Onco Actu du 9 septembre 2019

	3.1.1 PRÉVENTION - TABAC - E-CIGS
Severe Pulmonary Disease Associated with Electronic-Cigarette–Product Use — Interim Guidance [CDC] Until a definitive cause is known, persons should consider not using e-cigarettes. Those who use e-cigarettes should seek medical attention for any health concerns. Clinicians should report possible cases to their local or state health department.
Pneumonia cases linked to vaping are still rising. And federal officials don’t know what’s causing them [STAT] The FDA currently has 120 samples it is testing, looking for pesticides, toxins, poisons, cutting agents and additives as well as other chemicals, Zeller said. But so far there is no evident answer.
British vapers are safe, claim health experts after deaths in US [The Guardian] Outbreak of respiratory disease in the US, where five people have died, is blamed on lax controls and illicit fluid.
Lung illness tied to vaping has killed five people, may be a new ‘worrisome’ disease, officials say [Washington Post] Federal and state officials provide new details about the vaping-related lung injuries that have now been reported in 450 possible cases from 33 states.
What You Need to Know About Vaping-Related Lung Illness [NY Times] Coughing, fatigue and shortness of breath are warning signs for anyone who has vaped within the last 90 days.
US health officials report new vaping deaths, repeat warning [AP] It’s unclear whether such illnesses were happening before this year. “We’re all wondering if this is new or just newly recognized,” Dr. Dana Meaney-Delman of the Centers for Disease Control and Prevention told reporters Friday.
	4.10 DÉP., DIAG. & PRONO. - POUMON
Why more ex-smokers, and smokers, should take CT lung cancer test [Washington Post] The technique can be a real lifesaver and should be better known by people — and doctors, author says.
	5.12.3 IMMUNOTHÉRAPIES-COMBINAISONS
Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors [National Academies Press] To examine the challenges and opportunities to develop combination cancer therapies that include immune checkpoint inhibitors, the National Cancer Policy Forum held a workshop on July 16–17, 2018, in Washington, DC. This workshop convened stakeholders with a broad range of expertise, including cancer researchers, clinicians, patient advocates, and representatives from industry, academia, and government. This publication summarizes the presentations and discussions from the workshop.
	5.12.6 IMMUNOTHÉRAPIES - AMM
Roche's Tecentriq, on an EU hot streak, bags 2 new lung cancer approvals [Fierce Pharma] The double win follows another victory for Roche in a rival-free indication: Triple-negative breast cancer. European regulators blessed Tecentriq in that area last week, extending a head start it won in the U.S. in March. And unlike in lung cancer, where Keytruda runs the show, tough-to-treat TNBC has so far foiled Merck.
Roche boosts cancer approvals in Europe, pushing for a bigger slice of the I/O pie [EndPoints] Tecentriq is also approved for certain types of metastatic urothelial cancer, and in PD-L1-positive triple-negative breast cancer. The drug generated sales of about $790 million in the first half of this year.
	5.13 WCLC
Tobacco Cessation After Cancer Diagnosis: Declaration from the IASLC [IASLC] The International Association for the Study of Lung Cancer today used the platform of its largest international meeting to call attention to the importance of tobacco cessation after cancer diagnosis, and urged all physicians to screen cancer patients for tobacco use and recommend tobacco cessation.
	5.13.1 WCLC - IMMUNOTHÉRAPIES
Imfinzi is first immunotherapy to show both significant survival benefit and improved, durable responses in extensive-stage small cell lung cancer [AstraZeneca] In the Phase III CASPIAN trial Imfinzi (durvalumab) at a fixed, convenient dose improved survival with either a cisplatin or carboplatin chemotherapy backbone.
	5.13.1.1 WCLC - BIOMARQUEURS
WCLC: Merck analyses throw doubt on new biomarker's utility [Fierce Pharma] The findings are good news for Merck, as they “establish very clearly that all patients who can tolerate chemotherapy” should receive the Keytruda pairing in the front-line setting, Baynes said. But for companies that have sought to establish TMB as a way to segment the population, it’s not a great sign.
New KEYNOTE 021 Data Shows No Association with Tumor Mutational Burden [IASLC] TMB as a continuous variable was not significantly associated with objective response rate, progressionfree survival or overall survival for pembrolizumab plus chemotherapy or chemotherapy alone.
KEYNOTE 189: Tumor Mutational Burden Not Significantly Associated with Efficacy of Pembrolizumab [IASLC] TMB was determined by whole-exome sequencing oftumor and matched normal DNA. The clinical utility of TMB on outcomes was assessed usingprespecified TMB cut points of 175 and 150 Mut/.
	5.13.2 WCLC - THÉRAPIES CIBLÉES
Ipsen and Servier announce initial Phase II/III clinical data evaluating investigational liposomal irinotecan (ONIVYDE®) as a second-line treatment for small cell lung cancer (SCLC) at the IASLC 2019 World Conference on Lung Cancer [Servier] 44% of patients achieved a response and nearly half (48%) maintained disease control at week 12 (efficacy as secondary endpoint).
	5.13.2.2 WCLC - KRAS INHIB.
Amgen update shows promise, limits of KRAS cancer drug [Biopharma Dive] "My biggest concern with KRAS is there are many redundant pathways," he said in an interview. Tumors, in other words, may rely on other genetic growth drivers if mutant KRAS signaling is blocked.
Amgen Announces New Clinical Data Evaluating Novel Investigational KRAS(G12C) Inhibitor In Larger Patient Group At WCLC 2019 [Amgen] 54% of 13 Evaluable Non-Small Cell Lung Cancer Patients Experienced a Partial Response at the Target Dose of 960 mg in the Ongoing Phase 1 Study.
A stellar update on AMG510 stokes fresh enthusiasm on the future of Amgen's landmark KRAS G12C program [EndPoints] There are some caveats, of course. Primarily the data are still very, very early on small numbers. And as Liu later noted on Twitter, not all of the responses are confirmed. At this stage of the development game, the stance of objective observers will be “trust but verify.”
Amgen drug shrinks lung cancer tumors in half of patients: study [Reuters] The targeted mutation, KRASG12C, occurs in around 13% of NSCLC cases, as well as 3-5% of colorectal cancers and up to 2% of other solid tumor cancers, including pancreatic.
Phase 1 Study Shows Novel KRAS Inhibitor Well Tolerated by Patients with Adenocarcinoma and NonSmall Cell Lung Cancer [IASLC] “These data continue to show encouraging anti-tumor activity with AMG 510,underscoring the potential to close the treatment gap for non-small cell lung cancer patients withpreviously treated KRAS G12C-mutated NSCLC.”
	5.2 PHARMA
Novartis investigational lung cancer therapy capmatinib (INC280) granted FDA Breakthrough Therapy Designation for patients with MET-mutated advanced non-small cell lung cancer [Novartis] Regulatory filing for capmatinib in the U.S. is anticipated in Q4 2019.
Novartis' late-stage blockbuster push gets major boost with another 'breakthrough' for MET therapy [EndPoints] Originally discovered by Incyte and licensed to Novartis in 2009, capmatinib is an orally bioavailable inhibitor that works by binding to the c-Met cells that are altered and drive tumor growth in a small number – around 5%, per the NIH – of NSCLC cancer patients.
	5.3 TRAITEMENTS - FDA, EMA, NICE...
MD Anderson’s Stephen Hahn emerges as candidate for FDA commissioner’s job [The Cancer Letter] Though Hahn, 59, isn’t an obvious choice for FDA, no one questions his qualifications for the job. The bigger question is, why would he be any better than Sharpless, and how much time would he have to actually perform his duties—i.e. not only how much sense this appointment would make for the Trump administration, but how much sense it would make for FDA, the regulated industry?
	6.10 POLITIQUES
No-deal Brexit could hit cancer trials that save children’s lives [The Guardian] UK researchers fear being blocked from EU-wide testing of treatments for diseases including rare childhood cancers.