The first patient has been dosed in a phase 2 trial looking at a drug to treat peripheral T cell lymphomas – a heterogenous group of generally aggressive neoplasms.
Yingli Pharma made the announcement on Saturday (September 3) that patients were being dosed with linperlisib – a potent inhibitor of the delta isoform of PI3 kinase in patients with relapsed or refractory peripheral T/NK cell lymphoma.
The peripheral T cell lymphomas (PTCL) constitute less than 15 percent of all non-Hodgkin lymphomas (NHLs) in adults.
This single arm study will evaluate the safety, efficacy and pharmacokinetics of orally administered linperlisib under a strategic collaboration with The University of Texas MD Anderson Cancer Center.
Additional trial sites will include medical centers in the United States and Italy.
Michael Hui, MBA, chief executive officer of Yingli Pharma, said: “We are pleased to commence this study of linperlisib in the United States in patients suffering from advanced PTCL.
“Linperlisib is a next generation inhibitor of PI3Kδ with enhanced selectivity and potency to offer strong anti-tumor effect while minimizing potential adverse reactions.
“We are encouraged by the safety and preliminary efficacy data obtained in Phase 1 dose-finding studies in China and look forward to further evaluating linperlisib’s potential in this phase 2 study.
“Patients living with advanced PTCL, an aggressive type of lymphoma, face limited treatment options and most do not respond or stop responding to available therapies. Linperlisib may provide a solution for these patients who need an expanded treatment armamentarium, and we’re excited to continue studying the drug’s potential as we start the phase 2 study.”
Linperlisib, a convenient once daily oral drug, is a small molecule inhibitor of PI3Kδ, a validated target in lymphomas due to its critical role in cell proliferation and survival.
This phase 2, single arm, open-label trial will evaluate the safety, efficacy and pharmacokinetic properties of linperlisib monotherapy in adult patients with relapsed/refractory PTCL who have failed at least one prior line of systemic therapy.
Enrolled participants will receive linperlisib 80mg once daily orally in a 28-day cycle. The primary outcome is overall response rate to treatment. Secondary outcomes include duration of response, overall survival, progression-free survival, adverse effects and pharmacokinetics parameters.
An estimated 97 patients will be enrolled in the study.