Эффективность терапии понатинибом у пациентов в хронической фазе хронического миелоидного лейкоза: данные трех центров Российской Федерации

Ольга Владимировна Кулемина; Е. Ю. Челышева; С. В. Волошин; А. Н. Величко; И. С. Мартынкевич; Е. В. Ефремова; О. А. Шухов; Ю. Д. Матвиенко; Т. В. Читанава; Н. Т. Сиордия; Н. С. Лазорко; Е. И. Сбитякова; Е. Н. Точеная; Ю. А. Алексеева; Е. С. Милеева; А. А. Пирхало; Н. Н. Немсцверидзе; Н. А. Шналиева; Л. О. Хорджасов; Н. С. Казанская; В. А. Шуваев; А. Г. Туркина; Е. Г. Ломаиа

doi:10.21320/2500-2139-2026-19-4-419-433

Ponatinib Efficacy in Chronic Phase Chronic Myeloid Leukemia: Data from Three Centers in the Russian Federation

Olga Vladimirovna Kulemina, E.Yu. Chelysheva, S.V. Voloshin, A.N. Velichko, I.S. Martynkevich, E.V. Efremova, O.A. Shukhov, Yu.D. Matvienko, T.V. Chitanava, N.T. Siordiya, N.S. Lazorko, E.I. Sbityakova, E.N. Tochenaya, Ju.A. Alekseeva, E.S. Mileeva, A.A. Pirkhalo, N.N. Nemstsveridze, N.A. Shnalieva, L.O. Khordzhasov, N.S. Kazanskaia, V.A. Shuvaev, A.G. Turkina, Е.G. Lomaia,

DOI:

https://doi.org/10.21320/2500-2139-2026-19-4-419-433

Abstract Authors References

AIM. To assess the efficacy and tolerability of ponatinib in patients with the 1st chronic phase (CP) of chronic myeloid leukemia (CML) and with either prior tyrosine kinase inhibitor (ITK) resistance or the T315I mutation in the BCR::ABL1 gene.

MATERIALS & METHODS. The study is based on the retrospective analysis of 99 CP CML patients treated with ponatinib in ≥ 2 therapy lines (83.8 % in the third and subsequent lines) as part of the clinical studies OPTIC, OPTIC-2L, and expanded access program in three medical institutions of the Russian Federation. The T315I mutation was identified in 31/96 patients (32.3 %). Most patients (86/99; 58.6 %) did not show complete hematologic response upon the start of ponatinib therapy, and 39/99 patients (39.4 %) did not achieve any cytogenetic response (CyR) on prior ITK therapy lines.

RESULTS. On ponatinib therapy, the percentage of patients with complete CyR and molecular response 2 (CCyR/MR2) as well as major (MMR) and deep molecular response (DMR) was 55.4 %, 43.4 %, and 33.7 %, respectively. The median ponatinib therapy duration was 27.6 months (range 0.5–88.5 months). The probability of achieving CCyR/MR2 within 1 and 2 years of therapy was 45.9 % and 57.0 %, respectively. The median time before achieving CCyR/MR2 was 2.8 months (range 2.7–43.1 months), 38/51 patients (74.5 %) maintained CCyR/MR2 for 24 months. The number of patients with the T315I mutation and CCyR/MR2 was 12/31 (38.7 %), and the median time before achieving MR2 appeared to be comparable with that in the total cohort, i.e., 2.8 months (range 2.7–8.3 months). About half of patients achieved MMR and DMR by the 5th year of ponatinib therapy (57.7 % and 49.4 %, respectively). The median time before achieving MMR and DMR was 9.6 months (range 2.7–70.9 months) and 22.3 months (range 2.7–82.7 months), respectively. The multivariate regression analysis revealed favorable predictors of MR2 and MMR: BCR::ABL1 expression level ≤ 10 %, absence of mutations, and age ≤ 42 years at the start of ponatinib therapy. Rates of the 5-year OS, PFS, and EFS were 85.2 %, 86.6 %, and 34.3 %, respectively.

CONCLUSION. Ponatinib demonstrated high efficacy both in patients with the T315I mutation and in heavily pre-treated patients. This study showed that baseline high level of BCR::ABL1 gene transcript or/and the absence of any CyR dramatically worsen long-term therapy outcomes. Another unfavorable prognostic factor is a failure to achieve CCyR/MR2 within the 1st year of ponatinib therapy, which calls for finding alternative treatment.

Olga Vladimirovna Kulemina VA Almazov National Medical Research Center, 2 Akkuratova ul., Saint Petersburg, Russian Federation, 197341 https://orcid.org/0000-0002-0867-3547 (unauthenticated)
E.Yu. Chelysheva National Research Center for Hematology, 4 Novyi Zykovskii pr-d, Moscow, Russian Federation, 125167 https://orcid.org/0000-0001-6423-1789 (unauthenticated)
S.V. Voloshin Leningrad Regional Clinical Hospital, 45 korp. 2A Lunacharskogo pr-t, Saint Petersburg, Russian Federation, 194291 https://orcid.org/0000-0003-1784-0375 (unauthenticated)
A.N. Velichko National Research Center for Hematology, 4 Novyi Zykovskii pr-d, Moscow, Russian Federation, 125167 https://orcid.org/0000-0001-5730-2593 (unauthenticated)
I.S. Martynkevich Russian Research Institute of Hematology and Transfusiology, 16 2-ya Sovetskaya ul., Saint Petersburg, Russian Federation, 191024 https://orcid.org/0000-0001-5958-0490 (unauthenticated)
E.V. Efremova Russian Research Institute of Hematology and Transfusiology, 16 2-ya Sovetskaya ul., Saint Petersburg, Russian Federation, 191024 https://orcid.org/0000-0002-2183-5299 (unauthenticated)
O.A. Shukhov National Research Center for Hematology, 4 Novyi Zykovskii pr-d, Moscow, Russian Federation, 125167 https://orcid.org/0000-0001-5393-0816 (unauthenticated)
Yu.D. Matvienko Pharm Holding, 64 Kirochnaya ul., Saint Petersburg, Russian Federation, 191015 https://orcid.org/0000-0002-3655-1707 (unauthenticated)
T.V. Chitanava Clinical Oncology Dispensary No. 1, 146 Dimitrova ul., Krasnodar, Russian Federation, 350040 https://orcid.org/0000-0002-9390-9154 (unauthenticated)
N.T. Siordiya VA Almazov National Medical Research Center, 2 Akkuratova ul., Saint Petersburg, Russian Federation, 197341 https://orcid.org/0000-0001-7081-4999 (unauthenticated)
N.S. Lazorko VA Almazov National Medical Research Center, 2 Akkuratova ul., Saint Petersburg, Russian Federation, 197341 https://orcid.org/0000-0002-7199-3252 (unauthenticated)
E.I. Sbityakova VA Almazov National Medical Research Center, 2 Akkuratova ul., Saint Petersburg, Russian Federation, 197341 https://orcid.org/0009-0007-9943-4093 (unauthenticated)
E.N. Tochenaya VA Almazov National Medical Research Center, 2 Akkuratova ul., Saint Petersburg, Russian Federation, 197341 https://orcid.org/0009-0000-6256-7561 (unauthenticated)
Ju.A. Alekseeva VA Almazov National Medical Research Center, 2 Akkuratova ul., Saint Petersburg, Russian Federation, 197341 https://orcid.org/0000-0003-4453-5616 (unauthenticated)
E.S. Mileeva Russian Research Institute of Hematology and Transfusiology, 16 2-ya Sovetskaya ul., Saint Petersburg, Russian Federation, 191024 https://orcid.org/0009-0003-6709-6019 (unauthenticated)
A.A. Pirkhalo Russian Research Institute of Hematology and Transfusiology, 16 2-ya Sovetskaya ul., Saint Petersburg, Russian Federation, 191024 https://orcid.org/0009-0003-3646-5184 (unauthenticated)
N.N. Nemstsveridze Russian Research Institute of Hematology and Transfusiology, 16 2-ya Sovetskaya ul., Saint Petersburg, Russian Federation, 191024 https://orcid.org/0000-0002-3114-5902 (unauthenticated)
N.A. Shnalieva VA Almazov National Medical Research Center, 2 Akkuratova ul., Saint Petersburg, Russian Federation, 197341 https://orcid.org/0000-0003-2876-0434 (unauthenticated)
L.O. Khordzhasov Moscow City Clinical Hospital No. 52, 3 Pekhotnaya ul., Moscow, Russian Federation, 123182 https://orcid.org/0009-0006-9008-0463 (unauthenticated)
N.S. Kazanskaia First Republican Clinical Hospital, 57 Votkinskoe sh., Izhevsk, Udmurt Republic, Russian Federation, 426039 https://orcid.org/0009-0009-4356-8433 (unauthenticated)
V.A. Shuvaev AF Tsyb Medical Radiological Research Center, branch of the NMRC of Radiology, 4 Koroleva ul., Obninsk, Kaluga Region, Russian Federation, 249036 ; Russian Medical Academy of Postgraduate Education, 2/1 Barrikadnaya ul., Moscow, Russian Federation, 125993 https://orcid.org/0000-0003-3536-0770 (unauthenticated)
A.G. Turkina National Research Center for Hematology, 4 Novyi Zykovskii pr-d, Moscow, Russian Federation, 125167 ; IM Sechenov First Moscow State Medical University, 8 korp. 2 Trubetskaya ul., Moscow, Russian Federation, 119048 https://orcid.org/0000-0001-9947-2371 (unauthenticated)
Е.G. Lomaia VA Almazov National Medical Research Center, 2 Akkuratova ul., Saint Petersburg, Russian Federation, 197341 https://orcid.org/0000-0003-3290-7961 (unauthenticated)

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chronic myeloid leukemia, chronic phase, ponatinib, molecular response, survival

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Kulemina O.V., Chelysheva E.Y., Voloshin S.V., et al. Ponatinib Efficacy in Chronic Phase Chronic Myeloid Leukemia: Data from Three Centers in the Russian Federation. Clinical Oncohematology. Basic Research and Clinical Practice. 2026;19(4):419–433. doi:10.21320/2500-2139-2026-19-4-419-433.

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T.I. Ionova, E.A. Andreevskaya, E.N. Babich, N.B. Bulieva, O.Yu. Vinogradova, E.M. Volodicheva, S.V. Voloshin, N.N. Glonina, S.K. Dubov, N.B. Esef’eva, A.Yu. Zaritskey, E.E. Zinina, M.O. Ivanova, T.Yu. Klitochenko, A.V. Kopylova, A.D. Kulagin, G.B. Kuchma, O.Yu. Li, E.G. Lomaia, A.L. Melikyan, V.Ya. Melnichenko, S.N. Menshakova, N.V. Minaeva, T.A. Mitina, E.V. Morozova, Tatyana Pavlovna Nikitina, O.E. Ochirova, A.S. Polyakov, T.I. Pospelova, A.V. Proidakov, O.A. Rukavitsyn, G.Sh. Safuanova, I.N. Subortseva, M.S. Fominykh, M.V. Frolova, T.V. Shelekhova, D.G. Sherstnev, T.V. Shneider, V.A. Shuvaev, Z.K. Abdulkhalikova, L.V. Anchukova, I.A. Apanaskevich, A.N. Arnautova, M.V. Barabanshchikova, N.V. Berlina, A.P. Bityukov, E.A. Gilyazitdinova, V.I. Gilmanshina, E.K. Egorova, E.V. Efremova, E.B. Zhalsanova, E.N. Kabanova, O.B. Kalashnikova, A.E. Kersilova, T.I. Kolosheinova, P.M. Kondratovskii, E.V. Koroleva, A.N. Kotelnikova, N.A. Lazareva, N.S. Lazorko, E.V. Lyyurova, A.S. Lyamkina, Yu.N. Maslova, E.S. Mileeva, N.E. Mochkin, E.K. Nekhai, Ya.A. Noskov, E.S. Osipova, M.M. Pankrashkina, E.V. Potanina, O.D. Rudenko, T.Yu. Rozhenkova, E.I. Sbityakova, N.T. Siordiya, A.V. Talko, E.I. Usacheva, Yu.B. Chernykh, T.V. Chitanava, K.S. Shashkina, D.I. Shikhbabaeva, K.S. Yurovskaya, Current Quality-of-Life Aspects in Patients with Classical Ph-Negative Myeloproliferative Neoplasms in the Russian Federation: Results and Discussion of the National Observational Program MPN-QoL-2020 , Clinical Oncohematology. Basic Research and Clinical Practice: Vol. 15 No. 2 (2022)
T.V. Shelekhova, J. Kumar, S.J. Apte, Iu.S. Osipov, E.N. Misyurina, V.A. Doronin, T.S. Konstantinova, B.A. Bakirov, A.V. Proidakov, A.L. Uss, M. Kumar, E.V. Martynova, N.G. Chernova, M.A. Khokhar, A.D. Garifullin, C.R. Ross, S.L. Cyriac, S.V. Voloshin, M.A. Ulyanova, N.A. Falaleeva, N.A. Katin, D.V. Kirtbaya, M.O. Kiseleva, E.Yu. Komarceva, A.A. Myasnikov, D.K. Novik, M. Shabbir-Moosajee, S.V. Samarina, V.V. Denisova, G.N. Khusainova, T.K. Dolai, B. Bagchi, I.S. Zyuzgin, I.S. Moiseev, T.I. Pospelova, A.A. Semenova, M.A. Novikova, I.L. Davydkin, M.V. Kosinova, A.M. Pavlova, N. Sidharthan, H. Mukhopadhyay, A. Wahid, Q.M. Buttar, Yu.N. Linkova, A.V. Zinkina-Orikhan, Svyatoslav Vladimirovich Nechaev, A.S. Shadrina, A.A. Lutckii, D.O. Liaptseva, Results of a Double-Blind Prospective Comparative Randomized Phase 3 Clinical Trial of the Efficacy and Safety of BCD-264 and Darzalex as Monotherapy for Relapsed/Refractory Multiple Myeloma (BCD-264-2/DARVIVA) , Clinical Oncohematology. Basic Research and Clinical Practice: Vol. 19 No. 2 (2026)
Liudmila Valerevna Fedorova, N.B. Mikhailova, K.V. Lepik, A.M. Chekalov, O.G. Smykova, V.V. Markelov, G.S. Tumyan, A.A. Semenova, A.V. Arakelyan, L.S. Butaev, Iu.A. Oleinik, V.V. Ptushkin, Ya.K. Mangasarova, A.U. Magomedova, E.S. Gitelzon, N.G. Gabeeva, D.A. Koroleva, A.K. Smolianinova, E.E. Zvonkov, Iu.S. Osipov, N.V. Stepanova, T.V. Krinitsina, Yu.I. Podmankova, G.N. Khusainova, L.F. Mukharlyamova, O.R. Smirnova, I.V. Ishmatova, A.A. Zverkova, S.S. Elkhova, S.A. Volchenkov, I.S. Zyuzgin, D.D. Ivanova, E.A. Baryakh, E.N. Misyurina, P.A. Zeinalova, F.M. Abbasbeyli, O.L. Timofeeva, Yu.E. Ryabukhina, M.A. Ulyanova, V.V. Basmanova, T.N. Tsyganok, V.Yu. Kimaikina, S.V. Samarina, E.V. Zubkova, S.V. Ovanesyan, A.I. Iskhakova, A.Yu. Kuvshinov, A.A. Kuzyaeva, G.K. Isaeva, M.I. Andrievskikh, O.Yu. Arzhanukhina, T.V. Shelekhova, I.V. Morozova, P.V. Makarovskaya, O.S. Samoilova, I.V. Vasileva, A.Yu. Terekhova, N.A. Falaleeva, V.A. Shuvaev, S.V. Vlasova, V.A. Lapin, V.I. Bakhtina, A.D. Kulagin, Efficacy and Safety of Glofitamab Therapy in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A United Russian Experience Based on the Compassionate Use Program , Clinical Oncohematology. Basic Research and Clinical Practice: Vol. 19 No. 2 (2026)
A.G. Turkina, O. Yu. Vinogradova, E.G. Lomaia, B.A. Bakirov, N.M. Kalimulina, T.V. Shelekhova, I.L. Davydkin, T.I. Pospelova, O.A. Shukhov, E.Yu. Chelysheva, V.A. Shuvaev, S. Lavana, V. Khushoo, S. Apte, T.K. Dolai, R.K. Sahoo, Germes Grigorevich Chilov, Phase 3 Clinical Trial of 300 mg Vamotinib Directly Compared with High-Dose Imatinib in Chronic Myeloid Leukemia Patients in Chronic Phase with Failure of Standard-Dose Imatinib: Interim Analysis , Clinical Oncohematology. Basic Research and Clinical Practice: Vol. 19 No. 1 (2026)
A.G. Turkina, Elena Andreevna Kuzmina, E.G. Lomaia, E.V. Morozova, E.Yu. Chelysheva, O.A. Shukhov, A.N. Petrova, T.V. Chitanava, Yu.Yu. Vlasova, I.S. Nemchenko, A.V. Bykova, E.I. Sbityakova, M.A. Gurianova, N.N. Tsyba, A.V. Kokhno, E.N. Parovichnikova, Asciminib in Chronic Myeloid Leukemia Patients Without Therapeutic Alternatives: Results of the MAP (Managed Access Program, NCT04360005) Trial in Russia , Clinical Oncohematology. Basic Research and Clinical Practice: Vol. 16 No. 1 (2023)
T.I. Ionova, A.D. Kulagin, E.A. Lukina, V.V. Ptushkin, E.G. Arshanskaya, T.N. Babaeva, B.A. Bakirov, S.V. Voloshin, G.P. Dimov, O.U. Klimova, E.Yu. Komarceva, O.L. Panteleeva, R.V. Ponomarev, T.I. Pospelova, S.V. Samarina, N.O. Saraeva, K.O. Farizova, M.N. Finyakina, A.A. Shutylev, D.A. Lipatova, N.M. Porfirieva, Tatyana Pavlovna Nikitina, Sociomedical Profile and Quality of Life of Paroxysmal Nocturnal Hemoglobinuria Patients with Suboptimal Response to Pathogenetic Therapy , Clinical Oncohematology. Basic Research and Clinical Practice: Vol. 18 No. 3 (2025)
A.L. Melikyan, A.G. Turkina, Irina Nikolaevna Subortseva, E.Yu. Chelysheva, A.M. Kovrigina, V.A. Shuvaev, V.V. Baikov, O.Yu. Vinogradova, S.M. Kulikov, A.N. Petrova, A.V. Bykova, A.-P.A. Poshivai, Yu.Yu. Vlasova, M.M. Chukavina, O.D. Serdyuk, K.V. Naumova, N.T. Siordiya, N.S. Lazorko, R.V. Grozov, E.I. Mullo, A.S. Maksimova, O.M. Senderova, O.V. Kanya, M.S. Fominykh, D.I. Shikhbabaeva, E.A. Belyakova, I.S. Martynkevich, L.B. Polushkina, M.N. Zenina, E.V. Efremova, V.I. Rugal, L.P. Papayan, N.E. Korsakova, O.Yu. Matvienko, E.B. Syrtseva, S.V. Gappoev, M.V. Barabanshchikova, M.O. Ivanova, K.D. Kaplanov, E.S. Rogova, K.B. Trizna, A.S. Zhevnyak, O.E. Ochirova, A.A. Shakhaeva, A.S. Lyamkina, I.P. Mikhno, Yu.B. Chernykh, T.V. Chudanova, I.N. Kontievskii, N.N. Glonina, M.V. Burundukova, Materials of the II Conference “Current Issues of Diagnosis and Treatment of Ph-Negative and Ph-Positive Myeloproliferative Neoplasms” (March 15–16, 2019; National Research Center for Hematology, Moscow) , Clinical Oncohematology. Basic Research and Clinical Practice: Vol. 13 No. 2 (2020)
D.V. Motorin, L.L. Girshova, E.G. Lomaia, Yu.A. Alekseeva, A.V. Petukhov, V.V. Ivanov, E.K. Antonov, S.V. Efremova, A.I. Reshetova, E.N. Tochenaya, Aleksina Alekseevna Shatilova, E.N. Tochenaya, A.V. Petrov, T.S. Nikulina, K.V. Bogdanov, D.V. Ryzhkova, Yu.V. Mirolyubova, I.E. Prokop’ev, I.G. Budaeva, Gilteritinib as a New Option for the Treatment of Relapsed/Refractory Acute Myeloid Leukemias with FLT3 Gene Mutation: A Literature Review and Three Case Reports , Clinical Oncohematology. Basic Research and Clinical Practice: Vol. 16 No. 1 (2023)