Onco Actu du 14 février 2020

Pour information, Onco Actu interrompt sa parution pendant une semaine. 

Prochain numéro : lundi 24 février

	1. BIOLOGIE
Childhood Brain Tumor Discovery May Unlock New Treatments for Many Cancers [University of Virginia] Researchers at the University of Virginia School of Medicine have determined that the supposedly simple cancer, called medulloblastoma, forms an unexpectedly intricate network to drive its growth. Some tumor cells actually turn into another type of cell altogether. Zong and his colleagues have described their findings in the scientific journal Cell.
	2. ETIOLOGIE
Weight-loss drug to be pulled from market after FDA expresses concerns on cancer risk [STAT] Over the course of the trial, 462 patients, or 7.7%, treated with Belviq were diagnosed with 520 primary cancers compared to the placebo group, in which 423 patients (7.1%) were diagnosed with 470 cancers. The imbalance in cancer increased with longer duration on Belviq, according to the FDA.
8 years after its OK, Eisai yanks its flailing obesity drug from the market after FDA flagged higher cancer rate [EndPoints] Belviq was one of a group of drugs that had originally been cast as blockbusters but failed badly on the market.
FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market [FDA] The U.S. Food and Drug Administration (FDA) has requested that the manufacturer of Belviq, Belviq XR (lorcaserin) voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. The drug manufacturer, Eisai Inc,. has submitted a request to voluntarily withdraw the drug.
	4. DÉPISTAGE, DIAGNOSTIC ET PRONOSTIC
Researchers describe recently discovered condition involving numerous gastrointestinal polyps in childhood cancer survivors [Dana-Farber Cancer Institute] The condition, known as therapy-associated polyposis, or TAP, was first described by Dana-Farber scientists in 2014 based on a group of five patients. The new study presents a deeper look at the condition, based on data from 34 patients at eight cancer centers around the US.
	4.2 DÉP., DIAG. & PRONO. - GÉNOME
There could soon be a test to detect cancer years in advance. Would you take it? [The Guardian] The perfect test would tell you whether the mutations found in you, or your child, are something that you should worry about and take seriously, or whether they are something that can be left alone. This is a huge challenge for scientists, and is many years from being resolved.
	5.1 TRAITEMENTS - PRÉ-CLINIQUE
Scientists stop breast cancer cells from spreading in the lab [University of Manchester] "This discovery is an important milestone in the understanding of how metastatic cancer spreads - though clearly, there’s a long way to go before it has a chance of being translated into effective therapies."
	5.12.2 IMMUNOTHÉRAPIES - CAR-T, THÉRAPIES CELLULAIRES
Bristol-Myers' CAR-T gets priority review, mid-August PDUFA date [Fierce Biotech] Regardless of how competitive the data are, Bristol-Myers still faces the prospect of being the third drug to market in a class that has so far failed to live up to commercial expectations.
Bristol-Myers finds FDA receptive to speedy review of key cell therapy [Biopharma Dive] Liso-cel, which treats a type of lymphoma, was originally developed by biotech Juno Therapeutics before its acquisition by Celgene in 2018. An approval would make it the third CAR-T treatment to reach market after Gilead's Yescarta and Novartis' Kymriah.
U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol-Myers Squibb’s Biologics License Application (BLA) for Lisocabtagene Maraleucel (liso-cel) for Adult Patients with Relapsed or Refractory Large B-Cell Lymphoma [BMS] Application based on results from the TRANSCEND NHL 001 trial, the largest study of CD19-directed CAR T cells to support a BLA to date.
Bristol-Myers checks off another milestone on the Celgene CVR, hustling Yescarta rival to the market [EndPoints] Gilead’s pioneering CAR-T Yescarta was approved in the exact same indication in October 2017 based on similar data from a smaller trial.
	5.12.5 IMMUNOTHÉRAPIES - PHARMA
China National Medical Products Administration grants approval of Roche’s Tecentriq in combination with chemotherapy as first-line treatment of people with extensive-stage small cell lung cancer [Roche] This marks the first approval for a Tecentriq-based therapy in China, less than a year after the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals in this indication.
Roche scores its first PD-L1 win in China, going straight for SCLC niche [EndPoints] Just weeks after AstraZeneca’s Imfinzi became the first and only approved PD-L1 drug in China, regulators have ushered in Roche’s Tecentriq to the checkpoint frenzy.
	5.17 TRAITEMENTS - RADIOTHÉRAPIE
Much shorter radiation treatment found to be safe, effective for people with soft tissue sarcoma [UCLA] UCLA study shows radiation therapy can be cut from 5 weeks to 5 days.
	5.2 PHARMA
Seattle Genetics Announces FDA Filing Acceptance for Priority Review of Tucatinib New Drug Application (NDA) for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer [Seattle Genetics] Supported by Results from Pivotal HER2CLIMB Trial; First Investigational Therapy in a Pivotal Trial to Include Patients with Metastatic HER2-Positive Breast Cancer with Active Brain Metastases.
Seattle Genetics gets another drug close to the finish line [EndPoints] The drug, tucatinib,  is being assessed as part of a combination treatment for locally advanced or metastatic HER2-positive breast cancer. A PDUFA date has been set for August 20, 2020.
	5.2.3 PHARMA - ÉCONOMIE
How will coronavirus hit U.S. drugmakers? Depends what kind of drugmaker you are: Moody's [Fierce Pharma] Pharmas that focus on new meds are “unlikely to encounter material global supply disruptions,” because they don’t have a heavy manufacturing presence in China, Moody’s said.
	5.2.6 PHARMA - BIOTECH
What Happens to University-Based Biotech Startups – And Why [In The Pipeline] University administrators and state legislators are hoping for new economic activity and the benefits thereof, but they reward startup formation itself as if it were necessarily connected. And it isn’t.
	5.2.6.1 PHARMA - BIOTECH - REVOLUTION
Revolution pulls off $238M IPO to push KRAS pipeline into the clinic [Fierce Biotech] The funding will also bankroll a treatment that inhibits SOS1, a protein that spurs the conversion of RAS from the inactive form to the active form, RAS(OFF) to RAS(ON), as well as one that blocks mTOR Complex 1 (mTORC1) to restore the activity of the tumor suppressor 4EBP1.
The cancer genes Wall Street is flooding with cash [Biopharma Dive] The progress has fueled investor optimism in companies going after these genes, known as RAS, with the most recent example coming from a California biotech named Revolution Medicines.
The RAS rush: Revolution Medicines bags remarkable $238M IPO raise, more than doubling original goal [EndPoints] The Redwood City, CA-based biotech had started out focused on an allosteric SHP2 inhibitor dubbed RMC-4630, which Sanofi wagered $50 million upfront to partner on.
	5.2.6.2 PHARMA - BIOTECH - DECIPHERA
Deciphera nabs speedy review for GIST cancer hopeful [Fierce Biotech] Ripretinib came through a phase 3 trial in fourth-line GIST patients last year, generating data to show the broad-spectrum KIT and PDGFRα inhibitor extends progression-free survival (PFS) in a group with limited options. Median PFS in the treatment group came in at 6.3 months as compared to one month in the placebo cohort.
Deciphera Pharmaceuticals Announces U.S. Food and Drug Administration Acceptance of New Drug Application and Priority Review for Ripretinib in Patients with Advanced Gastrointestinal Stromal Tumors [Deciphera] The Company has submitted additional marketing applications in Canada and Australia for ripretinib in advanced GIST.
Deciphera's GIST therapy ripretinib wins speedy FDA review — setting the stage for battle with rival Blueprint [EndPoints] Ripretinib has a breakthrough drug designation, which should speed things along at the FDA that of late has no problem moving ahead of schedule, especially when it comes to oncology therapies for patients with few options.
	5.5.19 ASCO (REIN)
Targeted drug shows promise in advanced kidney cancer [Harvard Gazette] Researchers from Dana-Farber Cancer Institute report a response rate of 24 percent across all risk categories of patients given an oral first-in-class agent that targets hypoxia inducible factor (HIF) 2-a, which promotes new blood vessel growth that fuels kidney tumors. Based on these findings, a phase III trial has been launched.
	5.5.3 ASCO (PROSTATE)
Bayer to highlight data from its expanding cancer portfolio at 2020 ASCO GU Cancers Symposium [Bayer] 18 presentations feature data on radium-223 dichloride, including real-world analyses and investigational combination therapies in men with advanced prostate cancer.
	6.1 OBSERVATION
Saying sex increases cancer risk is neither totally correct, nor in any way helpful [The Conversation] While having a sexually transmissible infection (STI) can increase the risk of certain types of cancer, using a person’s lifetime number of sexual partners as a marker of their likely sexual health history is one of several flaws in this research.
Skin cancer "more common" among gay and bisexual men [NHS Choices] This study is quite limited, because we do not know why people's risk of skin cancer in the study varied according to sexual orientation. It may be, as the authors suggest, that attitudes to safe sun and use of sunbeds vary between groups. But the survey did not ask questions about sunbed use, so we do not know.
Link Between Genetic Variant and Poor Outcomes in Men with Advanced Prostate Cancer Validated [Cleveland Clinic] This study—the first clinical trial validation of the relationship between HSD3B1 status and clinical outcomes—suggests that genetic testing for the presence of HSD3B1(1245C) may help physicians identify those patients most likely to benefit from additional and more aggressive treatment.
	6.10.1 POLITIQUES (USA)
Funding the Global Benefits to Biopharmaceutical Innovation [White House] In this report, we find that foreign “free-riding” on U.S. investments and innovation in drug development has increased over the past 15 years.
The White House review of drug prices: Don't hate the player — hate the game [EndPoints] Foreign nations are sponging off American investment into pharmaceutical R&D and taking advantage of by US patients by systematically underpaying for drugs, a new study by the White House has concluded.