By Fineline Cube US-based Yingli Pharma, which targets the China and US drug markets, has dosed the first patient in a Phase II trial of linperlisib, its PI3 kinase (PI3Kδ) inhibitor, for relapsed/refractory peripheral T/NK cell lymphoma (r/r PTCL). The study follows positive Phase I data in China and leverages the drug’s Breakthrough Therapy designation in China and Orphan Drug status in the US.
Trial Design
The single-arm Phase II trial (NCT05274997), led by The University of Texas MD Anderson Cancer Center, will enroll 97 patients who failed prior therapy. Primary endpoints include overall response rate (ORR), with secondary outcomes such as duration of response, overall survival, and progression-free survival. The trial will expand to sites in the US and Italy.
Drug Profile
Linperlisib, a highly selective PI3Kδ inhibitor, received China’s Breakthrough Therapy status for follicular lymphoma (FL) and completed a Phase II study in FL, with an NDA filed in 2021. The drug also holds US FDA Orphan Drug designations for FL, CLL/SLL, and T cell lymphoma. Preliminary Phase Ib data in PTCL, presented at ASCO 2021, showed a 70% ORR and 33% complete response rate (CR).
Strategic Outlook
The Phase II trial builds on linperlisib’s promising efficacy and safety profile, aiming to establish it as a key therapy for r/r PTCL. Yingli plans to pursue global approvals, capitalizing on the drug’s dual-market focus and unmet need in aggressive lymphomas.-Fineline Info & Tech