Onco Actu du 7 décembre 2017

	2.8 Etiologie - Contraceptifs, THS
Newer birth control pills still modestly raise risk of breast cancer [STAT] Studies of older birth control pills have shown “a net cancer benefit” because of lowered risk of cancer of the colon, uterus and ovaries despite a raised breast cancer risk, said Mia Gaudet, a breast cancer epidemiologist at the American Cancer Society.
Even Low-Dose Contraceptives Slightly Increase Breast Cancer Risk [NPR] That may sound scary. But Morch and other doctors say it's important to consider how that additional risk translates in terms of actual cases of breast cancer. The illness is fairly rare among women in the age group studied.
Study confirms higher breast cancer risk with hormone-based contraception [Reuters] “If you compare this to other risks, such as obesity and being overweight, there’s more of a risk with obesity than if you take a few years of oral contraceptives.”
Birth Control Pills Still Linked to Breast Cancer, Study Finds [NY Times] The new paper estimated that for every 100,000 women, hormone contraceptive use causes an additional 13 breast cancer cases a year. That is, for every 100,000 women using hormonal birth control, there are 68 cases of breast cancer annually, compared with 55 cases a year among nonusers.
All forms of hormonal contraception carry breast cancer risk, study finds [The Guardian] In a commentary with the study, Professor David Hunter, of the Nuffield Department of Population Health, said that the small risks of the pill needed to be set against the benefits, which included not only preventing an unwanted pregnancy but also a “substantial reductions in the risks of ovarian, endometrial and colorectal cancers in later life”.
	4.13 Dép., diag. & prono. - Peau
Looking Below The Locks: Teaching Hairdressers To Spot Melanoma [NPR] In a report published Wednesday in JAMA Dermatology, researchers from the University of Southern California and University of Colorado Denver detailed their efforts to educate hairdressers with a training video.
	5. Traitements
An old drug for alcoholism finds new life as cancer treatment [Science] The drug could help extend the lives of patients with metastatic cancer—it’s already shown evidence of doing so when combined with chemotherapy in a small lung cancer trial. Bartek and collaborators are now launching trials to test a disulfiram-copper combo as a treatment for metastatic breast and colon cancers and for glioblastoma, a type of brain cancer.
The OlympiAD trial: who won the gold? [ecancermedicalscience] For a 2.8 months benefit in PFS without benefit in OS observed in an unblind trial against a weak comparator, are we ready as a society to pay $100,000 per patient?
	5.12 Immunothérapies
There are 2,004 cancer immunotherapies crowding into the pipeline. Now what? [EndPoints] “More and more of these studies are just being designed locally; there’s an appearance of overcrowding,” he says. “I wonder if these small studies are going to make a contribution.”
Landscape of Immuno-Oncology Drug Development [Cancer Research Institute] The Clinical Accelerator team presents an unbiased, neutral, scientifically curated, and timely updated analysis based on information collected from numerous trusted and publicly available sources.
	5.12.1 Immunothérapies - partenariats
Juno inks deals with Eli Lilly, the Hutch as it looks to leapfrog leaders on BCMA [EndPoints] The drug, which inhibits Notch signaling, has already been studied in hundreds of patients. The big idea here is that the drug can amp up levels of BCMA on the surface of multiple myeloma cells, leaving them as a better target for its BCMA-targeting CAR-Ts.
	5.12.2 Immunothérapies - CAR-T
Biotech veteran Gilman is back, heading up next-gen CAR-T startup Obsidian [FierceBiotech] In a nutshell, it is based on two elements: a biological “cassette” that is installed in the gene vector and a small-molecule drug that controls the activity of the cassette and, as a consequence, the activity of the modified gene sequence.
Looking for the next big breakthrough in CAR-T, Mike Gilman debuts Obsidian with $49.5M round [EndPoints] If you can regulate proteins, you can accomplish three things that limit CAR-Ts today, all of which revolve around the current spotlight in the clinic: Controlling the way this personalized therapy is dosed so you get maximum effect with manageable risks.
	5.2 Pharma
Clovis' Rubraca takes aim at Lynparza, Zejula with priority review for new use [FiercePharma] Unlike some other PARP studies, Ariel3 didn’t limit itself to patients who’d responded completely to platinum chemo.
	5.2.1 Pharma - Partenariats
Genomic Health Announces Research Collaboration with Janssen Pharmaceuticals to Evaluate the Oncotype DX® Genomic Prostate Score™ Test for Potential Drug Development [PR Newswire] Additionally, Genomic Health Makes a $4M Equity Investment in Biocartis, Furthering Collaboration to Develop an IVD version of the Oncotype DX Breast Recurrence Score® Test.
	5.3 Traitements - FDA, EMA, NICE...
FDA Launches Predictive Toxicology Roadmap to Enable Advances in Toxicity Testing [FDA Voice] FDA will be holding a public workshop as part of our efforts to foster opportunities for sharing ideas, discussing new technologies, and highlighting collaborations that are developing and testing new methods.
Cancer R&D tips the scales at the FDA as active INDs climb to record high [EndPoints] Breakthrough therapy designations, with their promise of speedy regulatory responses, have proven to be immensely popular. There have been 529 requests and 192 were granted. Fifty-one percent of that figure on OKs are for oncology and hematology — with a big emphasis on blood cancers — which represents the oncology division’s decision to embrace BTDs under the guidance of Richard Pazdur at a time cancer drug research has boomed.
	5.3.4 Traitements - AMM (FDA, EMA)
FDA Approves Alectinib For Initial Treatment of ALK-Positive Lung Cancer [NCI] The new FDA approval is based on results from a phase 3 clinical trial, called ALEX, of 303 patients with ALK-positive NSCLC who were randomly assigned to receive alectinib or crizotinib (Xalkori®), the first ALK inhibitor approved to treat ALK-positive NSCLC.
	5.4 Traitements - Economie
NICE issues early 'no' votes on Roche's RoActemra, Novartis' Rydapt [FiercePharma] With Rydapt, the committee concluded that clinical trial evience “did not reflect how the drug would be used in clinical practice,” NICE said, adding that “uncertainty and problems with the economic model” precluded an endorsement.
Novartis nets first acute myeloid leukaemia approval in Canada, but NICE says no [Pharmafile] Health Canada’s approval covers the use of Rydapt in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy. The decision was based on Phase 3 trial data which demonstrated that patients who took the drug in addition to chemotherapy lived for longer than those receiving chemotherapy alone.
	5.6 ESMO
ESMO IO 2017 Press Release: First Line Combination Therapy Improves Progression-Free Survival In Advanced Lung Cancer [ESMO] IMpower150 enrolled 1,202 patients who were randomised to one of three arms: A) chemotherapy plus atezolizumab; B) chemotherapy plus atezolizumab plus bevacizumab; or C) chemotherapy plus bevacizumab.
Looking for a come-from-behind win, Roche touts its pivotal success for Tecentriq combo in front-line lung cancer [EndPoints] Roche faces a big challenge on the checkpoint front. Top execs believe that Tecentriq is key to the company’s ability to replace revenue lost as its big three franchise drugs see generic competition build up and carve away revenue.
Roche drug cocktail doubles chance of holding lung cancer at bay [Reuters] Roche is counting on $150,000-per-year Tecentriq to help replace revenue from its $20 billion-per-year trio of Avastin, Herceptin and Rituxan whose patents have expired or will shortly, exposing them to cheaper competition.
Phase III IMpower150 study showed Tecentriq (atezolizumab) and Avastin (bevacizumab) plus chemotherapy reduced the risk of disease worsening or death by 38 percent for people with a type of advanced lung cancer [Roche] First Phase III combination trial of a cancer immunotherapy to show improvement in progression-free survival as an initial treatment in advanced non-squamous non-small-cell lung cancer.
	5.8 ASH
59th ASH Annual Meeting to Celebrate Major Advances in Hematology Research [ASH] The 2017 ASH Annual Meeting will feature nearly 5,000 scientific abstract presentations in malignant and non-malignant blood diseases – from cutting-edge advances in gene therapy to practice-changing discoveries in immunotherapies.
	5.9.1 AACR - sein
Updated Data from Phase 3 Trial of IBRANCE® (palbociclib) Plus Letrozole in ER+, HER2- Metastatic Breast Cancer Confirm Improvement in Progression-Free Survival [Pfizer] Median follow-up of more than three years is longest for any Phase 3 trial of a CDK 4/6 inhibitor.
Myriad Genetics Presents Pivotal Validation Study for New riskScore™ Test at the 2017 San Antonio Breast Cancer Symposium [Myriad] riskScore Demonstrates Highly Statistically-Significant Ability to Predict 5-Year and Lifetime Risk of Breast Cancer in Women Who Test Negative for Hereditary Breast Cancer Mutations.
Kisqali® first and only CDK4/6 inhibitor to show superior efficacy vs. oral endocrine therapy as 1L treatment in randomized Phase III trial in premenopausal women with HR+/HER2- advanced breast cancer [Novartis] Pending approval in this indication, the clinical benefit demonstrated in the MONALEESA-7 trial expected to support the use of Kisqali as a standard of care for premenopausal women with HR+/HER2- advanced breast cancer.
Increasing the Dose Intensity of Chemotherapy May Lower the Risk of Breast Cancer Recurrence and Death [AACR] For the meta-analysis, Gray and team used individual patient data from seven randomized trials (10,004 women) that tested chemotherapy given every two weeks versus every three weeks, and from nine randomized trials (11,533 women) that tested sequential versus concurrent anthracycline and taxane-based chemotherapies.
Immunotherapy Shows Early Promise for Patients With Trastuzumab-resistant Breast Cancer [AACR] In phase II, the investigators enrolled 40 patients and 12 patients to the PDL1-positive and PDL1-negative cohorts, respectively. Patients received 200mg of pembrolizumab every three weeks in combination with the standard dose of trastuzumab for 24 months or until disease progression.
Adjuvant Trastuzumab Did Not Improve Outcomes for Patients With HER2-low Breast Cancer [AACR] Current guidelines for defining HER2-positive status remain valid.
Ribociclib Improved Progression-free Survival for Pre- and Perimenopausal Women With Hormone Receptor–positive Advanced Breast Cancer [AACR] The study met its primary endpoint: Progression-free survival was significantly improved in the ribociclib arm compared with the placebo arm. Median progression-free survival was 23.8 months in the ribociclib arm compared with 13.0 months in the placebo arm.
	6.10.1 Politiques (USA)
Ninety-Six Leading Cancer Researchers and Physician-Scientists, Including Eighteen Nobel Laureates, Urge Congress to Reach a Bipartisan Budget Agreement and Invest in Lifesaving Medical Research [AACR] The letter also calls attention to urgent issues facing early-career scientists, remarking that significant annual NIH funding increases are crucial if we are to secure a strong and diverse pipeline of early-career investigators who are committed to advancing cancer research and reducing cancer incidence, morbidity, and mortality.
	6.9 Controverses
There’s No Such Thing As ‘Sound Science’ [FiveThirtyEight] Science matters, and we need to do it as rigorously as possible. But science can’t tell us how risky is too risky to allow products like cigarettes or potentially harmful pesticides to be sold — those are value judgements that only humans can make.