Pirtobrutinib Versus Ibrutinib in Treatment-Naïve and
Relapsed/Refractory Chronic Lymphocytic Leukemia/Small
Lymphocytic Lymphoma

J 2026

Pirtobrutinib Versus Ibrutinib in Treatment-Naïve and Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

WOYACH, Jennifer A; Lugui QIU; Sebastian GROSICKI; Tomasz WROBEL; Marcelo CAPRA et al.

Základní údaje

Originální název

Pirtobrutinib Versus Ibrutinib in Treatment-Naïve and Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Autoři

Vydání

Journal of clinical oncology, Philadelphia, LIPPINCOTT WILLIAMS & WILKINS, 2026, 0732-183X

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30205 Hematology

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 41.900 v roce 2024

Označené pro přenos do RIV

Ano

Organizační jednotka

Lékařská fakulta

Klíčová slova anglicky

chronic graft-versus-host disease; ruxolitinib; corticosteroid-refractory; long-term outcomes; phase III trial

Štítky

14110212, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 7. 4. 2026 12:52, Mgr. Tereza Miškechová

Anotace

V originále

PURPOSEPirtobrutinib, a highly selective, noncovalent Bruton tyrosine kinase inhibitor (BTKi), has shown efficacy and safety in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who received prior covalent BTKi. We report results, to our knowledge, from the first randomized head-to-head comparison of pirtobrutinib versus ibrutinib in BTKi-na & iuml;ve CLL/SLL in both treatment-na & iuml;ve (TN) patients and patients with relapsed/refractory (R/R) disease. PATIENTS AND METHODSPatients (N = 662) were randomly assigned 1:1 to receive pirtobrutinib or ibrutinib. All patients were BTKi-na & iuml;ve. Primary end points were overall response rate (ORR) by independent review committee (IRC) among all randomly assigned patients (intention to treat [ITT]) and in patients with R/R disease. RESULTSThe study met its primary end points, demonstrating statistically significant noninferiority (NI) of IRC-ORR for pirtobrutinib versus ibrutinib in both the ITT (87.0% [95% CI, 82.9 to 90.4] v 78.5% [95% CI, 73.7 to 82.9]; ORR ratio = 1.11 [95% CI, 1.03 to 1.19]; two-sided P < .0001) and R/R populations (n = 437; 84.0% [95% CI, 78.5 to 88.6] v 74.8% [95% CI, 68.5 to 80.4]; ORR ratio = 1.12 [95% CI, 1.02 to 1.24]; two-sided P < .0001). In TN patients (n = 225), IRC-ORR was 92.9% (95% CI, 86.4 to 96.9) with pirtobrutinib versus 85.8% (95% CI, 78.0 to 91.7) with ibrutinib. Investigator assessed ORR results were consistent. Investigator-assessed progression-free survival (PFS) favored pirtobrutinib in the ITT (hazard ratio [HR], 0.57 [95% CI, 0.39 to 0.83]), R/R (HR, 0.73 [95% CI, 0.47 to 1.13]), and TN (HR, 0.24 [95% CI, 0.10 to 0.59]) populations. Cardiac adverse event rates of atrial fibrillation/flutter and hypertension were lower with pirtobrutinib. CONCLUSIONPirtobrutinib demonstrated NI of ORR versus ibrutinib, with a favorable early PFS trend, particularly in TN patients, and a favorable safety profile including low rates of atrial fibrillation and hypertension.

Citovat

WOYACH, Jennifer A; Lugui QIU; Sebastian GROSICKI; Tomasz WROBEL; Marcelo CAPRA; Jaroslaw CZYZ; Shuhua YI; Ki-Seong EOM; Anna PANOVSKÁ; Wojciech JURCZAK; Kamel LARIBI; Lutz JACOBASCH; Ross BAKER; Richy AGAJANIAN; Alejandro BERKOVITS; Muhit OZCAN; Stephane LEPRETRE; Catherine C COOMBS; Paula CRAMER; Katharine L LEWIS; Marisa HILL; Katherine BAO; Yuanyuan BIAN; De Batista Ribeiro Silvia RAMALHO; Naleen Raj BHANDARI; Amy S RUPPERT; Ching Ching LEOW a William G WIERDA. Pirtobrutinib Versus Ibrutinib in Treatment-Naïve and Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Journal of clinical oncology. Philadelphia: LIPPINCOTT WILLIAMS & WILKINS, 2026, roč. 44, č. 6, s. 1-6, 12 s. ISSN 0732-183X. Dostupné z: https://doi.org/10.1200/JCO-25-02477.

@article{2565346,
   author = {Woyach, Jennifer A and Qiu, Lugui and Grosicki, Sebastian and Wrobel, Tomasz and Capra, Marcelo and Czyz, Jaroslaw and Yi, Shuhua and Eom, KiandSeong and Panovská, Anna and Jurczak, Wojciech and Laribi, Kamel and Jacobasch, Lutz and Baker, Ross and Agajanian, Richy and Berkovits, Alejandro and Ozcan, Muhit and Lepretre, Stephane and Coombs, Catherine C and Cramer, Paula and Lewis, Katharine L and Hill, Marisa and Bao, Katherine and Bian, Yuanyuan and Ramalho, De Batista Ribeiro Silvia and Bhandari, Naleen Raj and Ruppert, Amy S and Leow, Ching Ching and Wierda, William G},
   article_location = {Philadelphia},
   article_number = {6},
   doi = {https://doi.org/10.1200/JCO-25-02477},
   keywords = {chronic graft-versus-host disease; ruxolitinib; corticosteroid-refractory; long-term outcomes; phase III trial},
   language = {eng},
   issn = {0732-183X},
   journal = {Journal of clinical oncology},
   title = {Pirtobrutinib Versus Ibrutinib in Treatment-Naïve and Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma},
   url = {https://ascopubs.org/doi/10.1200/JCO-25-02477},
   volume = {44},
   year = {2026}
}

TY  - JOUR
ID  - 2565346
AU  - Woyach, Jennifer A - Qiu, Lugui - Grosicki, Sebastian - Wrobel, Tomasz - Capra, Marcelo - Czyz, Jaroslaw - Yi, Shuhua - Eom, Ki-Seong - Panovská, Anna - Jurczak, Wojciech - Laribi, Kamel - Jacobasch, Lutz - Baker, Ross - Agajanian, Richy - Berkovits, Alejandro - Ozcan, Muhit - Lepretre, Stephane - Coombs, Catherine C - Cramer, Paula - Lewis, Katharine L - Hill, Marisa - Bao, Katherine - Bian, Yuanyuan - Ramalho, De Batista Ribeiro Silvia - Bhandari, Naleen Raj - Ruppert, Amy S - Leow, Ching Ching - Wierda, William G
PY  - 2026
TI  - Pirtobrutinib Versus Ibrutinib in Treatment-Naïve and Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
JF  - Journal of clinical oncology
VL  - 44
IS  - 6
SP  - 1-6
EP  - 1-6
PB  - LIPPINCOTT WILLIAMS & WILKINS
SN  - 0732183X
KW  - chronic graft-versus-host disease
KW  - ruxolitinib
KW  - corticosteroid-refractory
KW  - long-term outcomes
KW  - phase III trial
UR  - https://ascopubs.org/doi/10.1200/JCO-25-02477
N2  - PURPOSEPirtobrutinib, a highly selective, noncovalent Bruton tyrosine kinase inhibitor (BTKi), has shown efficacy and safety in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who received prior covalent BTKi. We report results, to our knowledge, from the first randomized head-to-head comparison of pirtobrutinib versus ibrutinib in BTKi-na & iuml;ve CLL/SLL in both treatment-na & iuml;ve (TN) patients and patients with relapsed/refractory (R/R) disease. PATIENTS AND METHODSPatients (N = 662) were randomly assigned 1:1 to receive pirtobrutinib or ibrutinib. All patients were BTKi-na & iuml;ve. Primary end points were overall response rate (ORR) by independent review committee (IRC) among all randomly assigned patients (intention to treat [ITT]) and in patients with R/R disease. RESULTSThe study met its primary end points, demonstrating statistically significant noninferiority (NI) of IRC-ORR for pirtobrutinib versus ibrutinib in both the ITT (87.0% [95% CI, 82.9 to 90.4] v 78.5% [95% CI, 73.7 to 82.9]; ORR ratio = 1.11 [95% CI, 1.03 to 1.19]; two-sided P < .0001) and R/R populations (n = 437; 84.0% [95% CI, 78.5 to 88.6] v 74.8% [95% CI, 68.5 to 80.4]; ORR ratio = 1.12 [95% CI, 1.02 to 1.24]; two-sided P < .0001). In TN patients (n = 225), IRC-ORR was 92.9% (95% CI, 86.4 to 96.9) with pirtobrutinib versus 85.8% (95% CI, 78.0 to 91.7) with ibrutinib. Investigator assessed ORR results were consistent. Investigator-assessed progression-free survival (PFS) favored pirtobrutinib in the ITT (hazard ratio [HR], 0.57 [95% CI, 0.39 to 0.83]), R/R (HR, 0.73 [95% CI, 0.47 to 1.13]), and TN (HR, 0.24 [95% CI, 0.10 to 0.59]) populations. Cardiac adverse event rates of atrial fibrillation/flutter and hypertension were lower with pirtobrutinib. CONCLUSIONPirtobrutinib demonstrated NI of ORR versus ibrutinib, with a favorable early PFS trend, particularly in TN patients, and a favorable safety profile including low rates of atrial fibrillation and hypertension.
ER  -

WOYACH, Jennifer A; Lugui QIU; Sebastian GROSICKI; Tomasz WROBEL; Marcelo CAPRA; Jaroslaw CZYZ; Shuhua YI; Ki-Seong EOM; Anna PANOVSKÁ; Wojciech JURCZAK; Kamel LARIBI; Lutz JACOBASCH; Ross BAKER; Richy AGAJANIAN; Alejandro BERKOVITS; Muhit OZCAN; Stephane LEPRETRE; Catherine C COOMBS; Paula CRAMER; Katharine L LEWIS; Marisa HILL; Katherine BAO; Yuanyuan BIAN; De Batista Ribeiro Silvia RAMALHO; Naleen Raj BHANDARI; Amy S RUPPERT; Ching Ching LEOW a William G WIERDA. Pirtobrutinib Versus Ibrutinib in Treatment-Naïve and Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. \textit{Journal of clinical oncology}. Philadelphia: LIPPINCOTT WILLIAMS \&{} WILKINS, 2026, roč.~44, č.~6, s.~1-6, 12 s. ISSN~0732-183X. Dostupné z: https://doi.org/10.1200/JCO-25-02477.

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