Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 106 |
| INN | Pembrolizumab |
| Status | Approved |
| Drug code(s) | MK-3475, SCH-900475 |
| Brand name | Keytruda |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | PD-1 |
| Indications of clinical studies | Solid Tumors, Melanoma, colorectal cancer, non-small cell lung cancer, hematological cancers, renal cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2009 |
| Start of Phase 2 | December 04, 2012 |
| Start of Phase 3 | September 11, 2013 |
| Date BLA/NDA submitted to FDA | February 27, 2014 |
| Year of first approval (global) | 2014 |
| Date of first US approval | September 04, 2014 |
| INN, US product name | Pembrolizumab |
| US or EU approved indications | Melanoma, adjuvant therapy for patients with melanoma who have lymph node involvement after complete resection. Non-small-cell lung cancer, head & neck cancer, Hodgkin's lymphoma, bladder cancer, previously untreated micorsatellite instability-high cancer, gastric/gastroesophageal junction adenocarcinoma, recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test, pediatric and adult patients with refractory primary mediastinal large B-cell lymphoma who received two or more lines of therapy; first-line treatment of patients with metastatic squamous non-small cell lung cancer, in combination with carboplatin and either paclitaxel or nab-paclitaxel. April 2019: FDA approved Merck's Keytruda in combination with Pfizer's Inlyta as therapy for treatment-naive patients with advanced renal cell carcinoma. June 2019 FDA approval: metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. November 13, 2020, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co.) in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test. |
| Company | Merck |
| Licensee/Partner | None |
| Comments about company or candidate | As of mid-Feb 2019, Keytruda was approved in the US for 17 indications, including melanoma, non-small-cell lung cancer, head & neck cancer, Hodgkin's lymphoma, bladder cancer, previously untreated micorsatellite instability-high cancer, gastric/gastroesophageal junction adenocarcinoma. Keytruda was granted at least 11 Breakthrough Therapy designations. Approved in the EU in 2015 Approved by FDA on Sep 4, 2014. In Jan 2014, Merck announced it started a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application for MK-3475 for patients with advanced melanoma who have been previously treated with ipilimumab. Submission expected to be complete by mid-2014. BLA receives priority review; PDFUA date Oct 28, 2014. NCT01866319 Phase 3 study in melanoma recruiting as of Sep 11, 2013; NCT01905657 Phase 2/3 in non-small cell lung cancer recruiting as of Aug 14, 20133; Received Breakthrough Therapy designation from FDA in April 2013 |
| Full address of company | Rahway, NJ 07065 USA North America United States of America https://www.merck.com/contact-us/ |
Immune checkpoint target. S228P mutation for stability. INN was previously lambrolizumab
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |