Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
favezelimab/pembrolizumab · 4 trials · 5 indications
OS was defined as the time from randomization to death due to any cause.
Clinical benefit rate is defined as the percentage of participants who have clinical benefit. Clinical benefit is defined as major pathologic response (mPR) or pCR in participants who undergo surgery, or clinical complete response (cCR) \[defined as residual tumor not visible on clinical exam nor on imaging and a negative biopsy, if biopsy is available, in participants who decline surgery.
The ORR is defined as the percentage of participants who have an OR per investigator assessment. The OR is defined as a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
PFS was defined as the time from randomization to the first documented disease progression per Lugano criteria 2014 as assessed by investigator or death due to any cause, whichever occurred first. Progressive disease was defined as uptake moderately or markedly higher than the liver with an increase in overall uptake compared with nadir, and/or the appearance of new lesions consistent with lymphoma.
| Arm | Type | Description |
|---|---|---|
| Favezelimab/Pembrolizumab | EXPERIMENTAL | Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions. |
| Standard of Care (Regorafenib or TAS-102) | ACTIVE_COMPARATOR | At the Investigator's choice, participants will receive 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle or 35 mg/m\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle. |
| Pembrolizumab | EXPERIMENTAL | Participants will receive 200 mg pembrolizumab via an IV infusion Q3W for 3 cycles in the neoadjuvant period and 14 cycles of adjuvant therapy. Each cycle is 21 days. Participants who do not complete all 3 neoadjuvant cycles should have additional cycles in the adjuvant period so that the total number of study intervention administrations is 17 treatment cycles. |
| Favezelimab/Pembrolizumab + Lenvatinib (Cohort B) | EXPERIMENTAL | Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) via IV infusion Q3W for up to 35 cycles (each cycle is 21 days) PLUS lenvatinib every day (QD) 20 mg orally until disease progression, unacceptable toxicity, or discontinuation criteria are met. |
| Pembrolizumab + Lenvatinib (Cohort B) | EXPERIMENTAL | Participants will receive 200 mg pembrolizumab via IV infusion Q3W for up to 35 cycles (each cycle is 21 days) PLUS lenvatinib QD 20 mg orally until disease progression, unacceptable toxicity, or discontinuation criteria are met. |
| Chemotherapy (Bendamustine or Gemcitabine) | ACTIVE_COMPARATOR | Participants will receive physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles. |
| Name | Type | Description |
|---|---|---|
| favezelimab/pembrolizumab | BIOLOGICAL | Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion |
| regorafenib | DRUG | Oral |
| TAS-102 | DRUG | Oral |
| pembrolizumab | BIOLOGICAL | IV infusion |
| lenvatinib | DRUG | Oral administration of capsule |
| bendamustine | DRUG | IV infusion |
| gemcitabine | DRUG | IV infusion |
Inclusion Criteria: * Has a histologically confirmed colorectal adenocarcinoma that is metastatic and unresectable. * Has measurable disease per RECIST 1.1 as assessed by the local site investigator. * Has been previously treated for the disease and radiographically progressed on or after or could ...
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Favezelimab is an investigational monoclonal antibody being studied in oncology for the treatment of solid tumors, Hodgkin lymphoma, and colorectal cancer. It is being developed by Merck & Company, Inc. (MRK) and is currently in clinical development, with trials having reached Phase 3.
Favezelimab is a monoclonal antibody that targets the immune checkpoint molecule LAG-3. By binding to LAG-3, it is designed to modulate the immune response against tumor cells. It is often studied in combination with pembrolizumab, which targets PD-1.
Favezelimab is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug as a monotherapy and in combination with other agents for various cancer indications.
Favezelimab is an investigational drug that has been studied in Phase 1, Phase 2, and Phase 3 clinical trials. As of the latest data, it is not FDA approved and remains in clinical development. All listed trials have been completed.
Favezelimab has been evaluated in several completed trials, including NCT02720068 (Phase 1 in advanced solid tumors), NCT05064059 (Phase 3 in colorectal cancer), NCT05508867 (Phase 2 in Hodgkin lymphoma), and NCT06036836 (Phase 2 in selected solid tumors).
Favezelimab is also known as Favezelimab/Pembrolizumab, which refers to a coformulated combination of favezelimab and pembrolizumab. This combination is being studied under the code MK-4280A in clinical trials for various cancers.