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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Frontline Pembrolizumab for PD-L1–Positive Gastric Cancer: Kohei Shitara, MD

Gastric or gastroesophageal junction (G/GEJ) cancer constitutes the third leading cause of cancer death worldwide, and more therapeutic options are needed. In results from the phase 3 KEYNOTE-062 study, published last week in JAMA Oncology, Kohei Shitara, MD, and colleagues reported that in patients with previously untreated G/GEJ cancer with a programmed cell death ligand 1 (PD-L1) combined positive score (CPS) of 1 or greater, pembrolizumab, alone or in combination with chemotherapy, was nonin...
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PD-L1–Positive Gastric Cancer: Frontline Pembrolizumab Noninferior to Chemotherapy

Data from the phase 3 KEYNOTE-062 trial have revealed that in patients with advanced gastric or gastroesophageal junction (G/GEJ) cancer with a programmed cell death ligand 1 (PD-L1) combined positive score (CPS) of 1 or greater, first-line pembrolizumab, alone or in combination with chemotherapy, is noninferior but not superior to chemotherapy alone. In patients with a PD-L1 CPS of 10 or greater, pembrolizumab monotherapy showed a possible benefit, but one that cannot be considered definitive o...
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Advanced Melanoma: Pembrolizumab Effective Regardless of BRAF V600E/K Mutations

In patients with advanced melanoma, pembrolizumab achieves efficacy regardless of BRAF V600E/K mutation status or prior treatment with BRAF and/or MEK inhibitors, according to the results of a new pooled analysis published in JAMA Oncology. Approximately 40% of metastatic melanomas harbor a BRAF mutation, 90% of which are an activating BRAF V600E/K mutation. While targeted agents and immune checkpoint inhibitors, including pembrolizumab, have considerably improved outcomes for patients with adva...
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FDA Approves First-Line Pembrolizumab: Metastatic MSI-High/dMMR Colorectal Cancer

Patients with unresectable or metastatic colorectal cancer with high microsatellite instability (MSI) or a deficiency in mismatch repair (dMMR) now have their first frontline immunotherapy option, thanks to the FDA's approval of pembrolizumab (Keytruda®, Merck) in this population. Efficacy and safety were investigated in an open-label phase 3 trial, KEYNOTE-177 (NCT02563002), for which 307 patients with previously untreated MSI-high/dMMR metastatic colorectal cancer and an Eastern Cooperative On...
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