Onco Actu du 6 février 2019

	3.1 PRÉVENTION - TABAC
Younger than 100? Soon, you might not be able to smoke cigarettes in Hawaii. [Washington Post] Lawmakers have proposed legislation that would phase out cigarettes in the state, eventually banning them for everyone but the oldest residents.
EU health official slams Greek minister for defying smoking ban [Reuters] EU Health Commissioner Vytenis Andriukaitis, in Athens to mark World Cancer Day, was also asked to comment on video footage, which aired this week, showing deputy health minister Pavlos Polakis, who is also a surgeon, holding a cigarette while dancing in a club. “It’s shameful! It’s shameful! This guy knows nothing about health,” Kathimerini quoted Andriukaitis as saying.
	3.1.1 PRÉVENTION - TABAC - E-CIGS
Exploding e-cigarette kills 24-year-old Texas man [BBC News] The pen's battery blew up when William Brown tried to use it, sending shards of metal into his face and neck and severing an artery. He died two days later in hospital of a stroke, in what is at least the second such death in the US.
	5. TRAITEMENTS
Targets Versus Drugs [In The Pipeline] The main point is that a target, a mechanism is most certainly not a drug. This is true scientifically, and thanks to Univ. of Rochester v. Searle, it’s true legally as well.
	5.1 TRAITEMENTS - PRÉ-CLINIQUE
Shared genetic marker offers new promise in targeting specific ovarian and lung cancers [McGill University] Evidence has been obtained both in vitro on human cancer cells, and in vivo on animal models that CDK inhibitors are effective at quelling SMARCA4-deficient tumours.
	5.10 TRAITEMENTS - ESSAIS
Sanofi’s Darzalex rival hits primary endpoint in phase 3 [Fierce Biotech] Whatever the financial impact of isatuximab, the drug will have symbolic importance to Sanofi if it comes to market. Through a period in which partnerships have been critical to Sanofi, isatuximab was one of the in-house assets management pointed to as evidence that internal R&D was firing again.
Sanofi's multiple myeloma drug hits goal, setting up 2019 filing [Biopharma Dive] Sanofi plans to submit the therapy, isatuximab, to U.S. and European regulators in the first half of 2019 for potential approval as a third-line therapy for relapsed or refractory multiple myeloma.
Synthetic control arms can save time and money in clinical trials [STAT] While synthetic control arms may be a new concept to many, they have already been successfully used in regulatory decision-making. Roche, for example, met European Union coverage requirements for marketing Alecensa (alectinib) in 20 European markets using a synthetic control arm.
Isatuximab Phase 3 trial meets primary endpoint of prolonging progression free survival in patients with relapsed/refractory multiple myeloma [Sanofi] First randomized Phase 3 trial to evaluate the benefit of adding a monoclonal antibody to pomalidomide and dexamethasone for treatment of relapsed/refractory multiple myeloma.
Flying solo for a change, Sanofi says isatuximab scored an important success in first PhIII myeloma study [EndPoints] Researchers said the drug hit the endpoint on progression-free survival among patients who had been treated with at least two earlier therapies. There’s no data yet, but it will be closely watched when Sanofi does post the results as it hustles a new drug application to regulators.
	5.12 IMMUNOTHÉRAPIES
ACCC's New Publication Helps Provide Insights to Incorporate Cancer Immunotherapies into Practice [ACCC] Publication includes summary of the year’s most significant IO research, policy, and real-world care delivery.
	5.12.1 IMMUNOTHÉRAPIES - PARTENARIATS
GSK bets billions more on oncology [Biopharma Dive] GSK's deal with Merck KGaA comes just two weeks after the Tesaro acquisition closed and underscores how the U.K. drugmaker, like many of its rivals, has a particular interest in immuno-oncology.
Merck KGaA, GSK pen $4.2B biobucks pact for next-gen Bavencio [Fierce Biotech] One of the most advanced is a midstage test for M7824 pitted against U.S. Merck’s I-O giant Keytruda, as a first-line treatment in patients with PD-L1 expressing advanced non-small cell lung cancer (NSCLC). No small feat given its U.S. rival’s dominance.
GSK and Merck KGaA, Darmstadt, Germany announce global alliance to jointly develop and commercialise M7824, a novel immunotherapy with potential in multiple difficult-to-treat cancers [GSK] Eight high priority immuno-oncology clinical development studies ongoing or expected to commence in 2019, including studies in non-small cell lung and biliary tract cancers.
Xencor to Develop and Commercialize Novel IL-15 Immune Activating Cytokines with Genentech [Xencor] Xencor's IL-15 bispecific cytokine platform provides a more druggable version of IL-15 with potentially superior tolerability, slower receptor-mediated clearance and a prolonged half-life, and is intended for development with a wide range of combination agents due to its proposed mechanism of activating tumor-killing immune cells.
The bispecific boom: Genentech pays $120M to tie the knot with Xencor on an IL-15 alliance [EndPoints] The deal is primarily focused on cancer, but the antibody engineering approach that Xencor brings to the table can be applied in a variety of disease arenas.
GSK pays up to $4.2 billion for Merck KGaA cancer immunotherapy [Reuters] The M7824 drug, a fusion protein that triggers two immune responses to cancer cells, is being tested on 10 tumour types and was recently shown to delay the progression of a certain type of lung cancer for at least 9.5 months in half of the trial participants.
	5.12.2 IMMUNOTHÉRAPIES - CAR-T, THÉRAPIES CELLULAIRES
Gilead drops anti-BCMA CAR-T from Kite, takes $820M charge [Fierce Biotech] The crowded field explains why Gilead took the decision to ax its program but coupled with Yescarta’s sluggish uptake—described as “steady and measured” on the fourth-quarter results call—it is starting to make the Kite deal look increasingly like an expensive gamble.
	5.12.5 IMMUNOTHÉRAPIES - PHARMA
Bolt Bio Bags $54M for Drugs that Turn the Heat Up on “Cold” Tumors [Fierce Biotech] The company’s therapies consist of a tumor-targeting antibody that homes in on tumors and is paired with an immune stimulant that turns cold tumors into hot ones. In preclinical testing, the company says that these immune-stimulating antibody conjugates eliminated tumors. The company has not yet said which cancers it aims to treat.
	5.12.6 IMMUNOTHÉRAPIES - AMM
EMA Adopts a New Indication for Pembrolizumab [ESMO] It is indicated in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of metastatic squamous NSCLC.
	5.2 PHARMA
Roche nabs coveted FDA ‘real-time review’ for key Kadcyla move into early breast cancer [Fierce Pharma] It's Roche’s first drug to be reviewed under that program, which allows the agency to start analyzing trial data as soon as it becomes available, rather than waiting for the company’s formal application.
As Herceptin biosimilars eat into Roche sales, Swiss drugmaker makes case for expanded Kadcyla use [EndPoints] The application is based on data from the late-stage KATHERINE study that showed 88.3% of patients treated with Kadcyla did not see their breast cancer re-emerge versus 77% of those given Herceptin after three years.
	5.2.1 PHARMA - PARTENARIATS
Baeuerle-backed Cullinan grows its pipeline of portfolio plays, adopts a new cancer drug with eye to clinical development [EndPoints] The drug here is TAS6417, an EGFR tyrosine kinase inhibitor, which “spares wild type EGFR.
	5.2.3 PHARMA - ÉCONOMIE
WATCH: What is a biosimilar, exactly? [STAT] Drug companies can file patents not just on biologics themselves but also on how they’re made, how they’re formulated, and how they’re administered. That means the famed “patent cliff” that saw blockbuster pills rendered affordable within days of losing their exclusivity has never come for biosimilars.
	5.5 ASCO
Bayer to Showcase New Data from its Growing Cancer Portfolio at 2019 ASCO GU Cancers Symposium [Bayer] First presentation of data from the pivotal Phase III ARAMIS trial with the investigational compound darolutamide in patients with advanced prostate cancer that has not yet metastasized.
	6.10.1 POLITIQUES (USA)
As Trump calls on Congress to lower drug prices, some Democrats cheer. Others scoff [STAT] President Trump on Tuesday left Congress a two-syllable mandate on the issue of prescription drug pricing: “Do more.” To some Democrats, the words presented an open invitation to collaborate. Others were left confused as to what, exactly, the White House wants.
How Trump’s Latest Plan to Cut Drug Prices Will Affect You [NY Times] The proposal seeks to lower out-of-pocket spending in Medicare by taking aim at the secret deals that drug makers strike with industry go-betweens.
Bipartisan group of lawmakers introduces bill to fight high drug prices [Reuters] Makers of branded drugs have long been accused of refusing to provide samples of drugs on a government list of restricted medicines. Without the samples, generic competitors cannot prove their medicines are as safe and effective as the more expensive versions.
	6.6 PUBLICATIONS
#PIDapalooza19: A Whole Lotta PIDs [The Scholarly Kitchen] In late January, around 150 people gathered in Dublin for PIDapalooza, “the open festival for persistent identifiers” (aka PIDs). To quote one of the attendees, Herbert van de Sompel: “PIDs are not the goal. Long term accessibility of the scholarly record is the goal.”
	6.7.1 IA/BIOINFORMATIQUE
Making New Drugs With a Dose of Artificial Intelligence [NY Times] DeepMind’s victory showed how the future of biochemical research will increasingly be driven by machines and the people who oversee those machines.
	6.7.2 APPLIS
Slack is setting itself up for the $3.5 trillion health-care sector [CNBC] Slack, which confidentially filed to go public Monday, recently updated its security page to note that it is HIPAA compliant, suggesting that it is working toward a use case where health-care providers can begin using it to share sensitive patient health information.