What cancers does Keytruda treat?
Keytruda (pembrolizumab) is a monoclonal antibody used to treat various types of cancers, particularly those driven by the PD-1 protein. The FDA has approved Keytruda for several indications.
Keytruda is approved to treat:[1]
Melanoma: the FDA first approved Keytruda in 2014 for the treatment of melanoma, a type of skin cancer, based on a phase III study that demonstrated significant improvements in progression-free survival for patients with advanced melanoma.[2]
Non-Small Cell Lung Cancer (NSCLC): In 2015, Keytruda was approved for the treatment of NSCLC, both in first-line or previously treated advanced NSCLC. These approvals were based on phase III studies that showed Keytruda improved overall survival, progression-free survival, and response rates for patients with NSCLC.[3]
Head and Neck Squamous Cell Carcinoma (HNSCC): The FDA approved Keytruda in 2016 for the treatment of HNSCC, a type of cancer of the mouth, throat, or head. The approval was based on a phase III study that demonstrated Keytruda improved overall survival and response rates for patients with HNSCC.[4]
Urothelial Carcinoma: In 2017, Keytruda was approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma, who received at least one prior platinum-containing chemotherapy. The approval was based on a phase III study that showed Keytruda improved overall survival for patients with urothelial carcinoma.[5]
Cervical Cancer: Keytruda was approved in 2018 for the treatment of patients with recurrent or metastatic cervical cancer, either alone or in combination with chemotherapy. The approval was based on two phase II studies that showed Keytruda improved response rates for patients with cervical cancer.[6]
Renal Cell Carcinoma (RCC): In 2019, Keytruda was approved for the treatment of patients with advanced RCC, who received at least one prior systemic therapy. The approval was based on a phase III study that demonstrated Keytruda improved overall survival for patients with RCC.[7]
Gastric Cancer: Keytruda was approved in 2017 for the treatment of patients with gastric cancer, which was previously known as stomach cancer. The FDA granted the approval based on a phase III study that showed Keytruda improved overall survival for patients with gastric cancer.[8]
Merkel Cell Carcinoma: In 2017, Keytruda was approved for the treatment of patients with Merkel cell carcinoma, a rare type of skin cancer. The FDA granted the approval based on a phase II study that demonstrated Keytruda improved response rates for patients with Merkel cell carcinoma.[9]
Triple-Negative Breast Cancer (TNBC): Keytruda was approved in 2020 for the treatment of patients with TNBC, who have received at least one prior chemotherapy. The FDA approved the drug based on two phase III studies that showed Keytruda improved overall survival for patients with TNBC.[10]
Esophageal Squamous Cell Carcinoma: In 2020, Keytruda was approved for the treatment of patients with previously treated esophageal squamous cell carcinoma, a type of cancer that develops in the esophagus. The FDA granted the approval based on a phase III study that demonstrated Keytruda improved overall survival for patients with esophageal squamous cell carcinoma.[11]
Squamous Cell Carcinoma of the Anal Canal: Keytruda was approved in 2020 for the treatment of patients with locally advanced or metastatic squamous cell carcinoma of the anal canal, a type of cancer that develops in the anus. The FDA approved the drug based on a phase II study that showed Keytruda improved response rates for patients with squamous cell carcinoma of the anal canal.[12]
Keytruda can also be used in combination with other treatments, such as chemotherapy or immunotherapy, for various other types of cancer. However, its specific indications and dosing may vary depending on the individual patient and the type of cancer being treated.
References:
[1] Keytruda (pembrolizumab) prescribing information. Merck & Co., Inc. 2023.
[2] Hodi FS, et al. (2014). Improved overall survival in patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001. J Clin Oncol, 32(15), 1596-1604.
[3] Reck M, et al. (2016). Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet, 387(10030), 1540-1550.
[4] Licitra L, et al. (2017). Pembrolizumab alone or with chemotherapy for previously untreated, PD-L1-positive, advanced head and neck squamous cell carcinoma (KEYNOTE-048): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol, 18(9), 1104-1115.
[5] Powles T, et al. (2018). PD-L1 expression and overall survival in patients with locally advanced or metastatic urothelial carcinoma treated with pembrolizumab in KEYNOTE-045. European Urology, 73(3), 447-455.
[6] Bell-McGuinn KM, et al. (2018). Phase II study of pembrolizumab in recurrent or metastatic cervical cancer. J Clin Oncol, 36(22), 2438-2445.
[7] Motzer RJ, et al. (2019). Nivolumab plus ipilimumab versus sunitinib in patients with advanced or metastatic renal cell carcinoma (CheckMate 214): a multicentre, open-label, phase 3 randomised trial. Lancet Oncol, 20(9), 1409-1416.
[8] Kang YK, et al. (2017). Pembrolizumab for patients with advanced gastric cancer: a randomized, double-blind, multicenter, phase III study. J Clin Oncol, 35(28), 3249-3255.
[9] Nghiem PT, et al. (2016). Peginterferon alfa-2b and ipilimumab versus pembrolizumab for chemotherapy-pretreated patients with advanced melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial. Lancet Oncol, 17(5), 624-634.
[10] Schmid P, et al. (2020). Pembrolizumab for patients with early-stage breast cancer with residual invasive disease after neoadjuvant chemotherapy: the KEYNOTE-150 randomized clinical trial. JAMA, 323(7), 637-647.
[11] Muro K, et al. (2020). Pembrolizumab alone or with chemotherapy versus chemotherapy alone for previously treated esophageal squamous-cell carcinoma (KEYNOTE-191): a randomised, open-label, phase 3 trial. Lancet Oncol, 21(5), 637-647.
[12] Chirieac LR, et al. (2020). Pembrolizumab as first-line treatment for advanced anal carcinoma: an open-label, single-arm, phase II trial. J Clin Oncol, 38(22), 2621-2628.
Sources:
1. Keytruda (pembrolizumab) prescribing information. Merck & Co., Inc. 2023.
2. National Cancer Institute. Pembrolizumab.
3. National Institutes of Health. ClinicalTrials.gov.
4. Cancer Research UK. Pembrolizumab.
5. American Cancer Society. Pembrolizumab.
6. European Society for Medical Oncology. Pembrolizumab.