Trial reportClinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico2025
Exploratory biomarker analysis from a phase III study of the PI3K inhibitor, copanlisib, in combination with rituximab in patients with indolent non-Hodgkin lymphoma, a retrospective study.
Trial report in Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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10 authors.
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Abstract
purposeThere has been increased difficulty in developing safe and effective treatment using PI3K inhibitors in heme malignancies, despite the role of PI3K/AKT being well defined in this population. This study was an attempt to conduct exploratory biomarker analysis retrospectively from the phase III CHRONOS-3 trial with the aim to identify a sub-set of patients that could benefit from treatment. PATIENTS AND
methodsPatients with CD20-positive indolent B-cell lymphoma were randomized 2:1 to receive intravenous copanlisib plus rituximab (C + R) or placebo plus rituximab (P + R). Biomarker analyses were performed to examine potential associations between treatment outcome and phosphatase and tensin homolog (PTEN) protein expression, EZH2 and BCL2 mutation status via next-generation sequencing, and plasma cytokine levels.
resultsPTEN presence was associated with significant improvements in progression-free survival (PFS) for C + R over P + R in patients with iNHL (P = 0.001) and FL (P = 0.012). Both the mutant and wild-type EZH2 FL patients had equal PFS benefits when treated with copanlisib. A significant improvement in PFS was observed for patients with mutant versus wild-type BCL2 FL in the C + R arm (P = 0.002). Overall survival (OS) was significantly improved for patients with iNHL and low or undetectable versus high baseline IL-2 levels in the C + R arm (P < 0.0001, unadjusted).
conclusionsPTEN presence, BCL2 mutations, and low or undetectable baseline IL-2 levels were associated with improved patient survival following treatment with C + R, supporting a potential role for these biomarkers in guiding treatment selection for patients with indolent non-Hodgkin lymphoma.
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