Initial US Approval

2014 (2017 for MMI/MSI-H)1

Indications

Treatment of adult patients with unresectable or metastatic melanoma, non-small cell lung cancer (in combination or as single agent at multiple treatment stages), recurrent or metastatic head and neck squamous cell cancer, adult and pediatric refractory classical Hodgkin lymphoma, adult/pediatric primary large B-cell lymphoma, locally advanced or metastatic urothelial carcinoma, unresectable or metastatic microsatellite instability-high or mismatch repair deficient solid tumors, colorectal cancer, recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, recurrent or metastatic cervical cancer, hepatocellular cancer, adult and pediatric recurrent locally advanced or metastatic Merkel cell carcinoma. See Prescribing Information for details.1

Recommended Dose/Route

Given as an intravenous infusion over 30 minutes1:

  • Adults: Pembrolizumab, 200 mg, every 3 weeks
  • Pediatrics: Pembrolizumab, 2 mg/kg (up to 200 mg), every 3 weeks

Dose Reductions for Adverse Reactions

No dose reductions are recommended. Withhold or discontinue pembrolizumab to manage adverse reactions.1

Pivotal Studies2-6

Five uncontrolled, open-label, multicohort, multicenter, single-arm trials: KEYNOTE-016 (NCT01876511); KEYNOTE-164 (NCT02460198); KEYNOTE-012 (NCT01848834); KEYNOTE-028 (NCT02054806); KEYNOTE-158 (NCT02628067)

Key Inclusion Criteria: 149 patients with MSI-H or MMR deficient solid tumors.1

Treatment

Pembrolizumab 200 mg every 3 weeks or 10 mg/kg every 2 weeks. Treatment continued until unacceptable toxicity or disease progression that was either symptomatic, rapidly progressive, required urgent intervention, or occurred with a decline in performance status. A maximum of 24 months of treatment with pembrolizumab was administered.1

Pembrolizumab: Efficacy Data

Pembrolizumab: Efficacy Data

Safety

The most common adverse reactions or laboratory abnormalities leading to interruption were neutropenia (13%), asthenia/fatigue (7%), anemia (7%), thrombocytopenia (5%), diarrhea (4%), pneumonia (4%), increased blood creatinine (3%), dyspnea (2%), febrile neutropenia (2%), upper respiratory tract infection (2%), increased ALT (2%), and pyrexia (2%).1

References

1. Keytruda (pembrolizumab). Package insert. Merck & Co., Inc.; December 2018.

2. Le DT, Uram JN, Wang H, et al. PD-1 blockade in tumors with mismatch-repair deficiency. N Engl J Med. 2015; 372(26):2509–2520. doi:10.1056/NEJMoa1500596

3. Le DT, Kim TW, Van Cutsem E, et al. Phase II open-label study of pembrolizumab in treatment-refractory, microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer: KEYNOTE-164. J Clin Oncol. 2020; 38(1):11–19. doi:10.1200/JCO.19.02107

4. Muro K, Chung HC, Shankaran V, et al. Pembrolizumab for patients with PD-L1-positive advanced gastric cancer (KEYNOTE-012): a multicentre, open-label, phase 1b trial. Lancet Oncol. 2016; 17(6):717–726. doi:10.1016/S1470-2045(16)00175-3

5. Ott PA, Bang YJ, Berton-Rigaud D, et al. Safety and antitumor activity of pembrolizumab in advanced programmed death ligand 1-positive endometrial cancer: results from the KEYNOTE-028 study. J Clin Oncol. 2017; 35(22):2535–2541. doi:10.1200/JCO.2017.72.5952

6. Marabelle A, Le DT, Ascierto PA, et al. Efficacy of pembrolizumab in patients with noncolorectal high microsatellite instability/mismatch repair-deficient cancer: results from the phase II KEYNOTE-158 study. J Clin Oncol. 2020; 38(1):1–10. doi:10.1200/JCO.19.02105