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CDK4/6 Inhibitors for Metastatic Breast Cancer: What You Need to Know

In Clinical Trials by Barbara Jacoby

By: BRIELLE BENYON From: oncnursingnews.com The advent of CDK4/6 inhibitors has caused landmark change in the treatment and outcomes of patients with metastatic hormone receptor (HR)-positive, HER2-negative breast cancer. Three agents were already on the market – palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (Verzenio) – with a fourth, alpelisib (Piqray), approved this May. This could change the space even more …

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Study to evaluate breast cancer screening approaches amid mammography guidelines debate

In Clinical Trials by Barbara Jacoby

From: healio.com Mammography remains a controversial topic among medical societies, with conflicting guidelines on what age women should start and how frequently they should undergo screening. In April, the American College of Physicians recommended most women undergo mammography every other year, instead of yearly. The American College of Radiology disagreed, suggesting this would result in thousands of unnecessary breast cancer …

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Pfizer Receives U.S. FDA Approval for Its Oncology Biosimilar, ZIRABEV™ (bevacizumab-bvzr)

In Clinical Trials by Barbara Jacoby

Source: Business Wire From: biospace.com Pfizer, Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration(FDA) has approved ZIRABEV™ (bevacizumab-bvzr), a biosimilar to Avastin® (bevacizumab),1 for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or …

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Phase III Shows Benefit With Olaparib in Platinum-Sensitive BRCA+ Relapsed Ovarian Cancer

In Clinical Trials by Barbara Jacoby

By: Danielle Ternyila From: targetedonc.com According to topline findings from the multicenter, open-label, phase III SOLO3 trial, the overall objective response rate (ORR) was 72% with single-agent olaparib (Lynparza) versus 51% with chemotherapy in patients with platinum-sensitive, relapsed, germline BRCA-mutant ovarian cancer who were previously treated with at least 2 chemotherapy regimens. Further, in patients with only 2 prior lines …

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AstraZeneca’s immunotherapy drug scores key Phase III lung cancer win

In Clinical Trials by Barbara Jacoby

By: Alaric DeArment From: medcitynews.com The company said the Phase III CASPIAN study of Imfinzi in first-line, extensive-stage small-cell lung cancer was successful, but did not disclose further details. Roche’s Tecentriq is already approved for that indication, which accounts for two-thirds of SCLC cases. The days of Roche having an immunotherapy monopoly on the largest population of small-cell lung cancer …

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Study Identifies Potential Biomarkers for De-escalating Chemotherapy in HER2-Positive Breast Cancer

In Clinical Trials by Barbara Jacoby

From: specialtypharmacytimes.com Certain human epidermal growth factor receptor 2 (HER2)-positive breast cancer tumors may be more sensitive to treatment with anti-HER2 therapy alone, potentially eliminating the need for additional chemotherapy, according to a study published in the Journal of the National Cancer Institute. Approximately 1 in 5 patients with breast cancer have high levels of HER2 proteins, according to the …

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Precigen Announces First Patient Dosed in Phase 1/1b Study of PRGN-3006 UltraCAR-T™ in Patients with Relapsed or Refractory AML or Higher Risk MDS

In Clinical Trials by Barbara Jacoby

From: prnewswire.com – Milestone represents the first patient dosed with Precigen’s transformative non-viral UltraCAR-T therapeutic platform that eliminates ex vivo expansion and reduces manufacturing time to fewer than two days following gene transfer Precigen, Inc., a wholly-owned subsidiary of Intrexon Corporation (NASDAQ: XON) and a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the …

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Immutep Completes Patient Enrolment of the AIPAC Phase IIb Clinical Trial in Metastatic Breast Cancer

In Clinical Trials by Barbara Jacoby

Source: GLOBE NEWSWIRE From: yahoo.com 226 patients with metastatic breast cancer have been enrolled in the AIPAC study Combination of eftilagimod alpha, an antigen presenting cell (APC) activator, administered in combination with chemotherapy is designed to boost the T-cell immune responses against tumours Read-out of progression-free survival (PFS) primary endpoint expected to occur in Q1 of calendar year 2020 Immutep …

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Prestigious Cancer Centers Johns Hopkins and Moffitt Complete Patient Enrollment in Post Approval Study for MarginProbe®

In Clinical Trials by Barbara Jacoby

Source: Business Wire From: yahoo.com Dune Medical Devices has reached another milestone in their MarginProbe® Post Approval Study (PAS) as Johns Hopkins Hospital and Moffitt Cancer Center complete their patient enrollments for the trial. This PAS, required by the FDA, seeks to substantiate the vast body of data produced since MarginProbe’s original approval, demonstrating its effectiveness at intraoperatively identifying positive …

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Clinical Trial Solutions: Technology Disrupters

In Clinical Trials by Barbara Jacoby

By: A.K. Gupta, Senior VP and Chief Information Officer, UBC From: pharmavoice.com The biopharma industry faces myriad challenges in the pursuit of its mission to bring new treatments to patients in need of cures, chief among them the “Iron Triangle” of time, cost, and quality with respect to clinical research. The cost of conducting clinical trials is escalating, quality remains …