Onco Actu du 5 décembre 2018

	3.4 Chimioprévention
Can Topical Drugs Help Prevent Breast Cancer? [NCI] To explore alternatives to oral tamoxifen that might have fewer side effects, researchers are testing a topical form of the drug in two clinical trials. These randomized placebo-controlled studies are evaluating a gel formulation of tamoxifen called 4-hydroxytamoxifen (4-OHT) that women apply directly to the breasts.
	4.10 Dép., diag. & prono. - FDA, EMA, NICE,...
FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care [FDA] The FDA is recognizing the genetic variant information in the Clinical Genome Resource (ClinGen) consortium’s ClinGen Expert Curated Human Genetic Data, which is funded by the National Institutes of Health (NIH), as a source of valid scientific evidence that can be used to support clinical validity in premarket submissions.
	4.10 Dép., diag. & prono. - Poumon
Lung cancer screening part 1: the benefits and harms according to clinical trials [Cancer Research UK] The combined weight of data from the NELSON trial and its UK counterpart could be enough to settle the discussions on lung screening. But the decision on whether certain groups of people in the UK should be offered lung screening in the form of CT scans falls to the National Screening Committee. It has the difficult task of weighing up all the pros and cons to come up with a recommendation.
	4.12 Biopsies liquides
One test to diagnose them all: researchers exploit cancers’ unique DNA signature [The Conversation] So far we have tested more than 200 tissue and blood samples, with 90% accuracy. Accuracy is important to ensure there are fewer false positives – wrongly detecting cancer when there is none. The types of cancers we tested included breast, prostate, bowel and lymphoma.
Scientists develop 10-minute universal cancer test [The Guardian] The test was made possible by the Queensland team’s discovery that cancer DNA and normal DNA stick to metal surfaces in markedly different ways. This allowed them to develop a test that distinguishes between healthy cells and cancerous ones, even from the tiny traces of DNA that find their way into the bloodstream.
GRAIL Announces Plans to Initiate SUMMIT Study to Support Development of Blood Test for Early Cancer Detection [GRAIL] SUMMIT is a prospective, observational, longitudinal, cohort study designed to enroll approximately 50,000 men and women age 50 to 77 years who do not have a cancer diagnosis at the time of enrollment. The study will evaluate the ability of an investigational blood test using next-generation sequencing (NGS) technology to detect multiple cancer types, including lung cancer.
	5. Traitements
Last Month in Oncology with Dr. Bishal Gyawali: November 2018 [ecancer News] I read a lot of poorly planned, poorly conducted, and poorly reported trials in oncology that make me feel as if “I am glad I am not a part of this trial”; but time and again STAMPEDE reports make me feel “I wish I were a part of this trial team”.
	5.12.5 Immunothérapies - Pharma
Roche's Tecentriq wins speedy U.S. FDA review for small cell lung cancer [Reuters] Tecentriq’s 524 million Swiss francs ($526.53 million) in sales through September — in later-stage lung cancer treatment, as well as bladder cancer — grew by half and could help propel the drug to some 1 billion francs for the full year, but its revenue is still well behind that of Keytruda and Opdivo.
FDA Grants Priority Review to Genentech’s Tecentriq in Combination With Chemotherapy for the Initial Treatment of Extensive-Stage Small Cell Lung Cancer [Genentech] This supplemental Biologics License Application is based on results from the Phase III IMpower133 study, which met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) in the initial treatment of people with ES-SCLC.
	5.2 Pharma
Exelixis and Ipsen Initiate Phase 3 Pivotal Trial (COSMIC-312) of Cabozantinib in Combination with Atezolizumab versus Sorafenib in Previously Untreated Advanced Hepatocellular Carcinoma [Exelixis] Clinical trial will also explore single-agent activity of cabozantinib in the first-line setting.
	5.7 SABCS
SWOG Shares Trio of Studies in San Antonio [SWOG] "In these three studies, SWOG researchers share results that better define subsets of patients and tumors with respect to treatment response, toxicities, and cancer recurrence. These are strong examples of our work.”
	5.8 ASH
ASH Highlights for Tuesday, December 4, 2018 [OBR] Thierry Facon, Service des Maladies du Sang, Hôpital Claude Huriez, Lille, France, presented the pre-specified interim analysis of the MAIA study, a phase 3 trial evaluating daratumumab plus lenalidomide and low dose dexamethasone (D-Rd) versus Rd in patients with transplant-ineligible, newly diagnosed multiple myeloma.
	5.8.1 ASH - Communiqués
Late-Breaking Clinical Trials Advance Targeted Therapies for Patients with CLL and Multiple Myeloma [ASH] Results Are Expected to Prompt Changes in Practice, Improve Patient Outcomes.
	5.8.2 ASH - Pharma
Bispecifics vs CAR-T: Analysts select the big winners — and losers — at #ASH18’s biggest ever datapalooza [EndPoints] One standout seems to be a warm regard for much of the new data coming out on the wrangle for lead spot among BCMA bispecifics, with CAR-T slipping in comparison. Or is it the other way around?
	5.8.3 ASH - Divers
ASH: Can Johnson & Johnson sell regulators on Xarelto as clot prevention for cancer patients? [FiercePharma] One reason Xarelto may not have hit its statistical target? About 40% of patients stopped taking the drug during the trial. And when J&J removed those patients in a separate analysis, results were “highly significant,” Burton said.
New Phase 3 CASSINI Data Presented on the Use of XARELTO® (rivaroxaban) for Venous Thromboembolism (VTE) Prevention in High-Risk Cancer Patients [Johnson&Johson] The composite primary endpoint of VTE occurrence did not reach statistical significance during the full study period.
	5.8.4 ASH - CAR T
Updated Data from Phase 1/2 Open-Label Study of BCMA-Directed CAR-T Cell Therapy LCAR-B38M Show Tolerable Safety Profile, High Overall Response and MRD Negative Rate in Treatment of Patients with Advanced Relapsed or Refractory Multiple Myeloma [Johnson&Johnson] In this study update, 57 patients with advanced R/R multiple myeloma received LCAR-B38M CAR-T cell therapy.
Allogene Therapeutics and Servier Present Pooled Data from Phase 1 Trials of Allogeneic UCART19 in Relapsed/Refractory Acute Lymphoblastic Leukemia [Allogene] The updated pooled analysis from the Phase 1 CALM and PALL trials includes three additional patients since the previous update for a total of 21 patients.
BCMA Day: At ASH ‘18, Cell Therapies For Myeloma Take Center Stage [Xconomy] It’s impressive “how many companies, centers and investigators have jumped onto the BCMA bandwagon, and as a result, how crowded this space is becoming already.”
	5.8.5 ASH - Myélome multiple
ASH: Johnson & Johnson's fast-growing Darzalex lines up for 2nd front-line myeloma OK [FiercePharma] The new Maia data is “really for those elderly patients who really can’t tolerate” Velcade, he said. And now, with two batches of positive data in this patient population under its belt, J&J thinks it has the pool pretty well covered.
New DARZALEX® (daratumumab) Phase 3 Study Shows Efficacy and Safety Data of Anti-CD38 Monoclonal Antibody in Patients with Newly Diagnosed Multiple Myeloma [Johnson&Johnson] Phase 3 MAIA study results show DARZALEX in combination with lenalidomide and dexamethasone reduced the risk of disease progression or death in newly diagnosed patients who are transplant ineligible.
Johnson & Johnson's multiple myeloma drug reduces risk of death in late-stage study [Reuters] Darzalex when used with standard of care drugs, Celgene Corp’s Revlimid and dexamethasone, reduced the risk of the disease spreading or death by 44 percent at about 28 months in patients who are not eligible for stem cell transplant.
	5.8.6 ASH - Leucémies
ASH: Johnson & Johnson, AbbVie's Imbruvica steals the CLL spotlight with phase 3 study wins [FiercePharma] All told, Imbruvica has now come out on top in four phase 3 CLL studies that were “really made complementary.”
New Phase 3 Study Findings Show IMBRUVICA® (ibrutinib) Plus Rituximab Significantly Improved Survival Compared to Fludarabine, Cyclophosphamide, and Rituximab (FCR) in Previously Untreated Patients Aged 70 or Younger with Chronic Lymphocytic Leukemia [Johnson&Johnson] With nearly three years of follow-up, the data showed IMBRUVICA plus rituximab significantly prolonged progression-free survival (PFS) and overall survival (OS) versus FCR.
IMBRUVICA® (ibrutinib) Combination Regimen Significantly Improved Survival Versus the Chemoimmunotherapy FCR (Fludarabine, Cyclophosphamide and Rituximab) in Previously Untreated and Younger Chronic Lymphocytic Leukemia (CLL) Patients; Late-Breaking Phase 3 Data at ASH 2018 [AbbVie] Results from this interim analysis showed ibrutinib plus rituximab prolonged progression-free survival (PFS) compared to a standard chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab (FCR) at nearly 3 years of follow-up.
Ibrutinib plus rituximab superior to standard treatment for some patients with chronic leukemia [NIH] "These results are practice-changing and immediately establish ibrutinib and rituximab as the new standard of care for the initial treatment of CLL in patients age 70 and younger," said lead investigator Tait Shanafelt.
JNJ-AbbVie cancer drug Imbruvica succeeds in late-stage trial [Reuters] In the study, Imbruvica, jointly sold with AbbVie Inc, was given to newly diagnosed chronic lymphocytic leukemia (CLL) patients aged 70 or younger, in combination with Roche AG’s Rituxan.
	6.1 Observation
5 million healthy Britons will be tracked in bid to detect disease sooner [The Telegraph] The plans aim to speed up cancer diagnosis, potentially resulting in 22,000 fewer deaths a year within five years, as well as making breakthroughs detecting other major diseases far sooner.
	6.6 Publications
Researchers sign petition backing plans to end paywalls [Nature] Online letter argues that Plan S — which dictates that research papers be immediately free to read — will not impinge on academic freedom, as some critics claim.