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Featured Oncology News

Imfinzi Demonstrates Clinical Activity In Stage IV, 1st-Line Non-Small Cell Lung Cancer In Phase III MYSTIC Trial

(BioSpace) Dec 13, 2018 - AstraZeneca and MedImmune, its global biologics research and development arm, have presented overall survival (OS) and progression-free survival (PFS) data from the Phase III MYSTIC trial at the European Society for Medical Oncology (ESMO) Immuno-Oncology 2018 Congress in Geneva, Switzerland. The MYSTIC trial evaluated Imfinzi (durvalumab) monotherapy and the combination of Imfinzi plus tremelimumab, an anti-CTLA4 antibody, versus standard-of-care (SoC) platinum-based chemotherapy in previously-untreated patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC).1 Results show that Imfinzi monotherapy demonstrated clinical activity with an OS hazard ratio (HR) of 0.76 (97.54% CI 0.564-1.019; nominal p=0.036) in the primary analysis population of patients whose tumours express PD-L1 on 25% or more of their cancer cells, but this result did not meet statistical significance.

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Second-Line Nivolumab Is Not Superior to Chemotherapy in SCLC

(ESMO I-O Congress) Dec 13, 2018 - Treatment with the anti-PD1 antibody, nivolumab, did not improve response rates or survival over standard chemotherapy in patients with metastatic small-cell lung cancer (SCLC) who relapsed following first-line treatment, according to findings presented at the ESMO Immuno-Oncology Congress 2018 in Geneva, Switzerland. Martin Reck of the Lung Clinic Grosshansdorf, German Centre of Lung Research in Grosshansdorf, Germany noted that, although patients with SCLC often show high initial response rates, most patients will relapse soon after first-line treatment. These relapsing patients have few treatment options leaving them with a poor prognosis. Professor Reck and colleagues conducted the CheckMate 331 (NCT02481830) study evaluating nivolumab, which has been approved in the USA for treatment of patients with SCLC and progression after platinum-based chemotherapy and one or more other lines of treatment.

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Oncology Clinical News

Patients With Lower-Stage Small-Cell Lung Cancer Do Better

(Reuters Health/Medscape Medical News) Dec 14, 2018 - Patients with stage I to II small-cell lung cancer (SCLC) treated with chemoradiotherapy have better outcome than those with stage III disease, according to a secondary analysis of a randomized clinical trial.

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As Surgeons Tout Robot-Assisted Breast Cancer Surgeries, Safety Remains A Question

(Hartford Courant/Philadelphia Inquirer) Dec 14, 2018 - Is doing major surgery through small incisions better for the patient than more traumatic traditional methods?

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Exercise Significantly Cuts the Risk of Death from Cancer

(RPCCC) Dec 13, 2018 - New research out of Roswell Park Comprehensive Cancer Center shows that cancer patients who exercise regularly both before and after their diagnosis are significantly more likely to survive than those who are sedentary.

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Study Confirms Known Association Between Lupus and Cancer Risk

(The Lupus Foundation) Dec 13, 2018 - New research published in Arthritis Research & Therapy evaluates the link between lupus and cancer risk, supporting the data from earlier studies.

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Idera Pharmaceuticals Presents Clinical Safety and Efficacy Update from the ILLUMINATE-204 Trial of the Combination of Tilsotolimod and Ipilimumab for Unresectable or Metastatic Melanoma Following Failure of PD-1 Inhibitor Treatment

(NASDAQ) Dec 14, 2018 - Idera Pharmaceuticals, Inc. today is presenting data from the ongoing phase 2 expansion of the ILLUMINATE-204 trial investigating tilsotolimod, Idera’s intratumorally-delivered toll-like receptor 9 (TLR9) agonist, in combination with ipilimumab (Yervoy®*).

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Vargatef® Plus Docetaxel Could Be An Option After Failure Of Immunotherapy In Lung Cancer

(Boehringer Ingelheim) Dec 14, 2018 - Results from a real-world study support a recent update to the ESMO guidelines recommending nintedanib (Vargatef®) plus docetaxel following first-line chemotherapy (+/- immunotherapy) in advanced NSCLC of adenocarcinoma histology.

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Bellicum Reports Safety Results and Promising Activity of Its Controlled CAR-T Candidate BPX-601 in Patients with Advanced Pancreatic Cancer at ESMO-IO

(NASDAQ) Dec 14, 2018 - Bellicum Pharmaceuticals, Inc. today reported safety and promising activity of BPX-601 in Part 1 of a Phase 1/2 dose-escalation study in patients with advanced, metastatic pancreatic cancer expressing PSCA (prostate stem cell antigen).

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Leap Therapeutics Presents TRX518 Data at ESMO Immuno-Oncology Congress 2018 and Updated Data from DKN-01 Study in Biliary Tract Cancer

(Leap Therapeutics) Dec 14, 2018 - Leap Therapeutics, Inc. today presented clinical data from its ongoing Phase I/II study of TRX518 in combination with gemcitabine, Keytruda (pembrolizumab), or Opdivo (nivolumab) in patients with advanced solid tumors at the European Society for Molecular Oncology (ESMO) Immuno-Oncology Congress 2018.

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Oncology Business and Policy News

FDA Issues Warning About Differentiation Syndrome With Two IDH Inhibitors

(Clinical Oncology News) Dec 13, 2018 - The FDA issued a boxed warning for differentiation syndrome for two isocitrate dehydrogenase (IDH) inhibitors recently approved to treat acute myeloid leukemia (AML)—enasidenib and ivosidenib.

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Guardant Health Partners with AstraZeneca to Develop Blood-Based Companion Diagnostic Tests for Tagrisso and Imfinzi

(Yahoo! Finance) Dec 13, 2018 - Guardant Health announced a multi-year agreement with AstraZeneca to develop blood-based companion diagnostic (CDx) tests supporting the commercialization of AstraZeneca’s oncology portfolio based on Guardant’s industry-leading comprehensive liquid biopsy platform.

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CHMP Grants Positive Opinion for New Indication of Clovis Oncology’s Rubraca® (rucaparib) Tablets as Maintenance Treatment for Women with Relapsed Ovarian Cancer

(Yahoo! Finance) Dec 13, 2018 - European Commission (EC) marketing authorization is anticipated Q1 2019.

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Genmab Announces Submission of Supplemental New Drug Application for Daratumumab in Front Line Multiple Myeloma in Japan

(Associated Press) Dec 14, 2018 - Supplemental new drug application submitted in Japan for daratumumab in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplant. Submission based on data from Phase III ALCYONE study.

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Single-Cell Sequencing Startup Mission Bio Raises $30 Million

(Forbes) Dec 13, 2018 - The South San Francisco-based company’s machine and software, called the “Tapestri platform,” launched commercially last October and has since been put to use studying cellular mutations inside tumors of diseases like acute myeloid leukemia at cancer research centers and at pharmaceutical companies.

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Health Care Firm Expands With Acquisition Worth At Least $125M

(Business Observer Florida) Dec 13, 2018 - Fort Myers-baed NeoGenomics purchases Genoptix of Carlsbad, Calif., to expand its footprint into oncology practices.

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Navigating Cancer Hires Long-Time Tech Exec Bill Bunker To Lead Oncology Patient Management Startup

(GeekWire) Dec 12, 2018 - Navigating Cancer has hired longtime technology executive Bill Bunker as CEO to help the Seattle-based company “realize the vision” for its oncology patient management software platform.

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2018 ASH Advocacy Efforts to Ensure Patient Access to Care

(ASH) Dec 11, 2018 - In 2018, ASH worked to ensure patient access to care through a number of methods including ensuring drug access, pain management-related issues, and the Affordable Care Act.

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Broader Healthcare and Pharma News

N.I.H. to Scrutinize Private Donations to Scientific Research Projects

(New York Times) Dec 13, 2018 - After halting a discredited alcohol study, officials will enforce new policies to ensure that private support does not compromise scientific integrity.

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Mapping the Brain’s Genetic Landscape

(New York Times) Dec 13, 2018 - Scientists have taken a step toward building a computer model of the brain’s genome, one that may help clarify the genetic roots of schizophrenia, autism and other disorders.

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The Financial Impact Of Big Medical Bills

(Axios) Dec 13, 2018 - In any given year, one in six families will make an "extraordinary health care payment," according to a new study in Health Affairs.

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