The FDA has approved pembrolizumab (Keytruda®, Merck) for adjuvant treatment of stage IB, II, or IIIA non–small cell lung cancer (NSCLC), following resection and platinum-based chemotherapy. "Although adjuvant chemotherapy improves overall survival in completely resected NSCLC, the absolute 5-year survival benefit is moderate compared with observation alone," wrote Mary O'Brien, MD, Head of Royal Marsden Hospital's Lung Unit, and colleagues, in their published results of the KEYNOTE-091 trial (N...

The FDA has granted accelerated approval to enfortumab vedotin-ejfv (Padcev®, Astellas Pharma) with pembrolizumab (Keytruda®, Merck) for treatment of locally advanced or metastatic urothelial carcinoma, specifically for patients who are ineligible for cisplatin-containing chemotherapy. "Both enfortumab vedotin and pembrolizumab are effective monotherapy treatments in patients with locally advanced or metastatic urothelial carcinoma," began Christopher Hoimes, Associate Professor of Medicine at t...

The FDA has granted approval to pembrolizumab (Keytruda®, Merck) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express programmed death-ligand 1 (PD-L1). The FDA has also granted regular approval to single-agent pembrolizumab for patients with recurrent or metastatic cervical cancer whose tumors express PD-L1, with a combined positive score of ≥1, who experienced disease progression on or after c...

The FDA has approved pembrolizumab (Keytruda®, Merck) as a monotherapy for patients with advanced endometrial carcinoma that is microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression subsequent to systemic therapy and are not eligible for curative therapy or radiation. In addition, the FDA also approved the VENTANA MMR RxDx Panel (Ventana Medical Systems, Roche Tissue Diagnostics) to be used as a companion diagnostic device for selecting eligible...

The FDA has approved pembrolizumab (Keytruda®, Merck), a programmed death cell death protein 1 (PD-1)–blocking antibody, for the adjuvant treatment of adult and pediatric patients 12 years and older with stage IIB or IIC melanoma following complete resection. "Current standard of care for patients after resection of high-risk stage II melanoma is observation," wrote Jason Luke, MD, Director of the Cancer Immunotherapeutics Center in the Division of Hematology/Oncology at the University of Pittsb...

Dr. Samira Syed, MD, is an Associate Professor of Internal Medicine at UT Southwestern Simmons Comprehensive Cancer Center, where she treats patients and focuses on breast cancer research. In this interview, Dr. Syed discusses recent therapeutic advances and future directions in the treatment of patients with breast cancer. This interview has been conducted in partnership with the National Breast Cancer Foundation (NBCF). Recognized as one of the leading breast cancer organizations in the w...

The FDA has granted regular approval to pembrolizumab (Keytruda®, Merck) for the first-line treatment of patients with locally advanced/metastatic urothelial carcinoma who are ineligible for platinum-containing chemotherapy. This regular approval comes after the FDA granted pembrolizumab accelerated approval. "Programmed cell death protein 1 (PD-1) and programmed death-ligand 1 (PD-L1) inhibitors are active in metastatic urothelial carcinoma," wrote Thomas Powles, MD, Professor of Genitourinary ...

Yesterday, Merck announced that it will voluntarily withdraw the accelerated approval indication of pembrolizumab (Keytruda®, Merck) for patients with recurrent locally advanced/metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express programmed death-ligand 1 (PD-L1) with a combined positive score (CPS) ≥1 and who experienced disease progression on or after two or more prior lines of therapy, including fluoropyrimidine- and platinum-containing chemotherapy and human e...

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...

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...

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...

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 ...

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...

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...

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...

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...

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...

For patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC), pembrolizumab (Keytruda®, Merck & Co., Inc.) is now FDA approved. An immunotherapy originally approved for advanced non-small cell lung cancer, melanoma, high-risk non-muscle invasive bladder cancer, and advanced cervical cancer, among others, pembrolizumab targets the programmed death (PD-1) pathway to prevent cancer cells from hiding. This allows the body's T cells to attack and kill cancer cells. Approval ...

The FDA granted accelerated approval to pembrolizumab (Keytruda®, Merck) for adults and children with previously treated unresectable or metastatic tumor mutational burden (TMB)–high solid tumors, defined as tumors with at least 10 mutations per megabase, who have no satisfactory alternative treatment option. The FDA also approved the FoundationOne® CDx assay (Foundation Medicine) as the companion diagnostic used to determine treatment eligibility. The approval was based on data from a prospecti...