Drug: Pembrolizumab (Keytruda, Merck)

Status: Granted approval for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with a microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) biomarker. This indication includes patients with solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options and patients with colorectal cancer that has progressed following treatment with certain chemotherapy drugs

Significant Information:

• Targets the PD-1/PD-L1 pathway
• Based on data from patients with MSI-H or dMMR solid tumors enrolled in 1 of 5 uncontrolled, single-arm clinical trials
  • 15 cancer types were identified among 149 patients enrolled across these clinical trials
  • Most common cancers were colorectal, other gastrointestinal and endometrial cancers
  • Of the 149 patients who received pembrolizumab, 39.6% had a complete or partial response. For 78% of those patients, the response lasted for six months or more

Adverse Events: Colitis, constipation, cough, decreased appetite, diarrhea, dyspnea, endocrinopathies, fatigue, hepatitis, musculoskeletal pain, nausea, nephritis, pneumonitis, pruritus, pyrexia, rash

Other Indications: Metastatic urothelial carcinoma in patients who have disease progression during or following platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy and those who are not eligible for cisplatin-containing chemotherapy; metastatic non-small cell lung cancer patients whose tumors have high PD-L1 expression, both first-line and after progression with platinum-containing therapy; recurrent or metastatic head and neck squamous cell carcinoma after progression with platinum-containing therapy; and unresectable or metastatic melanoma

—Based on a FDA press release