Evidence Level:Sensitive: B - Late Trials
Title:
NMPA Grants Priority Review to the BLA for Envafolimab(KN035)
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:
KN035 for dMMR/MSI-H Advanced Solid Tumors
Excerpt:...- Confirmed MMR deficient or MSI-H status....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Neoadjuvant Envafolimab in Resectable and Locally Advanced MSI-H/dMMR Rectal Cancer
More C2 evidence
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)....
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....
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
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
Evidence Level:Sensitive: C3 – Early Trials
Title:
70MO Efficacy and safety of envafolimab (KN035) in advanced tumours with mismatch-repair deficiency
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