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Phase II study of novel orally PI3Kα/δ inhibitor TQ-B3525 in relapsed and/or refractory follicular lymphoma
Huaqing Wang1,2, Jifeng Feng3, Yanyan Liu4
1Department of Oncology, Tianjin Union Medical Center of Nankai University, Tianjin, 300121, PR China.
Abstract:
This registration study assessed clinical outcomes of TQ-B3525, the dual phosphatidylinositol-3-kinase (PI3K) α/δ inhibitor, in relapsed and/or refractory follicular lymphoma (R/R FL). This phase II study (ClinicalTrials.gov NCT04324879. Registered March 27, 2020) comprised run-in stage and stage 2. R/R FL patients after ≥2 lines therapies received oral 20 mg TQ-B3525 once daily in a 28-day cycle until intolerable toxicity or disease progression. Primary endpoint was independent review committee (IRC)-assessed objective response rate (ORR). Based on results (ORR, 88.0%; duration of response [DOR], 11.8 months; progression-free survival [PFS], 12.0 months) in 25 patients at run-in stage, second stage study was initiated and included 82 patients for efficacy/safety analysis. Patients received prior-line (median, 3) therapies, with 56.1% refractory to previous last therapies; 73.2% experienced POD24 at baseline. At stage 2, ORR was 86.6% (71/82; 95% CI, 77.3-93.1%), with 28 (34.2%) complete responses. Disease control rate was 95.1% due to 7 (8.5%) stable diseases. Median time to response was 1.8 months. Among 71 responders, median DOR was not reached; 18-month DOR rate was 51.6%. with median follow-up of 13.3 months, median PFS was 18.5 (95% CI, 10.2-not estimable) months. Median overall survival (OS) was not reached by cutoff date; 24-month OS rate was estimated as 86.1%. Response rates and survival data were consistent across all subgroups. Grade 3 or higher treatment-related adverse events were observed in 63 (76.8%) cases, with neutropenia (22.0%), hyperglycemia (19.5%), and diarrhea (13.4%) being common. TQ-B3525 showed favorable efficacy and safety for R/R FL patients after ≥2 lines prior therapies.
Insights
The dual PI3K α/δ inhibitor TQ-B3525 demonstrated significant efficacy in treating relapsed/refractory follicular lymphoma (R/R FL). Patients experienced high response rates and prolonged survival, indicating a promising new treatment option.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Follicular lymphoma (FL) is a common indolent non-Hodgkin lymphoma.
- Relapsed and/or refractory (R/R) FL after multiple prior therapies presents a significant unmet need.
- Novel therapeutic strategies are crucial for improving outcomes in R/R FL.
Purpose of the Study:
- To assess the clinical outcomes, including efficacy and safety, of TQ-B3525 in patients with R/R FL.
- To evaluate the objective response rate (ORR) as the primary endpoint.
- To determine the duration of response (DOR), progression-free survival (PFS), and overall survival (OS).
Main Methods:
- A phase II registration study (NCT04324879) involving R/R FL patients who received ≥2 prior lines of therapy.
- Patients were treated with oral TQ-B3525 20 mg once daily in 28-day cycles.
- Efficacy and safety were assessed in 82 patients at stage 2, following an initial run-in stage.
Main Results:
- High ORR of 86.6% (71/82) with 34.2% complete responses.
- Median DOR not reached, with an 18-month DOR rate of 51.6%.
- Median PFS of 18.5 months and an estimated 24-month OS rate of 86.1% were observed.
- Common Grade 3+ treatment-related adverse events included neutropenia (22.0%) and hyperglycemia (19.5%).
Conclusions:
- TQ-B3525 demonstrates favorable efficacy and a manageable safety profile in R/R FL patients.
- The drug shows potential as a new therapeutic option for heavily pretreated FL patients.
- Further investigation and clinical application of TQ-B3525 in R/R FL are warranted.
