Onco Actu du 10 décembre 2018

	3.8 Prévention - Alimentation
It’s Time to Study Whether Eating Particular Diets Can Help Heal Us [NY Times] For some cancers in the mouse models, the keto diet alone kept the tumor growth at bay. But for others, like some leukemias implanted into mice, the diet alone accelerated the cancer, while the drug-plus-diet approach slowed it down.
	4.10 Dép., diag. & prono. - FDA, EMA, NICE,...
FDA guide unveils vision for cancer diagnostics [Biopharma Dive] The draft guidance came the same day bipartisan House and Senate lawmakers released updated draft legislation establishing a framework to oversee in vitro clinical tests.
FDA Drafts Guidance on Oncology Companion Diagnostics [RAPS] FDA also recommends developers consider whether there is “detailed understanding” of three factors to support broader companion diagnostic labeling in oncology. These include the mechanism of action of a group or class of oncology therapeutic products, the interaction between the therapeutic products and the companion diagnostic-detected biomarker(s) at the genetic mutation level.
	4.3 Dép., diag. & prono. - Industriels
QIAGEN announces new collaboration to develop companion diagnostic to guide treatment for patients with PIK3CA-mutated advanced breast cancer [Quiagen] Fast-tracking clinical readiness of test to support identification of patients eligible for novel Novartis PI3K inhibitor BYL719 (alpelisib).
	4.5 Dép., diag. & prono. - Colorectal
Don't take my colonoscopy away! [UW Medicine] More than one-fourth of survey respondents strongly objected to losing access to the cancer screening late in life, surprising researchers.
Older adults may be unwilling to give up colorectal screening [Reuters] Nearly 50 percent of vets said age should never be used to decide when to stop screening, the study team reports in JAMA Network Open. And nearly one third said they were opposed to doctors using life expectancy as a factor in deciding whether a patient should get colonoscopy.
	4.7 Dép., diag. & prono. - Col de l'utérus
HPV type 16 or 18 in young women predicts risk of cervical cancer [Karolinska Institutet] The study included over 9,000 normal smear tests from women between the ages of 20 and 60 who took their tests under the Swedish screening programme from 2005 to 2007.
	5. Traitements
More than 260 new drugs to treat cancer? [Anticancer Fund] The study is the latest publication from the Repurposing Drugs in Oncology (ReDO) project, an international collaboration between the Anticancer Fund, based in Belgium, and the US-based GlobalCures.
ReDO_DB: the repurposing drugs in oncology database [ecancer Medical Science] Data from 268 drugs have been included in a database developed by the ReDO project. Summary results are outlined and an assessment of clinical trial activity also described. The database has been made available as an online open-access resource.
	5.10 Traitements - Essais
Targeted Treatment for Rare Digestive Tract Cancers May Extend Survival [NCI] "What I hope comes out of these findings, and what I think is supported by the data, is that patients at any point can be checked to see whether they have the BRAF mutation," Dr. Wainberg said. "If they do, consideration should be given to using these drugs."
	5.12.1 Immunothérapies - partenariats
Bristol-Myers Squibb and Vedanta Biosciences Announce a New Clinical Collaboration to Evaluate OPDIVO (Nivolumab) and VE800 in Patients with Advanced or Metastatic Cancers [BMS] In a range of preclinical models of cancer, including those sensitive and resistant to checkpoint inhibition, VE800 was shown to induce CD8+ T cells, potentiate the immune system’s attack of tumor cells, and significantly amplify the effects of anti-PD-1 therapy. These models support clinical research to explore whether modulating the microbiome with VE800 has the potential to broaden the efficacy of checkpoint inhibitors.
	5.12.5 Immunothérapies - Pharma
AstraZeneca's Imfinzi fails another phase 3 trial, this time in head and neck cancer [FiercePharma] Now, the company will have to pin its hopes on another phase 3 study, dubbed Kestrel, which is testing Imfinzi (durvalumab) and tremelimumab in previously untreated patients and should read out in the first half of next year.
	5.12.6 Immunothérapies - AMM
Roche’s Tecentriq wins key lung cancer approval. Its prize? A showdown with formidable Merck [FiercePharma] If Roche wants to make headway against Merck, it will also have to convince doctors to go with a three-drug regimen that could come along with more side effects than Merck’s duo does, not to mention a higher cost.
Roche's Tecentriq gets first-line lung cancer approval [Biopharma Dive] While a positive step for Roche's I/O ambitions, the label expansion doesn't include patients with EGFR or ALK mutations — a population that could have helped set Tecentriq apart from Keytruda and secure more market share.
Delay brings success for Roche as it finally wins FDA nod for Tecentriq regimen in frontline lung cancer [EndPoints] The drug, which is also used in patients with urothelial carcinoma, generated sales of 320 million Swiss Francs CHF (about $322 million) in the first half of 2018.
	5.2.1 Pharma - Partenariats
AstraZeneca and Cancer Research UK launch Functional Genomics Centre to accelerate the discovery of new medicines [AstraZeneca] Centre of excellence will use CRISPR technology, big data and clinical insights to discover new targets and disease pathways in oncology.
	5.2.2 Pharma - Fusions & Acquisitions
With Tesaro off the block, will Clovis be the next PARP maker to get swallowed up? [FiercePharma] Clovis markets Rubraca, a head-to-head competitor to Zejula, but the drug has struggled to keep up with the PARP competition, particularly AstraZeneca and Merck’s first-to-market Lynparza.
	5.3 Traitements - FDA, EMA, NICE...
FDA will allow observational studies as part of a push for real world evidence, new framework says [EndPoints] Specifically, the agency says its program will evaluate the use of RWE to support changes to labeling about drug product effectiveness, including adding or modifying an indication, such as a change in dose, dose regimen or route of administration; new populations; or the addition of comparative effectiveness or safety information.
	5.7.2 SABCS-divers
EndoPredict is the Only Test to Answer Three Critical Questions [Myriad] “Women with breast cancer, and the clinicians caring for them, will benefit from a single comprehensive solution to answer critical clinical questions about long-term prognosis, the need for adjuvant chemotherapy and the need for extended endocrine therapy.”
Novartis sheds light on liquid biopsies with SOLAR-1 analysis [Biopharma Dive] OLAR-1 is the first breast cancer trial to demonstrate the potential role of liquid biopsies.
New Studies Show MammaPrint® and BluePrint® Tests Provide Greater Clarity Regarding Risk of Breast Cancer Recurrence and Classifications for Treatment [Agendia] BluePrint reclassified 85 percent of tumors identified as HER2-amplified by IHC/FISH to non-HER2 molecular subtype and clarified the biology of HER2 “equivocal” breast cancer.
	5.7.3 SABCS-AACR
Choice of Surgery May Affect Quality of Life for Young Breast Cancer Survivors [AACR] In this study, Dominici and colleagues compared quality of life outcomes in young women across three different surgeries: breast-conserving surgery, unilateral mastectomy, and bilateral mastectomy.
Oxybutynin Decreased Frequency of Hot Flashes, Improved Quality of Life for Breast Cancer Survivors [AACR] The researchers enrolled 150 women who had experienced at least 28 hot flashes per week over more than a month, and who were bothered enough by them to want medication. Sixty-two percent of the women were on tamoxifen or an aromatase inhibitor for the duration of the study.
Lifestyle Intervention Helped Breast Cancer Survivors Lose Weight, and Was Associated with Higher Disease-free Survival Rates [AACR] Janni and colleagues studied a telephone-based lifestyle intervention as part of a larger Phase III study, the SUCCESS C study, which compared disease-free survival in patients with HER2-negative early-stage breast cancer who were treated with one of two chemotherapy regimens.
Exercise Performed During Adjuvant Breast Cancer Treatment May Improve Cardiovascular Function [AACR] In this study, researchers enrolled 375 women who were part of the Energy Balance and Breast Cancer Aspect (EBBA)-II trial. All the women had undergone surgery for stage 1 or stage 2 breast cancer.
	5.7.4 SABCS-essais
Novartis data demonstrates consistent efficacy and tolerability of Kisqali® combination therapy in HR+/HER2- advanced breast cancer in patients with difficult-to-treat visceral disease [Novartis] Subgroup analyses of three pivotal Phase III MONALEESA trials showed Kisqali plus endocrine therapy extended PFS in all patients with and without visceral involvement compared to endocrine therapy alone; consistent with the overall study populations.
	6. Lutte contre les cancers
Encouraging Edge Science through NIH Funding Practices [Stanford] These results are disheartening and consistent with a growing body of scholarship that finds NIH review panels becoming more conservative and risk-averse.
	6.1 Observation
Breast cancer survivors may have lingering mental health effects [Reuters] The study team examined data from 60 previously published studies of women who had survived breast cancer that focused on a variety of psychological issues as well as challenges with cognitive and sexual function one year or more after treatment.
	6.10.1 Politiques (USA)
Despite growing budget, U.S. cancer institute slashes operating budget by 5% [Science] To meet its obligations and prop up success rates, NCI is imposing a 5% cut to 2018 spending levels across all divisions, offices, and centers, Sharpless told his board and the NCI community in a 6 December email. That includes both NCI’s in-house or intramural labs as well as extramural grant programs.
	6.12 Ethique
What These Medical Journals Don’t Reveal: Top Doctors’ Ties to Industry [NY Times] Dr. Howard A. “Skip” Burris III, the president-elect of the American Society of Clinical Oncology, for instance, declared that he had no conflicts of interest in more than 50 journal articles in recent years, including in the prestigious New England Journal of Medicine. However, drug companies have paid his employer nearly $114,000 for consulting and speaking, and nearly $8 million for his research during the period for which disclosure was required.
He Jiankui’s Genetic Misadventure: Why Him? Why China? [Hastings Center] The case of He Jiankui’s transgression, as well as the authoritarian model of sciences, needs to be critically examined from bioethical and particularly socio-ethical perspectives. The moral stakes are high for China and the world.