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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:
3d
New P2 trial
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Lenvima (lenvatinib) • Enweida (envafolimab)
10d
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)
2ms
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)
3ms
Immune activation following PD-L1 inhibitor plus chemoradiotherapy in locally advanced rectal cancer: a retrospective, single-arm study. (PubMed, Front Immunol)
In this retrospective, single-arm design study, 36 LARC patients (T3+/N1-2/M0) received long-course radiotherapy (50.4 Gy/28 fractions) with capecitabine, followed by two cycles of XELOX chemotherapy and envafolimab...This approach enhances cytotoxic immunity while addressing immunosuppressive barriers. Further studies should explore strategies to overcome TME resistance.
Retrospective data • Journal
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • NCAM1 (Neural cell adhesion molecule 1)
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capecitabine • oxaliplatin • Enweida (envafolimab)
3ms
Intelligent bacterial platform induces programmed death-ligand 1 lysosomal degradation to enhance antitumor immunity. (PubMed, Int J Biol Macromol)
This process effectively alleviates immunosuppression in the TME and enhances the activation and proliferation of tumor-specific T cells. Experimental results demonstrated that CXCL12-KN035-expressing bacteria significantly inhibit tumor growth and metastasis through the synergistic action of the chemokine and nanobody, establishing a novel degradation-centric paradigm for bacteria-mediated tumor therapy beyond transient blockade.
Journal • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • CXCL12 (C-X-C Motif Chemokine Ligand 12) • ACKR3 (Atypical Chemokine Receptor 3)
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Enweida (envafolimab)
3ms
Envafolimab Combined With Neoadjuvant Chemotherapy Treat Stage IIb Resectable Osteosarcoma Patients (clinicaltrials.gov)
P2, N=23, Not yet recruiting, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
New P2 trial
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cisplatin • doxorubicin hydrochloride • Enweida (envafolimab)
4ms
Phase II Study of Concurrent Radiotherapy With Envafolimab and Capecitabine in Locally Advanced Pancreatic Cancer (ChiCTR2500106258)
P2, N=43, Recruiting, Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences
New P2 trial
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capecitabine • Enweida (envafolimab)
4ms
A Study of Regorafenib Combined With Envafolimab for Metastatic Gastrointestinal Stromal Tumors With Kit Gene Exon 17 Mutation That Failed Standard Treatment (clinicaltrials.gov)
P2, N=100, Not yet recruiting, Peking University | Trial completion date: Aug 2026 --> Jul 2028 | Initiation date: Jan 2025 --> Jul 2025 | Trial primary completion date: Aug 2025 --> Jul 2027
Trial completion date • Trial initiation date • Trial primary completion date
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Stivarga (regorafenib) • Enweida (envafolimab)
5ms
Focus on PD-1/PD-L1-Targeting Antibodies in Colorectal Cancer: Are There Options Beyond Dostarlimab, Nivolumab, and Pembrolizumab? A Comprehensive Review. (PubMed, Molecules)
However, a growing number of additional PD-1/PD-L1 inhibitors, including AMP-224, atezolizumab, avelumab, camrelizumab, durvalumab, envafolimab, sintilimab, spartalizumab, tislelizumab, and toripalimab, are currently under investigation, offering new possibilities for the expansion of treatment options...Additionally, it explores key challenges such as primary and acquired resistance, limited efficacy in microsatellite-stable (MSS) CRC, and the complexities of combination strategies aimed at enhancing immunotherapeutic responses. By addressing these obstacles and highlighting prospects, this review provides insights into the evolving landscape of PD-1/PD-L1-targeted therapies in CRC and their potential to improve patient outcomes.
Review • Journal
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MSI (Microsatellite instability)
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MSI-H/dMMR
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Tyvyt (sintilimab) • Bavencio (avelumab) • Loqtorzi (toripalimab-tpzi) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr) • Jemperli (dostarlimab-gxly) • spartalizumab (PDR001) • Enweida (envafolimab) • AMP-224
6ms
Safety and Efficacy of the First Subcutaneous ICI, Envafolimab, in the Treatment of Advanced Lung Cancer Patients: A Real-World Study. (PubMed, Thorac Cancer)
Envafolimab demonstrates a tolerable safety profile and favorable efficacy. With its subcutaneous formulation, Envafolimab shows promising potential for treating advanced lung cancer.
Retrospective data • Journal • Real-world evidence • PD(L)-1 Biomarker • IO biomarker
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
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PD-L1 expression • EGFR mutation
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Enweida (envafolimab)
6ms
A study on the effectiveness and safety of interventional embolization using drug-loaded microspheres in combination with sorafenib and envafolimab for intermediate and advanced renal cell carcinoma. (PubMed, Front Oncol)
Overall, the incidence of adverse reactions in the combination group was greatly decreased than that in the D-TAE group (P<0.05). Drug-loaded microsphere interventional embolization combined with sorafenib and envafolimab has certain efficacy and acceptable safety in treating intermediate and late-stage renal tumor, providing a new treatment option for patients with renal cell carcinoma.
Journal
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CEACAM5 (CEA Cell Adhesion Molecule 5)
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sorafenib • Enweida (envafolimab)