Expert Opinion on Biological Therapy最新文献

Comparability of aflibercept biosimilar with reference aflibercept in diabetic macular edema: subgroup analysis of the pivotal Phase-III insight randomized clinical trial. 阿非利西普生物类似药与参考阿非利西普治疗糖尿病黄斑水肿的可比性：关键iii期洞察随机临床试验的亚组分析

IF 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2026-05-08 DOI: 10.1080/14712598.2026.2672422

Susan B Bressler, Piotr Oleksy, Daniel Virgil Alfaro, Rajendra S Apte, Abhijit Barve, Kristine Baumane, Katrin Beckmann, Rozsa Degi, Jan Ernest, Vishali Gupta, Motohiro Kamei, Genichiro Kishino, Katrin Lorenz, Dennis M Marcus, Debdipta Bose, Prasanna C Ganapathi, Subramanian Loganathan

{"title":"Comparability of aflibercept biosimilar with reference aflibercept in diabetic macular edema: subgroup analysis of the pivotal Phase-III insight randomized clinical trial.","authors":"Susan B Bressler, Piotr Oleksy, Daniel Virgil Alfaro, Rajendra S Apte, Abhijit Barve, Kristine Baumane, Katrin Beckmann, Rozsa Degi, Jan Ernest, Vishali Gupta, Motohiro Kamei, Genichiro Kishino, Katrin Lorenz, Dennis M Marcus, Debdipta Bose, Prasanna C Ganapathi, Subramanian Loganathan","doi":"10.1080/14712598.2026.2672422","DOIUrl":"https://doi.org/10.1080/14712598.2026.2672422","url":null,"abstract":"Background: Phase-III INSIGHT study subgroup analyses observed best corrected visual acuity (BCVA) and central subfield thickness (CST) outcomes at Week 8/52 in diabetic macular edema treated with aflibercept biosimilar (MYL-1701P/Yesafili™) or reference aflibercept (Eylea®).Research design and methods: Two mg (0.05 mL) MYL-1701P (N = 179) or reference aflibercept (N = 176) were given intravitreally every 4 weeks for 5 doses, followed by 8-weekly dosing through Week 48. Subgroups were stratified by baseline BCVA/baseline CST/age/gender/race/ethnicity/region/glycated hemoglobin (HbA1c)/anti-drug antibody status/anti-vascular endothelial growth factor therapy in fellow eye. Main outcome measures included mean change in BCVA/CST from baseline to Week 8/52 with 90% confidence interval (CI).Results: For MYL-1701P and reference aflibercept, participants with baseline BCVA score (73-55 letters) had an adjusted mean difference of 0.03 letters in BCVA (90%CI:-1.26,1.31) and 15.46 µm in CST (90%CI:-0.02,30.93) at 8 weeks and 0.81 letters in BCVA (90%CI:-0.58,2.2) and 6.41 µm in CST (90%CI:17.31,30.12) at 52 weeks. Subgroup categories with ≥45% participants, including CST (<400/≥400 µm) and HbA1c (<8%>8%) had an adjusted mean difference within -3 to 3 letters (90%CI) in BCVA both at 8 and 52 weeks.Conclusions: The exploratory subgroup analyses supported clinical equivalence between MYL-1701P and reference aflibercept showing clinically comparable changes in BCVA/CST across most subgroups.Trial registration: ClinicalTrials.gov identifier is NCT03610646.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147856185","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Immunomodulator therapies in pandemics: lessons from COVID-19 and a blueprint for future outbreaks. 大流行病中的免疫调节疗法：2019冠状病毒病的教训和未来疫情的蓝图。

IF 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2026-05-05 DOI: 10.1080/14712598.2026.2663829

Matthew W McCarthy

引用次数: 0

An evaluation of telisotuzumab vedotin for the treatment of non-squamous non-small cell lung cancer. 替利妥珠单抗韦多汀治疗非鳞状非小细胞肺癌的评价。

IF 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2026-05-04 DOI: 10.1080/14712598.2026.2667333

Irfan Cicin

{"title":"An evaluation of telisotuzumab vedotin for the treatment of non-squamous non-small cell lung cancer.","authors":"Irfan Cicin","doi":"10.1080/14712598.2026.2667333","DOIUrl":"10.1080/14712598.2026.2667333","url":null,"abstract":"Introduction: Advanced non-squamous non-small cell lung cancer (NSCLC) remains associated with substantial mortality despite major advances in targeted therapy and immuno-oncology. c-Met protein overexpression represents a biologically relevant and relatively prevalent phenotype that may define a therapeutically vulnerable population lacking canonical genomic drivers.Areas covered: This review examines the scientific rationale for targeting c-Met protein overexpression and critically evaluates telisotuzumab vedotin (Teliso-V), a c-Met-directed antibody-drug conjugate (ADC) delivering the cytotoxic microtubule polymerization inhibitor MMAE. The structure, mechanism of action, dose optimization strategy, and exposure-toxicity relationships are discussed alongside emerging efficacy data from early-phase studies and the phase II LUMINOSITY trial. The evolving role of biomarker-driven ADC therapy in previously treated EGFR-wildtype non-squamous NSCLC, companion diagnostics, and regulatory considerations are also addressed.Expert opinion: Teliso-V represents an important extension of the ADC paradigm into a protein-expression-defined NSCLC population, demonstrating clinically meaningful activity with a predictable and manageable safety profile dominated by cumulative risk for peripheral neuropathy. While accelerated approval underscores its therapeutic promise, long-term positioning will depend on confirmatory trials, refinement of biomarker testing, and optimization of patient selection. If validated, this strategy may redefine later-line treatment expectations by aligning cytotoxic payload delivery with biologically enriched disease subsets.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-9"},"PeriodicalIF":4.0,"publicationDate":"2026-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147766603","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Immunotherapy for patients with melanoma in East Asia: current evidence, future directions, and clinical implications. 免疫治疗在东亚黑色素瘤患者：目前的证据，未来的方向和临床意义。

IF 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2026-05-03 DOI: 10.1080/14712598.2026.2650107

Junjie Gu, Yu Du, Hongwei Fan, Hongfei Li, Jun Guo, Lu Si

{"title":"Immunotherapy for patients with melanoma in East Asia: current evidence, future directions, and clinical implications.","authors":"Junjie Gu, Yu Du, Hongwei Fan, Hongfei Li, Jun Guo, Lu Si","doi":"10.1080/14712598.2026.2650107","DOIUrl":"10.1080/14712598.2026.2650107","url":null,"abstract":"Introduction: Melanomas cause the vast majority of skin-cancer related deaths, despite accounting for only around 2% of skin cancer cases. Moreover, due to genetic and environmental factors, the melanomas that predominate in East Asian populations, generally acral and mucosal melanomas, are extremely rare in Caucasian populations. These melanomas differ from other cutaneous melanomas in clinicopathological features and mutational landscapes, including a lower prevalence of commonly targetable mutations such as BRAF V600, and are usually diagnosed at a more advanced stage with a poor prognosis. The advent of immunotherapies therefore represents a great stride forward in the treatment of melanoma, including in East Asian countries, with immune checkpoint blockade now available as first-line treatment in China.Areas covered: This review briefly outlines the epidemiology and unique clinical characteristics of melanoma in East Asian patients; summarizes existing immunotherapy approvals, treatment landscape, and unmet needs; and aims to enable clinicians to make more informed treatment decisions for patients.Expert opinion: Further research is urgently needed into novel immunotherapeutic combinations, and biomarkers of response, to fully unlock the potential of immunotherapy for East Asian AM and MM and guide future therapeutic strategies.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-14"},"PeriodicalIF":4.0,"publicationDate":"2026-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147766572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparing the efficacy and safety of biosimilar BAT2506 with reference golimumab in patients with active psoriatic arthritis: 24-week results of a phase 3, multicenter, double-blind, randomized, parallel-group study. 比较生物仿制药BAT2506与参考戈利单抗在活动性银屑病关节炎患者中的疗效和安全性：一项为期24周的3期多中心、双盲、随机、平行组研究结果

IF 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2026-04-28 DOI: 10.1080/14712598.2026.2663826

Honghu Tang, Eva Dokoupilova, Bogdan Batko, Marek Zawadzki, Anastas Batalov, Yi Liu, Xiaolei Yang, Yinbo Zhou, Qingfeng Dong, Yi Liu

{"title":"Comparing the efficacy and safety of biosimilar BAT2506 with reference golimumab in patients with active psoriatic arthritis: 24-week results of a phase 3, multicenter, double-blind, randomized, parallel-group study.","authors":"Honghu Tang, Eva Dokoupilova, Bogdan Batko, Marek Zawadzki, Anastas Batalov, Yi Liu, Xiaolei Yang, Yinbo Zhou, Qingfeng Dong, Yi Liu","doi":"10.1080/14712598.2026.2663826","DOIUrl":"https://doi.org/10.1080/14712598.2026.2663826","url":null,"abstract":"Background: This study aimed to show equivalent efficacy, pharmacodynamics, pharmacokinetics (PK), safety, and immunogenicity of biosimilar BAT2506 to reference golimumab (Ref-GLM) in patients with active psoriatic arthritis.Research design and methods: This study comprised a 24-week initial treatment period 1. Patients were randomly assigned (1:2:1) into three groups: Ref-GLM, BAT2506, or start with Ref-GLM and switch to BAT2506 at week 24. The assessment of therapeutic equivalence between BAT2506 and Ref-GLM via percentage of patients achieving an American College of Rheumatology 20 (ACR 20) response at Week 14 was the primary endpoint.Results: 351 patients were randomized into the BAT2506 group and 353 patients in those groups that started the treatment with Ref-GLM. The 90% confidence interval (CI; -2.91, 7.63) and 95% CI (-3.92, 8.64) for the common risk difference in ACR 20 response between the BAT2506 group and groups that started the treatment with Ref-GLM fully fell within predefined equivalence margins supporting efficacy equivalence between BAT2506 and Ref-GLM at Week 14. Comparable safety, PK, and immunogenicity profiles were observed for BAT2506 and Ref-GLM groups.Conclusions: Data supported equivalence efficacy and comparable pharmacodynamics, PK, safety, and immunogenicity profiles between BAT2506 and Ref-GLM till Week 24.Clinical trial registration: www.clinicaltrials.gov identifier NCT05046431.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-10"},"PeriodicalIF":4.0,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147766563","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Emerging strategies for the prevention and management of chronic graft-versus-host disease. 预防和管理慢性移植物抗宿主病的新策略。

IF 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2026-04-28 DOI: 10.1080/14712598.2026.2664725

Xiaoli Liang, Duo Li, Rui Ji, Xinwen Zhang, Xiaoqi Wang, Xi Zhang

{"title":"Emerging strategies for the prevention and management of chronic graft-versus-host disease.","authors":"Xiaoli Liang, Duo Li, Rui Ji, Xinwen Zhang, Xiaoqi Wang, Xi Zhang","doi":"10.1080/14712598.2026.2664725","DOIUrl":"https://doi.org/10.1080/14712598.2026.2664725","url":null,"abstract":"Introduction: Chronic graft-versus-host disease remains a major cause of late morbidity and mortality after allogeneic hematopoietic stem cell transplantation. Conventional prevention and management strategies, heavily reliant on prolonged immunosuppression, are limited by suboptimal efficacy, substantial toxicity, and a failure to address disease heterogeneity.Areas covered: This review synthesizes recent advances in the biological understanding of cGVHD, particularly the immune dysregulation and fibrotic progression that underpin its diverse clinical manifestations. We discuss a paradigm shift from uniform immunosuppression toward a structured framework encompassing four sequential phases: comprehensive assessment, risk-adapted prevention, mechanism-driven treatment, and holistic long-term survivorship care. Key innovations highlighted include the use of predictive biomarkers for early intervention, the use of steroid-sparing targeted therapies (such as JAK/ROCK2 inhibitors), and the integration of patient-reported outcomes and functional measures into routine evaluation.Expert opinion: The field is poised for transformative change. We advocate for the routine implementation of risk-stratified prevention, preemptive antifibrotic strategies, and organ-specific multidisciplinary management. Crucially, therapeutic success should be redefined around patient-centered goals: safe steroid discontinuation, symptom control, functional recovery, and preserved quality of life. Embedding lifestyle support and longitudinal follow-up into standard care is essential to reduce the overall burden of cGVHD and improve long-term survival.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-12"},"PeriodicalIF":4.0,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147766589","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Monoclonal antibodies in the management of hereditary angioedema. 单克隆抗体在遗传性血管性水肿治疗中的应用。

IF 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2026-04-28 DOI: 10.1080/14712598.2026.2664733

Henriette Farkas, Lili Voloncs-Mindszenthy, Hanga Réka Horváth

{"title":"Monoclonal antibodies in the management of hereditary angioedema.","authors":"Henriette Farkas, Lili Voloncs-Mindszenthy, Hanga Réka Horváth","doi":"10.1080/14712598.2026.2664733","DOIUrl":"https://doi.org/10.1080/14712598.2026.2664733","url":null,"abstract":"Introduction: Hereditary angioedema (HAE) is a rare, potentially life-threatening, unpredictable disease characterized by recurrent subcutaneous and/or submucosal edema (HAE attacks). HAE imposes a significant biopsychosocial burden on patients and their families owing to the erratic nature and variable severity of HAE attacks. Current guidelines appoint sustained disease control as one of the main treatment goals, achievable through the initiation of long-term prophylaxis (LTP).Areas covered: This review focuses on the evaluation of three monoclonal antibodies developed for LTP of HAE, namely lanadelumab (Takhzyro®), garadacimab (Andembry®), and navenibart, in this order. Lanadelumab inhibits plasma kallikrein and has been an approved LTP option since 2018. Garadacimab inhibits activated factor XII (FXIIa) and has been approved for LTP in 2025. Navenibart, a drug currently under development, inhibits plasma kallikrein and has been modified to extend its circulating half-life.Expert opinion: The transition from older non-targeted LTP options to the use of monoclonal antibody-based therapies has fundamentally changed the treatment landscape by offering a safe, effective, and highly targeted solution. Although having different pharmacological characteristics, these LTP options share the same objective: to achieve complete disease control.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1-15"},"PeriodicalIF":4.0,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147766612","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Step-up or early intensive therapy in psoriatic arthritis: aligning treatment intensity with disease biology. 银屑病关节炎的加强或早期强化治疗：调整治疗强度与疾病生物学

IF 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2026-04-23 DOI: 10.1080/14712598.2026.2663828

Rubén Queiro, Sara Alonso

引用次数: 0

Aflibercept-ayyh (aflibercept 2 mg biosimilar) for treatment-naïve retinal vascular diseases: early real-world experience - the APEX study. afliberept -ayyh （afliberept 2 mg生物类似药）治疗treatment-naïve视网膜血管疾病：早期真实世界经验-顶点研究。

IF 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2026-04-01 Epub Date: 2026-04-09 DOI: 10.1080/14712598.2026.2655440

Ashish Sharma, Alexander Shaer, Jingwen Zhang, Carl Regillo

{"title":"Aflibercept-ayyh (aflibercept 2 mg biosimilar) for treatment-naïve retinal vascular diseases: early real-world experience - the APEX study.","authors":"Ashish Sharma, Alexander Shaer, Jingwen Zhang, Carl Regillo","doi":"10.1080/14712598.2026.2655440","DOIUrl":"10.1080/14712598.2026.2655440","url":null,"abstract":"Purpose: To evaluate the early real-world efficacy of intravitreal aflibercept 2 mg biosimilar (aflibercept-ayyh, Pavblu, Amgen, USA.) across common retinal vascular diseases in treatment-naïve eyes.Methods: This retrospective, observational study was conducted at The Retina Service of Wills Eye Hospital (Mid Atlantic Retina, Philadelphia, PA, USA.) and included treatment-naïve eyes with retinal vascular diseases treated with aflibercept-ayyh in a real-world clinical setting. Functional and anatomical changes from baseline to last follow-up were analyzed using paired t-tests and Wilcoxon signed-rank tests.Results: A total of 707 eyes (1,912 injections) were analyzed over a mean follow-up of 8.5 ± 6.5 weeks (2.7 ± 1.4 injections). Mean BCVA improved from 0.68 to 0.60 logMAR (+3.8 ETDRS letters, p < 0.001), and mean CFT decreased from 331.9 µm to 232.6 µm (-99.3 µm, p < 0.001). IRF decreased from 50.1% to 23.5%, SRF from 26.3% to 6.2%, and sub-RPE/PED fluid from 39.5% to 31.3%. CRVO and BRVO showed the greatest improvements. No intraocular inflammation, vascular occlusion, endophthalmitis, or systemic adverse events occurred; cataract progression was observed in 0.7% of eyes.Conclusion: Aflibercept-ayyh demonstrated significant early visual and anatomical improvements across major retinal vascular diseases with a favorable short-term safety profile.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"415-422"},"PeriodicalIF":4.0,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147590991","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Itepekimab for chronic obstructive pulmonary disease therapy. itpekimab用于慢性阻塞性肺疾病的治疗。

IF 4 3区医学

Expert Opinion on Biological Therapy Pub Date : 2026-04-01 Epub Date: 2026-04-08 DOI: 10.1080/14712598.2026.2654773

Sabina Antoniu, Theodor Penisoara, Stefan Rascu

引用次数: 0