Onco Actu du 3 février 2020

	1.1 BIOLOGIE - GÉNOME
Mutation’s role in blood cancers revealed by ideal team-up [Cold Spring Harbor Lab] Researchers from CSHL and MSKCC have determined that a mutation affecting the important process of RNA splicing can manipulate the “quality control” in your cell. The resulting conditions characterize many deadly blood cancers.
	4.10 DÉP., DIAG. & PRONO. - POUMON
Lung cancer screening decision aid delivered through tobacco quitlines improves informed decision-making ’MD Anderson Cancer Center] In the study published today in JAMA Network Open, the research team worked with 13 tobacco quitlines to identify callers eligible for screening. The 516 quitline clients who enrolled in the study were randomized to receive a decision aid video called “Lung Cancer Screening: Is It Right for Me?” or a standard lung cancer screening brochure for the control group.
	4.12 BIOPSIES LIQUIDES
These start-ups are racing to help doctors detect cancer early with a simple blood test [CNBC] They are taking markedly different approaches. Freenome is focusing on one cancer type, while Grail and Thrive are looking across multiple cancers.
	4.9 DÉP., DIAG. & PRONO. - SEIN
New View of the Brink of Cancer May Validate Preventive Mastectomy [DNA Science Blog] Women who have prophylactic mastectomies to stay ahead of a BRCA2 mutation may have made a wise choice, according to findings of a study just published in Science Advances. I’m amazed at the bravery of these women who go the Angelina Jolie route.
PIK3CA-mutated Metastatic Breast Cancer [ESMO] An analysis of outcomes and molecular landscape of patients with PIK3CA-mutated metastatic breast cancer (MBC) from the SAFIR02 trial showed that patients with PIK3CA-mutated hormone receptor (HR)-positive/HER2-negative tumours have a poor outcome and resistance to chemotherapy. Patients with PIK3CA-mutated triple-negative breast cancer (TNBC) present a better overall survival (OS).
	5.10 TRAITEMENTS - ESSAIS
Darolutamide plus androgen deprivation therapy significantly increased overall survival in men with non-metastatic castration-resistant prostate cancer [Bayer] Full data to be presented at upcoming scientific meeting.
	5.12.11 IMMUNOTHÉRAPIES - PRÉ-CLINIQUE
Researchers identify possible new combination treatment for advanced melanoma [UCLA] When tested in mice with melanoma tumors that were unlikely to stimulate an immune response, the approach increased the number of anti-tumor immune cells, and those immune cells lived longer and functioned better than the standard therapy, empowering the cells to destroy the tumor.
	5.12.2 IMMUNOTHÉRAPIES - CAR-T, THÉRAPIES CELLULAIRES
Resistant to CAR-T therapies? It's the cancer, not your immune system — study [EndPoints] “What we are hypothesizing here is that there can be a third mechanism…that even in the presence of CD19 those leukemic cells are unable to die when they are triggered by CAR-T.”
	5.12.5 IMMUNOTHÉRAPIES - PHARMA
Bristol-Myers Squibb Withdraws European Application of Opdivo (nivolumab) Plus Yervoy (ipilimumab) for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer [BMS] Though the Committee for Medicinal Products for Human Use (CHMP) acknowledged the integrity of the patient level data, the CHMP determined a full assessment of the application was not possible following multiple protocol changes the company made in response to rapidly evolving science and data. The company has no plans to refile this application in the EU.
GSK announces European Medicines Agency (EMA) accepted marketing authorisation application for belantamab mafodotin for the treatment of relapsed or refractory multiple myeloma [GSK] Submission based on data from the pivotal DREAMM-2 study of immunoconjugate targeting B-cell maturation antigen (BCMA) recently published in The Lancet Oncology.
	5.12.8 IMMUNOTHÉRAPIES - ECONOMIE
Not a kickback: Novartis’ Kymriah travel assistance program gets a green light from HHS [Fierce Pharma] Normally, a pharma company paying a patient to take its drug looks suspicious—like a kickback—and it’s considered so under federal law. But HHS has just made a special ruling for a novel therapy.
Are CAR T-Cell Therapies Worth the Costs? [ASH Clinical News] There’s also been talk about academic medical centers coming together to manufacture CAR T-cell products themselves at a reduced cost, thereby cutting out the pharmaceutical companies. Although that’s possible to do in the context of a clinical trial, I’m not sure it’s a sustainable model within our current reimbursement systems.
	5.2 PHARMA
EMA Validates Seattle Genetics’ Marketing Authorization Application for Tucatinib for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer [Seattle Genetics] Application Supported by Results of Pivotal HER2CLIMB Trial.
	5.2.1 PHARMA - PARTENARIATS
Onxeo Enters Clinical Research Agreement with Gustave Roussy to Conduct Clinical Trial of AsiDNA™ for Treatment of Relapsed Ovarian Cancer [Onxeo] The REVOCAN phase 1b/2 study, sponsored by Gustave Roussy, will evaluate the effect of AsiDNA™ on the acquired resistance to PARP inhibitor niraparib in 2nd line maintenance treatment of relapsed ovarian cancer.
	5.2.6 PHARMA - BIOTECH
Black Diamond doubles in value hours into Nasdaq debut, marking hot start to the 2020 IPO run [EndPoints] There are few allosteric therapies approved, but investors seem to like the idea — and the latest duo to pursue it.
	5.3 TRAITEMENTS - FDA, EMA,...
Hahn stresses importance of data, RWE in first all-hands meeting [EndPoints] “Specifically, I believe there is great promise in the effective use and integration of patient-level data or real-world evidence such as electronic health records, clinical trials, medical studies, and patient registries,” Hahn said.
UK withdrawal from the EU on 31 January 2020 [EMA] As of 1 February 2020, no one who represents the UK, or is appointed or nominated by the UK can participate in meetings of EMA’s scientific committees, working parties or the Agency’s Management Board.
	5.3.4 TRAITEMENTS - AMM (FDA, EMA,...)
Pfizer Receives Positive CHMP Opinion for Oncology Biosimilar, RUXIENCE™ (rituximab) [Pfizer] The regulatory submission is supported by a comprehensive data package which demonstrates biosimilarity of RUXIENCE to the reference product.
Bayer receives positive CHMP opinion for darolutamide as a new treatment for men with non-metastatic castration-resistant prostate cancer [Bayer] CHMP opinion is based on Phase III ARAMIS trial data evaluating the efficacy and safety of darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT.
AbbVie Receives Positive CHMP Opinion for VENCLYXTO® as a Chemotherapy-Free Combination Regimen for Patients with Previously Untreated Chronic Lymphocytic Leukemia [AbbVie] Positive opinion based on data from Phase 3 CLL14 trial, which showed that patients who completed one year of treatment with VENCLYXTO plus obinutuzumab had prolonged progression-free survival and higher rates of minimal residual disease negativity compared to patients receiving a standard of care chemoimmunotherapy regimen of obinutuzumab and chlorambucil.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2020 [EMA] - Nubeqa (darolutamide) received a positive opinion for the treatment of prostate cancer. - The application for an initial marketing authorisation for Idhifa (enasidenib) was withdrawn. This medicine was intended for the treatment of acute myeloid leukaemia, a cancer of white blood cells. The application to extend the use of Keytruda (pembrolizumab) in the treatment of cancer of the oesophagus was also withdrawn.
	6.1 OBSERVATION
Spike in US colorectal cancer rates from age 49 to 50 suggests many cases likely undiagnosed before screenings [Tulane University] The study adds fuel to the debate about whether screenings should begin at age 45. Karlitz said the combined burden of undetected and detected early onset colorectal cancer cases for those 45 to 49 may actually approach that of individuals in their early 50s.
Fall in US cancer death rates: Time to pop the champagne? [EClinical Medicine] Finally, it is important to remember that the ACS report is an ecological analysis and cannot prove any causal relations. The key take-home from this study for us is reassurance that we are moving in the right direction but not necessarily a cause for celebration yet.
	6.10 POLITIQUES
What happens after Brexit and what could it mean for cancer? [Cancer Research UK] The EU is bringing in new rules for how trials are run through a Clinical Trial Regulation. The changes are popular with researchers, who believe they’re a big upgrade on the current system. We want UK Government to look at becoming a part of the new system – including negotiating access to the Regulation’s new database, which will make setting up UK-EU trials safer and easier.
	6.4 MÉDICO-ÉCO
Financial toxicity of cancer treatment: Moving the discussion from acknowledgement of the problem to identifying solutions [EClinical Medicine] In this article, we propose a four-step approach addressing the issue of financial toxicity in patients with cancer: first, acknowledging and understanding the problem; second, quantifying the problem; third, engaging key stakeholders and fostering communication and fourth, implementing solutions at various levels of the healthcare system.
	6.8 COMMUNICATION
Research on a roll: FDA ad police tackle cancer drugs on TV [Fierce Pharma] The agency’s Office of Prescription Drug Promotion (OPDP) unveiled plans for two tests to study the impact and effect of endpoint disclosures and superimposed text information with consumers.