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DRUG:

Enweida (envafolimab)

i
Other names: KN035, KN 035, KN-035, ASC22, ASC-22, ASC 22
Company:
3DMed, Alphamab, Ascletis, Glenmark, Simcere
Drug class:
PD-L1 inhibitor
Related drugs:
1d
PD-L1 Blockade with Biodegradable Envafolimab-Loaded Microspheres Synergizes with Transarterial Chemoembolization to Overcome Myeloid-Derived Suppressor Cell-Driven Immune Escape in Hepatocellular Carcinoma. (PubMed, ACS Appl Mater Interfaces)
These findings establish KN035-MS as a synergistic adjunct to TACE, addressing both inefficient drug delivery and postembolization immune evasion. This dual-mechanism strategy provides a clinically translatable approach to mitigate HCC recurrence, warranting further investigation in combinatorial locoregional-immunotherapy paradigms.
Journal
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
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Enweida (envafolimab)
12d
New P2 trial
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EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • RAS (Rat Sarcoma Virus)
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BRAF wild-type • EGFR positive
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Erbitux (cetuximab) • Enweida (envafolimab)
20d
Long-term survival of an advanced gastric cancer patient with multiple liver metastases following maintenance therapy with envafolimab and oral chemotherapy: a case report. (PubMed, Front Oncol)
The patient had 46 months of overall survival time with a good performance status. This case recommends that maintenance therapy comprising of both PD-L1 blockage and oral fluoropyrimidine can serve as long-duration disease control and significant long-term advantage to a subset of the patients with metastatic immune-cold gastric cancer.
Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • TMB (Tumor Mutational Burden)
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HER-2 negative • PD-L1 negative • TMB-L
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5-fluorouracil • leucovorin calcium • Enweida (envafolimab) • Tomudex (raltitrexed)
1m
CEIL: Cetuximab and Envafolimab Plus mFOLFOXIRI as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer (clinicaltrials.gov)
P2, N=198, Recruiting, Sun Yat-sen University | Trial completion date: Dec 2027 --> Dec 2028 | Trial primary completion date: Mar 2026 --> Dec 2026
Trial completion date • Trial primary completion date
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EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene)
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BRAF wild-type
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Erbitux (cetuximab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • Enweida (envafolimab)
1m
Safety and Efficacy Analysis of Oral Etoposide Combined With Anlotinib and Envafolimab in First-line Treatment of Elderly Patients With Small Cell Lung Cancer/ Open-label, Single-arm, Exploratory Phase II Clinical Study (clinicaltrials.gov)
P2, N=30, Active, not recruiting, Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting --> Active, not recruiting | Trial completion date: May 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025
Enrollment closed • Trial completion date • Trial primary completion date
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Focus V (anlotinib) • etoposide oral • Enweida (envafolimab)
1m
Efficacy and safety of PD-L1 blockade envafolimab as neoadjuvant treatment in mismatch repair-deficient, locally advanced colorectal cancer: An open-label, single-arm study. (PubMed, Cancer)
This preliminary study suggests that envafolimab is a promising effective and safe neoadjuvant option for locally advanced dMMR CRC; confirmation in larger cohorts is awaited.
Journal • Mismatch repair • dMMR
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PD-L1 (Programmed death ligand 1)
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MSI-H/dMMR
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Enweida (envafolimab)
2ms
New P2 trial
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carboplatin • albumin-bound paclitaxel • Enweida (envafolimab)
2ms
Rare MSI-H hepatoid adenocarcinoma of the colon with BRAF V600E mutation achieving long-term disease-free survival after adjuvant envafolimab: a case report. (PubMed, Front Immunol)
Comprehensive molecular profiling can help guide personalized immunotherapy decisions. Further studies are needed to confirm long-term benefits, optimize treatment duration and dosing, and identify predictive biomarkers for high-risk CRC.
Journal • Tumor mutational burden • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker • MSI-H
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BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • PMS2 (PMS1 protein homolog 2)
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BRAF V600E • TMB-H • MSI-H/dMMR • BRAF V600
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Enweida (envafolimab)
2ms
New P2 trial
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Lenvima (lenvatinib) • Enweida (envafolimab)
2ms
Efficacy and Safety of Envafolimab Plus Doxorubicin and Ifosfamide for Advanced Soft Tissue Sarcoma (clinicaltrials.gov)
P2, N=15, Not yet recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University
New P2 trial
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ifosfamide • Enweida (envafolimab)
4ms
Efficacy, safety, and exploratory biomarker analysis of envafolimab plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer: a prospective, single-arm, phase II trial. (PubMed, BMC Med)
Envafolimab combined with chemotherapy as a first-line treatment for ES-SCLC yielded favorable clinical efficacy with a manageable safety profile, indicating that it may be a promising treatment modality.
P2 data • Journal
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CXCL8 (Chemokine (C-X-C motif) ligand 8) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • CCL3 (C-C Motif Chemokine Ligand 3)
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carboplatin • etoposide IV • Enweida (envafolimab)