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Iovance Reports Pivotal Cohort 4 Data for Tumor Infiltrating Lymphocyte (TIL) Therapy Lifileucel from C-144-01 Clinical Study in Advanced Melanoma

(Iovance) May 27, 2020 - Iovance Biotherapeutics, Inc., a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced initial data from pivotal Cohort 4 and updated long-term data from Cohort 2 in the C-144-01 study of lifileucel in advanced melanoma. “We are very pleased to announce our pivotal Cohort 4 early data from the C-144-01 clinical study in advanced melanoma today,” said Maria Fardis, Ph.D., President and Chief Executive Officer of Iovance Biotherapeutics.

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Novel Targeted Drug Induced Positive Response For Patients With Von Hippel-lindau Disease–associated Kidney Cancer

(MD Anderson) May 28, 2020 - In an international trial led by researchers at The University of Texas MD Anderson Cancer Center, treatment with MK-6482, the small molecule inhibitor of hypoxia-inducible factor (HIF)-2a was well tolerated and resulted in clinical responses for patients with von Hippel-Lindau disease (VHL)–associated renal cell carcinoma (RCC). The results of the Phase II trial were shared today in an oral presentation at the 2020 American Society of Clinical Oncology Annual Meeting by principal investigator Eric Jonasch, M.D., professor of Genitourinary Medical Oncology.

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Combination Therapy Well-tolerated And Highly Effective For Patients With IDH1-mutated Acute Myeloid Leukemia (AML)

(MD Anderson) May 28, 2020 - A combination therapy of ivosenidib (IVO) plus venetoclax (VEN) with or without azacitidine (AZA) was found to be effective against a specific genetic subtype of acute myeloid leukemia (AML) in a Phase Ib/II trial led by researchers at The University of Texas MD Anderson Cancer Center. The results of this trial may support a novel course of action for patients with AML harboring an IDH1 mutation who have historically had few treatment options.

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Oncology Clinical News

Zai Lab Announces Positive Topline Results from the NORA Phase 3 Study of ZEJULA® as Maintenance Therapy for Chinese Patients with Platinum-sensitive, Recurrent Ovarian Cancer

(Zai Lab) May 28, 2020 - Zai Lab Limited today announced positive topline results from the NORA study, the Phase 3 randomized, double-blind, placebo-controlled, study of ZEJULA (niraparib) as a maintenance therapy in Chinese patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (collectively termed as ovarian cancer) who are in a complete or partial response to platinum-based chemotherapy.

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At-home Screening For Ovarian, Breast Cancers Is Effective

(UW Medicine) May 27, 2020 - MAGENTA study also found no increased stress among test subjects who did not receive pre- and post-test counseling with their results.

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AI Could Predict Risk Of Lung Cancer Coming Back

(ICR [UK]) May 27, 2020 - Computer scientists working with pathologists have trained an artificial intelligence (AI) tool to determine which patients with lung cancer have a higher risk of their disease coming back after treatment.

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WindMIL Therapeutics Announces Dosing of First Patient in Phase 2 Clinical Study of MILs™ - NSCLC in Combination with Nivolumab (Opdivo®) for the Treatment of Non-Small Cell Lung Cancer

(MarketWatch) May 28, 2020 - WindMIL Therapeutics today announced that the first patient has been dosed in the combination therapy portion of its Phase 2 clinical trial to assess the safety and efficacy of MILs(TM) - NSCLC in patients with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) who are refractory to, or have relapsed on, an anti-PD-1-containing regimen.

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Oncology Business and Policy News

MacroGenics Provides Update on FDA Review of Margetuximab for HER2-Positive Metastatic Breast Cancer

(MacroGenics) May 28, 2020 - MacroGenics, Inc. today announced that during the recent mid-cycle communication with the U.S. Food and Drug Administration (FDA), the FDA notified the Company that it is no longer planning to hold an Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the Biologics License Application (BLA) for margetuximab. The FDA also stated it continues to anticipate meeting the Prescription Drug User Fee Act (PDUFA) goal date for the application review, which is December 18, 2020.

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Roche Signs Up With Oncimmune To Explore Immunotherapy Responses

(Pharmaphorum [UK]) May 28, 2020 - Roche has doubled down on a partnership with UK biotech Oncimmune looking at how autoantibodies can affect patients’ clinical response to cancer immunotherapies. Autoantibodies are produced by the immune system and directed at one or more proteins in the body, which may include some which target tumour cells.

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FDA Finds Carcinogen in Some Versions of Popular Diabetes Drug

(Bloomberg) May 27, 2020 - U.S. regulators are contacting pharmaceutical companies that make a popular diabetes medication after some of the pills were found to contain high levels of a chemical that can cause cancer.

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Clovis Oncology Announces New Recommendations For Rubraca® (Rucaparib) Tablets In Updated National Comprehensive Cancer Network (NCCN) Guidelines® For The Treatment Of Metastatic Castration-Resistant Prostate Cancer (MCRPC)

(Clovis Oncology) May 28, 2020 - Rubraca recommended as a treatment option for BRCA-mutant mCRPC in the second line setting and as a subsequent therapy; if the patient is not fit for chemotherapy, rucaparib can be considered prior to taxane.

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CU Anschutz Surgeons Study Guidelines for Treating Cancer Patients During Pandemic

(University of Colorado) May 27, 2020 - Aggressive cancers, such as pancreatic cancer, require the continuation of oncological care during the pandemic.

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Cardinal Health Oncology Insights: Oncologists Report Social Determinants of Health Play Important Role in Patient Outcomes

(Cardinal Health) May 28, 2020 - More than 90% of oncologists said social determinants of health (SDOH) such as financial security, access to food and social isolation are significantly impacting outcomes for cancer patients, according to new research from Cardinal Health Specialty Solutions.

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Florida Cancer Specialists Participation at ASCO® Demonstrates Progress Made Through Clinical Research

(FCS) May 27, 2020 - Florida Cancer Specialists & Research Institute (FCS) physicians are the co-authors of 20 research studies that will be presented at the ASCO20 Virtual Scientific Program being held May 29 – 31, 2020.

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Broader Healthcare and Pharma News

Financial Ties Between Leaders Of Influential US Professional Medical Associations And Industry: Cross Sectional Study

(The BMJ [UK]) May 27, 2020 - Objective: To investigate the nature and extent of financial relationships between leaders of influential professional medical associations in the United States and pharmaceutical and device companies.

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Roche Partners With Gilead in Covid Trial of Drug Combination

(Bloomberg) May 28, 2020 - Roche Holding AG and Gilead Sciences Inc. are initiating a late-stage trial of a two-drug combination in hopes of creating a new weapon in the battle against Covid-19.

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GSK Aims For One Billion Doses Of Booster As COVID-19 Vaccine Race Heats Up

(Reuters) May 28, 2020 - GSK, the world’s largest vaccine maker, laid out plans on Thursday to produce 1 billion doses of vaccine efficacy boosters for COVID-19 shots next year, as the race to develop a successful solution to the coronavirus crisis heats up.

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FDA Welcomes Variety of Phase 2/3 Trial Designs for COVID-19 Therapies

(Xconomy National) May 28, 2020 - The US FDA’s formal guidance on development of COVID-19 treatments and preventative agents takes a broadly flexible approach to Phase 2 and 3 trial design, repeatedly indicating a willingness to consider varied options while urging sponsors to discuss their trials plans with the agency earlier rather than later.

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