电邮这篇文章 Safety of Pembroria® during non-medical switching from Keytruda® in patients with advanced malignant neoplasms of various localizations: the REFLECTION real-world study
- 作者: Choynzonov E.1,2, Fedenko A.3, Falaleeva N.4, Andreeva T.5, Afanas'ev S.1, Bakaev Z.6, Valiev D.7, Volkov A.8, Kolomiets L.1, Krashikhina T.9, Miller S.1, Mikhaliuk V.10, Ogloblin A.11, Orlova S.12, Pataliak S.1, Pokataev I.13, Popova N.1, Rebrina O.5, Safin R.14, Stradaeva I.15, Trefilova I.16, Usol'tseva I.17, Usynin E.1, Sharov S.18, Iukal'chuk D.19, Iasieva A.13
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隶属关系:
- Cancer Research Institute – branch of the Tomsk National Research Medical Center of the Russian Academy of Sciences
- Siberian State Medical University
- Hertsen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Centre
- Tsyb Medical Radiological Research Center – branch of the National Medical Research Radiological Centre
- Smolensk Regional Oncologic Clinical Dispensary
- Khimki Hospital
- City Clinical Hospital No. 8
- PET Technology Center LLC
- Moscow Center for Restorative Treatment LLC
- Nizhnevartovsk Oncologic Dispensary
- Oryol Oncological Dispensary
- Republican Clinical Oncologic Dispensary
- Yudin Moscow City Hospital
- Sigal Republican Clinical Oncological Dispensary
- PET-Technology LLC
- Perm Krai Clinical Hospital
- Sakhalin Regional Oncologic Dispensary
- Clinical Oncologic Dispensary No. 1
- Regional Oncologic Dispensary
- 期: 卷 26, 编号 2 (2024)
- 页面: 173-181
- 栏目: Articles
- URL: https://journals.rcsi.science/1815-1434/article/view/260599
- DOI: https://doi.org/10.26442/18151434.2024.2.202744
- ID: 260599
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Background. Post-registration observational studies with switching therapy from the original drug to a biosimilar for non-medical indications allow us to assess the safety and effectiveness of this type of switching in real clinical practice.
Aim. Evaluation of the safety and effectiveness of non-medical switching from the original drug Keytruda® to the biosimilar drug Pembroria® in patients with various oncological pathologies in real clinical practice (REFLECTION).
Materials and methods. A retrospective analysis of data from electronic medical records from 21 medical institutions of the Russian Federation for the period 2020–2023 was carried out. Data were included from patients with cancer of various locations who received at least 2 injections of Keytruda® followed by switching to Pembroria® for non-medical indications (at least 2 injections). Primary criteria: incidence of immune-mediated adverse reactions (ImARs) of any severity. Secondary indicators: incidence of ImARs of various degrees of severity and infusion reactions, frequency of objective response rate (according to RECIST 1.1 criteria).
Results. The analysis included data from 382 patients (male/female 200/182, median age 62 years) with NSCLC (24.1%), RCC (23.3%), melanoma (20.4%) and cancer of other localization. Patients received Keytruda® on 1st and 2nd lines (54.2 and 25.4% of patients, respectively), on 3 or 4 lines (14.1%), or as part of adjuvant therapy (6.3%). 50.5% of patients received pembrolizumab as monotherapy. The median number of administrations was 7.0 and 5.0 for Keytruda® and Pembroria®, respectively. ImARs were registered in 44 (11.5%) patients (60 ImARs), including 40 ImARs in 35 (9.2%) patients while using Keytruda® and 20 ImARs in 17 (2.4%) patients with Pembroria®. The most common ImARs were hypothyroidism, hyperthyroidism, and hepatitis; the frequency of these ImARs was higher with Keytruda® (EAER for hypothyroidism 0.00422 and 0.00144, for hepatitis – 0.00124 and 0.00096, respectively). All 5 reported cases of hyperthyroidism in patients on Keytruda® (EAER 0.00124), were resolved before switching to Pembroria®. No infusion-related reactions or deaths due to ImARs have been reported. The objective response rate was comparable – 104 (32.6%) and 90 (29.2%) patients оn Keytruda® and Pembroria® therapy, respectively. Most patients maintained disease control after switching to Pembroria® [progression was recorded in 29 (9.4%) patients after switching to a biosimilar].
Conclusion. The safety profiles of Keytruda® and Pembroria® were satisfactory and comparable in this study. Switching from therapy with Keytruda® to Pembroria® is not accompanied by an increase in the frequency or severity of ImARs. Switching from Keytruda® to Pembroria® maintains disease control in most patients.
作者简介
Evgeny Choynzonov
Cancer Research Institute – branch of the Tomsk National Research Medical Center of the Russian Academy of Sciences; Siberian State Medical University
编辑信件的主要联系方式.
Email: center@tnimc.ru
ORCID iD: 0000-0002-3651-0665
D. Sci. (Med.), Prof., Acad. RAS
俄罗斯联邦, Tomsk; TomskAlexander Fedenko
Hertsen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Centre
Email: center@tnimc.ru
ORCID iD: 0000-0003-4927-5585
D. Sci. (Med.), Prof.
俄罗斯联邦, MoscowNatalia Falaleeva
Tsyb Medical Radiological Research Center – branch of the National Medical Research Radiological Centre
Email: center@tnimc.ru
ORCID iD: 0000-0002-0023-4216
D. Sci. (Med.)
俄罗斯联邦, ObninskTatiana Andreeva
Smolensk Regional Oncologic Clinical Dispensary
Email: center@tnimc.ru
Department Head
俄罗斯联邦, SmolenskSergei Afanas'ev
Cancer Research Institute – branch of the Tomsk National Research Medical Center of the Russian Academy of Sciences
Email: center@tnimc.ru
D. Sci. (Med.), Prof.
俄罗斯联邦, TomskZelimkhan Bakaev
Khimki Hospital
Email: center@tnimc.ru
Department Head
俄罗斯联邦, KhimkiDanila Valiev
City Clinical Hospital No. 8
Email: center@tnimc.ru
Department Head
俄罗斯联邦, ChelyabinskAleksandr Volkov
PET Technology Center LLC
Email: center@tnimc.ru
Chief doctor
俄罗斯联邦, UfaLarisa Kolomiets
Cancer Research Institute – branch of the Tomsk National Research Medical Center of the Russian Academy of Sciences
Email: center@tnimc.ru
D. Sci. (Med.), Prof.
俄罗斯联邦, TomskTatiana Krashikhina
Moscow Center for Restorative Treatment LLC
Email: center@tnimc.ru
Cand. Sci. (Med.)
俄罗斯联邦, KhimkiSergei Miller
Cancer Research Institute – branch of the Tomsk National Research Medical Center of the Russian Academy of Sciences
Email: center@tnimc.ru
D. Sci. (Med.)
俄罗斯联邦, TomskViktoriia Mikhaliuk
Nizhnevartovsk Oncologic Dispensary
Email: center@tnimc.ru
Department Head
俄罗斯联邦, NizhnevartovskAndrei Ogloblin
Oryol Oncological Dispensary
Email: center@tnimc.ru
Department Head
俄罗斯联邦, OryolSvetlana Orlova
Republican Clinical Oncologic Dispensary
Email: center@tnimc.ru
Department Head
俄罗斯联邦, CheboksaryStanislav Pataliak
Cancer Research Institute – branch of the Tomsk National Research Medical Center of the Russian Academy of Sciences
Email: center@tnimc.ru
Cand. Sci. (Med.)
俄罗斯联邦, TomskIlya Pokataev
Yudin Moscow City Hospital
Email: center@tnimc.ru
ORCID iD: 0000-0001-9864-3837
D. Sci. (Med.)
俄罗斯联邦, MoscowNataliia Popova
Cancer Research Institute – branch of the Tomsk National Research Medical Center of the Russian Academy of Sciences
Email: center@tnimc.ru
Cand. Sci. (Med.)
俄罗斯联邦, TomskOlesia Rebrina
Smolensk Regional Oncologic Clinical Dispensary
Email: center@tnimc.ru
oncologist
俄罗斯联邦, SmolenskRustem Safin
Sigal Republican Clinical Oncological Dispensary
Email: center@tnimc.ru
Department Head
俄罗斯联邦, KazanIrina Stradaeva
PET-Technology LLC
Email: center@tnimc.ru
Department Head
俄罗斯联邦, BalashikhaIuliia Trefilova
Perm Krai Clinical Hospital
Email: center@tnimc.ru
Department Head
俄罗斯联邦, PermInessa Usol'tseva
Sakhalin Regional Oncologic Dispensary
Email: center@tnimc.ru
Department Head
俄罗斯联邦, Yuzhno-SakhalinskEvgenii Usynin
Cancer Research Institute – branch of the Tomsk National Research Medical Center of the Russian Academy of Sciences
Email: center@tnimc.ru
D. Sci. (Med.)
俄罗斯联邦, TomskSergey Sharov
Clinical Oncologic Dispensary No. 1
Email: center@tnimc.ru
ORCID iD: 0000-0002-8715-2992
Cand. Sci. (Med.)
俄罗斯联邦, KrasnodarDenis Iukal'chuk
Regional Oncologic Dispensary
Email: center@tnimc.ru
Department Head
俄罗斯联邦, IrkutskAishat Iasieva
Yudin Moscow City Hospital
Email: center@tnimc.ru
oncologist
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