Anti-PD-L1 Monoclonal Antibody

City of Hope Medical Center · Phase 2 active Biologic

Anti-PD-L1 Monoclonal Antibody is a PD-1 inhibitor Biologic drug developed by City of Hope Medical Center. It is currently in Phase 2 development for Non-small cell lung cancer, PD-L1 positive, Head and neck squamous cell carcinoma, Urothelial carcinoma. Also known as: Envafolimab.

Anti-PD-L1 Monoclonal Antibody works by blocking the PD-L1 protein, allowing the immune system to attack cancer cells.

Anti-PD-L1 Monoclonal Antibody works by blocking the PD-L1 protein, allowing the immune system to attack cancer cells. Used for Non-small cell lung cancer, PD-L1 positive, Head and neck squamous cell carcinoma, Urothelial carcinoma.

Likelihood of approval

13.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

• Baseline phase 2 → approval rate +15.3pp
  Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
• Oncology Phase 2 attrition -2.0pp
  Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Anti-PD-L1 Monoclonal Antibody
Also known as	Envafolimab
Sponsor	City of Hope Medical Center
Drug class	PD-1 inhibitor
Target	PD-L1
Modality	Biologic
Therapeutic area	Oncology
Phase	Phase 2

Mechanism of action

PD-L1 is a protein that can help cancer cells evade the immune system. By blocking PD-L1, the immune system can recognize and attack cancer cells more effectively. This can lead to the destruction of cancer cells and the slowing or stopping of tumor growth.

Approved indications

• Non-small cell lung cancer, PD-L1 positive
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Triple-negative breast cancer

Common side effects

• Pneumonitis
• Hypothyroidism
• Hyperthyroidism
• Fatigue
• Nausea
• Diarrhea
• Rash

Key clinical trials

• Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial (PHASE2)
• Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial (PHASE2, PHASE3)
• Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatment in Stage IIIB-IV Non-small Cell Lung Cancer, IMMUNO-BIOMAP Trial (PHASE2)
• Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (PHASE2)
• Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Advanced Stage Non-small Cell Lung Cancer Patients Who Are PD-L1 Negative (PHASE2, PHASE3)
• Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma (PHASE2)
• Adebrelimab Combined With Gemcitabine, Cisplatin, and Simvastatin for Advanced Biliary Tract Cancer (PHASE1, PHASE2)
• Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy (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:

• Anti-PD-L1 Monoclonal Antibody CI brief — competitive landscape report
• Anti-PD-L1 Monoclonal Antibody updates RSS · CI watch RSS
• City of Hope Medical Center portfolio CI

Frequently asked questions about Anti-PD-L1 Monoclonal Antibody

What is Anti-PD-L1 Monoclonal Antibody?

Anti-PD-L1 Monoclonal Antibody is a PD-1 inhibitor drug developed by City of Hope Medical Center, indicated for Non-small cell lung cancer, PD-L1 positive, Head and neck squamous cell carcinoma, Urothelial carcinoma.

How does Anti-PD-L1 Monoclonal Antibody work?

Anti-PD-L1 Monoclonal Antibody works by blocking the PD-L1 protein, allowing the immune system to attack cancer cells.

What is Anti-PD-L1 Monoclonal Antibody used for?

Anti-PD-L1 Monoclonal Antibody is indicated for Non-small cell lung cancer, PD-L1 positive, Head and neck squamous cell carcinoma, Urothelial carcinoma, Triple-negative breast cancer.

Who makes Anti-PD-L1 Monoclonal Antibody?

Anti-PD-L1 Monoclonal Antibody is developed by City of Hope Medical Center (see full City of Hope Medical Center pipeline at /company/city-of-hope-medical-center).

Is Anti-PD-L1 Monoclonal Antibody also known as anything else?

Anti-PD-L1 Monoclonal Antibody is also known as Envafolimab.

What drug class is Anti-PD-L1 Monoclonal Antibody in?

Anti-PD-L1 Monoclonal Antibody belongs to the PD-1 inhibitor class. See all PD-1 inhibitor drugs at /class/pd-1-inhibitor.

What development phase is Anti-PD-L1 Monoclonal Antibody in?

Anti-PD-L1 Monoclonal Antibody is in Phase 2.

What are the side effects of Anti-PD-L1 Monoclonal Antibody?

Common side effects of Anti-PD-L1 Monoclonal Antibody include Pneumonitis, Hypothyroidism, Hyperthyroidism, Fatigue, Nausea, Diarrhea.

What does Anti-PD-L1 Monoclonal Antibody target?

Anti-PD-L1 Monoclonal Antibody targets PD-L1 and is a PD-1 inhibitor.

Related

• Drug class: All PD-1 inhibitor drugs
• Target: All drugs targeting PD-L1
• Manufacturer: City of Hope Medical Center — full pipeline
• Therapeutic area: All drugs in Oncology
• Indication: Drugs for Non-small cell lung cancer, PD-L1 positive
• Indication: Drugs for Head and neck squamous cell carcinoma
• Indication: Drugs for Urothelial carcinoma
• Also known as: Envafolimab