection process for high-stakes funding programme is flawed.