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AstraZeneca Digs Deeper Into Cancer With Innate Stake

(Reuters) Oct 23, 2018 - AstraZeneca is plowing deeper into cancer immunotherapy through a wide-ranging deal with Innate Pharma, which includes the British group buying a 9.8 percent stake in the French biotech company. Tuesday’s agreement is a coup for Innate - run by former AstraZeneca executive Mondher Mahjoubi - which gains rights to sell AstraZeneca’s newly approved rare blood cancer drug Lumoxiti as its first commercial product. AstraZeneca’s purchase of 6.26 million new shares in Innate at a price of 10 euros each, or double the market rate, marks a vote of confidence in the cancer immunotherapy specialist and Innate shares jumped 29 percent on the deal news.

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ESMO ’18: Precision Meds, Breast, Lung, and More from the Cancer Front

(Xconomy National) Oct 23, 2018 - The European Society for Medical Oncology is wrapping up its annual conference today, replete with clinical data from cancer’s front lines. We’ve sorted the headlines into a few big categories: immunotherapy combinations, breast cancer, lung cancer, the growing class of drugs called PARP inhibitors, and new drugs that treat tumors based on genetic signature. Patients with two different types of breast cancer got promising news at ESMO from studies exploring relatively new methods of treatment. Drugs that boost a patient’s immune system to fight back against cancer have been approved to fight several types of cancer and have even become a first-line option against some advanced lung and kidney cancers. But experimental results unveiled over the weekend are the first in immunotherapy to show a survival benefit in breast cancer, which causes the second-most cancer deaths among U.S. women.

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Spectrum Pharmaceuticals Receives FDA Approval of KHAPZORY™ (levoleucovorin) for injection

(Spectrum) Oct 23, 2018 - Spectrum Pharmaceuticals, Inc., a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that the U.S. Food and Drug Administration (FDA) has approved KHAPZORY (levoleucovorin) for injection, a folate analog for three indications: • Rescue after high-dose methotrexate therapy in patients with osteosarcoma. • Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination. • The treatment of patients with metastatic colorectal cancer in combination with fluorouracil.

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You Can Cut Your Cancer Risk By Eating Organic, A New Study Says

(CNN) Oct 22, 2018 - You can protect yourself from cancer by eating organic, a new study suggests. Those who frequently eat organic foods lowered their overall risk of developing cancer, a study published Monday in JAMA Internal Medicine finds. Specifically, those who primarily eat organic foods were more likely to ward off non-Hodgkin lymphoma and postmenopausal breast cancer compared to those who rarely or never ate organic foods. Led by Julia Baudry, an epidemiologist at Institut National de la Sante et de la Recherche Medicale in France, a team of researchers looked at the diets of 68,946 French adults.

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Oncology Clinical News

Palbociclib in Breast Cancer: New Overall Survival Data

(Medscape Medical News) Oct 21, 2018 - The new class of cyclin-dependent kinase (CDK) 4/6 inhibitors offer hope for patients with advanced breast cancer who have stopped responding to endocrine therapy.

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Details of Study That Led to Radium-223 Restriction in Europe

(Medscape Medical News) Oct 20, 2018 - Details of the ERA 223 clinical trial that led to a restriction in Europe of the use of the radiopharmaceutical radium-223 dichloride (Ra-223; Xofigo, Bayer) have now been presented here at the European Society for Medical Oncology (ESMO) 2018 Congress.

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Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Demonstrates Durable Four-Year Survival Benefits in Patients with Advanced Melanoma

(BMS) Oct 22, 2018 - Bristol-Myers Squibb Company today announced four-year data from the Phase 3 CheckMate -067 clinical trial – the longest follow-up to date – which continues to demonstrate durable, long-term survival benefits with the first-line combination of Opdivo (nivolumab) and Yervoy (ipilimumab), versus Yervoy alone, in patients with advanced melanoma.

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Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Results in Significantly Longer Treatment-Free Survival in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

(BMS) Oct 22, 2018 - Bristol-Myers Squibb Company today announced the results of a new analysis from the Phase 3 CheckMate -214 study, demonstrating that therapy with Opdivo (nivolumab) plus Yervoy (ipilimumab) in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC) was associated with significantly longer treatment-free survival (TFS).

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Kura Oncology Presents Update on Positive Phase 2 Trial of Tipifarnib in HRAS Mutant HNSCC and Preliminary Results in HRAS Mutant SCC

(Kura Oncology) Oct 22, 2018 - Kura Oncology, Inc., a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, today reported updated preliminary results from a Phase 2 clinical trial of its lead product candidate, tipifarnib, in squamous cell carcinomas with HRAS mutations.

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Incyte Announces Positive Interim Data from Phase 2 Trial of Pemigatinib, Its Selective FGFR Inhibitor, in Patients with Cholangiocarcinoma

(NASDAQ) Oct 21, 2018 - Incyte Corporation announces updated data from its ongoing Phase 2 FIGHT-202 trial evaluating pemigatinib (INCB54828), its selective fibroblast growth factor receptor (FGFR) inhibitor, in patients with advanced/metastatic or surgically unresectable cholangiocarcinoma (bile duct cancer) who failed at least one previous treatment.

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Dynavax’s SD-101 in Combination with KEYTRUDA® (pembrolizumab) Continues to Show a 70% Overall Response Rate in Advanced Melanoma Patients According to Data Presented Today at the ESMO 2018 Congress

(Dynavax) Oct 20, 2018 - Dynavax Technologies Corporation today presented interim data from its ongoing Phase 1b/2 SYNERGY-001 study investigating SD-101, Dynavax's intratumoral TLR9 agonist, in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy developed by Merck (known as MSD outside the United States and Canada) in patients with advanced melanoma naïve to anti-PD-1/L1 therapy.

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QED Therapeutics Presents Data for Infigratinib in Cholangiocarcinoma in Late Breaking Abstract at the European Society of Medical Oncology 2018 Congress

(The Business Journals) Oct 19, 2018 - QED Therapeutics today announced the presentation of positive, updated interim data of infigratinib (BGJ398), an orally administered, selective fibroblast growth factor receptor (FGFR) 1-3 tyrosine kinase inhibitor, for the treatment of advanced or metastatic cholangiocarcinoma (bile duct cancer) during a late-breaking poster discussion at the European Society for Medical Oncology (ESMO).

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Merck KGaA, Darmstadt, Germany, Presents Updated Results for Bifunctional Immunotherapy M7824 at ESMO 2018 Congress

(Merck KGaA) Oct 22, 2018 - New data include first disclosure of results for M7824 in advanced squamous cell carcinoma of the head and neck, biliary tract cancer and esophageal cancers; updated data also being presented include non-small cell lung cancer and gastric cancer; M7824 is a bifunctional immunotherapy designed to bring together transforming growth factor-β and anti-PD-L1 mechanisms.

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Exelixis Announces Results from the Dose-Escalation Stage of the Phase 1b COSMIC-021 Study of Cabozantinib in Combination with Atezolizumab in Previously Untreated Advanced Renal Cell Carcinoma

(Exelixis) Oct 22, 2018 - Combination of cabozantinib and atezolizumab is well tolerated and shows promising anti-tumor activity; safety and efficacy data support 18 expansion cohorts evaluating the combination in 12 different tumor types.

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TESARO Announces Data Presentations at ESMO 2018 Congress

(NASDAQ) Oct 20, 2018 - Data presented indicate that TSR-042 (anti-PD-1 antibody) is well tolerated and has robust activity in patients with MSI-H endometrial cancer; PRIMA safety data for individualized niraparib dose regimen presented; Top-line results for PRIMA trial of niraparib in first-line ovarian cancer regardless of biomarker status expected in late 2019.

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Drugs For Treating Breast Cancer In Women Are Effective And Well Tolerated In Men

(ESMO 2018 Congress) Oct 21, 2018 - There is growing evidence that drugs approved for the treatment of breast cancer in women are also effective and well tolerated in men, according to the largest real-life study yet to investigate treatment and outcomes in men with breast cancer (1) and two further studies reported at ESMO 2018 Congress.

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New Research Shows Benefits Of Exercise For First Time In Advanced Lung Cancer

(ESMO 2018 Congress) Oct 20, 2018 - Most people with lung cancer are unaware of the benefits of regular exercise, yet new data show it can significantly reduce fatigue and improve well being. Results of two studies to be presented at the ESMO 2018 Congress in Munich (1,2) underline the value of exercise, including in patients with advanced or metastatic lung cancer.

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Immunotherapy Is Safe And Feasible In Cancer Patients Treated For HIV, Study Suggests

(ESMO 2018 Congress) Oct 20, 2018 - Immunotherapy has been a major breakthrough in oncology, with registered drugs now approved for use in an increasing number of tumour types – but little is known about its safety for HIV-positive cancer patients.

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High-dose Radiation Therapy Substantially Improves Survival In Patients Once Thought To Be Incurable

(ASTRO 2018) Oct 17, 2018 - In the first randomized, phase II clinical trial of its kind, researchers have shown that an aggressive form of high-precision radiation therapy can greatly increase how long oligometastatic patients live and doubles how long they live without cancer.

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Aggressive Treatment For Some Stage IV Lung Cancer Patients Can Dramatically Improve Overall Survival

(ASTRO 2018) Oct 21, 2018 - Adding radiation therapy or surgery to systemic therapy for stage IV lung cancer patients whose cancer has spread to a limited number of sites can extend overall survival time significantly, according to new results from a multicenter, randomized, controlled phase II study.

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Radiation Therapy Outcomes Better For African-American Prostate Cancer Patients Than Caucasian Patients

(ASTRO 2018) Oct 22, 2018 - While popular beliefs and population data suggest that African-American men are at higher risk of dying from prostate cancer than Caucasian men, a new analysis of genetic data from a large prospective registry and clinical data from several randomized trials indicates that African-American patients may have comparatively higher cure rates when treated with radiation therapy.

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Combined Therapy Including Pelvic Lymph Node Radiation Provides Significant Benefit For Prostate Cancer Patients

(ASTRO 2018) Oct 22, 2018 - The first report of a large international clinical trial shows that, for men who show signs of prostate cancer after surgical removal of their prostates, extending radiation therapy to the pelvic lymph nodes combined with adding short-term hormone therapy to standard treatment can extend the amount of time before their cancer spreads.

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Short-Term Androgen-Deprivation Therapy with Radiotherapy Improves Survival over Radiotherapy Alone for up to 10 Years among Men with Early Stage Prostate Adenocarcinoma

(NRG Oncology) Oct 22, 2018 - Short-term androgen-deprivation therapy with radiotherapy improves survival over radiotherapy alone for up to 10 years among men with early stage prostate adenocarcinoma.

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Patient Reported Outcomes on NRG-RTOG 0232 Indicate Brachytherapy Alone is the Superior Treatment for Men with Intermediate Risk Prostate Cancer

(NRG Oncology) Oct 21, 2018 - Patient reported outcomes on NRG-RTOG 0232 indicate brachytherapy alone is the superior treatment for men with intermediate risk prostate cancer.

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Men with Low- And Intermediate-Risk Prostate Cancer Can Safely Benefit From Fewer, Higher-Dose Radiation Treatments

(ASTRO 2018) Oct 22, 2018 - Stereotactic body radiation therapy (SBRT) is a safe and effective treatment for men with low- and intermediate-risk prostate cancer, according to a long-term, multi-institutional study. The study clears the way for patients who may wish to shorten their course of treatment without fear of increasing their risk for severe, adverse side effects.

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Long-Term Side Effects Similarly Low For Once-Weekly and Conventional Breast Radiation Therapies, Trial Finds

(ASTRO 2018) Oct 21, 2018 - In a 10-year study of women who received radiation therapy to treat early-stage breast cancer, those receiving fewer, larger individual doses experienced similarly low rates of late-onset side effects as those undergoing conventional radiation therapy.

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Radiation Therapy Cuts Low Risk Of Recurrence By Nearly Three-Fourths For Patients With “Good Risk” Breast Cancer

(ASTRO 2018) Oct 21, 2018 - A subset of patients with low-risk breast cancer is highly unlikely to see cancer return following breast conservation surgery but can lower that risk even further with radiation therapy, finds a new long-term clinical trial report.

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High-dose, High-Precision Radiation Therapy Safe And Effective For Kidney Cancer Patients With Only One Kidney

(ASTRO 2018) Oct 22, 2018 - Treatment of renal cell carcinoma with stereotactic radiation therapy is as safe and effective for patients with one kidney as it is for those who have two, according to an analysis of the largest-ever, international dataset of solitary kidney patients to receive this emerging treatment.

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HPV Blood Test Shows Promise For Tracking Head And Neck Cancer After Treatment

(UNC Lineberger) Oct 23, 2018 - A new blood test developed by University of North Carolina Lineberger Comprehensive Cancer Center researchers shows promise for tracking HPV-linked head and neck cancer patients to ensure they remain cancer-free after treatment.

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New Stem Cell Research Aims To Stop Boys Losing Fertility After Childhood Cancer Treatment

(Forbes) Oct 22, 2018 - Researchers have found a way to make sperm from sperm stem cells in mice, giving hope that young boys treated for childhood cancer who are frequently left infertile, may be able to have children as adults.

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Oncology Business and Policy News

Bristol-Myers Faces a Costly Delay

(Wall Street Journal) Oct 22, 2018 - In lung cancer, one of the drug industry’s most lucrative and competitive markets, delays can be expensive.

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Bipartisan Group of More Than 100 Lawmakers Urges Improvements to Prior Authorization Under Medicare Advantage

(ASCO in Action) Oct 22, 2018 - A bipartisan group of more than 100 members of the U.S. House of Representatives signed a letter to Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma urging the Agency to review and improve prior authorization practices under Medicare Advantage (MA).

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Oncologists Demand More Education On The Use Of Biosimilars: ESMO Takes Action

(ESMO 2018 Congress) Oct 20, 2018 - Biological medicines are responsible for some of the most promising innovations in cancer treatment, including immunotherapy, targeted drugs and vaccines – but they are also expensive.

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Barriers To Early Clinical Trial Access For Adolescents And Young Adults Still Exist, Study Shows

(ESMO 2018 Congress) Oct 21, 2018 - Arbitrary age limits for participation prevent young patients from entering trials designed for their tumour type.

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A 2015 Guideline Recommending Removal of Only Half the Thyroid Gland Grows in Use, Benefits Patients with Thyroid Cancer

(American College of Surgeons) Oct 22, 2018 - Study findings show a growing trend among surgeons to shift to a less invasive operation, with fewer risks for thyroid cancer patients.

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Young Women With Breast Cancer Face A Frightening Diagnosis And Bigger Financial Burden

(CNBC) Oct 23, 2018 - The costs of breast cancer fall more heavily on younger women, who have several financial headwinds. They may also be paying down student debt or buying first homes. They haven’t had as much time to accumulate emergency funds. Since they aren’t as far along professionally, they usually earn less.

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Judge Reduces Jury Award Against Bayer’s Roundup to $78.5 Million

(Wall Street Journal) Oct 23, 2018 - A California judge reduced by more than $200 million a jury verdict linking Bayer’s Roundup weedkiller to cancer but upheld the jury’s findings that the company acted with malice.

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Broader Healthcare and Pharma News

Trump Administration Allows ACA Subsidies For Leaner Health Plans

(Washington Post/PowerPost) Oct 22, 2018 - The Trump administration is further moving to roll back the Affordable Care Act by allowing its insurance subsidies to be used for leaner health plans that don’t cover a full range of benefits.

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As Powerful New Opioid Nears FDA Approval, Critics Ask If U.S. Is Stoking Its Drug Crisis

(MarketWatch) Oct 23, 2018 - A new, potent opioid medication intended for quick pain relief has become the center of a maelstrom of controversy as the drug nears a U.S. Food and Drug Administration approval decision.

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Bain Capital Teams With Pfizer To Create New Neuroscience-Focused Company

(CNBC) Oct 23, 2018 - Diseases of the central nervous system — from Alzheimer's to Parkinson's to Lou Gehrig's disease — have been incredibly difficult for drug developers to crack.

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Biogen, UCB Drug Misses Primary Endpoint in Phase 2 Study

(Morningstar/Dow Jones Newswires) Oct 23, 2018 - Biopharmaceutical companies Biogen Inc. and UCB S.A. on Tuesday said a phase 2 study of dapirolizumab pegol, or DZP, in the autoimmune disease systemic lupus erythematosus failed to meet its primary endpoint.

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