Treatment-free remission after two nilotinib consolidation
durations in chronic myeloid leukemia treated with imatinib:
Phase 3 ENESTPath results

J 2026

Treatment-free remission after two nilotinib consolidation durations in chronic myeloid leukemia treated with imatinib: Phase 3 ENESTPath results

REA, Delphine; Slawomira KYRCZ-KRZEMIEN; Paolo SPORTOLETTI; Jiří MAYER; Arpad ILLES et al.

Základní údaje

Originální název

Treatment-free remission after two nilotinib consolidation durations in chronic myeloid leukemia treated with imatinib: Phase 3 ENESTPath results

Autoři

Vydání

Leukemia, LONDON, SPRINGERNATURE, 2026, 0887-6924

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30205 Hematology

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 13.400 v roce 2024

Označené pro přenos do RIV

Ano

Organizační jednotka

Lékařská fakulta

Klíčová slova anglicky

chronic myeloid leukemia; treatment-free remission; nilotinib; imatinib; phase III trial

Štítky

14110212, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 8. 4. 2026 11:02, Mgr. Tereza Miškechová

Anotace

V originále

The phase 3 ENESTPath study investigated treatment-free remission (TFR) rates in patients with chronic Philadelphia chromosome-positive (Ph+) and/or BCR::ABL1(+) chronic myeloid leukemia who had not achieved deep molecular response (DMR) after >2 years of imatinib treatment and were switched to nilotinib 300 mg twice daily (BID). After 24 months of treatment, patients with a stable DMR were randomized to either enter the TFR phase (Arm 1) or continue nilotinib consolidation for an additional 12 months and then enter the TFR phase if in stable DMR (Arm 2). The primary endpoint was the proportion of patients who remained in TFR (>= MR4.0 [BCR::ABL1(IS) <= 0.01%]) without molecular relapse at the end of 12 months. Of the 620 patients enrolled, 239 (38.5%) achieved stable MR4.0 and were randomized to Arm 1 (n = 120) or Arm 2 (n = 119). In the TFR phase, MR4.0 rates at 12 months (Arm 1: 31.9%, Arm 2: 37.5%; p = 0.383) and 24 months (Arm 1: 29.4%, Arm 2: 30.8%) revealed no differences in TFR success between 2 and 3 years of nilotinib. Irrespective of the consolidation duration, switching to nilotinib 300 mg BID provided the opportunity to achieve TFR if patients were unable to reach stable DMR with first-line imatinib.

Citovat

REA, Delphine; Slawomira KYRCZ-KRZEMIEN; Paolo SPORTOLETTI; Jiří MAYER; Arpad ILLES; Angona Figueras ANNA; Alexander KIANI; Aude CHARBONNIER; Theodoros MARINAKIS; Leif STENKE; Juan Luis STEEGMANN; Giuseppe SAGLIO; Andrzej HELLMANN; Dietger NIEDERWIESER; Peter SCHULD a Gianantonio ROSTI. Treatment-free remission after two nilotinib consolidation durations in chronic myeloid leukemia treated with imatinib: Phase 3 ENESTPath results. Leukemia. LONDON: SPRINGERNATURE, 2026, roč. 40, č. 3, s. 553-561. ISSN 0887-6924. Dostupné z: https://doi.org/10.1038/s41375-025-02847-5.

@article{2565447,
   author = {Rea, Delphine and KyrczandKrzemien, Slawomira and Sportoletti, Paolo and Mayer, Jiří and Illes, Arpad and Anna, Angona Figueras and Kiani, Alexander and Charbonnier, Aude and Marinakis, Theodoros and Stenke, Leif and Steegmann, Juan Luis and Saglio, Giuseppe and Hellmann, Andrzej and Niederwieser, Dietger and Schuld, Peter and Rosti, Gianantonio},
   article_location = {LONDON},
   article_number = {3},
   doi = {https://doi.org/10.1038/s41375-025-02847-5},
   keywords = {chronic myeloid leukemia; treatment-free remission; nilotinib; imatinib; phase III trial},
   language = {eng},
   issn = {0887-6924},
   journal = {Leukemia},
   title = {Treatment-free remission after two nilotinib consolidation durations in chronic myeloid leukemia treated with imatinib: Phase 3 ENESTPath results},
   url = {https://www.nature.com/articles/s41375-025-02847-5},
   volume = {40},
   year = {2026}
}

TY  - JOUR
ID  - 2565447
AU  - Rea, Delphine - Kyrcz-Krzemien, Slawomira - Sportoletti, Paolo - Mayer, Jiří - Illes, Arpad - Anna, Angona Figueras - Kiani, Alexander - Charbonnier, Aude - Marinakis, Theodoros - Stenke, Leif - Steegmann, Juan Luis - Saglio, Giuseppe - Hellmann, Andrzej - Niederwieser, Dietger - Schuld, Peter - Rosti, Gianantonio
PY  - 2026
TI  - Treatment-free remission after two nilotinib consolidation durations in chronic myeloid leukemia treated with imatinib: Phase 3 ENESTPath results
JF  - Leukemia
VL  - 40
IS  - 3
SP  - 553-561
EP  - 553-561
PB  - SPRINGERNATURE
SN  - 08876924
KW  - chronic myeloid leukemia
KW  - treatment-free remission
KW  - nilotinib
KW  - imatinib
KW  - phase III trial
UR  - https://www.nature.com/articles/s41375-025-02847-5
N2  - The phase 3 ENESTPath study investigated treatment-free remission (TFR) rates in patients with chronic Philadelphia chromosome-positive (Ph+) and/or BCR::ABL1(+) chronic myeloid leukemia who had not achieved deep molecular response (DMR) after >2 years of imatinib treatment and were switched to nilotinib 300 mg twice daily (BID). After 24 months of treatment, patients with a stable DMR were randomized to either enter the TFR phase (Arm 1) or continue nilotinib consolidation for an additional 12 months and then enter the TFR phase if in stable DMR (Arm 2). The primary endpoint was the proportion of patients who remained in TFR (>= MR4.0 [BCR::ABL1(IS) <= 0.01%]) without molecular relapse at the end of 12 months. Of the 620 patients enrolled, 239 (38.5%) achieved stable MR4.0 and were randomized to Arm 1 (n = 120) or Arm 2 (n = 119). In the TFR phase, MR4.0 rates at 12 months (Arm 1: 31.9%, Arm 2: 37.5%; p = 0.383) and 24 months (Arm 1: 29.4%, Arm 2: 30.8%) revealed no differences in TFR success between 2 and 3 years of nilotinib. Irrespective of the consolidation duration, switching to nilotinib 300 mg BID provided the opportunity to achieve TFR if patients were unable to reach stable DMR with first-line imatinib.
ER  -

REA, Delphine; Slawomira KYRCZ-KRZEMIEN; Paolo SPORTOLETTI; Jiří MAYER; Arpad ILLES; Angona Figueras ANNA; Alexander KIANI; Aude CHARBONNIER; Theodoros MARINAKIS; Leif STENKE; Juan Luis STEEGMANN; Giuseppe SAGLIO; Andrzej HELLMANN; Dietger NIEDERWIESER; Peter SCHULD a Gianantonio ROSTI. Treatment-free remission after two nilotinib consolidation durations in chronic myeloid leukemia treated with imatinib: Phase 3 ENESTPath results. \textit{Leukemia}. LONDON: SPRINGERNATURE, 2026, roč.~40, č.~3, s.~553-561. ISSN~0887-6924. Dostupné z: https://doi.org/10.1038/s41375-025-02847-5.

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