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FAP IL2V
FAP IL2V is a bispecific immunotherapy that targets fibroblast activation protein (FAP) on cancer-associated fibroblasts while delivering interleukin-2 (IL-2) to activate anti-tumor immune responses.
FAP IL2V is a bispecific immunotherapy that targets fibroblast activation protein (FAP) on cancer-associated fibroblasts while delivering interleukin-2 (IL-2) to activate anti-tumor immune responses. Used for Solid tumors (in clinical development), Cancer-associated fibroblast-rich tumors.
At a glance
| Generic name | FAP IL2V |
|---|---|
| Also known as | simlukafusp alfa |
| Sponsor | Hoffmann-La Roche |
| Drug class | Bispecific antibody-cytokine fusion |
| Target | FAP (fibroblast activation protein) and IL-2 receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This drug combines a FAP-targeting moiety with IL-2 to selectively deliver immune activation to the tumor microenvironment. By engaging FAP+ cancer-associated fibroblasts and simultaneously providing IL-2 signaling, it aims to reprogram the immunosuppressive tumor stroma and enhance T-cell infiltration and activation. This dual mechanism targets both the cellular and immunological components of the tumor microenvironment.
Approved indications
- Solid tumors (in clinical development)
- Cancer-associated fibroblast-rich tumors
Common side effects
- Cytokine-related toxicity (fever, chills, fatigue)
- Immune-related adverse events
- Injection site reactions
Key clinical trials
- A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (PHASE3)
- A Study to Evaluate Safety and Therapeutic Activity of RO6874281 in Combination with Pembrolizumab, in Participants with Advanced or Metastatic Melanoma (PHASE1)
- Basket Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors (PHASE2)
- A Study Evaluating Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281 as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C) (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- FAP IL2V CI brief — competitive landscape report
- FAP IL2V updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI