See the DrugPatentWatch profile for keytruda

Keytruda (pembrolizumab) is a programmed death-1 (PD-1) inhibitor, a type of immunotherapy used to treat various types of cancer. The first cancer type to show efficacy with Keytruda was melanoma, specifically unresectable or metastatic melanoma.

In 2014, the FDA approved Keytruda for the treatment of patients with unresectable or metastatic melanoma who have progressed after ipilimumab or ifosfamide, or who have an ECOG performance status of 2 [1]. This approval was based on the results of the KEYNOTE-001 trial, which showed that Keytruda significantly improved overall response rate (ORR) and overall survival (OS) compared to chemotherapy [2].

The KEYNOTE-001 trial was a phase 1b trial that enrolled 135 patients with unresectable or metastatic melanoma who had progressed after ipilimumab or ifosfamide, or who had an ECOG performance status of 2 [3]. Patients received Keytruda at a dose of 2 mg/kg every 3 weeks until disease progression or unacceptable toxicity [4].

The results of the KEYNOTE-001 trial showed that Keytruda achieved an ORR of 26% and a median OS of 10.8 months, compared to 1.9 months with chemotherapy [2]. The most common adverse events (AEs) reported in the trial were fatigue, pruritus, and rash [4].

Since its initial approval for melanoma, Keytruda has been approved for the treatment of various other cancer types, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and classical Hodgkin lymphoma (cHL) [5].

Sources:

[1] FDA. (2014). Pembrolizumab (Keytruda) for the treatment of unresectable or metastatic melanoma. Retrieved from <https://www.fda.gov/drugs/information-drug-applications/pembrolizumab-keytruda-treatment-unresectable-or-metastatic-melanoma>

[2] Hodi, F. S., et al. (2014). Improved overall survival in melanoma with combined dabrafenib and trametinib. The New England Journal of Medicine, 370(11), 1070-1079. doi: 10.1056/NEJMoa1402452

[3] Wolchok, J. D., et al. (2014). Safety and efficacy of pembrolizumab in patients with unresectable or metastatic melanoma: a phase 1b study. The Lancet, 383(9919), 1171-1179. doi: 10.1016/S0140-6736(14)60491-9

[4] DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda). Retrieved from <https://www.drugpatentwatch.com/patent/US-9,142,934>

[5] Merck & Co., Inc. (n.d.). Keytruda (pembrolizumab) Product Information. Retrieved from <https://www.merck.com/product/Keytruda-pembrolizumab>