Pembrolizumab Approval: Non-Muscle Invasive Bladder Cancer

The FDA has approved pembrolizumab (Keytruda®, Merck) for the treatment of patients with high-risk non-muscle invasive bladder cancer (NMIBC) carcinoma in situ, with or without papillary tumors. Pembrolizumab, a programmed cell death protein 1 (PD-1) inhibitor, is indicated for patients who are ineligible for or have elected not to receive radical cystectomy and who do not respond to bacillus Calmette-Guérin (BCG) therapy.The approval was based on Keynote 057 (NCT02625961), a multicenter, single...
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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 recur...
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Pembrolizumab After Locally Ablative Therapy in NSCLC: Joshua Bauml, MD

Locally ablative therapy, which consists of surgery, radiation, and other definitive treatments at all sites of metastasis, has shown efficacy in oligometastatic non-small cell lung cancer (NSCLC). Given that immunotherapy has also shown efficacy in NSCLC, Joshua Bauml, MD, and colleagues at the University of Pennsylvania's Perelman School of Medicine investigated the combination of locally ablative therapy with pembrolizumab (Keytruda®, Merck). The investigators found that adding pembrolizumab ...
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NSCLC: Pembrolizumab Following Locally Ablative Therapy

​A phase 2 clinical trial reports that the addition of pembrolizumab (Keytruda®, Merck) following locally ablative therapy for oligometastatic non-small cell lung cancer (NSCLC) improves median progression-free survival compared with historical data.About 7% of patients with NSCLC have oligometastatic disease, a state of limited systemic metastasis that could be cured by means of locally ablative therapy. A treatment consisting of surgery and radiation at all sites of metastasis, locally ablativ...
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