Onco Actu du 10 septembre 2019

	1.4 BIOLOGIE - TECHNOS, MODÈLES
Animal registries aim to reduce bias [Nature] Millions of mice and rats are used in research each year. But one-third to one-half of animal experiments are never published, and of those that are, many are too poorly conducted to be reliable.
	2. ETIOLOGIE
Black sheep: Why some strains of the Epstein Barr virus cause cancer [DKFZ] "This finding is a strong argument for pressing on with vaccine research in order to develop protection against the most dangerous strains of EBV in future," he concluded. The vaccination against human papillomavirus (HPV), which can cause cervical cancer, already uses a similar principle.
	3.1.1 PRÉVENTION - TABAC - E-CIGS
Juul Illegally Marketed E-Cigarettes, F.D.A. Says [NY Times] The investigation into Juul’s practices preceded this summer’s spate of lung illnesses, and was prompted by concerns that the company’s marketing and sales practices targeted youths.
Bloomberg to spend $160 million to ban flavored e-cigarettes [Washington Post] Effort marks philanthropist’s first major anti-tobacco initiative in the United States.
FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth [FDA] Agency sends additional letter requesting more information on several issues, including outreach and marketing practices, as part of ongoing investigation.
Juul warned by FDA over marketing practices [Reuters] The U.S. Food and Drug Administration warned Juul Labs Inc on Monday for marketing its e-cigarettes as safer than traditional cigarettes, the latest move by the agency to curb the use of vaping devices that have become extremely popular among teens.
U.S. doctors' group says just stop vaping as deaths, illnesses rise [Reuters] The American Medical Association on Monday urged Americans to stop using electronic cigarettes of any sort until scientists have a better handle on the cause of 450 lung illnesses and at least five deaths related to the use of the products.
New York governor proposes ban on flavored e-cigarettes [Reuters] If the proposed legislation were to become law, New York would become the second state to ban flavored e-cigarettes, following Michigan, which passed a ban on Wednesday.
	4.12 BIOPSIES LIQUIDES
Liquid biopsies reveal genetic alterations linked to cancer drug resistance [Broad Institute] The research team compared the results of both liquid and standard tissue biopsies from patients who were treated for gastrointestinal cancer but developed drug resistance. The findings, published today in Nature Medicine, reveal that liquid biopsies provide a more complete picture of both the genetic diversity of a patient’s cancer and how tumors evolve drug resistance at the molecular level.
	4.2 DÉP., DIAG. & PRONO. - GÉNOME
Gaps Exist In Understanding of Genomic Tests [SWOG] A majority of cancer patients don’t understand key aspects of the genomic test results they receive as participants in biomarker-driven clinical trials, according to a first-of-its-kind pilot study conducted under the Lung Cancer Master Protocol (Lung-MAP).
	5.1 TRAITEMENTS - PRÉ-CLINIQUE
To Treat Pancreatic Cancer, Mouse Study Suggests Altering Tumor Microbiome [NCI] Based on the results, an early-stage clinical trial is being planned to test fecal transplants in people with pancreatic cancer.
Overcoming resistance in pancreatic cancer [Cold Spring Harbor Lab] By inhibiting ERBB signaling in addition to MAPK signaling, the researchers observed pancreatic tumors shrink in organoid mouse model of PDA.
	5.13.1 WCLC - IMMUNOTHÉRAPIES
WCLC: AstraZeneca heads for Roche battle with Imfinzi small-cell survival win [Fierce Pharma] Unlike Tecentriq, which can only be used alongside carboplatin-based chemo, Imfinzi can be used with carboplatin- or cisplatin-based regimens.
PhIII lung cancer data signal potential approval for AstraZeneca's Imfinzi [EndPoints] Those numbers compare favorably to the results of the pivotal study that pushed Roche’s PD-L1 Tecentriq across the finish line.
Durvalumab combined with chemotherapy improves overall survival in patients with extensive lung stage cancer; First-line treatment reduces mortality risk by 27 percent. [IASLC] Paz-Ares and his team found that patients in the immunotherapy arm of the trial achieved a median overall survival of 13 months compared to 10.3 months for the etoposide-platinum control group.
	5.13.2 WCLC - THÉRAPIES CIBLÉES
Cancer drug data back up Lilly's Loxo buyout [Biopharma Dive] The findings are also notable because LOXO-292 was mainly tested in patients whose cancers had evaded prior therapies. More than half were previously treated with immunotherapies like Merck & Co.'s Keytruda, and all had received platinum-based chemotherapy before.
Lilly's RET drug, nabbed in Loxo buyout, hits 68% ORR in lung cancer [Fierce Biotech] Lilly/Loxo aren’t the only players in this space, with Blueprint Medicines and Stemline Therapeutics also working on rival RET drugs, namely pralsetinib and SL-1001, respectively. Lilly, though, via its $8 billion Loxo buyout, seems to be ahead of these two, for once at the forefront of oncology R&D.
Eli Lilly hustles up an impressive set of pivotal data for their $8B Loxo drug — as rival nips at their heels [EndPoints] With this kind of data and a breakthrough therapy designation in hand, Lilly appears confident that it can keep its lead — something that the company needs to prove. What is less certain is what this market is worth, with analysts pegging peak sales somewhere north of $500 million though possibly well under the $1 billion blockbuster mark.
National Lung Matrix Trial (NLMT): First Results from an Umbrella Phase II Trial in Advanced NonSmall Cell Lung Cancer (NSCLC) [IASLC] The National Lung Matrix Trial is the largest precision medicine trial in NSCLC patients globally, testing a wide range of therapies tailored specifically to target key genetic changes in cancer cells.
Lilly Announces Positive Results for Selpercatinib (LOXO-292), Demonstrating a 68 Percent Objective Response Rate and Sustained Durability in Heavily Pretreated RET Fusion-Positive Non-Small Cell Lung Cancer [Lilly] 68 percent objective response rate (ORR) in the registration dataset (n=105) of RET fusion-positive NSCLC patients who had previously received chemotherapy.
Registrational Data from LIBRETTO-001 Trial Demonstrate Compelling and Durable Activity of Selpercatinib (LOXO-292) in RET Fusion-Positive Lung Cancer [IASLC] The LIBRETTO001 trial includes 87 sites in 16 countries.
Lilly's targeted RET drug shrinks tumors in lung cancer trial [Reuters] The results, presented on Monday at the World Lung Conference on Lung Cancer in Barcelona, will support Lilly’s application for U.S. Food and Drug Administration approval later this year.
	5.13.2.2 WCLC - KRAS INHIB.
Amgen's KRAS drug continues to deliver but faces 'curse' of high expectations [Fierce Biotech] “The data, in totality, are still quite impressive … but initial investor reaction on the heels of the original 3-for-3 showing at ASCO is one of relative disappointment,” the analysts wrote. At ASCO, the data included a 100% response rate in three NSCLC patients who had received the highest dose of AMG 510.
	5.13.3 WCLC - DÉPISTAGE
Lung cancer screening model favored in Europe detects more cancers than one preferred in the United States [IASLC] Of the 5,013 patients screened, 110 were found to have lung cancer. Ninety-nine percent of the cancers were found using PLCOm2012 compared to 77 percent using USPSTF criteria.
Scottish Study Demonstrates that Autoantibody Test Followed By CT Imaging May Reduce Lung Cancer Mortality [IASLC] “The study was not powered to detect a difference in mortality after two years, however there was a non-significant trend suggesting fewer deaths in the intervention arm compared to the control (87 vs 108 respectively). Similar results were noted relating to lung cancer-specific mortality (17 vs 24).”
BioMILD Trial Demonstrates Lung Cancer Screening Using MicroRNA Blood Test Enhances Prevention Effort [IASLC] The bioMILD trial prospectively enrolled 4,119 volunteers at Istituto Nazionale Tumori of Milan with the median age of 60 years, median pack-years 42, current smokers 79% and females 39%.
Ground-breaking trial demonstrates potential of blood test which harnesses the power of the immune system to reduce late detection of lung cancer [Oncimmune] In a randomised controlled trial of 12,209 people in Scotland at high risk of developing lung cancer, it was shown that more people were diagnosed at an early stage of the disease in the two years after taking the EarlyCDT Lung test than those in the control arm who received standard clinical care.
New blood test trialled on 12,000 Scots catches lung cancer early [BBC News] The trial used technology by immunodiagnostics firm Oncimmune, which detects the presence of autoantibodies generated by the body's immune system as a natural defence against cancer cells. Experts hope the test will be given to another 200,000 patients for further research.
	5.13.4 WCLC - DIVERS
Video Assisted lung surgery reduces complications and hospital stays compared to open surgery [IASLC] After randomization, Lim and his researchers found that patients who received VATS had a significant reduction of overall in-hospital complications (32.8 percent) compared to patients who received open surgery (44.3 percent).
	5.3 TRAITEMENTS - FDA, EMA, NICE...
CDER chief Janet Woodcock has a message for pharma: 'It’s not working, and it won’t work in the future' [EndPoints] “Is the guy living under the bridge going to get a $2-million CAR-T cell curative treatment?” she asked. “If that guy can’t get the drug, then we’ve failed….” “The goal isn’t just improving knowledge. The goal isn’t FDA approval. The goal is to improve human health.”
Who’s Missing From Breast Cancer Trials? Men, Says the F.D.A. [NY Times] Men do get breast cancer, but they account for fewer than 1 percent of patients and often receive inadequate care.
	5.6 ESMO
Pivotal New Data from Merck’s Broad Oncology Portfolio at ESMO 2019 Congress [Merck] Phase 3 Data for KEYTRUDA® (pembrolizumab) as Neoadjuvant Therapy in Combination with Chemotherapy in Patients with Triple-Negative Breast Cancer (KEYNOTE-522) to be Featured in ESMO Presidential Symposium and Official Press Program.
	6.1 OBSERVATION
Colorectal cancer becoming more common at younger ages [Reuters] The trend toward more colon cancer in younger adults began in the mid-1990s, according to the report published in Gut.
	6.7 DMP, BIG DATA & APPLIS
FDA Developing Guidance on Real-World Data Quality Issues, Officials Say [RAPS] New data standards will need to be developed and FDA is “currently exploring,” they write, when the use of observational data “may be appropriate for evaluating effectiveness from a broad policy perspective and also, as individual drug manufacturers submit proposals for using real world data to support marketing applications."