Onco Actu du 21 février 2019

	1.4 BIOLOGIE - TECHNOS
Beyond Generations: My Vocabulary for Sequencing Tech [Omics! Omics!] Many writers have attempted to divide Next Generation Sequencing into Second Generation Sequencing and Third Generation Sequencing. Personally, I think it isn't helpful and just confuses matters. I'm not the biggest fan of Next Generation Sequencing (NGS) to start with.
	3.1 PRÉVENTION - TABAC
FDA advances framework for enabling the study of new tobacco products as part of the agency’s ongoing commitment to improve the efficiency and effectiveness of tobacco product regulation [FDA] It outlines the kind of information the agency intends to consider in making enforcement decisions regarding the use of investigational tobacco products, including potential human subject protection concerns or other impacts on public health.
	3.3 PRÉVENTION - VACCINS
Cervical cancer 'could become a thing of the past' [NHS Choices] Most cases of cervical cancer (85% in 2012) happen to women in low- or middle-income countries. That's why increasing vaccine coverage and screening is important if we want to eliminate cervical cancer worldwide, not just in wealthy countries.
Preventing cervical cancer: how a screening switch and HPV vaccination should cut cancer rates [Cancer Research UK] An HPV vaccine has been available to girls aged 11-13 in the UK since 2008 as well as some older girls as part of a catch-up programme. And it has led to a dramatic reduction in HPV infection in this age group. Figures released last year by Public Health England suggest there’s been an almost 90% reduction HPV 16 and 18 infections in young women following vaccination.
	4.10 DÉP., DIAG. & PRONO. - FDA, EMA, NICE,...
FDA Draft Guidance on Broader Labeling for Oncology Companion Diagnostics Draws Mixed Reactions [RAPS] Foundation Medicine, however, was also among those that expressed concerns with the unintended consequences relating to the impact on market competition, citing hindered innovation efforts. Another commenter with these concerns was AstraZeneca, which noted that “diagnostics manufacturers may be disincentivized to bring a new test to market if an existing test applies to full class.”
Balancing Benefit and Risk in Medical Device Regulation [FDA Law Blog] By imposing unnecessary clinical testing requirements in some cases, the authors’ proposal would make some beneficial devices less accessible to patients without good reason. As a result, patients would be harmed. The authors tout the benefits of their proposals but fail to address the possible costs.
	4.2 DÉP., DIAG. & PRONO. - GÉNOME
New recommendations say not all women need genetic testing for cancer. Critics say it could cost lives [CNN] Geneticist Mary-Claire King, who discovered the BRCA mutations and their link to breast cancer risk in 1990, said she'd like every woman to be offered complete sequencing of BRCA1 and BRCA2 as part of routine medical care. She called the new recommendations "short-sighted" and "not based on the most recent data" and said they "could cost lives."
BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing [USPSTF] The USPSTF recommends against routine screening, genetic counseling, or genetic testing for women whose family or personal history or ethnicity or ancestry is not associated with an increased risk for potentially harmful mutations in the BRCA1 or BRCA2 genes.
	5.1 TRAITEMENTS - PRÉ-CLINIQUE
Dormant Tumor Cells Can Be Sensitized to Chemotherapy [NCI] In a study published in Nature Cell Biology, a research team led by Dr. Ghajar showed in mice that, by disrupting the relationship between breast cancer cells that had spread to the bone and the normal cells surrounding them, they could make the hidden cancer cells sensitive to treatment. This was true whether the cancer cells were dividing or dormant.
	5.10 TRAITEMENTS - ESSAIS
Novel antibody-drug conjugate shows promise against metastatic triple-negative breast cancer [Mass. General Hospital] The MGH-led study – part of a larger, open-label clinical trial of sacituzumab govitecan against several types of advanced cancer – enrolled 108 patients with triple-negative breast cancers, all of whom had received several prior treatments, between June 2013 and February 2017. Treatment with sacituzumab govitecan produced a treatment response in 33 percent of patients, and responses lasted an average of 7.7 months.
Trial publishes data on preventing blood clots in cancer patients [ecancer News] While a significant reduction in risk of venous thromboembolism was observed during the on-treatment period, the study did not find a significant impact on its primary outcome of venous thromboembolism during the first 180 days, during which time many patients came off the study drug to a similar extent in both the intervention and placebo arms.
Immunomedics Announces Publication of Triple-Negative Breast Cancer Data with Sacituzumab Govitecan in the New England Journal Of Medicine [Immunomedics] Publication Highlights Safety and Efficacy Profile of Sacituzumab Govitecan Addressing High Unmet Need in Metastatic Triple-Negative Breast Cancer.
New “Smart Drug” Shows Promise for Metastatic Triple-Negative Breast Cancer [Columbia University] The drug is a fusion of an antibody that recognizes a protein expressed by breast cancer cells known as trop2 and the metabolite of an established chemotherapy drug (irinotecan), SN-38. The antibody delivers SN-38 directly to the cancer cell.
	5.12 IMMUNOTHÉRAPIES
Study finds melanoma brain metastases are immunosuppressive with treatment-resistant metabolism [MD Anderson Cancer Center] The team’s analysis showed that genes involved in oxidative phosphorylation were upregulated in brain metastases, leaving those tumors reliant on that form of metabolism. Previous research by their team and others has also shown that oxidative phosphorylation promotes resistance to immunotherapies and targeted therapies.
Study Finds Way to Potentially Improve Immunotherapy for Cancer [Cedars-Sinai] The study in laboratory mice found that the drug dasatinib, which is FDA-approved to treat certain types of leukemia, greatly enhances responses to a form of immunotherapy that is used against a wide range of other cancers.
	5.12.1 IMMUNOTHÉRAPIES - PARTENARIATS
Torque Announces Clinical Trial Collaboration with Merck [Torque] Phase 1/2 combination clinical trial evaluating Torque’s Deep IL-15 Primed T Cells (TRQ-1501) and KEYTRUDA® (pembrolizumab) for the treatment of multiple cancer indications.
	5.12.2 IMMUNOTHÉRAPIES - CAR-T, THÉRAPIES CELLULAIRES
Allogene Therapeutics to build out facility for allogeneic CAR T treatments [Fierce Pharma] While the two FDA-approved cancer CAR T treatments, Novartis’ Kymriah and Gilead's Yescarta, are made from autologous T cells taken directly from patients, Allogene is investigating the use allogeneic T cells that come from donors and can be stored for so-called “off the shelf” use.
Allogene Therapeutics Enters Lease to Build Manufacturing Facility to Develop and Commercialize Allogeneic CAR T (AlloCAR T™) Therapies [Allogene] “This manufacturing facility and continued build out of our in-house process development and characterization capability will allow us to advance manufacturing and secure the supply of our AlloCAR T™ therapies.”
Retraction Note: A homing system targets therapeutic T cells to brain cancer [Nature] The authors cannot confirm at present the results in the affected figures and thus would wish to retract the paper.
Nature Retracts Paper on Delivery System for CAR T Immunotherapy [The Scientist] Starting last October, a few weeks after the paper was posted online, comments about potential image manipulation in the article began to appear on PubPeer, and the issue quickly caught the attention of scientists on social media.
	5.12.4 IMMUNOTHÉRAPIES - ESSAIS
Merck's Keytruda hits the skids in pivotal trial, putting its liver cancer nod at risk [Fierce Pharma] When Keytruda won that nod late last year, researchers noted that patients with advanced HCC have few options. That’s one reason why a 17% response rate was enough to persuade the FDA to award Keytruda its accelerated approval.
After accelerated approval, Merck's Keytruda fails in liver cancer study [Biopharma Dive] The clinical failure poses a broader question of whether the FDA would issue a warning or caution against use of Keytruda as a second-line treatment for HCC.
	5.12.5 IMMUNOTHÉRAPIES - PHARMA
FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) Monotherapy for Third-Line Treatment of Patients with Advanced Small Cell Lung Cancer (SCLC) [Merck] This sBLA, which is seeking accelerated approval for this new indication, is based on data from the SCLC cohorts of the Phase 2 KEYNOTE-158 and Phase 1b KEYNOTE-028 trials.
	5.2 PHARMA
Turbulent times for Xencor as FDA slaps hold on AML bispecific [Fierce Biotech] Xencor didn’t have the best start to 2019—in January, its partner Novartis returned the rights to a bispecific antibody it had licensed as part of a 2016 deal worth up to $2.41 billion. Now, a second asset from that deal, in development for acute myeloid leukemia (AML), has hit a snag in the form of a partial clinical hold from the FDA.
Agios Announces FDA Acceptance of Supplemental New Drug Application for TIBSOVO® (ivosidenib) for the Treatment of Patients with Newly Diagnosed Acute Myeloid Leukemia with an IDH1 Mutation Not Eligible for Standard Therapy [Agios] TIBSOVO® is a first-in-class, oral, targeted inhibitor of mutant IDH1. The sNDA submission is based on results from the untreated AML patients from the Phase 1 dose-escalation and expansion study of ivosidenib in patients with newly diagnosed AML ineligible for standard treatment.
Xencor Announces Partial Clinical Hold on Phase 1 Study of XmAb14045 [Xencor] One patient experienced cytokine release syndrome (CRS) after their first dose, the treatment of which was complicated by the patient's decision to withdraw care. One patient developed acute pulmonary edema following several doses of XmAb14045.
Deaths spur partial hold for Xencor’s CD3 bispecific for leukemia, partnered with Novartis in $2.5B deal [EndPoints] Now you can expect plenty of more questions about what kind of safety issues these bispecifics pose as developers race each other to the finish line. That could be especially troubling for Xencor, particularly after J&J dropped it drug talacotuzumab (JNJ-56022473/CSL362) for acute myeloid leukemia in 2017.
	5.4 TRAITEMENTS - ECONOMIE
Drug Prices Based On Success Could Speed Up Cancer Patients' Treatment [Cancer Research UK] This flexible way of paying for cancer medicines, known as outcome-based payment (OBP), would mean a drug’s price could be adjusted based on how well it works for patients in the NHS. For example, the NHS could pay the company less for a drug that doesn’t work as well as expected, but more if it does.
	6. LUTTE CONTRE LES CANCERS
Report Says Health Systems Are Key to Improving Cancer Outcomes in the United States [ACS] Latest in American Cancer Society series outlining blueprint for cancer control.
Minimizing the burden of cancer in the United States: Goals for a high‐performing health care system [CA: A Cancer Journal for Clinicians] Indeed, one of the most pressing issues in American medicine is how to ensure that all populations, in every community, derive the benefit from scientific research that has already been completed. Addressing these questions from the perspective of health care delivery is necessary to accelerate the decline in cancer mortality that began in the early 1990s.
	6.10 POLITIQUES
A new law was supposed to protect South Africans' privacy. It may block important research instead [Science] Law may prevent researchers from reanalyzing data and samples in big databases.
	6.2 IMPLANTS MAMMAIRES
Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) – updated information [Swissmedic] Based on the information currently available, Swiss Plastic Surgery recommends using smooth implants rather than textured implants where permitted by the clinical situation.
	6.6 PUBLICATIONS
Large Teams and Small Ones in Science [In The Pipeline] When you look at the set of most-disruptive papers, they are much more likely to have been smaller-than-median teams, for any given scientific discipline. This distribution also holds for the patent databases, and even for code and routines published on GitHub.
	6.7 DMP, BIG DATA & APPLIS
ASCO Seeks Applicants for Research Grants to Use Data from CancerLinQ Discovery [ASCO] Oncology society will provide early and mid-career professionals with real-world data to inform their cancer research.
NHSX: new joint organisation for digital, data and technology [Gov.uk] The unit will take forward digital transformation in the NHS, allowing patients and staff to benefit from the latest digital systems and technology.
	6.7.1 IA/BIOINFORMATIQUE
New AI able to identify and predict the development of cancer symptom clusters [University of Surrey] “This is the first use of Network Analysis as a method of examining the relationships between common symptoms suffered by a large group of cancer patients undergoing chemotherapy. The detailed and intricate analysis this method provides could become crucial in planning the treatment of future patients – helping to better manage their symptoms across their healthcare journey.”
	6.9 CONTROVERSES
Facebook’s controversies now extend to health and medicine issues [STAT] It all started last week when journalists reported that Facebook allows advertisers to target users who have demonstrated interest in anti-vaccine information — and that anti-vaccine ads promoted on the site have been viewed millions of times.
U.S. Investigating Johnson & Johnson Over Baby Powder’s Safety [NY Times] Johnson & Johnson, which faces around 13,000 lawsuits in which its body powders are blamed for causing ovarian cancer or mesothelioma, has stood by the safety of its products. It said on Wednesday that “decades of independent tests by regulators and the world’s leading labs prove Johnson & Johnson’s baby powder is safe and asbestos-free, and does not cause cancer.”