HER2-overexpressing/amplified breast cancer as a testing ground for antibody-drug conjugate drug development in solid tumors.

HER2-overexpressing/amplified breast cancer as a testing ground for antibody-drug conjugate drug development in solid tumors. Clin Cancer Res. 2019 Oct 03;: Authors: Pegram MD, Miles D, Tsui CK, Zong Y Abstract Efficacy data from the KATHERINE clinical trial comparing ado-trastuzumab emtansine (T-DM1) to trastuzumab in patients with early-stage human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer with residual disease after neoadjuvant therapy (hazard ratio for invasive disease or death, 0.50; P
Source: Clinical Cancer Research - Category: Cancer & Oncology Authors: Tags: Clin Cancer Res Source Type: research

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Contributors : Ryosuke Matsukane ; Mitsuhiro HayashiSeries Type : Expression profiling by arrayOrganism : Homo sapiensOur novel drug imaging technique revealed that trastuzumab, which is representative antibody drug for breast and gastric cancer in clinical, distributed heterogeneously inside tumor even though its target receptor, HER2 (Human epidermal growth factor receptor 2) expressed homogeneously. For identifying a predominant regulator of trastuzumab tumor delivery in the tumor site, we tried tumor region-specific microarray analysis according to trastuzumab distribution in patient derived xenograft model.
Source: GEO: Gene Expression Omnibus - Category: Genetics & Stem Cells Tags: Expression profiling by array Homo sapiens Source Type: research
AbstractABP 980 was developed as a biosimilar to trastuzumab, a monoclonal antibody targeting human epidermal growth factor receptor 2 (HER2), that is indicated for the treatment of HER2-positive metastatic breast cancer, early breast cancer (EBC), and metastatic gastric cancer. ABP 980 is approved in the United States, European Union, and Japan for all the indications of trastuzumab, based on the totality of evidence (TOE) gathered by the systematic step-wise accumulation of comparative analytical, preclinical, and clinical (pharmacokinetics [PK], efficacy, safety and immunogenicity) data for ABP  980 and trastuzumab...
Source: Targeted Oncology - Category: Cancer & Oncology Source Type: research
ConclusionsBased on confirmed PR (n  = 16/33, 48.5%), DHP107 demonstrated adequate efficacy with manageable toxicity in the first line HER2 negative recurrent/metastatic breast cancer patients. Phase III trial in breast cancer is ongoing in Korea and China.Legal entity responsible for the studyDaehwa Pharmaceuticals. Co. Ltd.FundingDaehwa Pharmaceuticals. Co. Ltd.DisclosureK.S. Lee: Advisory / Consultancy: Roche; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Norvatis; Advisory / Consultancy: Lilly; Research grant / Funding (institution): Dong-A pharm. K. Lee: Advisory / Consultancy, Speaker Bureau /...
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research
Nature Reviews Clinical Oncology, Published online: 23 September 2019; doi:10.1038/s41571-019-0268-3HER2-targeted therapies have dramatically improved the outcomes in women with HER2-positive breast cancer. Furthermore, genetic sequencing studies have revealed HER2 alterations in a range of other cancers, including gastric cancer, colorectal cancer and non-small-cell lung cancer. In this Review the authors describe the available data on HER2-targeted therapies beyond breast cancer.
Source: Nature Reviews Clinical Oncology - Category: Cancer & Oncology Authors: Source Type: research
ConclusionOverall, the equivalence of SB3 with reference product in MoA-related qualities in in vitro mono- and combination therapy experiments may support clinical bioequivalence of the two substances.
Source: BioDrugs - Category: Drugs & Pharmacology Source Type: research
In this study, HER2 and MUC1-based peptides were synthesized and preclinically evaluated in an effort to develop peptide-based SPECT radiopharmaceuticals derived from tumor-associated antigens for the detection of breast cancer. Our findings demonstrate that the tumor antigen peptides radiolabeled efficiently with 99mTc and showed high metabolic stability in human plasma in vitro. The data from breast tumor cell binding confirmed the high affinity (in low nanomolar range) towards respective breast cancer cell lines. In healthy mice, 99mTc-labeled peptides displayed favorable pharmacokinetics, with high excretion by the ren...
Source: Molecules - Category: Chemistry Authors: Tags: Article Source Type: research
Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) announced that the U.S. Food and Drug Administration (FDA) has approved KANJINTITM (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab): for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Source: World Pharma News - Category: Pharmaceuticals Tags: Featured Amgen Business and Industry Source Type: news
Approval Based on Totality of Evidence Demonstrating KANJINTI is Biosimilar to Herceptin Third FDA Approval From Amgen's Biosimilars Portfolio THOUSAND OAKS, Calif., June 13, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved KANJINTI™ (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab):  for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. "...
Source: Amgen News Release - Category: Pharmaceuticals Tags: Uncategorized Source Type: news
ConclusionsPertuzumab exposure in JACOB was consistent with prior studies in advanced gastric cancer and breast cancer. The 840  mg q3w dose allowed the majority of patients in JACOB to achieve target pertuzumab concentrations and appears to be an appropriate dose selection.
Source: Cancer Chemotherapy and Pharmacology - Category: Cancer & Oncology Source Type: research
Purpose of review This manuscript aims at providing an update and overview on the role of Human epidermal growth factor receptor 2 (HER2) testing and HER2-directed therapies in digestive tumors. Recent findings Phase 3 trial data demonstrating a survival benefit of HER2-targeting treatments are limited to gastric cancer. However, HER2 positivity is also found in 5–6% of colorectal, 7% of pancreatic, and 16% of extrahepatic biliary cancers. Although phase 2 trial data support the use of the combination of trastuzumab and lapatinib with chemotherapy in HER2-positive colorectal cancer, the patient's benefit from ta...
Source: Current Opinion in Oncology - Category: Cancer & Oncology Tags: GASTROINTESTINAL TRACT: Edited by Alain Hendlisz Source Type: research
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