Yingli Pharma announce promising topline results of a Phase II registration study for treatment of relapsed/refractory follicular lymphoma with the once daily oral PI3KI? inhibitor, linperlisib

Linperlisib provides significant clinical improvement in the treatment for patients with relapsed and/or refractory follicular lymphoma

Linperlisib has a differentiated and well manageable safety profile

SHANGHAI, March 31, 2021 /PRNewswire/ -- Shanghai Yingli Pharmaceutical Co., Ltd. (Yingli Pharma) announced topline results of a Phase II registration study of linperlisib, aA PI3KI?A inhibitor, for the treatment of relapsed/refractory follicular lymphoma (FL). Linperlisib is a potent and highly selective oralA PI3KI?A inhibitor that was developed for potentially more efficacious with a potentially more manageable and differentiated safety profile A from otherA PI3KI?A class agents. The topline results of this single-arm Phase II study (NCT04370405) showed that linperlisib treatment led to significant clinical improvement A for the patients with relapsed/refractory FL. The results of the study indicated an 80.9% overall response rate (95% confidence interval, 71.2-88.5%) for 89 evaluable relapsed/refractory FL patients, as a primary outcome measure assessed by an Independent Review Committee (IRC). In addition, a disease control rate (DCR) of 96.6% was observed. Safety data demonstrated that linperlisib 80mg QD dosing regimen was well tolerable and manageable with a differentiated and favorable safety profile. Responding to the topline data of this Phase II registration study, Dr. Qiu Lugui of Institute of Hematology & Blood Diseases Hospital, Tianjin, China, and the leading Investigator on the clinical study, stated: "The Phase II clinical trial of linperlisib for the treatment of relapsed/refractory follicular lymphoma has demonstrated striking clinically meaningful results, suggesting that this newA PI3KI?A selective inhibitor may be very well differentiated from marketedA PI3KI? inhibitors available outside of China. It is encouraging that infrequent and manageable adverse events were observed for linperlisib, indicative of the agent being safe and well-tolerated for relapsed/refractory FL patients. We are hopeful that linperlisib may soon be made available as a valuable treatment option for this serious disease, bringing hope to these patients and their families.""We are very excited that linperlisib has demonstrated such outstanding therapeutic benefit in relapsed/refractory follicular lymphoma. These findings give us confidence in the performance of linperlisib for our other ongoing clinical studies for different types of tumors," said Dr. Xu Zusheng, President, Research and Development of Yingli Pharma. "We look forward to bringing this PI3KI? inhibitor that has been premiered in China, into global development for patients around the world." Full analysis of the data from the study will be forthcoming through medical conferences and publications and can be followed on the Yingli Pharma website. Yingli Pharma is planning to submit an NDA application to NMPA based on the results of this registration study.
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