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DRUG:

Enweida (envafolimab)

i
Other names: KN035, KN 035, KN-035, ASC22
Company:
3DMed, Alphamab, Ascletis, Glenmark, Simcere, Tracon Pharma
Drug class:
PD-L1 inhibitor
Related drugs:
15d
Chidamide plus envafolimab as subsequent treatment in advanced non-small cell lung cancer patients resistant to anti-PD-1 therapy: A multicohort, open-label, phase II trial with biomarker analysis. (PubMed, Cancer Med)
Combination of chidamide and envafolimab showed efficacy signals in certain NSCLC patients. But further identification of beneficial population is necessary for precision treatment.
P2 data • Clinical Trial,Phase II • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Metastases
|
TMB (Tumor Mutational Burden) • HDAC2 (Histone deacetylase 2)
|
PD-L1 negative • HDAC2 expression
|
Epidaza (chidamide) • Enweida (envafolimab)
24d
ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P2, N=126, Recruiting, 3D Medicines (Sichuan) Co., Ltd. | N=200 --> 126 | Trial completion date: Apr 2024 --> Apr 2028 | Trial primary completion date: Apr 2024 --> Aug 2027
Enrollment change • Trial completion date • Trial primary completion date • Metastases
|
TMB (Tumor Mutational Burden)
|
TMB-H
|
Enweida (envafolimab)
26d
ASC-ASC22-II-CTP-01: A Phase II Study of Subcutaneously Injected PD-L1 Antibody ASC22 in Chronic Hepatitis B Patients (clinicaltrials.gov)
P2, N=207, Active, not recruiting, Ascletis Pharmaceuticals Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Aug 2024 | Trial primary completion date: Jun 2023 --> Aug 2024
Enrollment closed • Trial completion date • Trial primary completion date
|
Enweida (envafolimab)
1m
Enrollment open • Metastases
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • SMAD4 (SMAD family member 4)
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KRAS mutation • BRAF mutation • NRAS mutation • BRAF wild-type • SMAD4 mutation
|
Erbitux (cetuximab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • Enweida (envafolimab)
1m
New P2 trial
|
BRAF (B-raf proto-oncogene)
|
Erbitux (cetuximab) • irinotecan • Enweida (envafolimab)
2ms
A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P2, N=86, Terminated, Jiangsu Simcere Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> Jul 2023 | Recruiting --> Terminated; The study was terminated due to the sponsor's research and development strategy adjustment.
Trial completion date • Trial termination • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
EGFR mutation • ALK positive • ROS1 positive • EGFR T790M negative
|
docetaxel • irinotecan • leucovorin calcium • Enweida (envafolimab) • suvemcitug (APX003)
2ms
New P2 trial • Metastases
|
Enweida (envafolimab) • Endostar (recombinant human endostatin)
2ms
KN035 for dMMR/MSI-H Advanced Solid Tumors (clinicaltrials.gov)
P2, N=200, Recruiting, 3D Medicines (Sichuan) Co., Ltd. | Trial primary completion date: Dec 2023 --> Jun 2024
Trial primary completion date • Metastases
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Enweida (envafolimab)
3ms
KN035-CN-017: Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC (clinicaltrials.gov)
P3, N=390, Recruiting, 3D Medicines (Sichuan) Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Enweida (envafolimab)
4ms
Imaging diagnosis and efficacy monitoring by [Zr]Zr-DFO-KN035 immunoPET in patients with PD-L1-positive solid malignancies. (PubMed, Theranostics)
Moreover, after antitumor treatment, [Zr]Zr-DFO-KN035 enabled observational imaging for therapeutic efficacy evaluation, which can help predict patient prognosis. [Zr]Zr-DFO-KN035 can be used for the diagnosis and therapy monitoring of PD-L1-positive tumors and provide noninvasive and comprehensive observations for tumor diagnostic imaging, prognosis prediction, and efficacy evaluation.
Journal
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Enweida (envafolimab)
4ms
Envafolimab Combined With Chemotherapy in Metastatic or Recurrent Gastric Adenocarcinoma (clinicaltrials.gov)
P2, N=38, Recruiting, Liangjun Zhu M.M. | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Mar 2023 --> Dec 2024
Trial completion date • Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • HER-2 expression
|
oxaliplatin • Enweida (envafolimab)
4ms
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Rituxan (rituximab) • Loqtorzi (toripalimab-tpzi) • Enweida (envafolimab) • LM-101
5ms
New P2 trial • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2)
|
Enweida (envafolimab)
5ms
New P2 trial
|
5-fluorouracil • Lenvima (lenvatinib) • oxaliplatin • leucovorin calcium • Enweida (envafolimab)
5ms
Journal • Metastases
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Enweida (envafolimab)
5ms
A Phase I/II Study of LM-101 Injection in Patients With Advanced Malignant Tumors (clinicaltrials.gov)
P1/2, N=145, Suspended, LaNova Medicines Limited | Recruiting --> Suspended
Trial suspension • Combination therapy • Metastases
|
Rituxan (rituximab) • Loqtorzi (toripalimab-tpzi) • Enweida (envafolimab) • LM-101
6ms
Enrollment closed • Metastases
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • SMAD4 (SMAD family member 4)
|
KRAS mutation • BRAF mutation • NRAS mutation • BRAF wild-type • SMAD4 mutation
|
Erbitux (cetuximab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • Enweida (envafolimab)
6ms
New P3 trial
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Enweida (envafolimab)
7ms
New P2 trial • Metastases
|
PD-L1 (Programmed death ligand 1)
|
MSI-H/dMMR
|
cisplatin • Enweida (envafolimab)
7ms
New P2 trial • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • BRAF V600
|
cisplatin • temozolomide • Enweida (envafolimab)
8ms
New P2 trial • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
paclitaxel • Lenvima (lenvatinib) • Enweida (envafolimab)
9ms
Efficacy and Safety of Combining Envafolimab with Endostar in Advanced NSCLC : A Multi-Center Prospective Study (Endouble) (IASLC-WCLC 2023)
This prospective study showed that Envafolimab combined with Endostar has promising efficacy and good tolerability in advanced NSCLC with PD-L11%. This combination provided a new choice and a prospective study in furture was expected.
Clinical • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker • Metastases
|
MSI (Microsatellite instability)
|
PD-L1 expression • MSI-H/dMMR • PD-L1 negative
|
Enweida (envafolimab) • Endostar (recombinant human endostatin)
9ms
ICONIC: Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer (clinicaltrials.gov)
P2, N=100, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting --> Recruiting | Trial completion date: Jun 2025 --> Aug 2030
Enrollment open • Trial completion date
|
FLT3LG (Fms Related Receptor Tyrosine Kinase 3 Ligand)
|
capecitabine • oxaliplatin • Enweida (envafolimab)
9ms
Efficacy and safety of envafolimab in the treatment of advanced dMMR/MSI‑H solid tumors: A single‑arm meta‑analysis. (PubMed, Oncol Lett)
Most of the adverse reactions were mild and the rate of 3/4 grade TEAE was 10.37% (95% CI, 6.14-14.60%). Gevokizumab was effective and safe in the treatment of patients with advanced dMMR/MSI-H solid tumors and its convenience could significantly improve patient compliance; therefore, the clinical application of envafolimab is promising.
Retrospective data • Journal • Metastases
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Enweida (envafolimab) • gevokizumab (VPM087)
9ms
New P2 trial
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene)
|
BRAF wild-type
|
Erbitux (cetuximab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • Enweida (envafolimab)
9ms
Combination therapy of envafolimab and suvemcitug with chemotherapy in patients with non-small cell lung cancer (NSCLC): Results from a phase II clinical trial (ESMO 2023)
Envafolimab plus suvemcitug and docetaxel were administrated until disease progression or unacceptable toxicity...There was no grade 5 TRAE in either cohort. Conclusions This phase II clinical trial demonstrated antitumor activity and manageable safety profile of immunotherapy plus anti-angiogenic agent and chemotherapy in pts with NSCLC, who had failed at least one line of therapy.
Clinical • P2 data • Combination therapy
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
docetaxel • Enweida (envafolimab) • suvemcitug (APX003)
9ms
Clinical • P2 data • Combination therapy
|
FLT1 (Fms-related tyrosine kinase 1)
|
Enweida (envafolimab) • suvemcitug (APX003)
9ms
Combination therapy of envafolimab, suvemcitug, and FOLFIRI in patients with metastatic microsatellite stable (MSS) or mismatch-repair proficient (pMMR) colorectal cancer: Results from a phase II clinical trial (ESMO 2023)
Eligible pts had received at least one prior line of treatment for MSS/pMMR mCRC and were treated with envafolimab plus suvemcitug and FOLFIRI (Irinotecan, Leucovorin, and 5-Fluorouracil)...Conclusions To the best of our knowledge, this is the first study demonstrated promising antitumor activity and a manageable safety profile of immunotherapy plus anti-angiogenic agent and chemotherapy in pts with MSS/ pMMR mCRC who had failed at least one line of therapy. The results support further evaluation of the therapy in a larger population.
Clinical • P2 data • Combination therapy • Mismatch repair • PD(L)-1 Biomarker • IO biomarker • Metastases
|
KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • SMAD4 (SMAD family member 4)
|
TP53 mutation • KRAS mutation • AR mutation
|
5-fluorouracil • irinotecan • leucovorin calcium • Enweida (envafolimab) • suvemcitug (APX003)
9ms
Envafolimab plus chemoradiotherapy for locally advanced nasopharyngeal carcinoma (NPC), a prospective, single-armed phase II trial (ESMO 2023)
Background Gemcitabine plus cisplatin (GP) prior to concurrent chemoradiotherapy (CCRT) has favorable survival outcomes with acceptable toxicity in patients with locoregionally advanced nasopharyngeal carcinoma (LANPC)...Conclusions Envafolimab plus chemoradiotherapy was effective and safety in the treatment of LANPC. Further follow-up is needed to confirm the long-term efficacy.
Clinical • P2 data • Metastases
|
PD-L1 (Programmed death ligand 1)
|
cisplatin • gemcitabine • Enweida (envafolimab)
10ms
ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P2, N=200, Recruiting, 3D Medicines (Sichuan) Co., Ltd. | Trial primary completion date: Apr 2023 --> Apr 2024
Trial primary completion date • Tumor mutational burden • Metastases
|
TMB (Tumor Mutational Burden)
|
TMB-H • TMB-L
|
Enweida (envafolimab)
10ms
New P2 trial • Metastases
|
Fruzaqla (fruquintinib) • Enweida (envafolimab)
10ms
ICONIC: Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer (clinicaltrials.gov)
P2, N=100, Not yet recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University
New P2 trial
|
FLT3LG (Fms Related Receptor Tyrosine Kinase 3 Ligand)
|
capecitabine • oxaliplatin • Enweida (envafolimab)
10ms
Envafolimab Combined With Endostar in the First-line Treatment of Advanced NSCLC (clinicaltrials.gov)
P2, N=40, Recruiting, The First People's Hospital of Lianyungang | Not yet recruiting --> Recruiting | Trial completion date: Jan 2024 --> Jun 2024 | Trial primary completion date: Jan 2023 --> May 2024
Enrollment open • Trial completion date • Trial primary completion date • IO biomarker • Metastases
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
Enweida (envafolimab) • Endostar (recombinant human endostatin)
11ms
New P2 trial • Combination therapy • Metastases
|
docetaxel • Enweida (envafolimab) • Cosela (trilaciclib)
11ms
The Study of Envafolimab Combined With Concurrent Chemoradiotherapy In LS-SCLC (clinicaltrials.gov)
P2, N=80, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
New P2 trial
|
cisplatin • carboplatin • Enweida (envafolimab)
11ms
CISLD-12: Study on Therapeutic Effect of Combination of Envafolimab, Lenavatinib and TACE in Advanced HCC Patients (clinicaltrials.gov)
P2, N=39, Completed, Zhejiang University | Recruiting --> Completed | Trial completion date: Jan 2024 --> Jun 2023
Trial completion • Trial completion date • Metastases
|
Lenvima (lenvatinib) • Enweida (envafolimab)
11ms
New trial • Metastases
|
cisplatin • Enweida (envafolimab) • Endostar (recombinant human endostatin)
12ms
New P2 trial • Metastases
|
capecitabine • oxaliplatin • Enweida (envafolimab)
12ms
Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma (PRECAM) (clinicaltrials.gov)
P2, N=32, Active, not recruiting, Sir Run Run Shaw Hospital | Recruiting --> Active, not recruiting
Enrollment closed • Metastases
|
capecitabine • oxaliplatin • Enweida (envafolimab)
12ms
Enrollment open
|
oxaliplatin • Enweida (envafolimab)
1year
New P2 trial • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Enweida (envafolimab)
over1year
A Phase I/II Study of LM-101 Injection in Patients With Advanced Malignant Tumors (clinicaltrials.gov)
P1/2, N=145, Recruiting, LaNova Medicines Limited | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CD163 (CD163 Molecule) • CD68 (CD68 Molecule)
|
Rituxan (rituximab) • Loqtorzi (toripalimab-tpzi) • Enweida (envafolimab) • LM-101