U.S. License Holder:

Merck Sharp Dohme

Date of License:

September-04-2014

FDA-Approved Indications

KEYTRUDA (pembrolizumab) is a programmed death receptor-1 (PD-1)-blocking antibody indicated in:

Melanoma: for the treatment of patients with unresectable or metastatic melanoma;

Non-Small Cell Lung Cancer (NSCLC): In combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations; in combindation with carboplatin and either paclitaxel or nabpaclitaxel, as first-line treatment of patients with metastatic squamous NSCLC; as a single agent for the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression [(Tumor Proportion Score (TPS) greater than or equal to 50 percent)] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations; as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS greater than or equal to 1 percent) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy; in combination with pemetrexed and carboplatin, as first-line treatment of patients with metastatic nonsquamous NSCLC;

Head and Neck Squamous Cell Cancer (HNSCC): for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy;

Classical Hodgkin Lymphoma (cHL): for the treatment of adult and pediatric patients with refractory cHL, or who have relapsed after 3 or more prior lines of therapy;

Primary Mediastinal Large B-Cell Lymphoma (PMBCL): for the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy;

Urothelial Carcinoma: for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [Combined Positive Score (CPS) greater than or equal to 10] as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status; for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant treatment with platinum-containing chemotherapy;

Microsatellite Instability-High Cancer: for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan;

Gastric Cancer: for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (Combined Positive Score (CPS) greater than or equal to 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy;

Cervical Cancer: for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS greater than or equal to 1) as determined by an FDA-approved test;

Hepatocellular Carcinoma (HCC): For the treatment of patients with HCC who have been previously treated with sorafenib.

Inter Partes Review Proceedings

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