Long-term results of a randomized controlled trial of biosimilar CT-P16 and reference bevacizumab in patients with metastatic or recurrent non-small cell lung cancer
Purpose: Data from the CT-P16 3.1 study demonstrated equivalent efficacy between CT-P16, a bevacizumab biosimilar, and European-approved reference bevacizumab (EU-bevacizumab) for the primary endpoint of objective response rate (ORR) during induction treatment in patients with metastatic or recurren...
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Elsevier
2025-01-01
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| Series: | Cancer Treatment and Research Communications |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2468294225001066 |
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| author | Zoran Andric Fedor Moiseenko Tamta Makharadze Alona Oleksiienko Eduardo Yañez Ruiz SungHyun Kim KeumYoung Ahn TaeHong Park Hana Ju Eric Hyungseok Baek Soonbum Kwon IlSung Chang SinHye Kim HyunAh Kim EunKyung Lee Claire Verschraegen |
| author_facet | Zoran Andric Fedor Moiseenko Tamta Makharadze Alona Oleksiienko Eduardo Yañez Ruiz SungHyun Kim KeumYoung Ahn TaeHong Park Hana Ju Eric Hyungseok Baek Soonbum Kwon IlSung Chang SinHye Kim HyunAh Kim EunKyung Lee Claire Verschraegen |
| author_sort | Zoran Andric |
| collection | DOAJ |
| description | Purpose: Data from the CT-P16 3.1 study demonstrated equivalent efficacy between CT-P16, a bevacizumab biosimilar, and European-approved reference bevacizumab (EU-bevacizumab) for the primary endpoint of objective response rate (ORR) during induction treatment in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). We now present long-term findings. Methods: In this randomized, double-blind, multicenter phase 3 study, patients with metastatic or recurrent non-squamous NSCLC received CT-P16 or EU-bevacizumab (15 mg/kg every 3 weeks; ≤6 cycles) together with paclitaxel (200 mg/m2) and carboplatin (area under the curve 6.0) for 4–6 cycles during the induction period. Patients with controlled disease entered the maintenance period, continuing with CT-P16 or EU-bevacizumab as monotherapy until disease progression/intolerable toxicity. They were then followed up every 9 weeks until death or end of study. Outcomes were evaluated ≤3 years after the last patient enrollment. Results: Of 689 patients receiving CT-P16 (N = 342) or EU-bevacizumab (N = 347), 499 (72.4 %) completed the induction period (CT-P16, n = 258 [75.4 %]; EU-bevacizumab, n = 241 [69.5 %]), 466 (67.6 %) initiated the maintenance period (CT-P16, n = 239 [69.9 %]; EU-bevacizumab, n = 227 [65.4 %]), and 389 (56.5 %) entered follow-up (CT-P16, n = 190 [55.6 %]; EU-bevacizumab, n = 199 [57.3 %]). Whole study ORRs were similar for CT-P16 (45.61 % [95 % confidence interval 40.34–50.89]) and EU-bevacizumab (46.11 % [95 % confidence interval 40.86–51.35]). Response duration, time to progression, progression-free survival, and overall survival were similar. No new safety signals were detected. Conclusions: Long-term results of the CT-P16 3.1 study confirm equivalent efficacy of CT-P16 and EU-bevacizumab in patients with metastatic or recurrent non-squamous NSCLC. Trial registration number: NCT03676192. Micro abstract: Equivalent efficacy between CT-P16, a bevacizumab biosimilar, and European-approved reference bevacizumab (EU-bevacizumab) was demonstrated in a phase 3 study of patients with metastatic or recurrent non-squamous NSCLC. Long-term findings in 689 patients confirmed equivalent efficacy of CT-P16 and EU-bevacizumab; objective response rates were 45.6 % and 46.1 %, respectively. Response duration, time to progression, progression-free survival, and overall survival were also similar. |
| format | Article |
| id | doaj-art-bd7b32f5aec0422b92f9ce0c07abd621 |
| institution | DOAJ |
| issn | 2468-2942 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Cancer Treatment and Research Communications |
| spelling | doaj-art-bd7b32f5aec0422b92f9ce0c07abd6212025-08-20T03:02:59ZengElsevierCancer Treatment and Research Communications2468-29422025-01-014410097010.1016/j.ctarc.2025.100970Long-term results of a randomized controlled trial of biosimilar CT-P16 and reference bevacizumab in patients with metastatic or recurrent non-small cell lung cancerZoran Andric0Fedor Moiseenko1Tamta Makharadze2Alona Oleksiienko3Eduardo Yañez Ruiz4SungHyun Kim5KeumYoung Ahn6TaeHong Park7Hana Ju8Eric Hyungseok Baek9Soonbum Kwon10IlSung Chang11SinHye Kim12HyunAh Kim13EunKyung Lee14Claire Verschraegen15Clinical Hospital Center Bezanijska Kosa, Belgrade 11000, SerbiaGBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology) named after N.P. Napalkov – Hospital, Ulitsa Leningradskaya 68a Litera A, Poselok Pesochny, Saint Petersburg, Leningradskaya oblast 197758, Russian FederationLTD “High Technology Hospital Medcenter”, 118 Pushkini Street, Batumi 6000, GeorgiaTreatment and Diagnostic Center of LLC Specialized Clinic Prognosis Optima, 40a Vatslava Havela Boulevard, Kyiv 03126, UkraineDepartment of Internal Medicine Oncology Unit - Hematology, School of Medicine, Universidad de la Frontera, Hochstetter 298, Temuco 4800827, ChileCelltrion, Inc., 23 Academy-ro, Yeonsu-gu, Incheon 22014, Republic of KoreaCelltrion, Inc., 23 Academy-ro, Yeonsu-gu, Incheon 22014, Republic of KoreaCelltrion, Inc., 23 Academy-ro, Yeonsu-gu, Incheon 22014, Republic of KoreaCelltrion, Inc., 23 Academy-ro, Yeonsu-gu, Incheon 22014, Republic of KoreaCelltrion, Inc., 23 Academy-ro, Yeonsu-gu, Incheon 22014, Republic of KoreaCelltrion, Inc., 23 Academy-ro, Yeonsu-gu, Incheon 22014, Republic of KoreaCelltrion, Inc., 23 Academy-ro, Yeonsu-gu, Incheon 22014, Republic of KoreaCelltrion, Inc., 23 Academy-ro, Yeonsu-gu, Incheon 22014, Republic of KoreaCelltrion, Inc., 23 Academy-ro, Yeonsu-gu, Incheon 22014, Republic of KoreaCelltrion, Inc., 23 Academy-ro, Yeonsu-gu, Incheon 22014, Republic of KoreaThe Ohio State University Comprehensive Cancer Center, 1800 Cannon Road - Lincoln Tower 1300, Columbus, OH 43210, USA; Corresponding author at: The Ohio State University Comprehensive Cancer Center, 1800 Cannon Road - Lincoln Tower 1300, Columbus, Ohio 43210, USA.Purpose: Data from the CT-P16 3.1 study demonstrated equivalent efficacy between CT-P16, a bevacizumab biosimilar, and European-approved reference bevacizumab (EU-bevacizumab) for the primary endpoint of objective response rate (ORR) during induction treatment in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). We now present long-term findings. Methods: In this randomized, double-blind, multicenter phase 3 study, patients with metastatic or recurrent non-squamous NSCLC received CT-P16 or EU-bevacizumab (15 mg/kg every 3 weeks; ≤6 cycles) together with paclitaxel (200 mg/m2) and carboplatin (area under the curve 6.0) for 4–6 cycles during the induction period. Patients with controlled disease entered the maintenance period, continuing with CT-P16 or EU-bevacizumab as monotherapy until disease progression/intolerable toxicity. They were then followed up every 9 weeks until death or end of study. Outcomes were evaluated ≤3 years after the last patient enrollment. Results: Of 689 patients receiving CT-P16 (N = 342) or EU-bevacizumab (N = 347), 499 (72.4 %) completed the induction period (CT-P16, n = 258 [75.4 %]; EU-bevacizumab, n = 241 [69.5 %]), 466 (67.6 %) initiated the maintenance period (CT-P16, n = 239 [69.9 %]; EU-bevacizumab, n = 227 [65.4 %]), and 389 (56.5 %) entered follow-up (CT-P16, n = 190 [55.6 %]; EU-bevacizumab, n = 199 [57.3 %]). Whole study ORRs were similar for CT-P16 (45.61 % [95 % confidence interval 40.34–50.89]) and EU-bevacizumab (46.11 % [95 % confidence interval 40.86–51.35]). Response duration, time to progression, progression-free survival, and overall survival were similar. No new safety signals were detected. Conclusions: Long-term results of the CT-P16 3.1 study confirm equivalent efficacy of CT-P16 and EU-bevacizumab in patients with metastatic or recurrent non-squamous NSCLC. Trial registration number: NCT03676192. Micro abstract: Equivalent efficacy between CT-P16, a bevacizumab biosimilar, and European-approved reference bevacizumab (EU-bevacizumab) was demonstrated in a phase 3 study of patients with metastatic or recurrent non-squamous NSCLC. Long-term findings in 689 patients confirmed equivalent efficacy of CT-P16 and EU-bevacizumab; objective response rates were 45.6 % and 46.1 %, respectively. Response duration, time to progression, progression-free survival, and overall survival were also similar.http://www.sciencedirect.com/science/article/pii/S2468294225001066BevacizumabBiosimilarCT-P16NSCLCAnti-VEGF |
| spellingShingle | Zoran Andric Fedor Moiseenko Tamta Makharadze Alona Oleksiienko Eduardo Yañez Ruiz SungHyun Kim KeumYoung Ahn TaeHong Park Hana Ju Eric Hyungseok Baek Soonbum Kwon IlSung Chang SinHye Kim HyunAh Kim EunKyung Lee Claire Verschraegen Long-term results of a randomized controlled trial of biosimilar CT-P16 and reference bevacizumab in patients with metastatic or recurrent non-small cell lung cancer Cancer Treatment and Research Communications Bevacizumab Biosimilar CT-P16 NSCLC Anti-VEGF |
| title | Long-term results of a randomized controlled trial of biosimilar CT-P16 and reference bevacizumab in patients with metastatic or recurrent non-small cell lung cancer |
| title_full | Long-term results of a randomized controlled trial of biosimilar CT-P16 and reference bevacizumab in patients with metastatic or recurrent non-small cell lung cancer |
| title_fullStr | Long-term results of a randomized controlled trial of biosimilar CT-P16 and reference bevacizumab in patients with metastatic or recurrent non-small cell lung cancer |
| title_full_unstemmed | Long-term results of a randomized controlled trial of biosimilar CT-P16 and reference bevacizumab in patients with metastatic or recurrent non-small cell lung cancer |
| title_short | Long-term results of a randomized controlled trial of biosimilar CT-P16 and reference bevacizumab in patients with metastatic or recurrent non-small cell lung cancer |
| title_sort | long term results of a randomized controlled trial of biosimilar ct p16 and reference bevacizumab in patients with metastatic or recurrent non small cell lung cancer |
| topic | Bevacizumab Biosimilar CT-P16 NSCLC Anti-VEGF |
| url | http://www.sciencedirect.com/science/article/pii/S2468294225001066 |
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