Interim results analysis of the PERFECTION observational study in patients with metastatic non-small cell lung cancer

Konstantin K. Laktionov; Лактионов Константин Константинович; Mikhail Fedyanin; Федянин Михаил Юрьевич; Daniil L. Stroyakovskiy; Cтрояковский Даниил Львович; Anastasiia S. Mochalova; Мочалова Анастасия Сергеевна; Aishat R. Iasieva; Ясиева Айшат Расуловна; Natal'ia V. Fadeeva; Фадеева Наталья Владимировна; Iuliia S. Shapovalova; Шаповалова Юлия Сергеевна; Oleg V. Mironov; Миронов Олег Вячеславович; Aleksandr S. Dergunov; Дергунов Александр Сергеевич; Sergey V. Orlov; Орлов Сергей Владимирович; Leonid A. Vasilev; Васильев Леонид Анатольевич; El'vira A. Bobrova; Боброва Эльвира Анатольевна; Svetlana A. Orlova; Орлова Светлана Александровна; Antonina A. Kosukhina; Косухина Антонина Анатольевна; Natal'ia I. Polshina; Польшина Наталья Ивановна; Sergei G. Vardanian; Варданян Сергей Гаспарович; Aleksei Iu. Fedoseev; Федосеев Алексей Юрьевич; Karina Sh. Tumasian; Тумасян Карина Шотаевна; Anastasiia E. Danilova; Данилова Анастасия Евгеньевна; Tatiana V. Krashikhina; Крашихина Татьяна Валерьевна; Ekaterina I. Tsygankova; Цыганкова Екатерина Ивановна; Dmitrii E. Staritsyn; Старицын Дмитрий Евгеньевич; Ol'ga V. Toporkova; Топоркова Ольга Владимировна; Mira V. Boskhomdzhieva; Босхомджиева Мира Владимировна; Alexander V. Sultanbaev; Султанбаев Александр Валерьевич; Margarita V. Edamenko; Едаменко Маргарита Владимировна; Vadim N. Dmitriev; Дмитриев Вадим Николаевич; Aleksandr V. Shkradiuk; Шкрадюк Александр Викторович; Konstantin A. Shkret; Шкрет Константин Александрович; Oxana N. Prosianikova; Просяникова Оксана Николаевна; Evgeny V. Svechnikov; Свечников Евгений Вячеславович; Semyon Yu. Grigorchuk; Григорчук Семен Юрьевич

doi:10.26442/18151434.2024.4.203109

Interim results analysis of the PERFECTION observational study in patients with metastatic non-small cell lung cancer

Authors: Laktionov K.K.¹^,2, Fedyanin M.¹^,3^,4, Stroyakovskiy D.L.⁵, Mochalova A.S.⁶, Iasieva A.R.⁷, Fadeeva N.V.⁸, Shapovalova I.S.⁹, Mironov O.V.¹⁰, Dergunov A.S.¹¹, Orlov S.V.¹², Vasilev L.A.¹³^,14, Bobrova E.A.¹⁵, Orlova S.A.¹⁶, Kosukhina A.A.¹⁷, Polshina N.I.¹⁵, Vardanian S.G.⁴, Fedoseev A.I.⁴, Tumasian K.S.¹⁷, Danilova A.E.¹⁸, Krashikhina T.V.¹⁹, Tsygankova E.I.²⁰, Staritsyn D.E.²¹, Toporkova O.V.¹⁰, Boskhomdzhieva M.V.²², Sultanbaev A.V.²³^,24, Edamenko M.V.¹⁷, Dmitriev V.N.¹⁷, Shkradiuk A.V.²⁵, Shkret K.A.²⁶, Prosianikova O.N.²⁷, Svechnikov E.V.²⁷, Grigorchuk S.Y.²⁷
Affiliations:
1. Blokhin National Medical Research Center of Oncology
2. Pirogov Russian National Research Medical University (Pirogov University)
3. Pirogov National Medical and Surgical Center
4. Moscow Multidisciplinary Clinical Center „Kommunarka“
5. Moscow City Oncology Hospital No. 62
6. Medsi group JSC
7. Moscow City Hospital named after S.S. Yudin, Moscow Healthcare Department
8. Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
9. Clinical Hospital “RZD-Medicine” of Chelyabinsk
10. Tambov Regional Oncologic Clinical Dispensary
11. Tver Regional Clinical Oncologic Dispensary
12. Pavlov First Saint Petersburg State Medical University
13. Current Medical Technologies JSC
14. Institute of Modern Medical Technologies
15. Loginov Moscow Clinical Scientific Center
16. Republican Clinical Oncologic Dispensary
17. Belgorod Regional Oncologic Dispensary
18. City Polyclinic No. 106
19. Moscow Center for Rehabilitation Treatment LLC
20. Sergiev Posad Hospital No. 2
21. Severodvinsk City Clinical Hospital No. 2 of Emergency Medical Care
22. Timoshkaeva Republican Oncologic Dispensary
23. Republican Clinical Oncology Dispensary
24. Bashkir State Medical University
25. Efetov Crimean Republican Oncologic Clinical Dispensary
26. Central City Clinical Hospital No. 24
27. BIOCAD JSC
Issue: Vol 26, No 4 (2024)
Pages: 454-466
Section: Articles
URL: https://bakhtiniada.ru/1815-1434/article/view/280727
DOI: https://doi.org/10.26442/18151434.2024.4.203109
ID: 280727

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Abstract

Aim. To evaluate the efficacy and safety profile of the pembrolizumab biosimilar, Pembroria, in patients with advanced lung cancer in routine clinical practice.

Materials and methods. The patients eligible for pembrolizumab therapy based on standard clinical indications and without contraindications participated in the multicenter, multicohort, post-marketing, prospective, non-interventional study. The primary endpoint was the best objective response rate (ORR) assessed within six months of treatment initiation. This report presents interim analysis for patients with non-squamous non-small cell lung cancer (nsNSCLC) and squamous non-small cell lung cancer (sNSCLC) using Fleming’s two-stage single-arm design (stages g1 and g2). Thresholds for hypothesis testing and sample size determination were based on established literature benchmarks.

Results

Non-squamous NSCLC. Stage g1 enrolled 20 patients with a median age of 64 years. The follow-up period for assessing the best objective response was 2.57 months. An objective response was achieved in 55% (11/20) of patients, meeting predefined efficacy criteria at stage g1.

Squamous NSCLC. Stage g1 included 23 patients and based on the results of stage g1, the study proceeded to stage g2 with the enrollment of an additional 23 patients in stage g2, yielding a total of 46 participants with a median age of 66 years. An ORR of 47.8% (22/46) was observed, confirming efficacy of the pembrolisumab biosimilar at stage g2. The median follow-up period to the objective response assessment was 2.88 months.

Across the six-month follow-up period, nine adverse events (AEs) were reported among seven patients (8.4%) in the NSCLC cohort. Four AEs were considered therapy-related and classified as Grade 2 per CTCAE v5.0. No AEs Grade 4/5 were recorded.

Conclusion. In the NSCLC cohort, the pembrolizumab biosimilar (Pembroria) has demonstrated an ORR comparable to that of the reference pembrolizumab reported in clinical trials for both nsNSCLC and sNSCLC, regardless of PD-L1 expression levels or pembrolizumab treatment regimens. These findings support the real-world efficacy and safety of Pembroria in a diverse patient population.

Keywords

immunotherapy, lung cancer, pembrolizumab, non-small cell lung cancer

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About the authors

Konstantin K. Laktionov

Blokhin National Medical Research Center of Oncology; Pirogov Russian National Research Medical University (Pirogov University)

Author for correspondence.
Email: lkoskos@mail.ru
ORCID iD: 0000-0003-4469-502X

D. Sci. (Med.), Prof.

Russian Federation, Moscow; Moscow

Mikhail Fedyanin

Blokhin National Medical Research Center of Oncology; Pirogov National Medical and Surgical Center; Moscow Multidisciplinary Clinical Center „Kommunarka“

Email: lkoskos@mail.ru
ORCID iD: 0000-0001-5615-7806
SPIN-code: 4381-5628

D. Sci. (Med.)

Russian Federation, Moscow; Moscow; Moscow