Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Favezelimab · 1 trial · 1 indication
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 |
|---|---|---|
| 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 | BIOLOGICAL | IV infusion |
| Pembrolizumab | BIOLOGICAL | IV infusion |
| Oxaliplatin | DRUG | IV infusion |
| Irinotecan | DRUG | IV infusion |
| Leucovorin (Calcium Folinate) | DRUG | IV infusion |
| Fluorouracil [5-FU] | DRUG | IV infusion |
| Favezelimab/Pembrolizumab | BIOLOGICAL | IV infusion |
| Lenvatinib | DRUG | Oral |
Inclusion Criteria: * Part A and Part B: Has histologically or cytologically-confirmed metastatic solid tumor. * Has measurable disease by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) 1.1 criteria. * Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Gr...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | ACE-536 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor, Ruxolitinib |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| Incyte Corporation | INCY | 10 | PHASE2 | Ruxolitinib |
| GSK plc Sponsored ADR | GSK | 2 | PHASE2 | MMB |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Elritercept, Ruxolitinib |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY3410738, Venetoclax, Azacitidine |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Galecto, Inc. | GLTO | 1 | PHASE2 | GB2064 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | bomedemstat |
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.