Regard Phase 3, Randomized Trial of Ramucirumab in Patients with Metastatic Gastric or Gej Adenocarcinoma Following Progression on First-Line Chemotherapy

Tabernero, Josep; Tomášek, Jiří; Filip, Dumitru; Passalacqua, Rodolfo; Goswami, Chanchal; Safran, Howard; Santos, Lucas dos; Aprile, Giuseppe; Ferry, David; Cho, Jae Yong; Melichar, Bohuslav; Tehfé, Mustapha; Topuzov, Eldar; Zalcberg, John; Chau, Ian; Schwartz, Jonathan; Koshiji, Minori; Hsu, Yanzhi; Fuchs, Charles S.

doi:10.1093/annonc/mdt201.8

Cited by 3 publications

(2 citation statements)

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“…Hypertension occurred more commonly in the ramucirumab group than in the placebo group (16.1% vs. 7.8%); grade 3 hypertension occurred in 7.6% and 2.6% of the groups, respectively, but no grade 4 hypertension was observed. Ramucirumab was not associated with higher rates of fatigue, decreased appetite, vomiting, anemia, or other notable toxicities when compared with placebo [28,29]. Both the clinical benefit and rates of grade 3 or higher adverse events associated with ramucirumab treatment appear to compare favorably to the rates associated with second-line chemotherapy reported in other phase 3 trials in this malignancy [22,30].…”

Section: Ramucirumabmentioning

confidence: 83%

“…Results from the randomized, placebo-controlled phase 3 REGARD study, one of the largest phase 3 trials in second-line therapy of gastric or GEJ cancer, were presented at the ASCO Gastrointestinal Cancers Symposium in January 2013 and at the 15 th World Congress on Gastrointestinal Cancer in July 2013 [28,29]. REGARD was designed to evaluate ramucirumab in patients with metastatic gastric or GEJ adenocarcinoma whose disease progressed after first-line platinum-and/or fluoropyrimidine-containing combination therapy.…”

Section: Ramucirumabmentioning

confidence: 99%

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Evaluating the evolving evidence: The challenges of molecular-targeted therapy in management of gastric cancer

Ahmed¹,

Ali²

2014

OJGas

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Over the past decade, a multitude of molecular targeted agents have been explored in the treatment of advanced metastatic gastric. Recent advances in molecular signaling pathways that are dysregulated in gastric cancer lead to the development of new targeted therapies for the treatment of advanced and metastatic gastric cancer. The addition of trastuzumab to first-line chemotherapy is now a standard of care for the treatment of Human epidermal growth factor receptor (HER2-) positive advanced or metastatic disease, and other HER2-targeted therapies are in late-stage clinical development. Findings from recent major clinical trials provide important insight into the future of metastatic gastric cancer management, which may include the use of anti-angiogenesis, Mesenchymal epithelial transition factor (MET) and Hedgehog Pathways Inhibitortherapy across multiple treatment lines, in the salvage setting, and as part of novel regimens in combination with other targeted agents.

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Section: Ramucirumabmentioning

confidence: 83%

Section: Ramucirumabmentioning

confidence: 99%

Evaluating the evolving evidence: The challenges of molecular-targeted therapy in management of gastric cancer

Ahmed¹,

Ali²

2014

OJGas

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Advances of Molecular Targeted Therapy in Gastric Cancer

Çetin

Gümüşay

Cengiz

et al. 2016

J Gastrointest Canc

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In the treatment of human epidermal growth factor receptor 2 (HER2)-positive gastric cancer, the addition of trastuzumab significantly improves survival in the first-line setting of therapy. Ramucirumab, an antibody directed against vascular endothelial growth factor receptor 2, significantly improved progression-free and overall survival and has been approved for second-line treatment of gastric cancer. Anti-mesenchymal-epithelial transition (c-MET), mammalian target of rapamycin inhibitors, and polo-like kinase 1 inhibitors are under investigation as a novel therapeutic option for the treatment of gastric cancer. The novel therapies target the key immune checkpoint interaction between a T cell co-inhibitory receptor called programmed death 1 (PD-1) and one of its immunosuppressive ligands, PD-L1. This article reviews molecular targeted therapies in gastric cancer, in light of recent advances.

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Critical Appraisal of Ramucirumab (IMC-1121B) for Cancer Treatment: From Benchside to Clinical Use

Aprile

Bonotto

Ongaro

et al. 2013

Drugs

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Although antiangiogenic treatments have produced milestone advances in the treatment of several diseases, and have significantly extended the median survival of cancer patients, these agents share some weaknesses, including a limited impact on the overall cure rate, a fleeting effect because of redundant pathways or early appearance of resistance mechanisms, and the lack of predictive factors for treatment selection. Recent data suggest that antibodies targeting the vascular endothelial growth factor axis exert their activity through the inhibition of vascular endothelial growth factor receptor-2 phosphorylation, which has a pivotal role in the neoangiogenic process. Ramucirumab, a fully humanized monoclonal antibody specifically directed against the extracellular domain of the receptor, administered intravenously every 2 or 3 weeks, is emerging as a novel antiangiogenic opportunity. Starting with preclinical data and early clinical results, this concise review focuses on the development of the novel compound across multiple cancers (including gastrointestinal malignancies, breast cancer, lung carcinoma, and genitourinary tumors), and presents available data from randomized phase II and phase III trials. REGARD was the first phase III study to report on the efficacy of single-agent ramucirumab in patients with advanced cancer. Many other ongoing phase III trials are testing the efficacy of this interesting antiangiogenic compound as a single agent or in combination with chemotherapy in different cancer types.

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Regard Phase 3, Randomized Trial of Ramucirumab in Patients with Metastatic Gastric or Gej Adenocarcinoma Following Progression on First-Line Chemotherapy

Cited by 3 publications

References 0 publications

Evaluating the evolving evidence: The challenges of molecular-targeted therapy in management of gastric cancer

Evaluating the evolving evidence: The challenges of molecular-targeted therapy in management of gastric cancer

Advances of Molecular Targeted Therapy in Gastric Cancer

Critical Appraisal of Ramucirumab (IMC-1121B) for Cancer Treatment: From Benchside to Clinical Use

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