Keytruda® (pembrolizumab)

BL 125514

Keytruda® (pembrolizumab)

BL 125514

U.S. License Holder:

Merck Sharp Dohme

Date of License:

September-04-2014

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications


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

Melanoma: for the treatment of patients with unresectable or metastatic melanoma; for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection;

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 combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC; as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) greater than or equal to 1 percent] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic; 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. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda; for the treatment of patients with resectable (tumors greater than or equal to 4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery; as a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a greater than or equal to 4 cm), II, or IIIA NSCLC;

Malignant Pleural Mesothelioma (MPM): in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with unresectable advanced or metastatic MPM;

Head and Neck Squamous Cell Cancer (HNSCC): in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC; as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) greater than or equal to 1] as determined by an FDA-approved test; as a single agent 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 patients with relapsed or refractory cHL; for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more 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 Cancer: in combination with enfortumab vedotin, for the treatment of adult patients with locally advanced or metastatic urothelial cancer; as a single agent for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: are not eligible for any platinum-containing chemotherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant treatment with platinum-containing chemotherapy; as a single agent for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy;

Microsatellite Instability-High or Mismatch Repair Deficient Cancer: for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options;

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer (CRC): for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test;

Gastric Cancer: in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS greater than or equal to 1) as determined by an FDA-approved test; In combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma;

Esophageal Cancer: for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: in combination with platinum- and fluoropyrimidine-based chemotherapy, or s a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS greater than or equal to 10) as determined by an FDA-approved test;

Cervical Cancer: In combination with chemoradiotherapy, for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer; in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS greater than or equal to 1) as determined by an FDA-approved test; as a single agent for the treatment of patients with recurrent or metastaticcervical 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 secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen;

Biliary Tract Cancer (BTC): In combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer;

Merkel Cell Carcinoma (MCC): for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma;

Renal Cell Carcinoma (RCC): In combination with axitinib, for the first-line treatment of adult patients with advanced RCC; In combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC; For the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions;

Endometrial Carcinoma: In combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma; In combination with lenvatinib, for the treatment of patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) as determined by an FDA-approved test or not MSI-H, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation; As a single agent, for the treatment of patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation;

Tumor Mutational Burden-High (™B-H) Cancer: For the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (™B-H) [greater than or equal to 10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options;

Cutaneous Squamous Cell Carcinoma (cSCC): For the treatment of patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation.

Triple-Negative Breast Cancer (TNBC): For the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery; In combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS greater than or equal to 10) as determined by an FDA approved test;

Adult Classical Hodgkin Lymphoma and Adult Primary Mediastinal Large B-Cell Lymphoma: Additional Dosing Regimen of 400 mg Every 6 Weeks: For use at an additional recommended dosage of 400 mg every 6 weeks for Classical Hodgkin Lymphoma and Primary Mediastinal Large B-Cell Lymphoma in adults.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

U.S. Patent No.
9,067,999 (Immunopotentiative Composition)

Patent Owner
Bristol-Myers Squibb Co.; ER Squibb and Sons, LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Petitioner(s)
Merck Sharp and Dohme Corp.

§ 102 Challenge
Y: Claims 1, 6-14, 19-20, 24-26, 29-30

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y: Claims 1, 6-14, 19-20, 24-27, 29-30

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

U.S. Patent No.
9,067,999 (Immunopotentiative Composition)

Patent Owner
Bristol-Myers Squibb Co.; ER Squibb and Sons, LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Petitioner(s)
Merck Sharp and Dohme Corp.

§ 102 Challenge
Y: Claims 1, 6-14, 19-20, 24-25

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y: Claims 1, 6-14, 19-20, 24-27, 29-30

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

U.S. Patent No.
9,073,994 (Immunopotentiative Composition)

Patent Owner
Bristol-Myers Squibb Co.; ER Squibb and Sons, LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Petitioner(s)
Merck and Co., Inc.; Merck Sharp and Dohme Corp.

§ 102 Challenge
Y: Claims 1-3, 8-9, 14-15, 19-22, 25

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y: Claims 1-3, 8-9, 14-15, 19-22, 25-26

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

U.S. Patent No.
9,073,994 (Immunopotentiative Composition)

Patent Owner
Bristol-Myers Squibb Co.; ER Squibb and Sons, LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Petitioner(s)
Merck Sharp and Dohme Corp.

§ 102 Challenge
Y: Claims 1-3, 8-9, 14-15, 19-22

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y: Claims 1-3, 8-9, 14-15, 19-22, 25-26

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

U.S. Patent No.
11,591,393 (Checkpoint Blockade and Microsatellite Instability)

Patent Owner
The Johns Hopkins University

Petitioner(s)
Merck Sharp & Dohme LLC; Merck & Co., Inc.

§ 102 Challenge
Y: Claims 1-2, 4-7, 11-12, 14-15, 17-20, 24-25, 27-42

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-42

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending; Request for Rehearing Denied

U.S. Patent No.
10,934,356 (Checkpoint Blockade and Microsatellite Instability)

Patent Owner
The Johns Hopkins University

Petitioner(s)
Merck Sharp & Dohme LLC; Merck & Co., Inc.

§ 102 Challenge
Y: Claims 1, 6-11, 13-20, 22-24, 26-28

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-28

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

U.S. Patent No.
11,325,974 (Checkpoint Blockade and Microsatellite Instability)

Patent Owner
The Johns Hopkins University

Petitioner(s)
Merck Sharp & Dohme LLC; Merck & Co., Inc.

§ 102 Challenge
Y: Claims 1-3, 5-7

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-7

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

U.S. Patent No.
11,325,975 (Checkpoint Blockade and Microsatellite Instability)

Patent Owner
The Johns Hopkins University

Petitioner(s)
Merck Sharp & Dohme LLC; Merck & Co., Inc.

§ 102 Challenge
Y: Claims 1-3, 6-10, 13-15

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-4, 6-10, 13-15

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

U.S. Patent No.
11,339,219 (Checkpoint Blockade and Microsatellite Instability)

Patent Owner
The Johns Hopkins University

Petitioner(s)
Merck Sharp & Dohme LLC; Merck & Co., Inc.

§ 102 Challenge
Y: Claims 1-4, 6-8

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-8

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

U.S. Patent No.
11,649,287 (Checkpoint Blockade and Microsatellite Instability)

Patent Owner
The Johns Hopkins University

Petitioner(s)
Merck Sharp & Dohme LLC; Merck & Co., Inc.

§ 102 Challenge
Y: Claims 1-2, 4-8, 11-12, 14-18, 21-36

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-36

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

U.S. Patent No.
11,643,462 (Checkpoint Blockade and Microsatellite Instability)

Patent Owner
The Johns Hopkins University

Petitioner(s)
Merck Sharp & Dohme LLC; Merck & Co., Inc.

§ 102 Challenge
Y: Claims 1-2, 4-7, 9-12, 14-17, 19-30

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-30

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

U.S. Patent No.
11,629,187 (Checkpoint Blockade and Microsatellite Instability)

Patent Owner
The Johns Hopkins University

Petitioner(s)
Merck Sharp & Dohme LLC; Merck & Co., Inc.

§ 102 Challenge
Y: Claims 1-2, 4-7, 9-12, 14-17, 19-28

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-28

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

U.S. Patent No.
11,634,491 (Checkpoint Blockade and Microsatellite Instability)

Patent Owner
The Johns Hopkins University

Petitioner(s)
Merck Sharp & Dohme LLC; Merck & Co., Inc.

§ 102 Challenge
Y: Claims 1-2, 4-7, 11-17, 19-22, 26-38

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-38

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

U.S. Patent No.
10,611,836 (Methods of Treating Cancer Using PD-1 Axis Binding Antagonists and TIGIT Inhibitors)

Patent Owner
Genentech, Inc.

Petitioner(s)
Merck Sharp & Dohme Corp.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1, 3-12

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
Challenges Also Include Written Description (Claims 1, 3-12) and Enablement (Claims 1, 3-12). PGR Not Instituted, Request for Rehearing Denied because Patent Owner Disclaimed Challenged Claims

U.S. Patent No.
10,626,174 (Methods of Treating Cancer Using PD-1 Axis Binding Antagonists and TIGIT Inhibitors)

Patent Owner
Genentech, Inc.

Petitioner(s)
Merck Sharp & Dohme Corp.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1, 3-22

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
Challenges Also Include Written Description (Claims 1, 3-22) and Enablement (Claims 1, 3-22). PGR Not Instituted, Request for Rehearing Denied because Patent Owner Disclaimed Challenged Claims

approved_indications U.S. Patent Litigations

PACER

Case No(s):

U.S. Patent Nos.
8,728,474 (Immunopotentiative Composition)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
Merck and Co., Inc.; Merck Sharp and Dohme Corp.

Status
Settled

BPCIA
N

U.S. Patent Nos.
9,067,999 (Immunopotentiative Composition)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
Merck and Co., Inc.; Merck Sharp and Dohme Corp.

Status
Settled

BPCIA
N

U.S. Patent Nos.
9,073,994 (Immunopotentiative Composition)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
Merck and Co., Inc.; Merck Sharp and Dohme Corp.

Status
Settled

BPCIA
N

U.S. Patent Nos.
5,693,761 (Polynucleotides Encoding Improved Humanized Immunoglobulins)

Plaintiffs
PDL Biopharma, Inc.

Defendants
Merck Sharpe & Dohme Corp.

Status
Settled

BPCIA
N

U.S. Patent Nos.
10,934,356 (Checkpoint Blockade and Microsatellite Instability) 11,325,974 (Checkpoint Blockade and Microsatellite Instability) 11,325,975 (Checkpoint Blockade and Microsatellite Instability) 11,339,219 (Checkpoint Blockade and Microsatellite Instability) 11,591,393 (Checkpoint Blockade and Microsatellite Instability) 11,629,187 (Checkpoint Blockade and Microsatellite Instability) 11,634,491 (Checkpoint Blockade and Microsatellite Instability) 11,643,462 (Checkpoint Blockade and Microsatellite Instability) 11,649,287 (Checkpoint Blockade and Microsatellite Instability)

Plaintiffs
Merck Sharp & Dohme LLC

Defendants
The Johns Hopkins University

Status
Case Ongoing; Stayed Pending IPR

BPCIA
N

U.S. Patent Nos.
5,693,761 (Polynucleotides Encoding Improved Humanized Immunoglobulins)

Plaintiffs
PDL Biopharma, Inc.

Defendants
Merck Sharpe & Dohme Corp.

Status
Case Voluntarily Dismissed

BPCIA
N

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

Disclaimer

The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

Subscribe for Future Updates

    captcha