A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Summary
The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.
Timeline
- Start
- 2021-09-23
- Primary completion
- 2025-07-11
- Completion
- 2027-10
Outcome
Met primary endpoint
paper IRC-assessed PFS was significantly improved with pirtobrutinib versus BendaR (hazard ratio [HR], 0.199 [95% CI, 0.107 to 0.367]; P < .0001) PMID 41363773 ↗
paper CONCLUSION: Pirtobrutinib demonstrated superiority over BendaR in IRC-assessed PFS in treatment-naïve CLL/SLL. PMID 41363773 ↗
release “In the Phase 3 BRUIN CLL-313 study, treatment with pirtobrutinib demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival versus bendamustine plus rituximab” lilly.com ↗
Publications
- Eyre TA, Hess LM, Masoudi E, Jen MH, Abhyankar S, Graham-Clarke PL, Bhandari NR, Maguire P, Winfree KB, Tracey M, Taipale KL, Davids MS. Efficacy of Pirtobrutinib Monotherapy in Treatment-Naive Chronic Lymphocytic Leukemia: A Bayesian Network Meta-Analysis of Randomized Controlled Trials. Cancers (Basel). 2026 Feb 18;18(4):660. doi: 10.3390/cancers18040660.
- Jurczak W, Kwiatek M, Czyz J, Roberto de Mattos E, Eom KS, Egle A, Panovska A, Popova ZG, Shih HJ, Casado Montero LF, Sportoletti P, Hua VM, D'Olimpio JT, Iida S, Ito R, Bao K, Fink A, Su W, Ruppert AS, Levy A, Wrobel T. BRUIN CLL-313: Randomized Phase III Trial of Pirtobrutinib Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. J Clin Oncol. 2026 Feb 20;44(6):466-475. doi: 10.1200/JCO-25-02380. Epub 2025 Dec 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bendamustine | Small molecule | 90 mg/m2 | Intravenous |
| Subject | Pirtobrutinib | Small molecule | 200 mg | Oral |
| Comparator | Rituximab | Monoclonal antibody | 500 mg/m2 | Intravenous |