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Association details:
| Biomarker: | MSI-H/dMMR |
|---|---|
| Cancer: | Colorectal Cancer |
| Drug: | Enweida (envafolimab) (PD-L1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
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.
Source:
Title:
Neoadjuvant Envafolimab in Resectable and Locally Advanced MSI-H/dMMR Rectal Cancer
Excerpt:
......
Trial ID:
Source:
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:
More C2 evidence
Source:
Title:
KN035 for dMMR/MSI-H Advanced Solid Tumors
Excerpt:
...- Confirmed MMR deficient or MSI-H status....
Trial ID:
Less C2 evidence
Source:
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:
Source:
Title:
Efficacy and safety of envafolimab (KN035) in advanced tumours with mismatch-repair deficiency
Published date:
11/17/2020
Excerpt:
...103 pts with dMMR/MSI-H advanced cancer were enrolled, including 65 with colorectal cancer...18 with gastric cancer (GC)…The 12 months OS rate was 72.9%, 83.3%, 75.0% and 74.6% for CRC, GC, other tumors, and overall population, respectively….Envafolimab demonstrated robust anti-tumor activity with a manageable safety profile in heavily pretreated pts with dMMR/MSI-H cancer.
Trial ID:
Title:
TRACON Pharmaceuticals Highlights Updated Envafolimab Clinical Results In MSI-H/DMMR Colorectal Cancer
Published date:
09/21/2020
Excerpt:
...updated clinical data from the pivotal trial of envafolimab in MSI-H/dMMR cancer patients...single agent envafolimab was shown to have a 32% confirmed objective response rate (ORR) by central radiographic review of 41 patients with MSI-H/dMMR colorectal cancer (CRC) who failed a fluoropyrimidine, oxaliplatin and irinotecan, and had at least two on-study tumor assessments. Duration of response (DOR) was greater than or equal to 12 months in 75% of patients and overall survival (OS) was greater than or equal to 12 months in 65% of patients.
Source:
Title:
Envafolimab (KN035) in advanced tumors with mismatch-repair deficiency.
Published date:
05/13/2020
Excerpt:
The confirmed objective response rate was 30% (95% CI: 17.9%, 44.6%) in the PEPi, 54.2% (95% CI: 32.8%, 74.4%) in the CRC patients who had prior therapy with F and O or I, and 34.0% (95% CI: 24.9%, 44.0%) in the overall population. Envafolimab demonstrated durable anti-tumor activity with a manageable safety profile in patients with previously treated advanced MSI-H/dMMR cancer.
DOI:
10.1200/JCO.2020.38.15_suppl.3021
Trial ID:
