FDA OKs Phase 3 Study of Linperlisib in Peripheral T-Cell Lymphoma
Following a successful Type B end-of-phase 2 meeting, the FDA has approved the start of a phase 3 trial of linperlisib in peripheral T-cell lymphoma.
US FDA
- The FDA has granted clearance to initiate a global phase 3 trial that will evaluate linperlisib vs physicians' choice of standard of care (SOC) for the treatment of relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL).
- This approval follows a successful Type B end-of-phase 2 meeting between the FDA and Shanghai Yingli Pharmaceutical Co., Ltd. (Yingli Pharma).
- Commencement of the phase 3 trial is planned during the second quarter of 2025.
The FDA has approved the initiation of a phase 3, global, registrational trial that will evaluate linperlisib, a potent oral small molecule inhibitor of the delta isoform of PI3 kinase, for the treatment of patients with R/R PTCL.1
With clearance from the FDA secured after a key Type B End-of-Phase 2 meeting, the phase 3 study is set to launch in the second quarter of 2025.
The phase 3 study will study linperlisib compared with physicians' choice of SOC in patients with R/R PTCL who have received at least 1 prior systemic therapy. The study will open enrollment in numerous countries, including the US.
"This is a major milestone for linperlisib,” said Michael Hui, chairman and chief executive officer of Yingli Pharma, in a press release. "We are very excited that linperlisib has entered the global pivotal study stage with the agreement from FDA. We will continue our mission to address patient unmet clinical needs globally and to accelerate the linperlisib clinical development program to bring more treatment options for patients with R/R PTCL."
Lymphomas: © David A Litman - stock.adobe.com
About Linperlisib
Linperlisib, a highly selective PI3Kδ inhibitor, has demonstrated promising efficacy and safety across multiple clinical trials.2 In follicular lymphoma (FL), T-cell lymphoma and other hematologic and solid tumor studies, the agent was also well tolerated and had a differentiated safety profile.1
This next-generation PI3Kδ inhibitor has been administered to over 6,000 patients, showing a consistent and tolerable safety profile. Three clinical trials in R/R PTCL have studied linperlisib in China, Europe, and the US, with over 165 patients with R/R PTCL treated. Ongoing evaluations of these studies have shown linperlisib to lead to a high objective response rate, high complete response rate, promising progression-free survival, overall survival, and a manageable safety profile.
Linperlisib was approved in China in 2022 for the treatment of adult patients with R/R FL. In the same year, the FDA granted linperlisib orphan drug designations in FL, chronic lymphocytic leukemia/small lymphocytic lymphoma, and T-cell lymphoma.
References
Yingli Pharma announces successful end-of-phase 2 meeting with FDA and clearance of global multi-center phase 3 registration study design of linperlisib for the treatment of relapsed and/or refractory peripheral T-cell lymphoma. News release. Shanghai Yingli Pharmaceutical Co., Ltd. April 1, 2025. Accessed April 3, 2025. https://tinyurl.com/y99zkmrp
Product pipeline. Shanghai Yingli Pharmaceutical Co., Ltd. Accessed April 3, 2025. http://www.yl-pharma.com/cn/pipeline.html
