Onco Actu du 20 septembre 2018

	2.6 Etiologie - Environnement
Factbox: Bayer's Monsanto faces broad U.S. glyphosate litigation [Reuters] At the center of Bayer’s defense is the U.S. government-backed November 2017 Agricultural Health Study. The largest human study on pesticides published, it found no statistically significant link between glyphosate and cancer in about 57,000 U.S. agricultural workers observed since the early 1990s.
	3.3 Prévention - Vaccins
HPV vaccine IS safe: Study finds just 0.001% of those given the life-saving jab proven to protect against several forms of cancer will experience 'serious' side effects [Daily Mail] Researchers at the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) led the study. They checked records of 723,502 people who had the bivalent HPV vaccine - used widely across the world - in the US between 2009 and 2017.
	3.4.1 Chimioprévention - aspirine
A Run of Contrary Results [In the Pipeline] Even if you’re not sure about the situation in all of the cases mentioned above, what we’ve found is that you can (at the very least) run large well-executed trials and not get the results you’d expect, which is certainly something to think about. Science really does march on, and sometimes it steps on things along the way.
	3.7 Prévention - Alcool
Those that fail to learn from history are doomed to repeat it [BMJ] Through Drinkaware, the alcohol industry gains valuable engagement with Public Health England, establishes working relations with PHE staff, and may even secure a seat at the table when other alcohol harm initiatives are planned and executed.
	5.10 Traitements - Essais
Denied ‘life-extending opportunities’: Black patients are being left out of clinical trials amid wave of new cancer therapies [STAT] Reflecting the reluctance of the FDA to force drug makers to enroll more minority patients, and the failure of most manufacturers to do so voluntarily, stark underrepresentation of African-Americans is widespread in clinical trials for cancer drugs, even when the type of cancer disproportionately affects them.
	5.12 Immunothérapies
Liver cancer: UK’s fastest rising cause of cancer death to be tackled [Cancer Research UK] The award will establish a European and UK network of clinicians and scientists specialising in hepatocellular carcinoma (HCC) - the most common primary liver cancer in adults in the UK. The researchers’ aim is to adapt immunotherapy treatments, which have shown an increase in survival in other cancer types, to treat HCC.
	5.12.2 Immunothérapies - CAR-T, thérapies cellulaires
Engineered cell therapy given initial ‘no’ for aggressive adult lymphoma on NHS in England [Cancer Research UK] The treatment’s manufacturer, Novartis, can now submit additional data, which will be reviewed by NICE before a final decision is reached. And there will be more negotiations between the company and NICE about the price of the treatment.
UK rejects adult Novartis CAR-T therapy, after 'yes' in kids [Reuters] NICE said the Swiss drugmaker had offered a confidential discount on the list price of 282,000 pounds ($372,000) per patient, but this was still above the level considered to be an acceptable use of resources.
NICE encourages further discussions on Kymriah for adult lymphoma [NICE] CAR-T is too expensive to recommend as a treatment for adults with lymphoma, NICE says in draft guidance today (19 September).
	5.12.5 Immunothérapies - Pharma
Two Genentech vets reunite at Immune-Onc to help steer its $33M drive to the clinic [EndPoints] The company isn’t divulging much about the program, except that it targets “an immune inhibitory receptor.”
	5.12.8 Immunothérapies - Economie
Merck follows Opdivo’s suit, prices Keytruda in China at half its U.S. tag: report [FiercePharma] Both drugs will likely have a hard time getting onto the country’s national insurance scheme. For one thing, their costs might still be a burden on healthcare expenditure after steep discounts; second, Professor Yilong Wu, who led Opdivo’s Chinese-specific phase 3 trial, has said PD-1s are less predictive of the most suitable patients compared to targeted therapies, meaning the government will likely favor the latter for coverage.
	5.2 Pharma
Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Erdafitinib for the Treatment of Metastatic Urothelial Cancer [Janssen] The NDA submission is based on data from the BLC2001 (NCT02365597) Phase 2 clinical trial, which evaluated the efficacy and safety of erdafitinib in the treatment of adult patients with locally advanced or metastatic UC, whose tumors have certain FGFR alterations.
	5.2.1 Pharma - Partenariats
Takeda blesses a little biotech’s engineered toxin tech for multiple myeloma, triggering a bases loaded home run [EndPoints] One of the most popular targets in multiple myeloma, the partners have been working together to create engineered toxin bodies, bacteria designed to target myeloma cells festooned with CD38 on the surface. And the companies like to spotlight that they’re traveling a separate path from the popular approach that relies heavily on the immune system to drive a therapeutic effect.
	5.2.3 Pharma - économie
Galera reels in $150M to test radiation side effect drug in phase 3 [FierceBiotech] In the study, presented at a meeting of the American Chemical Society, the researchers showed that GC4419, an enzyme mimetic, converts superoxide to molecular oxygen and hydrogen peroxide. And, the researchers think the enzyme’s benefits could go beyond the obvious—in addition to getting rid of superoxide, it increases levels of hydrogen peroxide, which kills cancer cells.
Clarus spearheads a big, $150M raise so Galera can flip the PhIII card on its new drug to treat radiation effects [EndPoints] The “beachhead” indication for Malvern, PA-based Galera is severe oral mucositis, a common side effect in patients with head and neck cancer. Their drug, GC4419, targets the toxic effect of radiation therapy as superoxide swiftly builds up in patients, afflicting the sensitive tissue in their mouths.
	5.3 Traitements - FDA, EMA, NICE...
EMA’s Committee for Medicinal Products for Human Use (CHMP) elects new chair [EMA] Dr Enzmann is a medical doctor. He works for the Federal Institute for Drugs and Medical Devices (BfArM)External link icon in Germany, where he is Head of European and International Affairs. Dr Enzmann has been a member of the CHMP since 2005 and its vice-chair since October 2016.
Harnessing the Power of Precision Medicine – Treating Cancers with Tissue-agnostic Therapies [Cancer Research Catalyst] Treating cancers with tissue-agnostic therapies came to fruition last year, when the U.S. Food and Drug Administration (FDA) approved the immunotherapeutic pembrolizumab for that purpose. Here’s a review of tissue-agnostic cancer therapies that are approved for use or waiting for a decision by the FDA, and some of those that are in development.
	5.3.4 Traitements - AMM (FDA, EMA,...)
Exelixis’ Partner Ipsen Announces Health Canada’s Approval of CABOMETYX® (cabozantinib) Tablets for the Treatment of Adults with Previously Treated Advanced Renal Cell Carcinoma [Exelixis] Approval based on the improvement in overall survival, progression-free survival and objective response rate for CABOMETYX versus everolimus in the phase 3 pivotal METEOR trial.
	5.4 Traitements - Economie
New whitepaper identifies reasons why ICER’s cost-effectiveness analyses are not useful for payers [PhRMA] Not only do ICER’s assessments fail to align with the needs of private payer decision making, but research released earlier this year found that if these assessments were used to determine medicine coverage, it could significantly limit patients’ access to life-changing innovative therapies.
	5.6 ESMO
ESMO 2018 Awardees announced [ESMO] The ESMO Award 2018 is bestowed on Jean-Charles Soria, international lung cancer expert and pioneer in the development of anti-cancer drugs.
	6. Lutte contre les cancers
European cancer research gets £30 million vote of confidence [Cancer Research UK] Scientists in the 5-year funded Accelerator Awards projects will investigate the potential of immunotherapies in treating liver cancer; develop manufacturing methods for CAR-T cell production; track cancer cell evolution; investigate drug resistance in blood cancers; devise a blood test for advanced prostate cancer and find new routes for personalising blood cancer treatment.
	6.10.1 Politiques (USA)
With more immigrant children in detention, HHS cuts funds for other programs — like cancer research [Yahoo News] The rest is being taken from other programs, including $16.7 million from Head Start, $5.7 million from the Ryan White HIV/AIDS program and $13.3 million from the National Cancer Institute. Money is also being diverted from programs dedicated to mental and maternal health, women’s shelters and substance abuse.
	6.11 Patients
Siblings affected by childhood cancer: ‘I’m so proud of what he’s done and how far he’s come’ – James’s story [Cancer Research UK] In part 2 of a 3-part series, James shares the story of his younger brother Max, who was diagnosed with chronic myeloid leukaemia – a type of blood cancer – in May 2003.
	6.6 Publications
‘Journalologists’ use scientific methods to study academic publishing. Is their work improving science? [Science] Its goal: improving the quality of at least a slice of the scientific record, in part by creating an evidence-based protocol for the path from the design of a study to its publication. That medical journals took a leading role isn't surprising. A sloppy paper on quantum dots has never killed anyone, but a clinical trial on a new cancer drug can mean the difference between life and death.
	6.7.1 IA/bioinformatique
Artificial Intelligence in Medicine: 21st Century Resurgence [Informatics Professor] All of this AI in medicine research is impressive. But its advocates will need to continue the perhaps more mundane research of how we make this data actionable and actually act on it in ways that improve patient outcomes. I personally find that kind of research more interesting and exciting anyways.
	6.8 Communication
'Twitter Cheerleaders': A Megaphone for Bad Science [Medscape] Instead of cheerleaders, what we desperately need from physicians are realistic appraisals of what has been accomplished. Clear statements of future cancer goals. Cancer research funding policies that are driven by evidence, and greater honesty daily in the examination room and on the wards.