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Bending the Curve Trial by Trial
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BRUIN

Pirtobrutinib after a covalent BTK inhibitor in chronic lymphocytic leukemia (BRUIN phase 1-2, CLL/SLL cohort)

Phase 1/2N = 317NCT03740529

Population
Relapsed or refractory CLL or SLL; efficacy population previously treated with a BTK inhibitor (n=247, median of 3 prior lines, 100 patients also with a BCL2 inhibitor)
Design
Phase 1-2 trial of pirtobrutinib in relapsed or refractory B-cell cancers. This report gives efficacy in 247 patients with CLL or SLL who had previously received a BTK inhibitor and safety in all 317 patients with CLL or SLL treated. Primary endpoint overall response (partial response or better) by independent review. The ClinicalTrials.gov record lists 803 enrolled across diseases.
Primary endpoint
ORR
Arms
  • Pirtobrutinib (experimental, n = 317): Pirtobrutinib, a non-covalent (reversible) BTK inhibitor
People
Mato AR
Show the numbers
Results reported for BRUIN
EndpointAnalysisPirtobrutinibControlEffect
ORRPatients with CLL or SLL previously treated with a BTK inhibitor (n=247)primaryMato 202373.3% (67.3–78.7%)—82.2% (95% CI 76.8 to 86.7) when partial response with lymphocytosis is included.
PFSPatients with CLL or SLL previously treated with a BTK inhibitor (n=247)primaryMato 2023median 19.6 months (16.9–22.1)—Secondary endpoint.
Results reported for BRUIN
EndpointAnalysisPirtobrutinibControlEffect
ORRPatients with CLL or SLL previously treated with a BTK inhibitor (n=247)primaryMato 202373.3% (67.3–78.7%)—82.2% (95% CI 76.8 to 86.7) when partial response with lymphocytosis is included.
PFSPatients with CLL or SLL previously treated with a BTK inhibitor (n=247)primaryMato 2023median 19.6 months (16.9–22.1)—Secondary endpoint.
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%010203040Months (modelled)
  • Pirtobrutinib (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsPirtobrutinib
0100.0%
1265.4%
2541.3%
3727.0%
4917.7%
Primary publication: Mato AR, Woyach JA, Brown JR, Ghia P, Patel K, Eyre TA, et al. Pirtobrutinib after a Covalent BTK Inhibitor in Chronic Lymphocytic Leukemia. N Engl J Med. 2023;389(1):33-44. PubMedDOI

Appears in

Sources

  1. Mato AR, Woyach JA, Brown JR, Ghia P, Patel K, Eyre TA, et al. Pirtobrutinib after a Covalent BTK Inhibitor in Chronic Lymphocytic Leukemia. N Engl J Med. 2023;389(1):33-44.

    PubMedDOI