Floatz Rating
B56/100
Confidence
Indicative
Sponsor
M.D. Anderson Cancer Center
Modality
monoclonal_antibody
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
52Indicative
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07511036CT.gov PROSECCO: A Phase 2, Single Arm, Neoadjuvant Study Evaluating Combination Cemiplimab, Fianlimab, And Ipilimumab In Patients With Surgically Resectable Melanoma | — | Not Yet Recruiting | — | — | — |
NCT07223411CT.gov Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma | — | Recruiting | — | — | — |
NCT06848088CT.gov A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment | — | Enrolling By Invitation | — | — | — |
NCT06190951CT.gov A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma | — | Active Not Recruiting | — | — | — |
NCT06594991CT.gov A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma | — | Recruiting | — | — | — |
NCT06246916CT.gov A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head) | — | Recruiting | — | — | — |
NCT05608291CT.gov A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery | — | Active Not Recruiting | — | — | — |
NCT05352672CT.gov Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma | — | Active Not Recruiting | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
65High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Melanoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Fianlimab (this asset) | M.D. Anderson Cancer Center | P3 | B · 56 |
| Gm-Csf | Ultimovacs ASA | P4 | BBB |
| Sargramostim | Mayo Clinic | P3 | BBB |
| Cediranib | M.D. Anderson Cancer Center | P3 | BBB |
| Ifa | Craig L Slingluff, Jr | P2 | BB |
| Cyclophosphamide | Primmune Therapeutics, Inc. | P4 | BB |
| Temsirolimus | University of Regensburg | P2 | BB |
| Tebentafusp | Immunocore Ltd | P3 | BB |
| Dacarbazine | Suzhou BlueHorse Therapeutics Co., Ltd. | P3 | BB |
+42 more in the Melanoma cohort
Other indications for Fianlimab
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Primary Peritoneal Carcinoma | — | P2 | CCC · 55 |
| Metastatic Melanoma | — | P2 | CCC · 53 |
| Cutaneous Melanoma | — | P2 | CCC · 53 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Fianlimab in Melanoma. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/fianlimab-melanoma
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