Onco Actu du 18 décembre 2018

	2. Etiologie
Johnson & Johnson shares slip after talc asbestos claims [The Guardian] On Monday, the company took out a full-page advertisement in the New York Times titled “Science. Not Sensationalism”, saying it has scientific evidence its talc is safe and beneficial to use.
Baby Powder’s Possible Asbestos Link Worried Johnson & Johnson for Years [NY Times] Executives proposed new testing procedures or replacing talc outright, while trying to discredit research suggesting that the powder could be contaminated with asbestos, according to corporate documents unearthed by litigation, government records obtained by The New York Times through the Freedom of Information Act, and interviews with scientists and lawyers.
Special Report: J&J knew for decades that asbestos lurked in its Baby Powder [Reuters] A Reuters examination of many of those documents, as well as deposition and trial testimony, shows that from at least 1971 to the early 2000s, the company’s raw talc and finished powders sometimes tested positive for small amounts of asbestos, and that company executives, mine managers, scientists, doctors and lawyers fretted over the problem and how to address it while failing to disclose it to regulators or the public.
J&J moves to limit impact of Reuters report on asbestos in Baby Powder [Reuters] Johnson & Johnson on Monday scrambled to contain fallout from a Reuters report that the healthcare conglomerate knew for decades that cancer-causing asbestos lurked in its Baby Powder, taking out full-page newspaper ads defending its product and practices, and readying its chief executive for his first television interview since investors erased tens of billions of dollars from the company’s market value.
	3.1.1 Prévention - Tabac - e-cigs
Vapers inhale lower levels of toxins than smokers [Reuters] Goniewicz and colleagues analyzed 2013-2014 data from the nationally representative Population Assessment of Tobacco and Health Study, which is designed to assess tobacco use and health in the U.S. The 5,105 adult participants provided urine samples to be analyzed for biomarkers.
E-cigarette usage nearly doubles in U.S. high-schools: survey [Reuters] The annual survey, which also measures use of other substances including marijuana, alcohol and opioids, questioned more than 44,000 students from 8th, 10th and 12th grades in U.S. public and private schools.
Study Shows Big Rise in Teen Vaping This Year [NY Times] Use of other drugs, including opioids, alcohol and tobacco cigarettes, was down and marijuana use was steady, the annual survey of American teenagers found.
Teens using vaping devices in record numbers [NIH] Reported use of vaping nicotine specifically in the 30 days prior to the survey nearly doubled among high school seniors from 11 percent in 2017 to 20.9 percent in 2018.
	4.9 Dép., diag. & prono. - Sein
Breast cancer screening error 'overstated' [BBC News] An independent review of breast screening in England has found that confusion and misunderstanding were behind an announcement in May that hundreds of thousands of women had missed out on final scans.
	5.1 Traitements - Pré-clinique
Drug Combination May Target the Unique Metabolism of Leukemia Stem Cells [NCI] Specifically, the studies showed, the drugs venetoclax (Venclexta) and azacitidine (Vidaza) team up to block the unique metabolism of leukemia stem cells.
	5.12.1 Immunothérapies - partenariats
Bristol-Myers Squibb and Boston Medical Center Announce Research Collaboration to Investigate Markers of Immuno-Oncology Response and Resistance [BMS] Through the study, researchers will explore the role of tissue and circulating biomarkers on treatment sensitivity and resistance. In addition, scientists will investigate the role of the microbiome as a potential predictive biomarker in patients receiving treatment with immune checkpoint inhibitors.
	5.12.2 Immunothérapies - CAR-T, thérapies cellulaires
Bellicum reports first data on ‘controllable’ CAR-T [FierceBiotech] Data from 12 patients enrolled in a phase 1/2 dose-escalation study in PSCA-positive metastatic pancreatic cancer treated with the CAR-T showed that out of six evaluable patients, four had stabilized disease, with two seeing tumor shrinkage of at least 20%. More importantly, however, the results suggest BPX-601 is working as intended.
	5.12.3 Immunothérapies-combinaisons
AstraZeneca wants a do-over on MYSTIC combo data. But a changeup in focus won’t end the death watch on this pairing [EndPoints] We already knew that the hazard ratio for the combination was a poor 0.85, but Imfinzi’s 24-month overall survival rate was 38.3% compared to an embarrassing 35.4% for the PD-L1 plus CTLA-4 approach.
	5.12.6 Immunothérapies - AMM
European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy for Adults with Resected Stage III Melanoma [Merck] European Approval Based on Significant Recurrence-Free Survival Benefit Demonstrated with KEYTRUDA in the Pivotal Phase 3 EORTC1325/KEYNOTE-054 Trial.
Junshi wins the race for first made-in-China PD-1 approval as execs reap $394M IPO harvest [EndPoints] Conditionally approved under priority review, toripalimab is indicated for fast-growing cases of melanoma, according to the National Medical Products Administration.
	5.12.7 Immunothérapies - vaccins
Imugene ‘encouraged’ by data for HER2 vaccine in gastric cancer [FierceBiotech] Australian biotech Imugene says its HER2 vaccine hit the mark in a phase 1b trial, setting up a phase 2 study that will start recruiting patients in the new year.
	5.2.1 Pharma - Partenariats
Innovent buys Chinese rights to Incyte drugs for $40M upfront [FierceBiotech] The most advanced of the three candidates is itacitinib, a JAK1 inhibitor Incyte is testing in patients with graft-versus-host disease (GvHD). Data from a phase 3 trial of itacitinib in acute GvHD are due next year. Incyte is also developing itacitinib as a treatment for non-small cell lung cancer.
Bristol-Myers, H3 Biomedicine explore RNA splicing drugs for cancer [FierceBiotech] H3 has three molecules in its pipeline: H3B-6527, an inhibitor of fibroblast growth factor receptor 4 (FGFR4) for liver cancer; H3B-6545, a modulator of wild-type and mutant estrogen receptor (ERα); and H3B-8800 inhibitor of wild-type and mutant SF3b complex, a splicing factor gene.
Broadening its oncology focus, Innovent adds three Incyte drugs to portfolio for $40M cash [EndPoints] Innovent is betting on three distinct candidates in Incyte’s pipeline: itacitinib (JAK1 inhibitor), pemigatinib (FGFR1/2/3 inhibitor) and parsaclisib (PI3Kδ inhibitor).
	5.3 Traitements - FDA, EMA, NICE...
Amy Abernethy to join FDA as principal deputy commissioner [The Cancer Letter] On one hand, I have been working on the topic of real-world evidence and confident evidence generation for a very long time. This is my area of expertise. On the other hand, I work for a for-profit company in this space. I am going to be very upfront about it with the ethics officials at the FDA and anyone who asks so that we can navigate conflicts transparently.
Amy Abernethy: Poised To Propel FDA Into Tech-Savvy, Patient-Centric Future [Forbes] Gottlieb would have been hard-pressed to find a person better suited to many of the key challenges facing the industry. For starters, Abernethy has an appreciation for both the complexity of clinical data and the limitations, as well as the promise, of technology.
FDA Names Flatiron Health Executive Amy Abernethy Deputy Commissioner [Forbes] Abernethy, an oncologist who is credited with helping Flatiron transform data collected from electronic medical records into information that might become acceptable to FDA regulators, will be the Principal Deputy Commissioner for Food and Drugs. This is the highest position at the FDA that is not a political appointment.
	5.3.4 Traitements - AMM (FDA, EMA,...)
FDA approves another Herceptin biosimilar in blow to Roche [BiopharmaDive] Celltrion and Teva Pharmaceutical gained approval of their Herceptin biosimilar Herzuma from the Food and Drug Administration, the second biosimilar approval for Celltrion within a month.
Pfizer Receives Positive CHMP Opinion for Oncology Biosimilar, ZIRABEV™ (bevacizumab) [Pfizer] ZIRABEV ™ (bevacizumab), a potential biosimilar to Avastin ®* (bevacizumab), is Pfizer’s second therapeutic oncology biosimilar to receive a positive CHMP opinion in Europe in 2018.
Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Sprycel (dasatinib) for Pediatric Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia [BMS] The application is based on data from CA180-372 (NCT01460160), an ongoing Phase 2 trial evaluating the addition of Sprycel to a chemotherapy regimen modeled on a Berlin-Frankfurt-Munster high-risk backbone in pediatric patients with newly diagnosed Ph+ ALL.
Takeda Receives Positive CHMP Opinion for ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage IV Hodgkin Lymphoma in Combination with AVD [Takeda] If Authorized in Europe, ADCETRIS in Combination with AVD (Adriamycin, Vinblastine and Dacarbazine) Will Be the First New Treatment Regimen Available for Adult Patients with Previously Untreated CD30+ Stage IV Hodgkin Lymphoma in Decades.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018 [EMA] The Committee recommended extensions of indication for Adcetris, Rapiscan, Rubraca, Simponi, Sprycel and Trimbow.
	5.4 Traitements - Economie
The new Cancer Drugs Fund has quietly reached a significant milestone [Cancer Research UK] Vandetanib was the last on a list of 33 treatment options that NICE has been working its way through since 2016, when a pot of money put aside to pay for treatments not routinely approved – called the Cancer Drugs Fund (CDF) – was redesigned. So, this decision marks the end of an important shift in the way drugs are reviewed and approved in England.
	5.5 ASCO
ASCO, ESMO Publish Joint Assessment of Their Value Frameworks [ASCO] The ASCO Value Framework’s Net Health Benefit (NHB) score and the ESMO-Magnitude of Clinical Benefit Scale (MCBS) are both intended to be objective measures of the magnitude of clinically meaningful benefit of anti-cancer treatments. Both frameworks account for the clinical benefits as well as the side effects of the treatments they compare.
	5.6.7 ESMO - Immunothérapies
Proton Pump Inhibitor Therapy Negatively Impacts the Efficacy of Nivolumab Plus Ipilimumab Combination Treatment in Melanoma [ESMO] Reduced efficacy not apparent with patients on PPIs receiving ipilimumab monotherapy.
Neoadjuvant Ipilimumab plus Nivolumab Demonstrates Promising Overall Survival and Relapse-free Survival in Stage III Melanoma [ESMO] None of the patients that achieved a pathologic response upon neoadjuvant therapy have relapsed.
Pembrolizumab Improves Long-term Overall Survival over Docetaxel in Advanced NSCLC [ESMO] Pembrolizumab significantly prolongs overall survival in previously treated patients with advanced NSCLC.
Data from the OAK Trial Show Fast Progression Is Not More Common with Atezolizumab [ESMO] Similar proportions of patients treated with atezolizumab or docetaxel show post-treatment fast progression.
	6.1 Observation
NIH scientists find that breast cancer protection from pregnancy starts decades later [NIH] "We were surprised to find that an increase in breast cancer risk lasted for an average of 24 years before childbirth became protective," said Sandler. "Before this study, most researchers believed that any increase in risk lasted less than 10 years."
	6.3 Associations/Fondations
Conflicts have killed trust in the system. Advocates must rebuild it [The Cancer Letter] The existing system and the relationship among researchers, doctors and other industry stakeholders demand that the system be thoroughly investigated and revamped and that advocates be at the forefront.
	6.6 Publications
The 2018 Altmetric Top 100 [Altmetric] In the past year, Altmetric has tracked over 25 million mentions of 2.8 million research outputs. This page highlights the top 100 most-mentioned scholarly articles published in the past year – those which have truly captured the public imagination.
	6.8 Communication
Reflections on a 45-year career and 13 years leading HealthNewsReview.org [HealthNewsReview] In this, our final week of daily publishing as we wind down operations due to a loss of sufficient funding, I want to share some observations after a 45-year career in health care journalism, 13 of which were the pinnacle for me as Publisher of this website.
	6.9 Controverses
The Parachute Trial: useful caricature or just a joke? [Unboxing Evidence Based Medicine] My concern is that a reader of this funny study take the following message home: if a promising study is negative, consider that clinical trials tend to include patients less predisposed to the benefit. This message is wrong, as clinical trials tend to select samples more predisposed to the benefit.