Partners Alphamab Oncology (HKG: 9966) and 3D Medicines (HKG: 1244) have announced that they have received approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical study for envafolimab (KN035) in proficient mismatch repair (fMMR) advanced or recurrent endometrial cancer combined with lenvatinib. This approval is a significant step forward in the development of innovative cancer treatments.
Study Design and Objectives
The multi-region, multi-center, randomized, open Phase III study is designed to assess the efficacy and safety of envafolimab combined with lenvatinib in fMMR advanced or recurrent endometrial cancer. This comprehensive study aims to provide robust data on the potential benefits of this combination therapy for patients with this challenging form of cancer.
Envafolimab’s Development and Previous Approvals
Envafolimab, the world’s first PD-L1 single-domain antibody and human IgG1 Fc fusion protein capable of subcutaneous injection, was developed by Alphamab Oncology. The drug has already concluded Phase I clinical studies in advanced solid tumors in the US and has received orphan drug designations (ODDs) for the treatment of advanced cholangiocarcinoma and soft tissue sarcoma. Additionally, a Phase II study in dMMR patients has been approved.
Partnership and Commercialization Efforts
3D Medicines acts as a co-development partner under a January 2019 deal, and Simcere Pharmaceutical Group (HKG: 2096) joined the alliance in March 2020, taking on the exclusive responsibility for the commercial promotion of envafolimab in mainland China. This collaborative approach underscores the commitment of all partners to bring innovative cancer therapies to patients globally.
Conclusion
The FDA’s approval for the Phase III clinical study of envafolimab in fMMR advanced or recurrent endometrial cancer is a testament to the potential of this treatment to address a significant unmet medical need. With a focus on advancing cancer care, Alphamab Oncology and its partners continue to lead the way in developing novel therapeutic options for patients.-Fineline Info & Tech
