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| Item Type: | Article |
|---|---|
| Title: | Chemotherapy-free combination of ibrutinib and obinutuzumab for untreated advanced follicular lymphoma: results of a phase II study from the German Lymphoma Alliance |
| Creators Name: | Schmidt, Christian, Scheubeck, Gabriel, Jurinovic, Vindi, Sökler, Martin, Forstpointner, Roswitha, Buske, Christian, Viardot, Andreas, Keller, Ulrich, Graeven, Ullrich, Marks, Reinhard, Hänel, Mathias, Liersch, Rüdiger, Dürig, Jan, Pott, Christiane, Hoster, Eva, Unterhalt, Michael and Hiddemann, Wolfgang |
| Abstract: | Immunochemotherapy induces long-term responses in patients with follicular lymphoma. However, the toxicity of chemotherapy remains a relevant challenge. The Bruton tyrosine kinase inhibitor ibrutinib has shown significant activity in patients with indolent B-cell lymphoma. Combining ibrutinib with obinutuzumab may, therefore, be an attractive chemotherapy-free option. We conducted a prospective, single-arm, multicenter phase II trial to evaluate the chemotherapy-free regimen of obinutuzumab plus ibrutinib in patients with previously untreated advanced-stage follicular lymphoma. Patients received six 21-day cycles of ibrutinib and obinutuzumab for induction and 12 additional 2-month cycles for maintenance. The primary endpoint was 1-year progression-free survival (PFS). The study was powered to detect an improvement of 10% over the 1-year PFS of 85%. Ninety-eight patients were enrolled in the trial. The median follow-up was 5.5 years. After induction, five patients (5%) had a complete response and 82 (85%) had a partial response. The 1-year PFS was 80%, missing the prospected improvement of a 1-year PFS of 85% (P=0.93). The median PFS was 4.5 years; median duration of response and overall survival were not reached. The most common adverse events of grade 3/4 were neutropenia, lung infection, hypertension, fatigue, rash and thrombocytopenia. The trial of a chemotherapy-free regimen of obinutuzumab and ibrutinib in follicular lymphoma patients failed to demonstrate a 10% improvement in the primary efficacy endpoint. However, the combination produced durable and deep responses and had an acceptable safety profile. TRIAL REGISTRATION: EudraCT-Number: 2014-005164-15. |
| Keywords: | Adenine, Antineoplastic Combined Chemotherapy Protocols, Follicular Lymphoma, Humanized Monoclonal Antibodies, Neoplasm Staging, Piperidines, Pyrazoles, Treatment Outcome |
| Source: | Haematologica |
| ISSN: | 0390-6078 |
| Publisher: | Ferrata Storti Foundation |
| Volume: | 110 |
| Number: | 12 |
| Page Range: | 3022-3031 |
| Date: | 1 December 2025 |
| Additional Information: | Erratum in: Haematologica. 2025 Dec 1;110(12):3180-3181. |
| Official Publication: | https://doi.org/10.3324/haematol.2024.287162 |
| PubMed: | View item in PubMed |
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