Ken Kato, MD, PhD: FDA Approval of Nivolumab for Esophageal Squamous Cell Carcinoma

The FDA recently approved nivolumab for patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) who have received prior fluoropyrimidine- and platinum-based chemotherapy. Ken Kato, MD, PhD, lead author on the study the approval was based on, spoke to i3 Health about the challenges of treating this patient population, in addition to the significance of this approval. What are the most challenging aspects of treating patients with advanced ESCC refra...
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Nivolumab FDA Approved for Esophageal Squamous Cell Carcinoma

Nivolumab (Opdivo®, Bristol Myers Squibb) is now FDA approved for patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) who have received prior fluoropyrimidine- and platinum-based chemotherapy. Previously approved for metastatic non-small cell lung cancer, melanoma, and advanced renal cell carcinoma, among others, nivolumab is an immunotherapy that works by helping immune cells discover and attack cancer cells by inhibiting a cancer cell's abili...
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Nivolumab Proves Effective in Advanced Esophageal Cancer

According to the results of the phase 3 trial, ATTRACTION-3, nivolumab significantly improves overall survival compared with chemotherapy in patients who have been previously treated for advanced esophageal squamous cell carcinoma. For this study, results of which are published in The Lancet Oncology, researchers enrolled 419 patients from 90 hospital and cancer centers in Denmark, Germany, Italy, Japan, South Korea, Taiwan, the UK, and the USA. Patients with unresectable advanced or recurrent e...
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Pembrolizumab for Advanced Esophageal Squamous Cell Carcinoma: An Interview with Ken Kato, MD

On July 30, 2019, the FDA approved pembrolizumab (Keytruda®, Merck) for patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus (ESCC) whose tumors expressed a programmed death-ligand 1 (PD-L1) combined positive score (CPS) of at least 10 and whose disease progressed after at least one line of systemic therapy. The approval was based on two clinical trials. One of these was Keynote-181, which enrolled 628 patients with locally advanced or metastatic ESCC w...
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Pembrolizumab Approved for Advanced Esophageal Squamous Cell Carcinoma

Pembrolizumab (Keytruda®, Merck) has been approved by the FDA for patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus (ESCC) with tumors expressing a programmed death ligand-1 (PD-L1) combined positive score (CPS) of at least 10 and with disease progression following one or more previous systemic treatments. The approval was based on the Keynote-181 (NCT02559687) and Keynote-180 (NCT02564263) clinical trials. Keynote-181 enrolled 628 patients with recu...
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