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Also known as Pembrolizumab, MK-3475, pembrolizumab, KEYTRUDA®, KEYTRUDA, Pembrolizumab Injection [Keytruda], Pembrolizumab (Keytruda), Pembrolizumab (MK-3475)
Pembrolizumab/ml · 3 trials · 2 indications
iDFS is the time from randomization to invasive local, regional, or distant recurrence, invasive contralateral breast cancer, or death due to any cause, whichever occurs first.
Distant disease-free survival is defined as the delay between date of inclusion and distant tumor relapse, second cancer, or death from any cause, whichever occurs first.
CRR is defined as the proportion of patients who reached complete response (CR), according to RECIST v1.1 after the first sequence therapy including chemotherapy associated with immunotherapy and surgery.
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab + sacituzumab tirumotecan | EXPERIMENTAL | Participants receive pembrolizumab every 6 weeks (q6w) in combination with sacituzumab tirumotecan every 2 weeks (q2w) for 24 weeks. In addition, participants receive an antihistamine, an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to sacituzumab tirumotecan infusions. |
| Treatment of Physician's Choice | ACTIVE_COMPARATOR | Participants receive pembrolizumab q6w or pembrolizumab q6w in combination with capecitabine (twice daily \[BID\] on Days 1 to 14 and 22 to 35 every 42 days x 4 \[2 weeks 1, 1 week off\]) for 24 weeks. |
| Cohort 1-Pembrolizumab plus Paclitaxel | EXPERIMENTAL | Pembrolizumab will be administered at a fixed dose of 200 mg every 3 weeks (Q3W), with a total of 9 cycles and Paclitaxel 80 mg/m² weekly for 12 cycles |
| Cohort 2-Observation | NO_INTERVENTION | No treatment will be administered, patients will undergo standard surveillance every 6 months according to local practice. |
| Pembrolizumab | EXPERIMENTAL | Single arm study |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab | BIOLOGICAL | Pembrolizumab 400 mg intravenous (IV) infusion q6w |
| Sacituzumab tirumotecan | BIOLOGICAL | Sacituzumab tirumotecan 4 mg/kg IV infusion q2w |
| Capecitabine | DRUG | Capecitabine 1000 mg/m\^2 to 1250 mg/m\^2 by mouth BID |
| Pembrolizumab 25 mg/ml | DRUG | Pembrolizumab drug product is a sterile-filtered liquid and is aseptically filled into single-use vials. The vials contain 4 mL of sterile solution for IV infusion. |
| Paclitaxel injection | DRUG | Injectable solution for IV administration. Dose of 80 mg/m² weekly. |
| Pembrolizumab 25 MG/ML [Keytruda] | DRUG | Pembrolizumab (200mg flat dose) will be administred in combinaison with PAVEP chemotherapy for the first 6 cycles (21-day cycle) Then, Pembrolizumab (200mg flat dose) will be administred in monotherapy until one year for patients with complete response and up to two years for patients with Stable disease or Progression response after the end of first-sequence therapy (PAVEP chemotherapy +/- High dose chemotherapy) or until disease progression. |
Inclusion Criteria: * Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines * Has no evidence of locoregional or distant relapse, as assessed by the treating physician * Had neoadjuvant treatment base...
MK-3475, also known as pembrolizumab and marketed as KEYTRUDA, is an investigational oncology therapy being studied for stomach neoplasms, small cell lung carcinoma, advanced hepatocellular carcinoma, adenocarcinoma of the pancreas, head and neck squamous cell cancer, and high-grade serous ovarian carcinoma. It is developed by Merck & Company, Inc. (MRK).
MK-3475 targets PDCD1, the gene encoding programmed cell death protein 1 (PD-1), and acts as an inhibitor of this target. By inhibiting PD-1, it is designed to modulate immune responses in the treatment of various cancers.
MK-3475 is developed by Merck & Company, Inc., which trades under the ticker MRK. The drug is also known as pembrolizumab and is marketed under the brand name KEYTRUDA.
MK-3475 is in Phase 1 clinical development. It has received FDA Priority Review designation. The drug is investigational and not yet approved, with ongoing clinical trials across multiple oncology indications.
MK-3475 has been studied in 17 clinical trials with a total enrollment of 8,038 participants. Notable trials include NCT02635360 for advanced cervical cancer, NCT03635567 for persistent, recurrent, or metastatic cervical cancer, NCT04875195 for relapsed or refractory classical Hodgkin's lymphoma, and NCT05258279 for non-small-cell lung cancer with EGFR mutations.
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 Monotherapy, among others.