3D Medicines (HKG: 1244), a China-based oncology specialist, has announced the enrollment of the first patient in a Phase III clinical study for its PD-L1 monoclonal antibody (mAb), envafolimab. The randomized, controlled, double-blinded, multi-center trial will evaluate envafolimab in combination with chemotherapy as a neoadjuvant/adjuvant therapy for patients with resectable stage III non-small cell lung cancer (NSCLC). The study, which is anticipated to enroll 390 patients across 60 centers in China, aims to assess the efficacy and safety of this treatment approach.
Envafolimab, recognized as the world’s first single-domain PD-L1 antibody and a human IgG1 Fc fusion protein capable of subcutaneous injection, received approval in China in November 2021 for the treatment of unresectable or metastatic advanced solid tumors with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR). Clinical studies have demonstrated that the combination of PD-1/PD-L1 products with chemotherapy as neoadjuvant/adjuvant therapy can significantly improve event-free survival (EFS) in patients with resectable stage III NSCLC. Moreover, the rates of major pathological response (MPR) and pathological complete response (pCR) are markedly higher compared to control therapies.- Flcube.com
