{"title":"An evaluation of datopotamab deruxtecan for the treatment of non-small cell lung cancer.","authors":"Neel Belani, Anjali Donnelly, Alexander Spira","doi":"10.1080/14712598.2025.2519532","DOIUrl":"10.1080/14712598.2025.2519532","url":null,"abstract":"<p><strong>Introduction: </strong>Despite recent treatment breakthroughs, non-small cell lung cancer (NSCLC) remains the highest cause of cancer-related mortality. New therapies are urgently needed, particularly in patients without actionable genomic alterations (AGAs), who currently receive a combination of chemotherapy and anti-PD1/PD-L1 therapy. Datopotamab deruxtecan (Dato-DXd) is an antibody-drug conjugate combining an antibody against Trop-2 and an exatecan payload which has shown activity in both breast cancer and NSCLC. With several drugs in this class, it is important to understand their activity and limitations in different subtypes of NSCLC.</p><p><strong>Areas covered: </strong>The literature was reviewed for trials demonstrating activity of their preliminary and/or final results, Dato-DXd, was studied across multiple clinical trials, including the Phase 1 TROPION-PanTumor01 and Phase 3 TROPION-Lung01 studies that are deemed pivotal in demonstrating its efficacy across different patients.</p><p><strong>Expert opinion: </strong>Dato-DXd is a promising new option for NSCLC treatment with clear evidence of activity, shown early signals of efficacy, particularly in non-squamous NSCLC and patients with AGAs. However, patient selection remains paramount for future clinical development. Further research is necessary to optimize dosing strategies, manage adverse events, and better understand its role in both frontline and relapsed/refractory treatment settings as part of combination therapy, as well as neoadjuvant therapy prior to surgery.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"695-701"},"PeriodicalIF":3.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144293592","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}
{"title":"Tight competition for the first-line treatment of Hodgkin's lymphoma: a comprehensive review of practice-changing developments in recent years.","authors":"Umut Yılmaz, Elif Birtaş Ateşoğlu, Burhan Ferhanoğlu","doi":"10.1080/14712598.2025.2519524","DOIUrl":"10.1080/14712598.2025.2519524","url":null,"abstract":"<p><strong>Introduction: </strong>There has been a giant leap forward in the management of Hodgkin's lymphoma (HL) over the past decade. Emergence of long-term data from large, randomized trials in early-stage disease (eHL) and incorporation of brentuximab vedotin (BV) or nivolumab into the frontline setting through three large phase-3 trials in advanced stages (aHL) are driving the paradigm shift in HL. The new landscape promises chances of cure to over 90% newly diagnosed patients while maintaining caution for long-term toxicity.</p><p><strong>Areas covered: </strong>This review will cover the published evidence regarding primary analyses or updates within the last 5 years on phase-3 clinical trials conducted in the frontline treatment setting for HL. Concerning areas of clinical significance where no comparative trial data is available, data from phase-2 trials or real-world analyses will be briefly discussed.</p><p><strong>Expert opinion: </strong>Consolidative radiotherapy is no longer a strict necessity in eHL cases with complete response to frontline chemotherapy and the decision to irradiate in such cases should be individualized. The state-of-the-art in managing aHL requires the use of either BV or nivolumab as introduced by the GHSG HD21 and SWOG S1826 trials, respectively.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"731-747"},"PeriodicalIF":3.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144283050","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}
Matteo Megna, Giuseppe Lauletta, Michela D'Agostino, Nello Tommasino, Antonia Salsano, Matteo Noto, Claudio Brescia, Luciano Foggia, Lorenzo Scaramuzzino, Luca Potestio
{"title":"Biologics targeting IL-23 in moderate-to-severe psoriasis: lessons learned from real-world use.","authors":"Matteo Megna, Giuseppe Lauletta, Michela D'Agostino, Nello Tommasino, Antonia Salsano, Matteo Noto, Claudio Brescia, Luciano Foggia, Lorenzo Scaramuzzino, Luca Potestio","doi":"10.1080/14712598.2025.2519525","DOIUrl":"10.1080/14712598.2025.2519525","url":null,"abstract":"<p><strong>Introduction: </strong>Psoriasis is a chronic, systemic inflammatory disease with significant physical and psychosocial burden. Advances in understanding the pathogenesis of psoriasis, particularly the role of interleukin (IL)23/Th17 axis, have led to the development of selective drugs targeting these cytokines. Among these, IL23 inhibitors (guselkumab, risankizumab, and tildrakizumab), represent the most recent class of biologic drugs approved for the management of moderate-to-severe plaque psoriasis. Since their approval, real-life data on the use of anti-IL23 have confirmed their high efficacy, durability, and favorable safety profile.</p><p><strong>Areas covered: </strong>This narrative review summarizes real-world data on the effectiveness, also in difficult-to-treat areas, safety, and drug survival of IL23 inhibitors in psoriasis.</p><p><strong>Expert opinion: </strong>Real-world evidence consistently confirms the strong efficacy, favorable safety profile, and long-term treatment durability of IL23 inhibitors across various patient subgroups, including those with comorbidities, prior biologic failures, and the involvement of difficult-to-treat areas. IL23 inhibitors have become key components of the therapeutic arsenal in psoriasis, and their performance in real-world settings continues to support their widespread adoption in clinical practice.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"711-729"},"PeriodicalIF":3.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144301433","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}
{"title":"Hypoxic storage of red blood cells to improve transfusion outcomes in hematological malignancies.","authors":"Håkon Reikvam, Tor Hervig","doi":"10.1080/14712598.2025.2517852","DOIUrl":"10.1080/14712598.2025.2517852","url":null,"abstract":"","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"679-682"},"PeriodicalIF":3.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144247175","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}
{"title":"Comparing the noninfectious adverse effects of two rabbit anti-thymocyte globulin immunosuppression in kidney transplantation: a multicenter, retrospective study.","authors":"Mojtaba Shafiekhani, Ayda Esmaeili, Fatemeh-Sadat Emami, Kazem Heidari, Niloufar Saberi Moghadam, Shirinsadat Badri, Leila Kouti, Amir Hooshang Mohammadpour, Hadi Hamishehkar, Afshin Gharekhani, Maryam Amini-Pouya, Negin Zare, Fatemeh Abdoli, Mohammad Amin Jafarzadeh, Simin Dashti-Khavidaki","doi":"10.1080/14712598.2025.2512127","DOIUrl":"10.1080/14712598.2025.2512127","url":null,"abstract":"<p><strong>Background: </strong>Rabbit anti-thymocyte globulin (rATG) is widely used for induction immunosuppression in kidney transplantation; however, its administration carries some adverse effects. This study aimed to detect the incidence of thromboembolic events (TEEs) after kidney transplantation and the causality relationship between these events and rATG administration as induction therapy.</p><p><strong>Methods: </strong>This multicenter retrospective study included 654 kidney recipients from six Iranian centers receiving [Thymoglobulin® (rATG-A) or TGlobulin25™ or (rATG-B)]. Outcomes included TEEs within 30 days post-transplant, hematologic adverse effects, and graft-related outcomes. Risk factors were analyzed using multivariable regression.</p><p><strong>Results: </strong>TEEs occurred in 4.9% of patients, with no significant difference between rATG-A (4.0%) and rATG-B (5.9%) (<i>p</i> = 0.26). Independent risk factors included peripheral rATG infusion without heparin (<i>p</i> < 0.001), preexisting thromboembolic risk conditions (<i>p</i> < 0.001), cytomegalovirus (CMV) infection (<i>p</i> = 0.01), and recipient age >40 years (<i>p</i> = 0.02). No inter-band difference in thromboembolic risk was observed (odds ratio = 1.63, 95% confidence interval 0.71-3.76). Delayed graft function, rejection, mortality, and nephrectomy rates showed no inter-group differences.</p><p><strong>Conclusion: </strong>TEEs happened in about 5% of the patients. Peripheral administration of rATG without adding heparin, history of underlying diseases predisposing to TEEs, CMV infection, and recipient age over 40 years were found as risk factors for the occurrence of TEEs.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"799-806"},"PeriodicalIF":3.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144173362","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}
{"title":"Addressing practical challenges with bispecific antibody therapy in multiple myeloma.","authors":"Sreeraj Vasudevan, Bhavesh Mohan Lal, Nikhil Vojjala, Meera Mohan","doi":"10.1080/14712598.2025.2495984","DOIUrl":"10.1080/14712598.2025.2495984","url":null,"abstract":"<p><strong>Introduction: </strong>Bispecific antibodies (bsAbs) have demonstrated impressive standalone effectiveness in relapsed and refractory multiple myeloma, as evidenced by clinical trials and real-world findings. Current clinical studies are investigating these drugs as both monotherapies and in combination treatments for earlier stages of myeloma, including newly diagnosed cases.</p><p><strong>Areas covered: </strong>With many options available in clinical settings, several questions emerge: How can one bsAb be chosen over another? What is the best way to administer bsAbs, including initial step-up and continuous dosing schedules? How can unique toxicities be managed, and what strategies should be used to address disease relapses following bsAb treatment?</p><p><strong>Expert opinion: </strong>Tocilizumab is being investigated in the prevention of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Steroids can be used to safely treat CRS in myeloma patients on bsAb therapy. This may allow a safe outpatient step-up dosing program. Despite improved infection management with intravenous immunoglobulin prophylaxis, infection risks continue as long as patients are on therapy. This indicates alternative strategies like less frequent dosing or finite duration therapy are needed. Optimal management of disease relapse after bsAb therapy and the sequencing of bsAb and chimeric antigen receptor (CAR) T-cell therapies require further investigation.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"607-613"},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143980668","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}
Angelo Valerio Marzano, Carlo Alberto Maronese, Anna Balato, Antonio Costanzo, Annunziata Dattola, Maria Concetta Fargnoli, Paolo Gisondi, Stefano Piaserico, Francesca Prignano
{"title":"What is '<i>chronic</i>' pustular psoriasis? Identifying candidates for long-term subcutaneous spesolimab treatment.","authors":"Angelo Valerio Marzano, Carlo Alberto Maronese, Anna Balato, Antonio Costanzo, Annunziata Dattola, Maria Concetta Fargnoli, Paolo Gisondi, Stefano Piaserico, Francesca Prignano","doi":"10.1080/14712598.2025.2501728","DOIUrl":"10.1080/14712598.2025.2501728","url":null,"abstract":"","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"565-567"},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143969428","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}
Santeri Artturi Pakola, James Hugo Armstrong Clubb, Joao Manuel Santos, Riikka Havunen, Heini Lassus, Victor Cervera-Carrascon, Akseli Hemminki
{"title":"Oncolytic adenoviruses in platinum-resistant ovarian cancer: a new era in immunotherapy?","authors":"Santeri Artturi Pakola, James Hugo Armstrong Clubb, Joao Manuel Santos, Riikka Havunen, Heini Lassus, Victor Cervera-Carrascon, Akseli Hemminki","doi":"10.1080/14712598.2025.2501731","DOIUrl":"10.1080/14712598.2025.2501731","url":null,"abstract":"","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"561-564"},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143993588","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}
{"title":"An evaluation of recaticimab for the treatment of hypercholesterolemia.","authors":"Xuan L Tang, Amanda J Hooper, John R Burnett","doi":"10.1080/14712598.2025.2508837","DOIUrl":"10.1080/14712598.2025.2508837","url":null,"abstract":"<p><strong>Introduction: </strong>Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, by preventing the degradation of LDL receptors, either through interference in the binding of PCSK9 to LDL receptors or through silencing of PCSK9 at a molecular level, have revolutionized lipid-lowering treatment and offer the opportunity to further improve clinical outcomes for patients with hypercholesterolemia.</p><p><strong>Areas covered: </strong>We discuss the role of PCSK9 as a therapeutic target for hypercholesterolemia, describe the pharmacodynamics, pharmacokinetics, and metabolism of recaticimab, and report the recent clinical trials with this 'humanized' IgG1 monoclonal antibody (mAb) against PCSK9.</p><p><strong>Expert opinion: </strong>Recaticimab has a high affinity for PCSK9 that confers a prolonged duration of action. Recaticimab durably decreases LDL-cholesterol, non-HDL-cholesterol and apoB, but can also lower Lp(a). Recaticimab may offer advantages over current mAbs in clinical use in terms of its long half-life, dosing interval of up to 12 weeks, and potentially a lower cost; however, long-term concerns regarding immunogenicity remain. Longer-term studies in a variety of more diverse patient cohorts will be needed to further evaluate the efficacy, safety, and durability of recaticimab and to ascertain the optimal dosing schedule for cardiovascular outcome studies.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"577-582"},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144086013","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}
Ashish Sharma, Carl D Regillo, Luke Nicholson, Nilesh Kumar, Nikulaa Parachuri, Taku Wakabayashi, Se Joon Woo, Baruch D Kuppermann
{"title":"The conundrum of abundance: challenges of having too many biosimilars.","authors":"Ashish Sharma, Carl D Regillo, Luke Nicholson, Nilesh Kumar, Nikulaa Parachuri, Taku Wakabayashi, Se Joon Woo, Baruch D Kuppermann","doi":"10.1080/14712598.2025.2506445","DOIUrl":"10.1080/14712598.2025.2506445","url":null,"abstract":"","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"573-576"},"PeriodicalIF":3.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143981442","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}