Phase Ib study of the oral PI3Kδ inhibitor linperlisib in patients with advanced solid tumors
Jin Li1, Junli Xue2, Tianshu Liu3
1Department of Oncology, East Hospital Affiliated to Tongji University, No. 150 Jimo Road, Pudong New Area, Shanghai, 200120, China. jili9871116@163.com.
Background:
Patients with advanced solid tumors have a suboptimal prognosis. This study investigated the safety and feasibility of linperlisib, a selective phosphatidylinositol 3-kinase delta isoform (PI3Kδ) inhibitor, for treating patients with advanced solid tumors.
Methods:
In this phase Ib, single-arm, open-label, multi-center clinical trial, patients with histologically confirmed advanced solid tumors from eight centers in China were enrolled to receive oral linperlisib (80 mg/day). The primary endpoint was safety.
Results:
Between August 2019 and June 2022, 94 patients were enrolled in the trial and received the study treatment. The most common (≥ 20%) treatment emergent adverse events (TEAEs) of all grades irrespective of causality were increased aspartate aminotransferase (AST) (26.6%), proteinuria (26.6%), decreased appetite (25.5%), increased alanine aminotransferase (ALT) (22.3%), weight loss (21.3%), and anemia (21.3%). The most common grade ≥ 3 TEAEs were diarrhea (4.3%), increased AST (3.2%), increased ALT (3.2%), neutropenia (3.2%), anemia (3.2%), increased blood alkaline phosphatase (3.2%). The objective response rate (ORR) was 1.1% (95% confidence interval [CI] 0.0-5.8), and the disease control rate (DCR) was 37.2% (95% CI 27.5-47.8). As of the data cutoff, the median follow-up time was 4.2 months (95% CI 2.8-6.9). The median progression-free survival (PFS) was 1.85 months (95% CI 1.79-1.88). The median overall survival (OS) was not reached.
Conclusion:
Linperlisib showed an acceptable safety profile and preliminary clinical benefit in patients with a range of advanced solid tumors. Further studies of linperlisib safety and efficacy are warranted.
Insights
Linperlisib, a PI3Kδ inhibitor, demonstrated an acceptable safety profile and preliminary clinical benefit in patients with advanced solid tumors. Further investigation into its safety and efficacy is warranted.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Patients with advanced solid tumors face poor prognoses.
- Investigating novel targeted therapies is crucial for improving outcomes.
- Linperlisib, a selective PI3Kδ inhibitor, is explored for its potential in this patient population.
Purpose of the Study:
- To assess the safety and feasibility of linperlisib in patients with advanced solid tumors.
- To evaluate the preliminary clinical activity of linperlisib.
Main Methods:
- A phase Ib, single-arm, open-label, multi-center clinical trial was conducted.
- 94 patients with advanced solid tumors received oral linperlisib (80 mg/day).
- The primary endpoint was safety assessment, with secondary endpoints including efficacy measures.
Main Results:
- The most frequent treatment-emergent adverse events included elevated liver enzymes and proteinuria.
- Grade ≥3 adverse events of special interest included diarrhea and cytopenias.
- The objective response rate was 1.1%, and the disease control rate was 37.2% with a median PFS of 1.85 months.
Conclusions:
- Linperlisib exhibited an acceptable safety profile in patients with advanced solid tumors.
- Preliminary clinical benefit was observed, suggesting potential therapeutic value.
- Further studies are recommended to confirm the safety and efficacy of linperlisib.
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