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Roche Takes On Loxo, Bayer In Gene-Defined Cancer Class

(Reuters) Oct 21, 2018 - Roche’s entrectinib cancer pill was shown to shrink tumors in 57 percent of patients within a group that can only be identified via genetic profiling, as the Swiss drugmaker challenges an alliance of Bayer and Loxo Oncology in a new targeted treatment area. The trial results on patients with a gene anomaly known as NTRK fusion, which occurs in less than 1 percent across a range of tumor types, were presented at the annual congress of the European Society for Medical Oncology (ESMO) in Munich on Sunday. Germany’s Bayer and U.S. partner Loxo, in turn, released data for their rival compound larotrectinib, which slightly improved on previous high-efficacy readings in an enlarged trial.

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Immunotherapy Scores a First Win Against Some Breast Cancers

(Associated Press) Oct 20, 2018 - For the first time, one of the new immunotherapy drugs has shown promise against breast cancer in a large study that combined it with chemotherapy to treat an aggressive form of the disease. Results were discussed Saturday at a cancer conference in Munich and published by the New England Journal of Medicine. Drugs called checkpoint inhibitors have transformed treatment of many types of cancer by removing a chemical brake that keeps the immune system from killing tumor cells. Their discovery recently earned scientists a Nobel Prize. Until now, though, they haven’t proved valuable against breast cancer.

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Study Indicates HER2+ Early Breast Cancers Where Shorter-Course Trastuzumab Could Be An Option

(ESMO 2018 Congress) Oct 19, 2019 - Women with HER2-positive early breast cancer with small tumours have similar disease-free survival and lower risk of cardiac toxicity with a nine-week course of adjuvant trastuzumab compared to those treated for one year, according to a subgroup analysis of the Short-HER trial reported at ESMO 2018 Congress in Munich.

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Roche Lands Tecentriq Trial Win, Still Trails Merck In Lung Cancer

(Reuters) Oct 22, 2018 - Roche’s Tecentriq plus chemotherapy boosted lung cancer patients’ survival by nearly five months, study data released on Monday showed, underscoring benefits of the Swiss group’s immunotherapy but still leaving it trailing a rival’s drug.

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Clovis Aims At New Market For Cancer Drug Rubraca

(BioPharma Dive) Oct 19, 2018 - Clovis Oncology, trailing PARP inhibitor rivals AstraZeneca and Tesaro, aims to jump ahead in a new market for the targeted therapies, announcing Friday positive early data for its drug Rubraca in metastatic castration-resistant prostate cancer.

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Olaparib Maintenance Extends Progression-free Survival By Estimated 3 Years In Advanced Ovarian Cancer

(ESMO 2018 Congress) Oct 21, 2018 - Two-year maintenance therapy with olaparib, a PARP (poly ADP ribose polymerase) inhibitor, olaparib, led to a substantial, unprecedented improvement in progression-free survival (PFS) in newly diagnosed patients with advanced ovarian cancer and a BRCA1 or 2 mutation, results from the phase 3 SOLO-1 trial show. “The median PFS for patients who received placebo was only 13.8 months while the median PFS for those who received olaparib was not reached but looks to be approximately three years longer than the placebo group [HR was 0.30; 95% CI: 0.23, 0.41; p<0.0001],” reported Dr Kathleen Moore, Associate Professor at the Stephenson Cancer Center, University of Oklahoma, US, presenting the results at ESMO 2018 Congress.

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Novartis Investigational BYL719 (alpelisib) Plus Fulvestrant Nearly Doubles Median PFS in Patients With PIK3CA Mutated HR+/HER2- Advanced Breast Cancer Compared to Fulvestrant Alone

(Novartis) Oct 20, 2018 - In SOLAR-1 trial, BYL719 plus fulvestrant significantly improved PFS and ORR in these patients, following progression on or after an aromatase inhibitor with or without a CDK4/6 inhibitor, vs. fulvestrant alone. Approximately 40% of HR+ advanced breast cancer patients have a PIK3CA mutation which is associated with poor prognosis; currently there are no treatments that specifically target this mutation. BYL719 is first and only investigational alpha-specific PI3K inhibitor to show superior PFS and predictable, manageable tolerability in patients with PIK3CA mutated HR+/HER2- advanced breast cancer when added to fulvestrant.

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Researchers, Cancer Patients, And Philanthropists Launch “Count Me In”

(Broad Institute) Oct 18, 2018 - Researchers, cancer patients, and philanthropists have come together to launch Count Me In, a new nonprofit organization and model of patient-partnered research. Count Me In allows cancer patients anywhere in the United States or Canada to easily share their medical information, personal experience, and tumor samples for genetic analysis, propelling progress against cancer.

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Oncology Clinical News

Promising Anti-Tumour Activity Demonstrated with First-Line Nazartinib in Adult Patients with EGFR-Mutant NSCLC

(ESMO 2018 Congress) Oct 19, 2018 - Treatment with nazartinib (EGF816), a third generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), provided durable responses in adult patients with EGFR-mutated non-small lung cancer (NSCLC) who had not received prior treatment.

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Patients with Lung Adenocarcinomas and Specific Uncommon EGFR Mutations Have Improved Survival with Chemotherapy Compared to TKIs

(ESMO 2018 Congress) Oct 19, 2019 - Tyrosine kinase inhibitors (TKIs) targeting the epidermal growth factor receptor (EGFR) are a standard treatment in patients with lung adenocarcinomas.

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First-in-Class NBTXR3 Provides a New Option for Preoperative Treatment in Patients with Locally Advanced STS (Act-In-Sarc)

(ESMO 2018 Congress) Oct 19, 2019 - 2019 - More patients with locally advanced soft tissue sarcoma (STS) of the extremity and trunk wall who received treatment with NBTXR3 hafnium oxide nanoparticles activated by radiotherapyshowed a pathological response than patients treated with radiotherapy alone, according to findings presented at the ESMO 2018 Congress in Munich, Germany.

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One in Six Premenopausal Early Breast Cancer Patients Do Not Adhere To Hormonal Therapy

(ESMO 2018 Congress) Oct 19, 2018 - Nearly one in six premenopausal women being treated for early stage breast cancer do not adhere adequately to tamoxifen therapy after one year of treatment, potentially putting themselves at increased risk of recurrence and reduced survival, a French prospective study reports at ESMO 2018 Congress.

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Women More Prone To Selected Oesophagogastric Cancer Chemotherapy Side-Effects

(ESMO 2018 Congress) Oct 19, 2018 - Men and women may need to be treated differently – at least when it comes to some types of cancer. In an analysis to be presented at the ESMO 2018 Congress in Munich, data was pooled from four UK randomised controlled clinical trials (RCTs) of first line chemotherapy in oesophagogastric (OG) cancer, finding significant differences in a number of important side-effects experienced by male and female patients.

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BL-8040 in Combination With Keytruda® (Pembrolizumab) Demonstrated Encouraging Disease Control And Overall Survival In Patients With Metastatic Pancreatic Cancer

(MarketWatch) Oct 19, 2018 - Encouraging results support further development of combination and expansion of collaboration; triple combination expansion cohort (BL-8040 + KEYTRUDA® (pembrolizumab) + chemotherapy) to commence by year-end.

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Takeda to Present Results from Phase 3 ALTA-1L Trial Highlighting Intracranial Efficacy of ALUNBRIG® (brigatinib) Versus Crizotinib in First-Line Advanced ALK+ Non-Small Cell Lung Cancer

(Takeda) Oct 19, 2018 - Takeda Pharmaceutical Company Limited today announced that intracranial efficacy data from the Phase 3 ALTA-1L (ALK in Lung Cancer Trial of BrigAtinib in 1st Line) trial showed improved intracranial progression-free survival (PFS) and intracranial objective response rate (ORR) with ALUNBRIG (brigatinib) compared to crizotinib among anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) patients.

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Project Baseline Aims to Ward Off Illness Before We Get Sick

(New York Times) Oct 18, 2018 - One of the sobering facts about cancer treatment is that it often begins when it is already too late: Studies show that an alarming number of treatable cancers are diagnosed in the advanced stages of disease.

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Researchers Explore a Cancer Paradox

(New York Times) Oct 18, 2018- Healthy cells carry a surprising number of cancer-linked mutations, but they don’t turn into tumors. What’s holding them back?

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Why Some Cancers Affect Only Young Women

(University of Geneva [Switzerland]) Oct 19, 2018 - Among several forms of pancreatic cancer, one of them affects specifically women, often young. How is this possible, even though the pancreas is an organ with little exposure to sex hormones?

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Cancer Patients Can Now Use Skin Creams During Radiation Therapy

(Penn Medicine) Oct 18, 2018 - Contrary to the advice most cancer patients receive when they go through radiation treatment, topical skin treatments, unless applied very heavily, do not increase the radiation dose to the skin and can be used in moderation before daily radiation treatments.

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Oncology Business and Policy News

Securing Access To Optimal Cancer Care Through Innovation, Integration And Sustainability

(ESMO 2018 Congress) Oct 19, 2018 - Securing access to optimal cancer care for all patients can only be achieved through integrated, sustainable translation of today’s scientific advances into tomorrow’s treatments, reinforced by a clear understanding of the magnitude of clinical effects and accurate identification of patients most likely to benefit.

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Huge Variations Between Countries In Time For Reimbursement Decisions On New Cancer Drugs

(ESMO 2018 Congress) Oct 19, 2018 - Some European countries take more than twice as long as others to reach health technology assessment (HTA) decisions to reimburse new cancer drugs following their approval by the European Medicines Agency (EMA). The average decision time is longer than one year in some countries, according to a study to be reported at ESMO 2018 Congress.

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FDA to Update Mammography Regulations

(MedPage Today) Oct 18, 2018 - Set to include revised screening recommendations, breast density information.

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How FDA's Breakthrough Therapy Designation Program Changed the Rare Disease Space

(Rare Disease Report) Oct 17, 2018 - On July 9, 2012, officials signed the Food and Drug Administration Safety and Innovation Act (FDASIA) which had a section within it that established a new designation—the Breakthrough Therapy Designation—which allows for expedited development and review of drugs to treat serious or life-threatening diseases if substantial evidence is provided.

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Opinion: Looking To The Future Of Patient-Centered Cancer Research And Treatment

(Boston Globe) Oct 18, 2018 - Over the past 40 years, cancer research has seen revolutionary discoveries — about genes, targeted drugs, and immune therapies — that have already had dramatic effects for some patients.

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A New Targeted Cancer Company To Watch

(Forbes) Oct 19, 2018 - If you’re paying attention to biotech firms developing targeted cancer drugs — and you should, it’s one of the most medically important, scientifically interesting, and lucrative areas in the sector — Cui's company, TP Therapeutics, is one you should be watching along with existing stories like Loxo Oncology, Agios Pharmaceuticals, and BluePrint Medicines.

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NICE Rejects Lilly’s Breast Cancer Drug Verzenios

(PharmaTimes [UK]) Oct 19, 2018 - As it stands Eli Lilly’s Verzenios will not be routinely funded on the NHS for breast cancer, as cost-regulators have now issued draft guidelines rejecting the drug.

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Can This App Help China's Forgotten Cancer Sufferers?

(CNN) Oct 18, 2018 - A new app in China is hoping to remove some of that demand on oncologists by connecting patients with some of the world's best cancer hospitals and researchers. The app, called Driver, was co-founded by two Harvard trained oncologists and backed financially by Hong Kong billionaire Li Ka Shing, among others.

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Broader Healthcare and Pharma News

Trump Says ‘All Republicans’ Back Protections For Preexisting Conditions, Despite Repeated Attempts To Repeal Obamacare

(Washington Post) Oct 18, 2018 - President Trump expressed support Thursday for one of the most popular provisions of an Obama-era law protecting people with preexisting conditions, even as he has repeatedly promised to scrap the law and his administration is waging a legal fight to overturn it.

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Opinion: The Trump Administration’s Latest Plan To Lower Drug Prices Is Hollow — And Maybe Counterproductive

(Washington Post) Oct 18, 2018 - It might even hurt patients.

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Advancing Toward the Goal of Global Approval for Generic Drugs: FDA Proposes Critical First Steps to Harmonize the Global Scientific and Technical Standards for Generic Drugs

(FDA.gov/FDA Voices) Oct 18, 2018 - The FDA launched a Drug Competition Action Plan that focuses on three key areas designed to facilitate more generic competition, promote patient access, and improve the economics of developing generic medicines.

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An FDA Expert Panel Chairman Defies His Own Panel For Endorsing An Opioid Painkiller

(STAT Plus) Oct 18, 2018 - In an unusual move, the chair of a Food and Drug Administration panel is defying a recommendation that his own panel made last week to endorse a powerful opioid painkiller, because he believes the drug represents a “danger” to public health. And to make sure his views are known, Dr. Raeford Brown, the panel chair, conveyed his concerns in a letter on Thursday to FDA officials.

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AbbVie Commits $100M to Morphic in Fibrosis Drug R&D Alliance

(Xconomy Boston) Oct 18, 2018 - AbbVie is positioning itself to add fibrosis drugs to its pipeline through a new research and development partnership with startup Morphic Therapeutics.

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