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Association details:
Biomarker:MSI-H/dMMR
Cancer:Solid Tumor
Drug:Enweida (envafolimab) (PD-L1 inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Title:

NMPA Grants Priority Review to the BLA for Envafolimab(KN035)

Published date:
01/19/2021
Excerpt:
Alphamab Oncology...announced that, the recombinant humanized PD-L1 single-domain antibody Envafolimab (Project Code: KN035) was granted priority review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The Envafolimab BLA is accepted for the treatment of microsatellite instability-high (MSI-H) advanced colorectal cancer, gastric cancer / mismatch repair deficient (dMMR) advanced solid tumors that have failed previous standard of care.
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Envafolimab as Neoadjuvant Immuntherapy in Resectable Local Advanced dMMR/MSI-H Colorectal Cancer

Excerpt:
...Tumor tissues were identified as mismatch repair-deficient (dMMR) by immunohistochemistry (IHC) method or microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
Title:

KN035 for dMMR/MSI-H Advanced Solid Tumors

Excerpt:
...- Confirmed MMR deficient or MSI-H status....
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC.

Excerpt:
...Pathologically confirmed diagnosis of nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, WHO type II or III) without the need to detect MSI and dMMR status....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Neoadjuvant Envafolimab in Resectable and Locally Advanced MSI-H/dMMR Rectal Cancer

Excerpt:
......
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Subcutaneous envafolimab monotherapy in patients with advanced defective mismatch repair/microsatellite instability high solid tumors

Published date:
06/21/2021
Excerpt:
One hundred and three patients (65 with colorectal cancer, 18 with gastric cancer, and 20 with other solid tumors) were enrolled....Median progression-free survival was 11.1 months (95% CI 5.5 to not evaluable). Overall survival at 12 months was 74.6% (95% CI 64.7–82.1)....Envafolimab was effective and had acceptable safety in the treatment of previously treated advanced dMMR/MSI-H solid tumors.
DOI:
https://doi.org/10.1186/s13045-021-01095-1
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

70MO Efficacy and safety of envafolimab (KN035) in advanced tumours with mismatch-repair deficiency

Published date:
11/01/2020
Excerpt:
...study evaluated the efficacy and safety of KN035 in patients (pts) with advanced microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) cancer...103 pts with dMMR/MSI-H advanced cancer were enrolled...20 with other tumors...Confirmed ORR per BIRC was...40.0% in other tumors population...Envafolimab demonstrated robust anti-tumor activity...
DOI:
10.1016/j.annonc.2020.10.090
Trial ID: