Shanghai Yingli Pharmaceuticals Ltd, a clinical stage pharmaceutical company providing new therapies for cancer and metabolic diseases, announced today that there will be three presentations on clinical trials sponsored by the company at the annual meeting of the American Society for Clinical Oncology (ASCO) June 4-7, 2021.
Linperlisib in Peripheral T cell lymphoma
The clinical trial report entitled "A phase Ib study of a PI3Kδ inhibitor Linperlisib in patients with relapsed or refractory peripheral T-cell lymphoma" was presented at the June 4, 2021 proceedings of the conference.
In this phase Ib study that enrolled 38 relapsed and refractory Peripheral T cell lymphoma patients, linperlisib, a novel oral PI3Kδ inhibitor, was evaluated as monotherapy for safety, tolerability and efficacy at recommended phase 2 dose of 80mg once daily. The clinical data from an interim data cutoff was presented at ASCO by Dr. Jie Jin, professor of First Hospital Affiliated with Zhe Jiang Medical University. Top line data from this study indicated that for the 38 r/r PTCL patients enrolled, 30 were evaluable. As of the data cutoff, an Overall Response Rate (ORR) of 70% was reported of which 33% were complete responses. A 100% disease control rate was also observed. Linperlisib was well-tolerated with Grade 1 and Grade 2 adverse events most frequently observed, and with limited Grade 3 adverse events of neutrophil decrease in 4 pts, (10.5%), and 1 (2.6%) case each of leukopenia, thrombocytopenia, blood lipase increase, pneumonia and stomatitis.
"Peripheral T cell lymphoma is a devastating and aggressive lymphoma where patients have very few treatment options in the relapsed and refractory setting," said Dr. Jie Jin. "The results of this Phase1b clinical trial suggest that linperlisib is a promising PI3Kδ selective inhibitor with important anti-tumor properties in this indication, and we hope it will be able to bring clinical benefits of linerlisib to patients suffering from this serious disease. Globally, there are no PI3K inhibitors that have been approved for the treatment of T cell lymphomas. In China, no PI3K inhibitors have been approved for any indications. By evaluating linperlisib for its safety, tolerability and efficacy, we are optimistic that this novel oral therapy will advance into registration clinical trials in PTCL for regulatory approval."
Linperlisib evaluated in advanced solid tumors
Another clinical study of linperlisib was also presented at ASCO entitled "A phase Ib study of the PI3Kδ inhibitor linperlisib in patients with advanced solid tumors". In this study that enrolled 78 advanced solid tumor patients, linperlisib monotherapy was evaluated for safety, tolerability, and durability at the recommended phase2 dose of 80 mg once daily, the dose previously established for the treatment of lymphomas. The clinical data from an interim analysis of this study was presented by Dr. Jin Li, Professor and Oncologist at Shanghai East Hospital.
Linperlisib is an immunomodulatory PI3Kδ inhibitor in solid tumors that has been demonstrated to alter the tumor immune microenvironment in preclinical research. "These properties of solid tumors are a challenge for therapeutic intervention because the regulatory immune cells will frequently repress an anti-tumor immune response. Our hypothesis is that linperlisib will unleash the anti-tumor suppression in a beneficial manner for patient treatments", said Zusheng Xu, General Manager of Yingli Pharma.
In the open-label Phase 1b study including 15 advanced solid tumor types, linperlisib was demonstrated to be safe and well-tolerated. The most common treatment related adverse events were Grade 1 and Grade 2, with the Grade 3 TRAE of neutropenia (3.8%), diarrhea (2.6%), elevated γ-glutaminase (1.3%) and leukopenia (1.3%) observed. The disease control rate with linperlisib monotherapy was reported to be 41.4%, with one complete response observed in a patient with thymic carcinoma.
Dr. Jin Li stated "Linperlisib is a PI3K inhibitor with a distinct chemical structure highly selective to the δ isoform, compared to other PI3K inhibitors. The preliminary clinical findings are supportive of Linperlisib demonstrating a favorable safety profile with very limited off-target effects that have been associated with other PI3K inhibitors in the clinic. We were pleased to see that L...
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