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Another myeloma drug with same target as CAR-Ts shows successful Phase II results

In Clinical Trials by Barbara Jacoby

By: Alaric DeArment From: medcitynews.com Without providing details, GlaxoSmithKline said its trial of BCMA-targeting belantamab mafodotin was positive. The company plans to submit for regulatory approvals later this year – potentially ahead of bluebird and Celgene’s expected filing next year for the CAR-T bb2121. A Phase II study of a GlaxoSmithKline drug to treat the blood cancer multiple myeloma has …

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Roche drug is third to win biomarker-driven cancer approval from FDA

In Clinical Trials by Barbara Jacoby

By: Alaric DeArment From: medcitynews.com Another drug designed to treat cancer patients based on a genetic driver rather than where tumors occur in the body has received approval from the Food and Drug Administration. The FDA on Thursday granted Swiss drugmaker Roche’s Rozlytrek (entrectinib) approval for ROS1-positive non-small cell lung cancer and accelerated approval for solid tumors with NTRK gene …

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Newer Treatments and Combinations Emerging for Breast Cancer Brain Metastases

In Clinical Trials by Barbara Jacoby

By: Dylann Cohn-Emery From: targetedonc.com Multiple treatment options are emerging for patients with breast cancer that has metastasized to the brain, looking to improve upon the standards of care for patients with breast cancer–related brain metastases (BM) across breast cancer subtypes. A phase II study looking at abemaciclib (Verzenio), a CDK4/6 inhibitor, in patients with HR-positive, HER2-negative metastatic breast cancer …

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Targeted therapy erdafitinib effective for patients with advanced bladder cancer and specific gene mutations

In Clinical Trials by Barbara Jacoby

From: mdanderson.org FGFR inhibitor gains FDA approval based on 40% response rate in MD Anderson-led Phase II trial Treatment with the FGFR inhibitor erdafitinib in patients with metastatic bladder cancers marked by mutations in the FGFR3 gene resulted in a 40% overall response rate (ORR) and was well-tolerated, according to an international Phase II trial led by The University of …

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Study of SM-88 Shows Promising Results in Advanced Pancreatic Cancer

In Clinical Trials by Barbara Jacoby

By: Gina Columbus From: targetedonc.com The investigational agent SM-88 demonstrated promising survival in the phase II TYME-88-Panc study in patients with advanced pancreatic cancer.1,2 The oral modified dysfunctional tyrosine induced a median overall survival (OS) of 6.4 months in patients. The RECIST clinical benefit rate (CBR) of stable disease (SD) or better was 44% with available imaging, and there was a 92% …

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Capivasertib Combined With Fulvestrant Improves PFS in ER+ Breast Cancer

In Clinical Trials by Barbara Jacoby

By: Wayne Kuznar From: onclive.com Adding the Akt inhibitor capivasertib to fulvestrant led to a more than doubling of progression-free survival (PFS) compared with fulvestrant alone in patients with endocrine-resistant estrogen receptor (ER)-positive advanced breast cancer. In the placebo-controlled phase II FAKTION trial, patients who relapsed or progressed on aromatase inhibitor (AI) therapy who were randomized to capivasertib plus fulvestrant …

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Puma Biotechnology Presents Interim Results of Phase II CONTROL Trial of Neratinib in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

In Clinical Trials by Barbara Jacoby

From: apnews.com Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, will present updated interim results from a Phase II clinical trial of Puma’s drug neratinib at the American Society of Clinical Oncology (ASCO) 2019 Annual Meeting in Chicago. Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients …

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Exercise Proves Beneficial for Breast Cancer Survivors, Yet Again

In Clinical Trials by Barbara Jacoby

By: Christina Bennett, MS From: cancernetwork.com A 4-month exercise program reduced the risk of cardiovascular disease among breast cancer survivors who were considered sedentary and overweight or obese, a prospective, randomized, single-center clinical trial (ClinicalTrials.gov identifier: NCT01140282) published in JAMA Oncology showed. These findings are the latest to show the various benefits exercise has for breast cancer patients. For instance, …

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AstraZeneca, Daiichi Sankyo’s $6.9B breast cancer drug partnership bears fruit in less than two months

In Clinical Trials by Barbara Jacoby

By: Alaric DeArment   From: medcitynews.com The companies announced the partnership in March to develop trastuzumab deruxtecan, for which they plan to file approval later this year based on the successful Phase II study. The growing field of antibody-drug conjugates may soon get a new member with positive Phase II data in breast cancer. Anglo-Swedish drugmaker AstraZeneca and Japan-based Daiichi …

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Dr. Carcas on the Design and Findings of CONTROL Trial in HER2+ Breast Cancer

In Clinical Trials by Barbara Jacoby

By: Lauren Carcas, MD From: onclive.com Lauren Carcas, MD, medical oncologist, Miami Cancer Institute, Baptist Health South Florida, discusses the design of the CONTROL trial and her personal experience with prophylaxis interventions for women with early-stage HER2-positive breast cancer receiving neratinib (Nerlynx). The phase II CONTROL trial looked at how to control early-onset diarrhea within the first 2 cycles of …