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BCD-100
BCD-100 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and restoring anti-tumor immune responses.
BCD-100 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and restoring anti-tumor immune responses. Used for Non-small cell lung cancer, Other solid tumors (under investigation).
At a glance
| Generic name | BCD-100 |
|---|---|
| Also known as | prolgolimab, Forteca |
| Sponsor | Biocad |
| Drug class | PD-L1 inhibitor |
| Target | PD-L1 |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
BCD-100 targets programmed death ligand 1 (PD-L1) expressed on tumor cells and immune cells, preventing the suppression of T-cell mediated immunity. By blocking the PD-L1/PD-1 axis, the drug releases the brakes on the immune system, allowing T cells to recognize and attack cancer cells more effectively. This mechanism is similar to other checkpoint inhibitors in the immuno-oncology space.
Approved indications
- Non-small cell lung cancer
- Other solid tumors (under investigation)
Common side effects
- Fatigue
- Immune-related pneumonitis
- Diarrhea
- Rash
- Immune-related hepatitis
Key clinical trials
- A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma (PHASE3)
- Study of Efficacy and Safety of BCD-217 (Anti-CTLA-4 and Anti-PD-1) Followed By BCD-100 (Anti-PD-1) Versus BCD-100 Monotherapy as First-Line Treatment in Patients With Unresectable or Metastatic Melanoma (PHASE2)
- Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS) (PHASE2, PHASE3)
- International Trial of the Efficacy and Safety of BCD-100 in Patients With Melanoma (PHASE2)
- Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy With and Without Bevacizumab as First-Line Treatment of Subjects With Advanced Cervical Cancer (FERMATA) (PHASE3)
- Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy as First Line Treatment in Patients With Advanced Non-Squamous NSCLC (PHASE3)
- Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy and Bevacizumab in Patients With Recurrent, Persistent or Metastatic Cervical Cancer (CAESURA) (PHASE2)
- A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of BCD-100 in Patients With Advanced Solid Tumors (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:
- BCD-100 CI brief — competitive landscape report
- BCD-100 updates RSS · CI watch RSS
- Biocad portfolio CI