Pembrolizumab Approved for HER2-Positive Gastric Cancer

The FDA has granted accelerated approval to pembrolizumab (Keytruda®, Merck & Co.) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of patients with locally advanced unresectable or metastatic HER2- positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. "The PD-1 (programmed cell death protein 1)/PD-L1 (programmed death-ligand 1) pathway is an important regulatory component of the immune response and plays a critica...
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Pembrolizumab for Esophageal or Gastroesophageal Junction Carcinoma: Ken Kato, MD, PhD

Recently, the FDA approved pembrolizumab (Keytruda®, Merck Sharp & Dohme Corp.) in combination with platinum/fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal junction (GEJ) carcinoma who do not qualify for surgical resection or definitive chemoradiation. The approval was based on the results of KEYNOTE-590, a phase 3 trial that demonstrated significant improvements in progression-free survival and overall survival for patient...
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Pembrolizumab Plus Chemotherapy Approved for Esophageal and Gastroesophageal Junction Carcinoma

The FDA has approved pembrolizumab (Keytruda®, Merck Sharp & Dohme Corp.) in combination with platinum/fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal junction (GEJ) carcinoma who do not qualify for surgical resection or definitive chemoradiation. "Pembrolizumab plus chemotherapy versus chemotherapy was superior for overall survival in patients with esophageal squamous cell carcinoma (ESCC) with a combined positive score (CP...
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Lenvatinib/Pembrolizumab Improves Survival in Renal Cell Carcinoma

Results from a phase 3 trial of patients with advanced renal cell carcinoma (RCC) presented this week at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium and simultaneously published in The New England Journal of Medicine demonstrated that the first-line treatment regimen of lenvatinib, a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor, plus pembrolizumab, an anti–programmed cell death protein 1 (PD-1) monoclonal antibody, lengthened ...
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Pembrolizumab FDA Approved for Triple-Negative Breast Cancer

The FDA recently approved pembrolizumab (Keytruda®, Merck & Co) with chemotherapy for patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) for those whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test. In addition, the FDA approved the companion diagnostic, PD-L1 IHC 22C3 pharmDx (Dako North America, Inc.), to select patients with TNBC for pembrolizumab. Efficacy was shown in KEYNOTE-355 (NCT02819518), a multicenter, double-bl...
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