Onco Actu du 27 novembre 2018

	1. Biologie
Science Snaps: spotting lung cancers’ ‘crime hotspots’ [Cancer Research UK] Their aim is to understand how the body’s immune system responds to cancer as it evolves and develops. “Cancer cells don’t live alone, and we need to understand how they interact and the evolutionary pressure they’re under, to be able to stay one step ahead and anticipate cancer’s next move,” she says.
	1.4 Biologie - Technos
An outsider claimed to make genome-editing history — and the world snapped to attention [STAT] In 2010, a Rice University graduate student named He Jiankui published a paper describing the nitty-gritty details of a then-arcane bacterial immune system called CRISPR. It was well before scientists unlocked the knowledge that CRISPR could be used to manipulate DNA with a precision and ease that other genome editors lacked. Now, just eight years later, and after returning to his native China, He has burst onto the global stage in the most spectacular way.
Chinese university to investigate after academic claims to have edited twins’ genes [Reuters] The Southern University of Science and Technology in the southern Chinese city of Shenzhen said it had been unaware of the research project and that the academic, He Jiankui, had been on leave without pay since February.
	4.2 Dép., diag. & prono. - Génome
Gene test predicts likelihood of stomach or oesophageal cancer relapse [Institute of Cancer Research] The next step is to validate these findings in patients treated with the most common type of chemotherapy, called Docetaxel-OxaliplatinFluorocil (FLOT) chemotherapy.
	5.10 Traitements - Essais
Tailored Radiation to Treat Brain Metastases Reduces Impact on Cognitive Function [NCI] The results confirm earlier studies that had suggested the hippocampus is highly sensitive to radiation, he said. They also verify that, by sparing the hippocampus, “we can achieve the objectives of protecting patients’ cognitive function, effectively managing their brain metastases, and improving neurological symptoms.”
	5.12.3 Immunothérapies-combinaisons
CheckMate-451: Bristol-Myers’ Opdivo — plus Yervoy — fails PhIII combo lung cancer study, the latest in a series of setbacks [EndPoints] The failure follows close on the heels of another Phase III flop for their CheckMate-331 study, where Opdivo was unable to beat the standard of care for treating second-line small cell lung cancer.
Bristol-Myers Squibb says cancer drug combination fails late-stage trial [Reuters] Shares of the company fell 2.6 percent to $51.34 after the bell on Monday.
Bristol-Myers Squibb Announces CheckMate -451 Study Did Not Meet Primary Endpoint of Overall Survival with Opdivo Plus Yervoy Vs. Placebo as A Maintenance Therapy in Patients with Extensive-Stage Small Cell Lung Cancer After Completion of First-Line Chemotherapy [BMS] The Company will work with study investigators on the future publication of these results.
	5.12.8 Immunothérapies - Economie
Novartis CEO says four factors can help with pricing and payment of lifesaving cell and gene therapies [CNBC] I recognize that the industry is divided on this approach. This is because for companies that do not have a strong record of real innovation or are focused only on providing patients with incremental improvements, a value-based model creates additional risk.
	5.2 Pharma
AbbVie, Roche aim to face down Pfizer with Venclexta’s move into AML arena [FiercePharma] If the companies want to see big contributions from the new AML indication, Venclexta will have to get past competitors from companies including Pfizer and Novartis.
On a roll with FDA approvals, Pfizer doubles down in AML with Daurismo nod [FiercePharma] Those cancer sales will be key to Pfizer as generics bite into one of its top sellers, Lyrica. Copycats are expected in December or in the middle of next year. And meanwhile, the pharma giant is hoping to eventually grab additional indications for Daurismo, too.
	5.3.4 Traitements - AMM (FDA, EMA,...)
Loxo, Bayer drug for cancers driven by rare mutation gets U.S. nod [Reuters] The mutation, known as TRK fusion, occurs in no more than 3,000 Americans each year, or less than 1 percent of patients with solid tumor cancers, according to Bayer.
Shattering an old record, FDA quickly OKs pioneering, site-agnostic cancer drug larotrectinib from Loxo and Bayer [EndPoints] Specifically there were 50 patients — 43 adults and 12 children and adults with TRK fusion cancer — with 12% complete and 64% partial responders. That’s a high rate of success and it qualified for a priority review at an agency that likes to press the metal on new drug OKs — particularly for cancer.
Genetic Medicine: FDA OKs 2nd Cancer Drug that Targets DNA, not Tissues [Xconomy] Basket trials are a fairly new phenomenon in oncology and have their share of skeptics. This essay in the New England Journal of Medicine in 2015, for instance, warned that the small number of patients in each arm of a basket study could lead to “over-interpretation” of the results from any one arm. Loxo’s results are an example of relying on those types of data.
FDA Approves Vitrakvi® (larotrectinib), the First Ever TRK Inhibitor, for Patients with Advanced Solid Tumors Harboring an NTRK Gene Fusion(1,2) [Loxo Oncology] TRK fusion cancer occurs across a broad range of tumor types with varying frequency in both adult and pediatric patients. It is diagnosed through the identification of NTRK gene fusions using specific tests, including those that employ next-generation sequencing (NGS) and fluorescence in situ hybridization (FISH).
Loxo And Bayer's Amazing Drug Has An Expensive Price [Forbes] In an oral capsule form for adults, Vitrakvi will have a wholesale acquisition cost of $32,800 a month for a 30-day supply of 100 milligram capsules. That's $393,600 annually.
FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor [FDA] Vitrakvi (larotrectinib) is indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity and have no satisfactory alternative treatments or that have progressed following treatment.
FDA approves ‘precision medicine’ drug for different cancers with same mutation [Washington Post] The action is called a milestone, but many challenges remain.
Kyowa Kirin Announces POTELIGEO® Receives Marketing Authorisation in Europe for the Treatment of Mycosis Fungoides and Sézary Syndrome [Kyowa Kirin] POTELIGEO will be the first biologic agent targeting CCR4 to be available for patients in Europe.
	5.8 ASH
ASH 2018: A Guide to the Latest for Blood-Borne Cancers and More [Xconomy] Using the previews of major studies that were released earlier this month, we’ll dive into five of the disease areas under scrutiny at ASH this year—leukemia/lymphoma, multiple myeloma, beta-thalassemia, hemophilia, and sickle cell disease—and give you plenty of background in case you haven’t been following each one closely.
	5.8.2 ASH - Pharma
AstraZeneca presents clinical research advances for blood cancer patients at 2018 American Society of Hematology Annual Meeting [AstraZeneca] 27 scientific presentations, including long-term data from Calquence in mantle cell lymphoma and updated early-phase trial results in chronic lymphocytic leukaemia.
	5.8.4 ASH - CAR T
Fred Hutch at ASH: Press briefing on a combination CAR T-cell therapy, other CAR T insights, CRISPR for blood disorders, and more [Fred Hutch] This year’s ASH press program will include a press briefing, “CAR T-Cell Therapies: New Research and Updates from Pivotal Trials,” featuring Fred Hutch research on a combination therapy for chronic lymphocytic leukemia.
	6.1 Observation
Cancer early detection rates stall as patients 'too embarrassed' to trouble their GP with symptoms [The Telegraph] The Health Foundation report said more than a fifth of patients are worried about wasting their doctor’s time. Meanwhile nearly half put off checking out symptoms because of difficulty securing an appointment.
Cancer care: England still lagging behind the best [BBC News] The review by the Health Foundation of the government's record between 1995 and 2015 said that despite four strategies setting ambitious goals, the NHS was still lagging behind the best. It said if services were improved, 10,000 lives could be saved each year.
	6.2 Implants mammaires
Australian database seeks to identify breast implant risks [The Guardian] Work on building the database began about four years ago. Neil said it was still being refined and it would take a while for patterns to emerge.
Breast implants study reveals serious safety concerns [The Guardian] Global investigation finds lack of clinical oversight and failure to track long-term outcomes.
Rare cancer linked to breast implant used by millions of women [The Guardian] Figures suggest at least 615 cases worldwide of lymphoma related to textured implants.
	6.6 Publications
European funders detail their open-access plan [Science] The guidance aims to explain practicalities and “sets things straight,” said Robert-Jan Smits, the European Commission’s OA envoy and one of the creators of Plan S, at a news briefing in London today. Referring to the often-acrimonious debate that has emerged since Plan S was released on 4 September, he admitted to a “lack of clear communication” from his side.
Do You Have Concerns about Plan S? Then You Must be an Irresponsible, Privileged, Conspiratorial Hypocrite [The Scholarly Kitchen] After all, as Science Europe’s Robert-Jan Smits puts it: “Why do we need Plan S? Because researchers are irresponsible.” There you have it. The freedom to choose how to publish isn’t for everyone; it’s only for those who are “responsible” — which is to say, those who agree with Plan S.
	6.7.3 DMP
Patient-Led Data Sharing — A New Paradigm for Electronic Health Data [NEJM Catalyst] The pieces are in place for a truly disruptive shift in how patients can access and use their own clinical data to improve their health, increase record portability, enable the use of novel third-party applications, and facilitate participation in research studies.
	6.9 Controverses
Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices [FDA] In making these reviews, where appropriate, we want to rely on modern safety and performance criteria. At the same time, we’re going to pursue additional actions that will allow the FDA to retire outdated predicates, especially in cases where we’ve seen safer or more effective technology emerge.
FDA plans overhaul of decades-old medical device system [STAT] Some of the reforms proposed by the FDA could take years to implement, in some cases requiring new guidelines and regulations for manufacturers. And the most substantive changes could require action by Congress.
RCS statement on medical device regulation [Royal College of Surgeons] The RCS believes that all new surgical procedures and devices should be registered, with related data collected in the appropriate national audits, before they are routinely offered to patients. All implantable devices should be registered and tracked to monitor efficacy and patient safety in the long-term. This requires Government funding and support, and potentially national guidelines on the introduction of new procedures and technologies.