Onco Actu du 3 mars 2020

	1. BIOLOGIE
Science Surgery: ‘Are benign tumours different from cancerous tumours?’ [Cancer Research UK] Smith says the definition is less clear cut in his area of expertise, brain tumours. “Even with the most malignant, fastest growing brain tumours, it’s pretty rare for them to spread elsewhere in the body.”
	2.13 ETIOLOGIE - NDMA
Testing lab challenges FDA findings that carcinogens in metformin do not exceed acceptable levels [Fierce Pharma] Valisure said it tested 38 batches of diabetes medicine metformin from 22 companies and found 16 batches from 11 companies had the suspected carcinogen NDMA exceeding the FDA’s acceptable daily level of 96 ng.
	3.1.1 PRÉVENTION - TABAC - E-CIGS
Is vaping safe? What the latest research says about the cigarette substitute [The Telegraph] On one side, we have Public Health England (PHE), which , since 2015, has been encouraging smokers to take up vaping as an aid to quitting. And in the other corner is the World Health Organisation (WHO), which is damning of the practise.
	4.1 DÉP., DIAG. & PRONO. - PROSTATE
Before Prostate Surgery, Consider ‘Active Surveillance’ [NY Times] Not to be confused with “watchful waiting,” active surveillance is not a do-nothing approach. Rather, patients are routinely monitored and referred for surgery or radiation therapy only if their cancer begins to grow or show molecular signs of aggression.
	4.2 DÉP., DIAG. & PRONO. - GÉNOME
Mayo researchers recommend all women with breast cancer diagnosis under age 66 be offered genetic testing [Mayo Clinic] For their study, Dr. Couch and his colleagues evaluated all known breast cancer predisposition genes in a Mayo Clinic breast cancer registry and showed that NCCN guidelines overlooked approximately 30% of patients with genetic mutations known to increase the risk of developing breast cancer.
	4.9 DÉP., DIAG. & PRONO. - SEIN
Study: AI improves radiologists’ readings of mammograms [UW Medicine] The study was based on results from the Digital Mammography (DM) DREAM Challenge, a crowd-sourced competition to engage an international scientific community to assess whether artificial intelligence (AI) algorithms could meet or beat radiologist interpretive accuracy.
	5.12.10 IMMUNOTHÉRAPIES - FUSIONS ET ACQUISITIONS
Gilead strikes $4.9B Forty Seven acquisition, paying a hefty premium for cancer drug [Fierce Biotech] Forty Seven set up shop in 2015 to build on evidence of the role of CD47 in immune evasion that Irv Weissman and his colleagues at Stanford University generated.
Gilead Boosts Cancer Drug Pipeline With $4.9B Deal for Forty Seven [Xconomy] The company takes its name from CD47, which is overexpressed on cancer cells and is the target of its drugs.
Gilead breaks M&A lull with $5B immuno-oncology deal [Biopharma Dive] The most advanced of Forty Seven's drugs, an antibody called magrolimab, is in early- to mid-stage testing for a variety of blood cancers, including acute myeloid leukemia and B cell lymphoma, as well as solid tumors in the bladder, ovaries, rectum and colon.
	5.12.11 IMMUNOTHÉRAPIES - PRÉ-CLINIQUE
Vitamin C and Immuno-oncology [In The Pipeline] But if this work makes some headlines of the “Linus Pauling was right” sort, don’t believe them. Pauling was right about a lot of things, but like many bold scientific thinkers, when he was wrong he was wrong in grand fashion. And he was wrong about vitamin C and cancer.
	5.12.2 IMMUNOTHÉRAPIES - CAR-T, THÉRAPIES CELLULAIRES
FDA Accepts MorphoSys' Biologics License Application (BLA) and Grants Priority Review for Tafasitamab and Lenalidomide for the Treatment of Relapsed/Refractory DLBCL (news with additional features) [MorphoSys] Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19.
MorphoSys’ off-the-shelf rival to CAR-T approaches finish line with a speedy review [EndPoints] CAR-T therapies, custom-made from the extracted and then re-injected cells of each patient, have been consistently hampered by their lengthy and costly manufacturing process. Tafasitamab is an antibody that can be scaled, stored and taken, essentially, off-the-shelf when a patient needs it.
	5.12.5 IMMUNOTHÉRAPIES - PHARMA
Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Progression-Free Survival Compared with Brentuximab Vedotin in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (cHL) [Merck] Per the pre-specified analysis plan, the other dual primary endpoint of overall survival (OS) was not formally tested at this interim analysis. The study will continue to evaluate OS.
Merck clears PFS endpoint in confirmatory trial for Keytruda in classical Hodgkin lymphoma [EndPoints] The study, KEYNOTE-204, will continue to evaluate the other co-primary endpoint of overall survival. Results will be presented at an upcoming medical meeting.
	5.12.5.1.1 IMMUNOTHÉRAPIES - BIOTECH - IMMUNOCORE
Immunocore raises $130M to fund pivotal cancer program [Fierce Biotech] The anti-cancer assets are bispecifics that feature a T cell receptor (TCR)-targeting system and an anti-CD3 antibody fragment.
Woodford who? TCR-focused Immunocore soldiers on with $130M+ B round [EndPoints] “You see the success of the checkpoint inhibitors in cancer, but they’re still addressing only the antigen-specific T cells,” she said. “Our technology can bring any T cells and render them, if you will, killer cells to kill the tumor cells.”
	5.12.5.1.2 IMMUNOTHÉRAPIES - BIOTECH - XILIO
Akrevia no more, Xilio Therapeutics bags $101M for I-O programs [Fierce Biotech] With technology licensed from City of Hope and Thomas Jefferson University, Xilio is creating tumor-selective treatments that stay “turned off” or “dark” in the body until they reach the tumor microenvironment, where they “turn on.”
Xilio Unveils New Name, $100M to Bring Targeted Cancer Drugs to Clinic [Xconomy] Lead Xilio program XTX101 is an antibody that blocks CTLA-4, a receptor that acts like a brake on immune responses. It’s the same target as ipilimumab (Yervoy), a Bristol-Myers Squibb drug that became the first so-called checkpoint inhibitor to become approved by the FDA.
Ex nihilo: Takeda leads $100M+ round to fund biotech's sneak attack on tumors, propelling new IL-2, CTLA-4 drugs to clinic [EndPoints] Xilio’s protein engineering approaches shield the binding activity of molecules while they are travelling around the body, explained Tim Clackson, president and head of R&D. Once they meet the proteases in the tumor, the blocking modules are removed, releasing the therapy just where it’s needed.
	5.2 PHARMA
AbbVie, Roche's Venclexta endangers AML approval with flopped confirmatory trial [Fierce Pharma] The newest failure could dent AbbVie and Roche's attempts to bring Venclexta outside of the profitable chronic lymphocytic leukemia (CLL) market where it's made its name.
Takeda Receives Positive CHMP Opinion for ALUNBRIG® (brigatinib) as a First-Line Treatment for ALK+ Non-Small Cell Lung Cancer [Takeda] Positive Opinion is Based on Data from Phase 3 ALTA-1L Trial, in which ALUNBRIG Demonstrated Superiority in both Overall and Intracranial Efficacy Compared to Crizotinib.
	5.2.6 PHARMA - BIOTECH
ORIC Pharma Plans IPO to Test Therapies for Drug-Resistant Cancers [Xconomy] The company’s lead drug, ORIC-101, is under evaluation in Phase 1b studies in combination with enzalutamide (Xtandi) in prostate cancer and nab-paclitaxel (Abraxane) in advanced or metastatic solid tumors. Interim data from each trial are expected in 2021.
	5.2.6.1 PHARMA - BIOTECH - KARYOPHARM
Karyopharm shares jump on positive study data for multiple myeloma drug [Biopharma Dive] In a study known as BOSTON, adding Xpovio to a common myeloma treatment regimen reduced the risk of disease progression or death by 30% versus using the regimen without Karyopharm's drug.
Karyopharm Announces Phase 3 BOSTON Study Meets Primary Endpoint with Significant Increase in Progression-Free Survival in Patients with Multiple Myeloma Following One to Three Prior Lines of Therapy [Karyopharm] The full top-line data will be submitted for presentation at upcoming medical meetings.
Karyopharm spotlights PhIII results after controversial FDA approval [EndPoints] The numbers help clarify long-running questions about the drug’s efficacy, but they continue to show nearly three quarters of patients suffer from severe adverse events.
	5.3.4 TRAITEMENTS - AMM (FDA, EMA,...)
Sanofi wins US approval for myeloma drug key to its cancer ambitions [Biopharma Dive] Approval of Sarclisa comes eight weeks ahead of schedule, making the antibody another example of the FDA's recent urgency to wave through new medicines.
Ending a grueling 10-year drought, Sanofi finally wins an OK for an in-house cancer drug [EndPoints] Berger notes that the approval also marks a key turning point for the company as it makes immunology and oncology a key focus for the pharma giant. Their PD-1 out of the Regeneron partnership is a backbone therapy they hope to build a number of cancer franchises around.
FDA approves isatuximab-irfc for multiple myeloma [FDA] ICARIA-MM (NCT02990338), a multicenter, multinational, randomized, open-label, two-arm, phase 3 study in 307 patients with relapsed and refractory multiple myeloma who had received at least two prior therapies including lenalidomide and a proteasome inhibitor.
	6. LUTTE CONTRE LES CANCERS
Squaring up to silent tumours: the research burden of pancreatic cancer [Institute of Cancer Research] There is a clear unmet need when it comes to pancreatic neuroendocrine cancer – we know that patients diagnosed with pancreatic tumours are not seeing the same improvements in treatment that we see for other cancer types.”