Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Pembrolizumab, MK-3475, pembrolizumab, KEYTRUDA®, KEYTRUDA, Pembrolizumab Injection [Keytruda], Pembrolizumab (Keytruda), Pembrolizumab (MK-3475)
Pembrolizumab/kg · 2 trials · 3 indications
Overall response rate (ORR) was defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by the investigator.
The following toxicities graded per the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v.4.0) were considered DLTs if judged by the investigator to be related to either study drug: * Grade (G) 4 neutropenia lasting \>7 days * Grade 3 and Grade 4 febrile neutropenia * Grade 4 thrombocytopenia (\<25,000/mm\^3) * Grade 4 anemia * Grade 4 non-hematologic toxicity (not laboratory) * Grade 3 non-hematologic toxicity (not laboratory) lasting \>3 days despite optimal supportive care * Any Grade 3 non-hematologic laboratory value if medical intervention is required to treat the participant or the abnormality persists for \>7 days. * (Part D only) Missing the second dose of pembrolizumab (Cycle1 Day 22) due to drug-related adverse event
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab | EXPERIMENTAL | Participants receive pembrolizumab 10 mg/kg, intravenously (IV), once every 2 weeks (Q2W) for up to \~2 years |
| Pembrolizumab 2 mg/kg | EXPERIMENTAL | In Part A, participants receive intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days). |
| Pembrolizumab 10 mg/kg | EXPERIMENTAL | In Part A, participants receive IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days). |
| Pembrolizumab+Cisplatin/Pemetrexed | EXPERIMENTAL | In Part B, participants receive IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks. |
| Pembrolizumab+Carboplatin/Pemetrexed | EXPERIMENTAL | In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks. |
| Pembrolizumab+Carboplatin/Paclitaxel | EXPERIMENTAL | In Part C, participants receive IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m\^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks. |
| Pembrolizumab+Carboplatin/Nab-paclitaxel | EXPERIMENTAL | In Part C, participants receive IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks. |
| Pembrolizumab+Ipilimumab | EXPERIMENTAL | In Part D, participants receive IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab). |
| Pembrolizumab+Cisplatin/Etoposide | EXPERIMENTAL | In Part E, participants receive IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks. |
| Pembrolizumab+Carboplatin/Etoposide | EXPERIMENTAL | In Part E, participants receive IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks. |
| Pembrolizumab+Cisplatin/Etoposide+G-CSF | EXPERIMENTAL | In Part E, participants receive IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m\^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab | BIOLOGICAL | IV infusion |
| Pembrolizumab 2 mg/kg | BIOLOGICAL | Administered as an intravenous (IV) infusion on Day 1 of Cycle 1 (28 days), Cycle 2 (14 days), and Cycle 3 (14 days) |
| Pembrolizumab 10 mg/kg | BIOLOGICAL | Administered as an IV infusion on Day 1 of Cycle 1 (28 days), Cycle 2 (14 days), and Cycle 3 (14 days) |
| Pembrolizumab 200 mg | BIOLOGICAL | Administered as an IV infusion on Day 1 of each 21-day cycle |
| Cisplatin 75 mg/m^2 | DRUG | Administered as an IV infusion on Day 1 of each 21-day cycle |
| Pemetrexed 500 mg/m^2 | DRUG | Administered as an IV infusion on Day 1 of each 21-day cycle |
| Carboplatin AUC 5 mg/mL/min | DRUG | Administered as an IV infusion on Day 1 of each 21-day cycle |
| Carboplatin AUC 6 mg/mL/min | DRUG | Administered as an IV infusion on Day 1 of each 21-day cycle |
| Paclitaxel 200 mg/m^2 | DRUG | Administered as an IV infusion on Day 1 of each 21-day cycle |
| Nab-paclitaxel 100 mg/m^2 | DRUG | Administered as an IV infusion on Days 1, 8, and 15 of each 21-day cycle |
| Ipilimumab 1 mg/kg | BIOLOGICAL | Administered as an IV infusion on Day 1 of every other 21-day cycle (every 42 days) |
| Etoposide 100 mg/m^2 | DRUG | Administered as an IV infusion on Days 1, 2, and 3 of each 21-day cycle |
| G-CSF (pegfilgrastim) 3.6 mg | DRUG | Administered as a subcutaneous injection on Day 4 of Cycle 1 |
Inclusion Criteria: * Histologically or cytologically documented locally-advanced and/or metastatic solid malignancy that is incurable, and has failed prior standard therapy or for which standard therapy is not appropriate * Have biomarker-positive solid tumor * Have measurable disease based on Res...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
MK-3475, also known as pembrolizumab and marketed as KEYTRUDA, is an investigational antibody being studied for several oncology indications, including Primary Mediastinal Large B-cell Lymphoma (PMBCL), prostate cancer, anal cancer, squamous cell carcinoma, non-small-cell lung cancer, B-cell lymphoma, and oligometastatic squamous cell carcinoma of the head and neck.
MK-3475 is a monoclonal antibody (target class -mab) that targets the PD-1 receptor. By binding to PD-1, it is designed to block the interaction with its ligands, potentially enhancing the immune system's ability to fight cancer cells.
MK-3475 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is conducting clinical trials to evaluate the drug's safety and efficacy across multiple cancer types.
MK-3475 is in Phase 1 clinical development. It has received a Priority Review designation from the FDA. The drug is investigational and not yet approved, with ongoing trials assessing its use in various cancers.
MK-3475 is being studied in 17 clinical trials, with 5 active and 12 completed, enrolling over 8,000 participants. Notable trials include NCT02635360 for cervical cancer, NCT04875195 for Hodgkin's lymphoma and PMBCL, NCT04976634 for solid tumors, and NCT05815927 for head and neck cancer.
Yes, MK-3475 is the same as pembrolizumab, which is also known by the brand name KEYTRUDA. The drug is referred to by multiple names including Pembrolizumab 200 mg, Pembrolizumab Injection, and Pembrolizumab (MK-3475), among others.