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Published on: September 25, 2018
PI3Kδ inhibitor linperlisib combined with gemcitabine and oxaliplatin for relapsed or refractory diffuse large B-cell
Peng Sun1, Hong Cen2, Haiyan Yang3
1Department of Medical Oncology, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Yuexiu District, Guangzhou, China.
Background:
This investigation assessed the therapeutic potential of combining linperlisib, a targeted inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ), with gemcitabine and oxaliplatin (GEMOX) for patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
Methods:
This was a multicenter, phase Ib/II clinical study conducted across six sites in China, enrolling 39 individuals with histologically confirmed R/R DLBCL. The treatment protocol included oral linperlisib alongside GEMOX administered intravenously every three weeks for up to six cycles. The primary efficacy endpoint was the objective response rate (ORR).
Results:
The ORR observed in the full study population was 53.8% (95% confidence interval [CI]: 37.2-69.9). The median duration of response was 5.7 months (95% CI: 4.3-9.1), and the median progression-free survival was 5.4 months (95% CI: 1.8-6.7). The 1-year OS rate was 65.5% (95% CI: 48.1-78.3). Frequently observed adverse events included decreases in neutrophil counts (74.4%), white blood cell counts (64.1%) and platelet counts (64.1%).
Conclusions:
This study highlights the potential of linperlisib plus GEMOX as a treatment for R/R DLBCL, demonstrating a tolerable safety profile and encouraging efficacy results.
Trial Registration:
NCT04500561.
Insights
Linperlisib combined with chemotherapy shows promise for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This treatment demonstrated a 53.8% objective response rate and a tolerable safety profile in a clinical study.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Diffuse large B-cell lymphoma (DLBCL) is an aggressive non-Hodgkin lymphoma.
- Relapsed or refractory (R/R) DLBCL presents significant treatment challenges.
- Targeted therapies are being explored to improve outcomes in R/R DLBCL.
Purpose of the Study:
- To evaluate the efficacy and safety of linperlisib, a PI3Kδ inhibitor, in combination with gemcitabine and oxaliplatin (GEMOX).
- To assess this combination therapy in patients with R/R DLBCL who have limited treatment options.
Main Methods:
- A multicenter, phase Ib/II clinical study involving 39 patients with R/R DLBCL.
- Patients received oral linperlisib plus intravenous GEMOX every three weeks for up to six cycles.
- The primary endpoint was the objective response rate (ORR).
Main Results:
- The objective response rate (ORR) was 53.8% (95% CI: 37.2-69.9).
- Median duration of response was 5.7 months, and median progression-free survival was 5.4 months.
- The 1-year overall survival (OS) rate was 65.5%. Common adverse events included neutropenia and thrombocytopenia.
Conclusions:
- Linperlisib plus GEMOX demonstrates encouraging efficacy in patients with R/R DLBCL.
- The combination therapy exhibits a tolerable safety profile.
- This regimen represents a potential new treatment option for R/R DLBCL.
