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Phase Ⅱ Clinical Data of Envafolimab in MSI-H/dMMR Solid Tumors Published in the Journal of Hematology & Oncolog

Release time:2021-07-21

On June 21st, 2021, the data of a Phase Ⅱ clinical study on Envafolimab as monotherapy in treating patients with advanced MSI-H/dMMR solid tumors was published in the official journal of the Chinese American Hematologist and Oncologist Network: Journal of Hematology & Oncology (2020 IF: 17.388). This novel fusion protein of a humanized single-domain PD-L1 antibody is currently being developed as part of the strategic partnership by Simcere, 3D Medicines Inc. and Alphamab Oncology (9966.HK).


The study, led by the principal investigator from Peking University Cancer Hospital and Institute Professor Shen Lin, evaluated the efficacy and safety of Envafolimab in patients with advanced dMMR/MSI-H tumors from 25 clinical sites across China. 

103 patients with previously treated advanced dMMR/MSI-H tumors from 25 clinical sites across China were enrolled in the study. They received weekly subcutaneous injections of 150mg of Envafolimab in a 28 day treatment cycle until disease progression, death, intolerable toxicity, or their withdrawal of consent.

Therapeutic effect: evaluated by BIRC



(95% CI 33.0%-52.8%)



(95% CI 56.0%-75.1%)

DoR rate at 12 months


(95% CI 77.5%-97.4%)



(95% CI 5.5个months-NE)


Not reached

OS in 12 month


(95% CI 64.7%-82.1%)

From this study, most of the treatment-emergent adverse events related to Envafolimab were grade 1~2. No infusion reactions, or immune-related pneumonitis, immune-related colitis, immune-related nephritis, immune-related thrombocytopenia, or immune-related neurological AEs were reported.

As the world's first PD-L1 single-domain antibody to enter clinical development, Envolimab demonstrated positive efficacy and a good safety profile in the phase II clinical study against MSI-H/dMMR advanced solid tumors. Compared with the PD-1/PD-L1 inhibitors already available, the unique subcutaneous injection administration route of Envolimab that can be completed within 30 seconds—is expected to save medical resources and provide patients with choice of more convenient clinical care.

Forward Looking Statements

Information set forth in this press release contains forward-looking statements, which involve a number of known and unknown risks, uncertainties and assumptions. The forward-looking statements contained herein reflect the current judgment and views of Simcere Pharmaceutical Group Limited as of the date of this press release. Such forward-looking statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, or may not materialize, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements, whether as a result of new information, future events or otherwise, to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.