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BRUIN CLL-313

BRUIN CLL-313: randomized phase III trial of pirtobrutinib versus bendamustine plus rituximab in untreated CLL/SLL

Phase 3N = 282NCT05023980

Population
Previously untreated CLL or SLL without del(17p)
Design
Randomised, open-label, global phase 3 study; previously untreated CLL or SLL without del(17p) randomly assigned 1:1 to continuous pirtobrutinib monotherapy or bendamustine-rituximab, stratified by IGHV mutation status and Rai stage. Primary endpoint PFS by independent review committee. An effective crossover rate of 52.9% is reported.
Primary endpoint
PFS
Arms
  • Pirtobrutinib (experimental, n = 141): Continuous pirtobrutinib monotherapy
  • Bendamustine-rituximab (control, n = 141): Bendamustine plus rituximab
People
Jurczak W
PFSHR 0.199 (95% CI 0.107–0.367)Δ 24-month PFS+22.7 pointsOSHR 0.257 (95% CI 0.070–0.934)
Show the numbers
Results reported for BRUIN CLL-313
EndpointAnalysisPirtobrutinibBendamustine-rituximabEffect
PFSprimaryJurczak 202693.4% at 2 y (87.6–96.5%)70.7% at 2 y (61.5–78.1%)HR 0.199 (95% CI 0.107–0.367)P<.0001PFS rate at 24 months (IRC-assessed; median PFS not reached with pirtobrutinib). Investigator-assessed PFS hazard ratio 0.186 (95% CI 0.093 to 0.371). Median follow-up for IRC-assessed PFS 28.1 months; data cut-off 11 July 2025.
OSinterimmedian follow-up 32 monthsJurczak 2026——HR 0.257 (95% CI 0.070–0.934)Interim analysis of OS (median follow-up 32 months); effective crossover rate 52.9% (18 of 34 patients on bendamustine-rituximab with investigator-assessed progression). The abstract gives no P value; the full text reports a nominal P=0.0261 against a two-sided interim alpha of 0.000001 and describes OS as trending in favour of pirtobrutinib, with final testing planned.
Results reported for BRUIN CLL-313
EndpointAnalysisPirtobrutinibBendamustine-rituximabEffect
PFSprimaryJurczak 202693.4% at 2 y (87.6–96.5%)70.7% at 2 y (61.5–78.1%)HR 0.199 (95% CI 0.107–0.367)P<.0001PFS rate at 24 months (IRC-assessed; median PFS not reached with pirtobrutinib). Investigator-assessed PFS hazard ratio 0.186 (95% CI 0.093 to 0.371). Median follow-up for IRC-assessed PFS 28.1 months; data cut-off 11 July 2025.
OSinterimmedian follow-up 32 monthsJurczak 2026——HR 0.257 (95% CI 0.070–0.934)Interim analysis of OS (median follow-up 32 months); effective crossover rate 52.9% (18 of 34 patients on bendamustine-rituximab with investigator-assessed progression). The abstract gives no P value; the full text reports a nominal P=0.0261 against a two-sided interim alpha of 0.000001 and describes OS as trending in favour of pirtobrutinib, with final testing planned.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.1990.107–0.367
OS0.2570.07–0.934
Primary publication: Jurczak W, Kwiatek M, Czyz J, Roberto de Mattos E, Eom KS, Egle A, et al. 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;44(6):466-475. PubMedDOI

Appears in

Sources

  1. Jurczak W, Kwiatek M, Czyz J, Roberto de Mattos E, Eom KS, Egle A, et al. 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;44(6):466-475.

    PubMedDOI