Onco Actu du 14 avril 2020

	3.3 PRÉVENTION - VACCINS
Single Dose of HPV Vaccine Yields Long-Term Protection from Many Cancer-Causing Types [NCI] None of the published studies to date have randomly assigned women to receive a single vaccine dose. It is possible that women in the Costa Rica Trial who received a single dose “were different in some way,” Dr. Markowitz said.
	4.10 DÉP., DIAG. & PRONO. - FDA, EMA, NICE,...
FDA Releases Guidance Outlining Considerations for CDx Labeling for Oncology Drug Groups [Genome Web] The FDA encouraged sponsors interested in broadening CDx indications to an oncology therapy group to contact its drug and device divisions and discuss a regulatory plan.
Companion Diagnostics: FDA Finalizes Guidance to Broaden Labeling for Precision Oncology [RAPS] The nine-page guidance largely follows the recommendations made in the draft version released in late2018 and includes some clarifications and additional information from the previous version.
Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products [FDA] This guidance describes considerations for the development and labeling of in vitro companion diagnostic devices (referred to as “companion diagnostics” herein) to support the indicated uses of multiple drug or biological oncology products, when appropriate.
	4.2 DÉP., DIAG. & PRONO. - GÉNOME
Pediatric Low-Grade Glioma Molecular and Clinical Analysis Defines Subtypes That Predict Outcome [Genome Web] By bringing together imaging, histology, targeted DNA sequencing, RNA sequencing, clinical, and other data for more than 1,000 children with pLGG, the researchers narrowed in on two broad groups of tumors marked either by recurrent rearrangements or by single-nucleotide variants.
Analysis of Advanced, Metastatic Tumors Indicates How Treatment Influences Mutational Profiles [Genome Web] As they reported in Nature Cancer, the researchers' pan-cancer analysis uncovered links between exposure to DNA-damaging treatments and particular mutational signatures as well as gene alterations associated with drug resistance or sensitivity.
	5. TRAITEMENTS
Who Benefits from Herceptin and Other Anti-HER2 Cancer Therapies? [The Scientist] Calls to include a new breast cancer subtype in future clinical trials reveal fundamental disagreements about HER2’s role in the disease.
	5.1 TRAITEMENTS - PRÉ-CLINIQUE
Tailoring treatment for triple-negative breast cancer [Penn Today] Blocking this signaling using an antibody against the interferon gamma receptor 1, or by genetically manipulating tumor cells to express lower levels of the receptor caused tumors to grow and spread more slowly.
	5.12.11 IMMUNOTHÉRAPIES - PRÉ-CLINIQUE
Tumors hijack the cell death pathway to live [UT Southwestern] Using a combination of CASP9 inhibitors with anti-PD-L1 could offer a new strategy for boosting the effects of radiation.
	5.12.5 IMMUNOTHÉRAPIES - PHARMA
BeiGene Announces that the Phase 3 Trial of Tislelizumab Combined with Chemotherapy in Patients with First-Line Non-Squamous Non-Small Cell Lung Cancer Met the Primary Endpoint of Progression-Free Survival at Interim Analysis [BeiGene] BeiGene plans to discuss its plans for filing a supplemental new drug application (sNDA) for tislelizumab as a first-line treatment for non-squamous NSCLC with the Center for Drug Evaluation (CDE) at the National Medical Products Administration (NMPA) in China and present detailed data at upcoming medical conferences.
	5.12.8 IMMUNOTHÉRAPIES - ECONOMIE
Judge slaps enhanced damages on Gilead/Kite for ‘willful’ patent violation, boosting award to a blockbuster $1.2B — with the meter running [EndPoints] If this judgment holds up — and that’s a big if, given the way IP battles have been settled in the past — the laggard in the race may yet wind up with a big payday.
	5.2 PHARMA
AstraZeneca stops lung cancer trial early, after star drug Tagrisso induces 'overwhelming' efficacy [EndPoints] Tagrisso is a third-generation EGFR TKI. This Tagrisso trial is the first to demonstrate the benefit of targeted EGFR inhibition in the adjuvant NSCLC setting and the drug will likely gain approval in this indication by 2021 with no competitors in sight, wrote Cowen analyst Steve Scala in a note.
AstraZeneca's top-selling cancer drug sees early unblinding in key trial [Reuters] In the fourth quarter, sales of Tagrisso fell short of forecasts due to adjustments for U.S. rebates and discounts, as AstraZeneca forecast a slowdown in revenue growth this year due to the hit from the coronavirus outbreak.
Tagrisso Phase III ADAURA trial will be unblinded early after overwhelming efficacy in the adjuvant treatment of patients with EGFR-mutated lung cancer [AstraZeneca] The data will be presented at a forthcoming medical meeting.
	5.3.4 TRAITEMENTS - AMM (FDA, EMA,...)
AstraZeneca, Merck finally grab a green light for rare-disease med Koselugo [Fierce Pharma] The genetic condition affects an estimated 10,000 to 12,000 children in the U.S., and Koselugo will come with a rare-disease list price to match its niche indication.
AstraZeneca and Merck drug wins approval for rare cancer after failing elsewhere [Biopharma Dive] Koselugo was among the pipeline projects AstraZeneca executives pointed to as future growth drivers when the company's sales were shrinking following the loss of patent protection for key moneymakers. However, until now the drug has failed to live up to AstraZeneca's hopes, unlike fellow cancer treatments Tagrisso and Lynparza.
KOSELUGO® (selumetinib) Approved by FDA for Pediatric Patients Two Years and Older With Neurofibromatosis Type 1 and Symptomatic, Inoperable Plexiform Neurofibromas [Merck] First Medicine Approved to Treat This Rare and Debilitating Condition.
	6.12 ETHIQUE
Nonresearch Pharmaceutical Industry Payments to Oncology Physician Editors [The Oncologist] Our study shows the high prevalence and lack of transparency of nonresearch industry payments to oncology editors. Higher impact journals appear to be associated with greater nonresearch industry payments.
	6.15 LUTTE CONTRE LES CANCERS - COVID-19
Challenges In Managing Clinical Trials In Oncology In The COVID-19 Era [ESMO] Dr Stefan Zimmerman from the Lausanne University Hospital, Switzerland, shares his experience on how to balance maximal compliance with the protocol with the need to minimise exposure of trial participants to coronavirus.
American Cancer Society Invites Study Participants to Help COVID-19 Tracking [ACS] The goal of the app is to better understand the symptoms of COVID-19; understand how fast the virus is spreading in different areas; identify high-risk areas in the country; identify who is most at risk by better understanding symptoms linked to health conditions; and identify the exposure of healthcare workers to COVID-19.
New COVID-19 Cancer Registry Aims to Understand Impact on Patients During Pandemic, Inform Future Care [ASCO] The ASCO Registry is designed to capture not just point-in-time data on patients with cancer, but longitudinal data on how the virus impacts care and outcomes during the COVID-19 pandemic and into 2021.
Coronavirus is forcing breast cancer patients to make tough decisions [Los Angeles Times] “Good oncology has always been about balancing the risks and benefits to a patient,” said Dr. John Glaspy, a breast cancer researcher at UCLA. “Now there is a new risk on that side of the equation, and so we have to recalibrate the balance.”