Onco Actu du 7 juin 2016 - spécial ASCO

	2.6 Etiologie - Environnement
EU countries refuse to back new license for glyphosate weed-killer [Reuters] Seven member states abstained and 20 backed the proposal, a German environment ministry spokeswoman said. Only Malta voted against, diplomats said.
	3.1 Tabac
Cigarette-pack warnings work better with photos [Reuters] Quitting for at least a week before the end of the study was 53 percent more likely with photos than with text alone.
	5.2 Pharma
Drug makers pay $67m for misleading docs about cancer drug survival data [STAT] Two drug makers — Roche’s Genentech and OSI Pharmaceuticals — announced a deal on Monday to pay $67 million to resolve charges they made misleading statements about the effectiveness of the Tarceva drug to treat non-small cell lung cancer.
Bristol-Myers Squibb Promises To Publish Failed Study After Long Delay [Forbes] Positive studies are rushed out in months, but this one has been allowed to sit around for more than a year before it is even submitted for peer review. But better late than never, and now Bristol knows people are watching which should (fingers crossed) prevent more delays.
Christi Shaw: Sad and Inspiring Reason She Stepped Down from Novartis [Fortune] For Shaw, 49, one of the top-ranking women in the pharma industry, the decision to take on that caretaker role was an easy one. She deliberated just two days before submitting her resignation. What surprised her was the disbelief she encountered from friends, co-workers, and colleagues in the industry.
Big Biotech is here — and it’s starting to look a lot like Big Pharma [STAT] There are 17 biotech companies in the US that generate more than $500 million per year in revenue. And they’re increasingly focused on buying innovative new products through mergers and acquisitions, rather than developing them in house, according to a report from EY (formerly Ernst & Young) released Monday.
	5.5 ASCO
TAPUR Study Achieves Milestones: Forty-Nine Patients Consent to Participate, Bayer and Merck Sign on as Drug Providers, and Thirty-Seven Sites Are Participating Twelve Weeks Post-Launch [ASCO] TAPUR is currently underway at 37 clinical sites with additional sites to be added in the coming months. Nearly 100 clinical sites around the country have expressed interest in participating in the study.
	5.5.1 ASCO (général)
Vice President Joe Biden, Speaking at ASCO's 2016 Annual Meeting, Challenges Cancer Community to Expand Data-Sharing to Advance the National Cancer Moonshot [ASCO] Vice President Biden took the opportunity to reiterate four critical priorities for achieving his "moonshot" to end cancer. They included: significant new federal investment in cancer research; enhanced sharing of research and patient data; increased use of team-based approaches that harness different medical and scientific disciplines; and new approaches to developing and recruiting for clinical trials.
Newly launched Genomic Data Commons to facilitate data and clinical information sharing [NIH] Part of the National Cancer Moonshot, GDC to centralize, standardize accessible data.
Biden Designates NCI’s Genomic Data Commons As “Foundational Element” of Cancer Moonshot [The Cancer Letter] Biden’s announcement—hours before his address at the 2016 annual meeting of the American Society of Clinical Oncology in Chicago—establishes NCI as the leader in a high-stakes debate over who gets to set standards for how health records data should be aggregated and organized.
Cancer needs Ebola-level action - Biden [BBC News] He told scientists their success could "literally change the world" but criticised the barriers to getting on clinical trials.
U.S. project launched to promote data sharing by cancer researchers [Reuters] Biden was speaking at the American Society of Clinical Oncology meeting in Chicago in conjunction with the launch of a new system to facilitate sharing of genomic and clinical data among cancer researchers to help promote advances in personalized treatment for the many forms of the disease.
	5.5.1.1 ASCO (général) - Industriels
Myriad myRisk® Hereditary Cancer Test Demonstrates the Magnitude of Breast and Ovarian Cancer Risk in Nearly 100,000 Patients [Myriad] These presentations demonstrate the importance of using a 25-gene panel to evaluate risk for hereditary breast and ovarian cancers.
Myriad On Genetic Testing For Cancer Risk: Insurance Gap Is A 'Crisis' (Forbes] Johnathan Lancaster, Myriad’s chief medical officer, is an oncologist who practiced for more than 20 years before joining the company in 2015. He hopes the new data from Myriad will help quiet some of the concerns often cited about trying to predict cancer risk from genetic tests, when the science of genomics is still in its infancy.
Clovis Oncology Presents Data from Phase 2 Studies of Rucaparib in Advanced Ovarian Cancer and Pancreatic Cancer at 2016 ASCO Annual Meeting [Clovis Oncology] Rucaparib is the Company’s oral, potent, small molecule inhibitor of PARP1, PARP2 and PARP3 currently being developed for the treatment of ovarian cancer, specifically in patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, including those with high genomic loss of heterozygosity (LOH) also known as “BRCA-like."
Cancer Drug Stocks: The Winners and Losers From ASCO 2016 [The Street] A summary (and somewhat subjective) breakdown of winners and losers from the American Society of Clinical Oncology annual meeting.
Winners And Losers From Cancer Research's Big Event [Forbes] In recent years, there have often been big (and wonderful) surprises as new medicines proved in big studies to be more effective than researchers had hoped–and also data disasters where companies completely imploded. That’s not the theme this year. This year’s winners won by presenting data that left hopes for their new treatments intact, while the big loser simply failed to keep expectations in check.
	5.5.10 ASCO (hémato)
New Phase 3 Secondary Analysis Shows ProgressionFree Survival Benefit In Early Relapsing Multiple Myeloma Patients Treated With Kyprolis CarfilzomibBased Regimen [Amgen] Analysis Assessed Efficacy and Safety of Kyprolis in Combination With Lenalidomide and Dexamethasone (KRd) Using Results From Pivotal ASPIRE Trial.
Kite Pharma Announces the First Meta-Analysis of Outcomes in Chemorefractory Diffuse Large B-Cell Lymphoma (SCHOLAR-1) [Kite] The study showed that patients with chemorefractory disease - defined as disease that does not respond to treatment with a chemotherapy-based regimen or has relapsed less than 12 months after autologous stem cell transplant (ASCT) - have consistently poor outcomes regardless of refractory subgroup, line of therapy, and disease stage.
	5.5.12 ASCO (médico-éco)
Cancer drugs, though cheaper in the developing world, remain unaffordable in poorer countries [STAT] “If there are effective cancer therapies available in the West and not in developing countries, it will become a serious issue in coming years,” said Goldstein, an oncologist at Israel’s Rabin Medical Center.
Huge global variation in cost of cancer drugs [Cancer Research UK] Costs in Australia, China, India, South Africa, the UK and US were assessed, with prices taken from locally and nationally recognised institutions and was converted into US dollars. The study used so-called ‘list prices’ to make its comparisons, so did not take into account any discounts the NHS receives through negotiation.
Cancer Drug Retail Prices Vastly Different Between Countries [ASCO] Despite Lower Cost in Low-Income Countries, Cancer Drugs May Be Less Affordable.
Cancer drug prices highest in U.S., least affordable in India, China: study [Reuters] The lowest drug prices were found in India and South Africa. But after calculating price as a percentage of wealth adjusted for the cost of living, cancer drugs appeared to be least affordable in India and China.
	5.5.13 ASCO (divers)
Cancer patients keep getting aggressive end-of-life treatment, despite lack of benefit [STAT] Aggressive care includes chemotherapy after multiple earlier rounds of treatment have stopped working and being admitted to an intensive care unit. Such interventions at the end of life “are widely recognized to be harmful,” Chen said.
Many Patients Younger Than 65 Receive Aggressive Care at the End of Life [ASCO] Lack of Change in Practice Following an ASCO 2012 Chosing Wisely® Recommendation.
	5.5.15 ASCO (biopsies liquides)
Readers drowning in flawed “liquid biopsy” stories; other coverage throws a lifeline [HealthNewsReview] The researchers were not trying to “find cancer” as the Post misleadingly suggests. Nor did the study involve a “blood test for cancer” as TIME states. The cancer had already been found and diagnosed using a surgical biopsy.
	5.5.2 ASCO (sein)
Ten years of hormone breast cancer drugs 'may benefit some' [NHS Choices] Overall, the results of this large and well-designed randomised controlled trial suggest that extended treatment with an aromatase inhibitor to 10 years may be suitable for some women. However, the potential side effects should be balanced with the quality of life that could be had from this treatment.
Staying on oestrogen-blocking drugs for five extra years 'prevents more breast cancers returning' [Cancer Research UK] However, while the study showed lower rates of recurrence, it ultimately didn't show a difference in overall survival between the two groups, Purushotham said. "We will need more long-term studies to see if this could also improve survival for breast cancer patients."
Minority BRCA-Positive Breast Cancer Survivors Appear Less Likely to Receive Preventive Surgery [ASCO] Study Reveals Racial Disparity in Breast and Ovarian Cancer Risk Management.
Breast cancer drug increases survival (BBC News] "The results are pretty impressive and we hope they will lead to the drug being licensed in the EU later this year. But the price in the US is expensive."
	5.5.3 ASCO (prostate)
MRI scans help men avoid unnecessary prostate biopsy [Cancer Research UK] ​ Comparing the results of all the tests, the research team calculated that using MRI before a TRUS biospy could help avoid a primary biopsy in 27 per cent of men.
	5.5.4 ASCO (immunothérapies)
New Cancer Drugs Fire Up Body’s Hunters in Tumor Hide and Seek [Bloomberg] Researchers called the data shown at the meeting, combining the immune agonists with the checkpoint inhibitors, a promising start.
Kite Pharma Presents Ongoing Complete Responses at 9 Months in Phase 1 of ZUMA-1 in Patients with Chemorefractory Non-Hodgkin Lymphoma [Kite] KTE-C19 is an investigational therapy in which a patient's T-cells are genetically modified to express a chimeric antigen receptor (CAR) that is designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias.
Kite/NCI Anti-CD19 CAR T-Cell Therapy Demonstrates Durable Complete Remissions in Advanced Non-Hodgkin Lymphoma [Kite] 9 of 19 patients (47%) with diffuse large B-cell lymphoma achieved complete responses, which are all ongoing with a duration of 7 to 20 months.
	5.5.6 ASCO (peau-mélanome)
ASCO 2016: Pivotal Avelumab Study Shows Positive Results in Metastatic Merkel Cell Carcinoma [Pfizer] International, multicenter Phase II study results in metastatic MCC with 88 patients represents largest data set of any anti-PD-L1/PD-1 reported in this patient population.
Novartis combination therapy Tafinlar® + Mekinist® demonstrates overall survival benefit at three-year follow-up in patients with advanced melanoma [Novartis] Study is longest Ph III survival follow-up to date of BRAF V600E/K mutation-positive melanoma patients who received a targeted combination therapy.
Long-Term Data from Two Trials Evaluating the Opdivo® (nivolumab) and Yervoy® (ipilimumab) Regimen in Advanced Melanoma Continues to Validate Bristol-Myers Squibb’s Immuno-Oncology Combination Approach [BMS] Significantly longer progression-free survival and higher objective response rates with Opdivo and Yervoy combination and Opdivo monotherapy versus Yervoy alone, with a minimum of 18-month follow-up, from CheckMate -067.
Novartis study shows skin cancer combo also works on lungs [Reuters] Novartis's Tafinlar and Mekinist combination shrank tumours in 63 percent of the trial's 57 people with BRAF V600E-mutation positive non-small cell lung cancer who had failed on chemotherapy, the company said, citing a Phase II study.
	5.5.8 ASCO (poumon)
Pfizer Presents Promising Data from Next Generation ALK/ROS1 Inhibitor in Advanced Non-Small Cell Lung Cancer [Pfizer] Among patients with ALK-positive metastatic NSCLC, the overall response rate (ORR) with lorlatinib was 46 percent, with three patients achieving complete responses and 16 patients achieving a partial response.
AbbVie Shares Fall on Low Survival Data for Lung Cancer Drug [Bloomberg] Patients survived fewer month than typical with chemotherapy.
Novartis pivotal data for Tafinlar® + Mekinist® demonstrated a 63 percent overall response rate in treating rare form of lung cancer [Novartis] The median Duration of Response for BRAF V600E-mutant NSCLC patients treated with Tafinlar® + Mekinist® combination therapy was 9 months.
ARIAD's Investigational Medicine Brigatinib Demonstrates 54 Percent Confirmed Objective Response Rate and 12.9-Month Median Progression-Free Survival in ALTA Study [ARIAD] 67 Percent Confirmed Intracranial Objective Response Rate in Patients with Measurable Brain Metastases.
Mobile-Friendly Web Application Extends Lung Cancer Survival [ASCO] A Web-mediated follow-up application (Moovcare™) improves advanced lung cancer survival, according to a French multicenter randomized phase III study.
Ariad Drug Appears To Delay Lung Cancer's Return Longer Than Rival Medicines (Forbes] That means that brigatinib worked longer in patients who had failed Xalkori than Xalkori does in the first place. There is also data that the drug may get into the brain and affect lung tumors that have spread there.
	5.5.9 ASCO (autres organes)
Seattle Genetics and Astellas Present ASG-15ME and Enfortumab Vedotin Phase I Clinical Data in Metastatic Urothelial Cancer at ASCO Annual Meeting [Seattle Genetics] Clinical Data Indicating Antitumor Activity Presented from Two Antibody-Drug Conjugate Programs.
Updated Findings from KEYNOTE-012 for KEYTRUDA® (pembrolizumab) Show Continued Benefit in Response Rates and Duration of Response Lasting Up to 30 Months in Patients with Previously Treated Recurrent or Metastatic Head and Neck Cancer [Merck] Response Rates from KEYNOTE-055 Show Nearly One in Five Patients Responding with KEYTRUDA; Results Confirm Findings from KEYNOTE-012.
Exelixis and Its Partner Ipsen Announce Positive Overall Survival Results from Subgroup Analyses of Phase 3 Trial of CABOMETYX™ (cabozantinib) Tablets in Advanced Renal Cell Carcinoma at 2016 ASCO Annual Meeting [Exelixis] Additional data from pivotal METEOR trial underscore clinically meaningful benefit of CABOMETYX across subgroups of patients.
	6.10 Politiques
Vermont Governor Signs Bill With Possible $10K Fines for Drug Price Hikes [RAPS] The signing comes as 13 other states, including New York, California, Ohio, Massachusetts and Virginia, are drafting new drug price transparency bills. Ohio and California are offering ballot measures that would place new price caps on some drugs.
The Future of Cancer Research and the Cancer Drugs Fund [Inside Government] Details: Thursday 22nd September 2016, Central London, 08:45 - 16:40.
	6.3 Associations
Charity calls for new breast cancer drug to be given to UK women [The Guardian] Pfizer, the company that makes palbociclib, which is sold under the brand name Ibrance, only applied for a European licence last August, even though it was licensed for sale in the US in February 2015 and has been prescribed for 27,000 women.
	6.9 Controverses
The NIH is abandoning vital clinical research centers. That’s a mistake [STAT] One of the most successful research enterprises funded by the NIH, the Clinical Research Center (CRC) program, is dying, its highly productive life cut short with virtually no discussion in the scientific community.
NIH in uproar over report slamming Clinical Center, leadership shakeup [Science] In a recent letter, department chiefs at the center wrote that the review, triggered by problems with a drug production facility, unfairly concluded that patient safety has been compromised across the research hospital. They say the working group’s report has demoralized staff, worried patients, and “demonized” the center’s leadership.