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Also known as Pembrolizumab, MK-3475, pembrolizumab, KEYTRUDA®, KEYTRUDA, Pembrolizumab Injection [Keytruda], Pembrolizumab (Keytruda), Pembrolizumab (MK-3475)
Pembrolizumab/Vibostolimab · 2 trials · 1 indication
OS is defined as the time from the date of randomization to death due to any cause. The OS is reported for all participants with PD-L1 positive tumors (PD-L1 TPS≥1%). The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.
OS is defined as the time from randomization to the date of death due to any cause.
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. PFS was assessed by blinded independent central review (BICR) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
| Arm | Type | Description |
|---|---|---|
| MK-7684A + Chemotherapy | EXPERIMENTAL | Participants receive pembrolizumab/vibostolimab (co-formulation of 200mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. |
| Pembrolizumab + Chemotherapy | ACTIVE_COMPARATOR | Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous. |
| Pembrolizumab+Lenvatinib | EXPERIMENTAL | Participants receive pembrolizumab at 200 mg, every 3 weeks (Q3W) via intravenous (IV) infusion on Day 1 of each 21-day cycle, in combination with lenvatinib at 20 mg, once daily (QD) via oral capsule. Pembrolizumab will be administered for up to 35 treatment cycles (\~2 years). Lenvantinib will be administered until progressive disease or unacceptable toxicity. |
| Docetaxel | ACTIVE_COMPARATOR | Participants receive docetaxel at 75 mg/m\^2, Q3W via IV infusion over 1-hour infusion on Day 1 of each 21-day cycle. Docetaxel will be administered until progressive disease or unacceptable toxicity. |
| Lenvatinib Monotherapy | EXPERIMENTAL | Participants receive lenvatinib at 24 mg, QD via oral capsule. Lenvantinib will be administered until progressive disease or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab/Vibostolimab | BIOLOGICAL | Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 35 administrations |
| Carboplatin | DRUG | Carboplatin 10 mg/ml administered as IV infusion Q3W for 4 administrations |
| Cisplatin | DRUG | Cisplatin 1 mg/ml administered as IV infusion Q3W for 4 administrations |
| Paclitaxel | DRUG | Paclitaxel 6mg/ml administered as IV infusion Q3W for 4 administrations |
| Nab-paclitaxel | DRUG | Nab-paclitaxel 100 mg/vial administered as IV infusion Days 1, 8, and 15 of each 21-day cycle for 4 administrations |
| Pemetrexed | DRUG | Pemetrexed 500 mg/vial administered as IV infusion Q3W until progression, intolerable adverse event (AE), or participant or physician decision |
| Pembrolizumab | BIOLOGICAL | Pembrolizumab 25 mg/mL administered as IV infusion Q3W for up to 35 administrations |
| Lenvatinib | DRUG | Oral capsules (unit strength: 4 and 10 mg) at 20 mg or 24 mg total daily dose. |
| Docetaxel | DRUG | IV infusion of docetaxel at 75 mg/m\^2. |
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * A histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous NSCLC * Has not received prior systemic treatment for metastatic NSCLC * Has measurable disease b...
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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.