Onco Actu du 8 janvier 2019

	1. BIOLOGIE
New insights into a rare type of cancer open novel avenues of study [Karolinska Institutet] Undifferentiated uterine sarcoma is a very rare but extremely aggressive cancer type. It can be divided into four groups with different characteristics of clinical importance - a new study at Karolinska Institutet reveals. The results, published in the journal Clinical Cancer Research, also show that the survival rate of patients with a certain type of tumour is better than predicted.
	3.1.1 PRÉVENTION - TABAC - E-CIGS
Flavored tobacco use rising in U.S. kids as vaping takes off [Reuters] Among young people who use tobacco, the proportion using flavored products dropped from 69.4 percent in 2014 to 57.7 percent in 2016 but then rebounded to 63.6 percent in 2017.
	4.10 DÉP., DIAG. & PRONO. - FDA, EMA, NICE,...
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations [FDA] Our digital health team has been working with patients, providers, the nine diverse companies participating in the Pre-Cert pilot program and other stakeholders to build this framework. Today we’re issuing three documents that, together, launch us into the next phase of the agency’s vision of Pre-Cert.
	4.5 DÉP., DIAG. & PRONO. - COLORECTAL
Hopkins Researchers ID New Biomarker for Colorectal Cancers [Johns Hopkins] The findings demonstrate that and lactosylceramide could be added to a growing list of biomarkers such as NMT1, APC and TP53 in blood tests for colorectal or potentially other cancers to increase their success at early detection of disease.
	4.7 DÉP., DIAG. & PRONO. - COL DE L'UTÉRUS
Mayo researchers find ‘unacceptable low’ cervical cancer screening rates [May Clinic] Less than two-thirds of women ages 30 to 65 were up-to-date with cervical cancer screenings in 2016. The percentage is even lower for women ages 21 to 29, with just over half current on screenings. Those figures are well below the 81 percent screening compliance rate self-reported in the 2015 National Health Interview Survey.
	5.12 IMMUNOTHÉRAPIES
Could Immunotherapy Offer a Cure for Cancer? [NY Times] The new book by Charles Graeber, “The Breakthrough: Immunotherapy and the Race to Cure Cancer,” artfully traces the history of old and new developments that may have — finally — resulted in an actual cure for the most dreaded of all diseases.
	5.12.1 IMMUNOTHÉRAPIES - PARTENARIATS
Sanofi pays Regeneron $462M to exit immuno-oncology R&D pact [Fierce Biotech] Sanofi has the option to opt in to the two clinical assets—BCMAxCD3 and MUC16xCD3 bispecific programs—when they achieve proof of concept or further funding is required. Regeneron will spend up to $70 million to develop the BCMAxCD3 drug in multiple myeloma and as much as $50 million on the MUC16xCD3 bispecific in mucin-16 expressing cancers.
JPM19: Sanofi zeroes in on bispecifics in reworked Regeneron deal [Biopharma Dive] The companies' partnership has already yielded an approved cancer immunotherapy in Libtayo, which will be unaffected by the restructuring. Sanofi, though, indicated it aims to develop its early-stage immuno-oncology pipeline more independently, excepting the two bispecific therapies selected.
bluebird bio and Inhibrx Announce Collaboration to Research, Develop and Commercialize CAR T Cell Immunotherapies [bluebird bio] Inhibrx is a clinical-stage biotechnology company focused on developing a broad pipeline of novel biologic therapeutic candidates. Inhibrx utilizes diverse methods of protein engineering to address the specific requirements of complex target and disease biology, including its proprietary sdAb platform.
	5.12.2 IMMUNOTHÉRAPIES - CAR-T, THÉRAPIES CELLULAIRES
Novartis building out cell and gene therapy platform that'll lead the pack, CEO promises [Fierce Pharma] The company is partnering with groups around the world to produce its cell therapy Kymriah, a complicated process that the Big Pharma has struggled with early on.
TCR deal spree intensifies as Roche commits up to $2B in Adaptive Biotech to develop personalized cancer drugs [EndPoints] Unlike CAR-T cells that can recognize abnormal proteins expressed on the surface, TCRs can recognize tumor-specific proteins on the inside of cells. That makes CAR-T therapies more amenable to blood cancers, while TCR therapies-in-development have potential across multiple tumors.
	5.12.6 IMMUNOTHÉRAPIES - AMM
Atezolizumab Approved for Initial Treatment of Metastatic Lung Cancer [NCI] Because the efficacies of the atezolizumab and pembrolizumab combinations have not been compared directly, “it’s going to be difficult to know how to pick,” Dr. Wakelee said. One point of difference between the two combinations is potential side effects.
	5.2 PHARMA
AstraZeneca announces organisational changes [AstraZeneca] "I am delighted to welcome José to AstraZeneca. An outstanding scientific leader in Oncology, José’s research and clinical achievements have led to the development of several innovative medicines, and he is an international thought leader in cancer care and clinical research."
Top Cancer Doctor, Forced Out Over Ties to Drug Makers, Joins Their Ranks [NY Times] Dr. Baselga, 59, is an expert in breast cancer research and played a key role in the development of Herceptin by Genentech, a subsidiary of Roche.
AstraZeneca picks Baselga to lead oncology R&D in growth plan [Reuters] Baselga, who also worked as chief of hematology/oncology at the Massachusetts General Hospital Cancer Center and has been a professor at Harvard Medical School, said his position at AstraZeneca was newly created and brought discovery through to late-stage development chain into one unit.
	5.2.2 PHARMA - FUSIONS & ACQUISITIONS
Eli Lilly Makes an $8B Cancer Genetics Bet with Loxo Acquisition [Xconomy] Lily’s acquisition of Loxo follows other recent high-profile buyouts in the oncology space, notably the $5.1 billion acquisition of Tesaro by GlaxoSmithKline announced last month, and the Bristol-Myers Squibb announcement last week that it pay $74 billion to buy Celgene.
JPM 2019: Bristol-Myers, Celgene CEOs trot out detailed case for $74B megadeal [Fierce Pharma] At a fireside chat Monday, Bristol-Myers CEO Giovanni Caforio said the tie-up will create the leading immuno-oncology player in solid tumors and hematology, plus a top five player in immunology and inflammation.
JPM19: Lilly to buy Loxo Oncology for $8B [Biopharma Dive] As for the broader oncology market, Leerink analyst Andrew Berens expected shares of other cancer companies to benefit from the news, namely Blueprint Medicines, Clovis Oncology, Epizyme and Agios Pharmaceuticals.
Lilly Announces Agreement To Acquire Loxo Oncology [Lilly] Loxo Oncology is developing a pipeline of targeted medicines focused on cancers that are uniquely dependent on single gene abnormalities that can be detected by genomic testing.
Eli Lilly to buy Loxo Oncology for $8 billion in huge bet on cancer genetics [STAT] Even if Loxo never starts work on another drug, the deal already means two more for Lilly: a follow-up to Vitrakvi, for patients who become resistant to that drug, and a new molecule for patients who have become resistant to AbbVie’s Imbruvica or similar medicines used to treat some leukemias and lymphomas. That could be a substantial market.
	5.3 TRAITEMENTS - FDA, EMA, NICE...
Human medicines: highlights of 2018 [EMA] In 2018, EMA recommended 84 medicines for marketing authorisation. Of these, 42 had a new active substance which has never been authorised in the EU before. Many of these medicines represent a significant improvement in their therapeutic areas; they include medicines for children, for rare diseases and advanced therapies.
All seven of the FDA’s recent commissioners agree it should be independent — but not on how to accomplish it [STAT] “This is really a plea to reduce the short-term political influence in favor of long-term policy,” said Dr. Robert Califf, FDA commissioner from 2016 to 2017, and a co-author of the papers.
	6.1 OBSERVATION
How important is medical care to life expectancy gains? [Healthcare Economist] There is a stronger case that personal medicine affected health in the second half of the 20th century than in the preceding 150 years. Big medicine brought big benefits, especially to the older population, at big cost. In contrast, much of the health advance prior to the mid-20th century was a result of public health improvements, perhaps sometimes supported by physicians but not resulting from clinical therapies for individual patients.
	6.10 POLITIQUES
NHS 10-year plan: clear commitments for cancer, but no long-term fix for staff shortages [Cancer Research UK] The NHS is about people, and NHS cancer services are already struggling under pressure because they don’t have the staff they need. This problem is only going to get worse as more and more people develop cancer in the future.
Cancer Research UK cautiously optimistic over the NHS England Long Term Plan [Cancer Research UK] There needs to be a detailed plan to address staff shortages in areas such as radiology, pathology, endoscopy and oncology – backed up by extra investment through training and education budgets. Only then can the health service get close to achieving the Prime Minister’s ambition of 3 in 4 people diagnosed at an early stage of cancer by 2028.
	6.5 MÉDECINES ALTERNATIVES/COMPLÉMENTAIRES
China authorities arrest 18 at TCM firm after cancer case sparks outcry [Reuters] Chinese people expressed anger over the case and shared their own experiences about how the company overstated the efficacy of its treatments. Some criticized Quanjian for operating a pyramid scheme for sales.
	6.7 DMP, BIG DATA & APPLIS
Here’s what scientists searched for in 2018: AI is up, stress is down [Nature] ‘Cancer’, ‘blockchain’ and ‘big data’ were among the top search terms in a major science database in 2018.
	6.7.1 IA/BIOINFORMATIQUE
High-performance medicine: the convergence of human and artificial intelligence [Nature Medicine] Despite all the promises of AI technology, there are formidable obstacles and pitfalls. The state of AI hype has far exceeded the state of AI science, especially when it pertains to validation and readiness for implementation in patient care. A recent example is IBM Watson Health’s cancer AI algorithm (known as Watson for Oncology).
	6.9 CONTROVERSES
Latest trial in J&J talc litigations gets under way in California [Reuters] A lawyer for co-defendant Imerys Talc America, a unit of French Imerys SA, told the jury the evidence would show there is no asbestos in its talc and that Leavitt’s disease was not caused by its product.