Shanghai Junshi Biosciences Co., Ltd (HKG: 1877) has announced receiving approval from the US Food and Drug Administration (FDA) to conduct a randomized, double-blind, placebo-controlled, global multi-center Phase III study for its drug tifcemalimab (TAB004/JS004) in combination with Tuoyi (toripalimab). This consolidation therapy is intended for patients with limited-stage small-cell lung cancer (LS-SCLC) who have not progressed after radiotherapy and chemotherapy (CRT). The study aims to enroll 756 patients across China, the US, and Europe.
Tifcemalimab and Tuoyi: A Promising Combination Therapy
Tifcemalimab, a monoclonal antibody specifically targeting B- and T-lymphocyte attenuator (BTLA), is currently undergoing multiple Phase Ib/II clinical studies in the US and China in combination with Tuoyi. Tuoyi, a programmed death-1 (PD-1) inhibitor, was the first domestic PD-1 inhibitor approved in China in December 2018 for second-line treatment of melanoma. To date, it has received six indication approvals in China, with multiple market filings under review in the US, EU, and UK.
Expanding Treatment Options for LS-SCLC Patients
The Phase III study represents a significant step forward in expanding treatment options for patients with LS-SCLC, a particularly aggressive form of lung cancer. The combination of tifcemalimab and Tuoyi has the potential to improve outcomes for patients who have not progressed after initial CRT, offering a new approach to consolidating therapy in this challenging disease setting.-Fineline Info & Tech
