Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MK-4280
Favezelimab · 5 trials · 6 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.
DLTs were assessed during the first cycle (21 days) \& were defined as: Grade (Gr) 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days, except Gr 4 thrombocytopenia of any duration or Gr 3 thrombocytopenia associated with bleeding; Gr 3 nonhematologic toxicity lasting ≥3 days despite optimal supportive care (with exceptions); Gr 3 or 4 nonhematologic lab abnormality (if medical intervention was required, lead to hospitalization, or persisted for \>1 week); Gr 3 or 4 febrile neutropenia; any drug-related AE that caused the participant to discontinue treatment during Cycle 1; Grade 5 toxicity; Any treatment-related toxicity that causes ≥2-week delay in initiation of Cycle 2.
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE is presented.
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE is presented.
| 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. |
| Part A: Favezelimab 7 mg Monotherapy | EXPERIMENTAL | Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle. |
| Part A: Favezelimab 21 mg Monotherapy | EXPERIMENTAL | Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle. |
| Part A: Favezelimab 70 mg Monotherapy | EXPERIMENTAL | Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle. |
| Part A: Favezelimab 210 mg Monotherapy | EXPERIMENTAL | Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle. |
| Part A: Favezelimab 700 mg Monotherapy | EXPERIMENTAL | Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle. |
| Part A: Favezelimab 7 mg + Pembrolizumab 200 mg | EXPERIMENTAL | Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle. |
| Part A: Favezelimab 21 mg + Pembrolizumab 200 mg | EXPERIMENTAL | Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle. |
| Part A: Favezelimab 70 mg + Pembrolizumab 200 mg | EXPERIMENTAL | Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle. |
| Part A: Favezelimab 210 mg + Pembrolizumab 200 mg | EXPERIMENTAL | Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle. |
| Part A: Favezelimab 700 mg + Pembrolizumab 200 mg | EXPERIMENTAL | Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle. |
| Part B: Favezelimab 800 mg Monotherapy (Arm 1) | EXPERIMENTAL | Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle. |
| Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A) | EXPERIMENTAL | Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle. |
| Part B: Favezelimab 700 mg + Pembrolizumab 200 mg (Arm 2B) | EXPERIMENTAL | Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle. |
| Part B: Favezelimab 800 mg + Pembrolizumab 200 mg (Arm 2C) | EXPERIMENTAL | Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle. |
| Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + mFOLFOX7 (Arm 3) | EXPERIMENTAL | Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV, and fluorouracil \[5-FU\] 2400 mg/m\^2 IV over 46 to 48 hours, every 2 weeks \[Q2W\]). |
| Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + FOLFIRI (Arm 4) | EXPERIMENTAL | Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m\^2 IV, leucovorin \[calcium folinate\] 400 mg/m\^2 IV and 5-FU 2400 mg/m\^2 IV over 46 to 48 hours, Q2W). |
| Part B: MK-4280A (Arm 5) | EXPERIMENTAL | Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle. |
| Part B: Favezelimab 800 mg + Pembrolizumab 200 mg + Lenvatinib 20 mg (Arm 6) | EXPERIMENTAL | Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily. |
| 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 |
| Favezelimab | BIOLOGICAL | IV infusion |
| Oxaliplatin | DRUG | IV infusion |
| Irinotecan | DRUG | IV infusion |
| Leucovorin (Calcium Folinate) | DRUG | IV infusion |
| Fluorouracil [5-FU] | 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 colorectal cancer, Hodgkin lymphoma, and selected solid tumors. It is being developed as a coformulated combination with pembrolizumab, known as MK-4280A, and is not yet approved for any indication.
Favezelimab targets LAG-3, and in its coformulated form MK-4280A it combines LAG-3 blockade with pembrolizumab's PD-1 blockade. This dual targeting aims to address immune checkpoint pathways in tumors.
Favezelimab is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is advancing the coformulated favezelimab/pembrolizumab combination, designated MK-4280A, across multiple cancer indications.
Favezelimab is in Phase 3 development. The Phase 3 trial NCT05064059 evaluated the coformulated favezelimab/pembrolizumab combination in previously treated metastatic PD-L1 positive colorectal cancer, and it has been completed.
Favezelimab has been studied in completed trials including NCT05064059 and its China extension NCT05600309 in colorectal cancer, NCT05508867 in relapsed or refractory classical Hodgkin lymphoma, and NCT06036836 in selected solid tumors including cutaneous squamous cell carcinoma and endometrial cancer.