{"title":"Real-World Testing Landscape and Costs of Companion Diagnostics and Comprehensive Genomic Profiling Across Nine Solid Tumors in Japan: A 10-Year Analysis.","authors":"Kuniko Sunami, Sona-Sanae Aoyagi, Masashi Mikami, Kanae Togo","doi":"10.1007/s40487-026-00459-2","DOIUrl":"https://doi.org/10.1007/s40487-026-00459-2","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to examine utilization, testing sequences, and associated genomic testing costs of companion diagnostics (CDx) and comprehensive genomic profiling (CGP) among Japanese patients with nine representative solid tumors.</p><p><strong>Methods: </strong>This retrospective study used anonymized data, from Medical Data Vision Co., Ltd. (MDV; January 2015-March 2025) and JMDC Inc. (JMDC; January 2015-January 2025), for patients with solid tumors of nine cancer types who underwent CDx and/or CGP testing or received any cancer treatment. Patient demographics, distribution and testing sequences of CDx and CGP, and associated genomic testing costs per patient were evaluated.</p><p><strong>Results: </strong>Proportions of CDx and CGP testing varied across nine cancer types. Most patients underwent CDx testing once or twice, although some cohorts, particularly with non-small cell lung cancer (NSCLC), were tested thrice or more. Biliary tract cancer demonstrated the highest proportions for CGP testing alone, and both CDx and CGP testing. For both CDx and CGP testing, the greatest median costs were observed for ovarian and breast cancers, with bimodal peaks near US dollars (USD) 4000 and USD 5000. Median CDx costs were equal to or higher for patients who underwent both CDx and CGP testing compared with those who had CDx testing alone, particularly in breast, pancreatic, prostate, and ovarian cancers. For CDx testing alone, NSCLC, ovarian cancer, and prostate cancer had the highest costs, with a small peak near USD 1333. These results were mostly consistent across databases.</p><p><strong>Conclusions: </strong>Multiple CDx testing followed by CGP testing increased genomic testing costs per patient. Early implementation of CGP testing could reduce redundant testing and associated delays in treatment, thereby contributing to lower overall healthcare costs and more efficient treatment selection amid rapid advances in targeted therapies.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2026-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148897897","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A Qualitative Study of Patient and Caregiver Perspectives on Locally Advanced Head and Neck Cancer in the United States.","authors":"Esther Yu, Veronica Ashton, OluYemisi Falope, Toby Hanna, Teresa Kessell, Matt Scott, Denise D'Andrea, Maureen Tucker O'Malley, Rebecca Genin","doi":"10.1007/s40487-026-00464-5","DOIUrl":"https://doi.org/10.1007/s40487-026-00464-5","url":null,"abstract":"<p><strong>Introduction: </strong>Locally advanced head and neck squamous cell carcinoma (LA-HNSCC) has major physical and psychosocial burdens. Although treatment challenges are well recognized, few studies have explored the full LA-HNSCC experience from first symptoms through to post-treatment recovery and survivorship. This exploratory, qualitative study sought to understand patient and caregiver perspectives across the LA-HNSCC journey.</p><p><strong>Methods: </strong>US adults with lived experience of LA-HNSCC (seven patients; two caregivers) participated in Johnson & Johnson's Head & Neck Cancer Patient Engagement Research Council via virtual focus groups and online bulletin board activities. Transcripts and written responses were thematically analyzed using an a priori framework of three key stages: diagnosis and treatment planning, treatment, and post-treatment recovery and survivorship.</p><p><strong>Results: </strong>Diagnostic journeys varied, with delays to diagnosis commonly perceived by participants as being attributed to multiple factors, including misinterpreted symptoms, difficulty accessing specialists, and limited provider awareness. Participants reported fear, uncertainty, and information overload during early decision-making. Treatment was described as burdensome, with side effects from radiation and chemotherapy leading to profound functional impairments affecting eating, swallowing, speech, and energy levels. Post-treatment long-term effects such as dry mouth, hearing loss, peripheral neuropathy, and anxiety about recurrence persisted and were often unexpected. Throughout these challenges, participants found strength, encouragement, and hope in peer support networks and valued knowledgeable and empathic communication with providers, as well as access to clear and digestible information; in particular, participants recommended early mental health support, tailored communication, and access to peer mentorship services.</p><p><strong>Conclusions: </strong>These exploratory, qualitative insights highlight unmet informational, psychosocial, and support needs in LA-HNSCC. Patients and their caregivers reported experiencing substantial, long-lasting physical and mental health effects that providers should be aware of to better support and empower patients throughout the care experience. A graphical abstract and patient journey infographic are available for this article.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2026-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148892632","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ingolf Griebsch, Sunil Shrestha, Carolyn C Gotay, John L Gore, Fran Curtis, Andrew Bottomley
{"title":"Patient-Reported Outcome Instruments in Non-Muscle-Invasive Bladder Cancer (NMIBC): A Systematic Review.","authors":"Ingolf Griebsch, Sunil Shrestha, Carolyn C Gotay, John L Gore, Fran Curtis, Andrew Bottomley","doi":"10.1007/s40487-026-00463-6","DOIUrl":"https://doi.org/10.1007/s40487-026-00463-6","url":null,"abstract":"<p><strong>Introduction: </strong>Non-muscle-invasive bladder cancer (NMIBC) is a chronic and recurrent condition requiring repeated intravesical treatments and lifelong surveillance, imposing a substantial burden on patients. Patient-reported outcomes (PROs) are increasingly required by regulatory bodies and HTA bodies to capture treatment impact from the patient perspective, yet no consensus on the optimal PRO instruments for use in NMIBC trials exists. This systematic review evaluated PRO instruments used in NMIBC and appraised their psychometric evidence using a structured evidence-maturity framework informed by the consensus-based standards for the selection of health measurement instruments (COSMIN) methodology.</p><p><strong>Methods: </strong>Six electronic databases (MEDLINE, CENTRAL, Embase, Scopus, Web of Science, and APA PsycINFO) were searched from January 2000 to 31 December 2024. Studies reporting the development, validation, or application of PRO instruments in adult NMIBC populations were eligible. Eligible instruments were required to be multi-item measures with psychometric validation, evidence of interpretability, or documented use in clinical trials. No language restrictions were applied. Conference abstracts and grey literature without peer-reviewed full texts were excluded. Data were extracted using Covidence, synthesized by instrument, and mapped against an NMIBC conceptual model. Evidence maturity was classified as tier 1 (well-established evidence base), tier 2 (moderate evidence base or context-specific validation), or tier 3 (preliminary evidence or under active development), on the basis of prespecified criteria. The COSMIN risk of bias checklist was used to appraise the methodological quality of included measurement property studies. Single-item measures were excluded from the main synthesis but are discussed in the context of future use.</p><p><strong>Results: </strong>A total of 39 studies covering eight PRO instruments met the inclusion criteria. The European organization for research and treatment of cancer quality of life questionnaire-non-muscle-invasive bladder cancer 24-item module (EORTC QLQ-NMIBC24) and bladder cancer index (BCI) demonstrated strong validity, reliability, and responsiveness in NMIBC, covering urinary, sexual, and recurrence-related domains, and were classified as tier 1 (well-established evidence base). The European organisation for the research and treatment of cancer quality of life questionnaire core 30 (EORTC QLQ-C30), functional assessment of cancer therapy-general (FACT-G), and FACT-Bladder were classified as tier 2, having been validated across broader cancer populations but with limited NMIBC-specific evidence. The NMIBC-symptom index (SI), PRO-common terminology criteria for adverse events (CTCAE), and M.D. Anderson symptom inventory (MDASI) were classified as tier 3, as conceptually relevant instruments with promising early validation but insufficient NMIBC-specific psychometric ev","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2026-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148819906","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ola Brodin, Carlos Fernandez Moro, Mattias Hedman, Ozan Aricak, Tímea Szekerczés, Per Grybäck, Mikael Björnstedt
{"title":"Exceptional Cure of a Patient with Progressive Advanced Squamous-Cell Lung Cancer after Selenite Treatment followed by Chemotherapy: A Case Report.","authors":"Ola Brodin, Carlos Fernandez Moro, Mattias Hedman, Ozan Aricak, Tímea Szekerczés, Per Grybäck, Mikael Björnstedt","doi":"10.1007/s40487-026-00460-9","DOIUrl":"https://doi.org/10.1007/s40487-026-00460-9","url":null,"abstract":"<p><p>Intravenous (i.v.) sodium selenite has been evaluated in patients with advanced cancer, but its potential clinical and biomarker-related effects remain incompletely understood. We report a patient with advanced squamous-cell lung cancer who was treated with high-dose intravenous sodium selenite within the SECAR phase I trial. The patient had recurrent, progressive disease after previous chemotherapy, radiotherapy, and targeted treatment, and no further standard treatment options were available. Sodium selenite was administered according to the study protocol and was followed by gemcitabine plus carboplatin. Imaging shortly after treatment showed stable disease; however, the patient subsequently improved clinically followed by gradual tumor regression. 2-[<sup>18</sup>F]fluoro-2-deoxy-D-glucose positron emission tomography-computed tomography (FDG-PET/CT) performed in 2011 demonstrated no residual tumor, repeated bronchial and stent-related biopsies between 2014 and 2017 showed no malignancy, and available autopsy material 10 years after SECAR treatment showed no malignancy. Retrospective biomarker analyses showed strong membranous programmed death-ligand 1 (PD-L1) expression in the pretreatment tumor biopsy and a sustained decrease in plasma soluble programmed death-ligand 1 (sPD-L1) from 93 pg/mL before sodium selenite treatment to 70 pg/mL after treatment and 38 pg/mL at 12 weeks after completion of subsequent chemotherapy. This case describes an exceptional durable complete remission in a patient with advanced squamous-cell lung cancer after sodium selenite treatment followed by chemotherapy within a phase I trial. Although causality cannot be established from a single case, the approximately 10-year malignancy-free clinical course, repeated tumor-free bronchial biopsies, absence of malignancy in available autopsy material, and exploratory PD-L1/sPD-L1 findings support reporting this observation as hypothesis-generating. The case merits further investigation of sodium selenite in the treatment of PD-L1 expressing tumors.Trial Registration European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) number 2006-004076-13.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2026-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148799176","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yuping Sun, Jia Zhong, Huiwen Sun, Graeme Parr, Edit Lukacs, Daniel Slade, Yizhao Zhou, Xiaoyu Ren, David Kirk, Aleksandra Kmieciak, Tingting Yao, Jie Wang
{"title":"Publisher Correction: Ceralasertib Plus Durvalumab in Chinese Patients with Advanced Solid Tumors: A Nonrandomized Clinical Trial.","authors":"Yuping Sun, Jia Zhong, Huiwen Sun, Graeme Parr, Edit Lukacs, Daniel Slade, Yizhao Zhou, Xiaoyu Ren, David Kirk, Aleksandra Kmieciak, Tingting Yao, Jie Wang","doi":"10.1007/s40487-026-00461-8","DOIUrl":"https://doi.org/10.1007/s40487-026-00461-8","url":null,"abstract":"","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2026-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148799163","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yuping Sun, Jia Zhong, Huiwen Sun, Graeme Parr, Edit Lukacs, Daniel Slade, Yizhao Zhou, Xiaoyu Ren, David Kirk, Aleksandra Kmieciak, Tingting Yao, Jie Wang
{"title":"Ceralasertib Plus Durvalumab in Chinese Patients with Advanced Solid Tumors: A Nonrandomized Clinical Trial.","authors":"Yuping Sun, Jia Zhong, Huiwen Sun, Graeme Parr, Edit Lukacs, Daniel Slade, Yizhao Zhou, Xiaoyu Ren, David Kirk, Aleksandra Kmieciak, Tingting Yao, Jie Wang","doi":"10.1007/s40487-026-00458-3","DOIUrl":"10.1007/s40487-026-00458-3","url":null,"abstract":"<p><strong>Introduction: </strong>This phase I, multicenter, nonrandomized open-label study is the first study to investigate the safety, pharmacokinetics, and antitumor activity of ceralasertib, an oral ATR kinase inhibitor, in combination with durvalumab in Chinese patients with advanced solid tumors who are refractory or resistant to prior anti-PD-(L)1 immunotherapy or for whom no standard of care exists.</p><p><strong>Methods: </strong>Patients were enrolled into one of two cohorts. Cohort 1 received ceralasertib 240 mg twice daily on days 1‒7 of cycle 0 then on days 22‒28 from cycle 1 onwards (28-day cycle). Cohort 2 received ceralasertib 160 mg twice daily on days 1‒14 of cycle 0 then on days 15‒28 from cycle 1 onwards (28-day cycle). All patients received durvalumab 1500 mg on day 1 (28-day cycle). Patients were treated until disease progression, discontinuation due to adverse events, or patient or investigator's decision to withdraw. The primary endpoint was safety and tolerability of ceralasertib combined with durvalumab. Secondary endpoints included ceralasertib pharmacokinetics and antitumor activity.</p><p><strong>Results: </strong>Overall, 14 patients were enrolled (cohort 1, n = 8; cohort 2, n = 6). All patients were Chinese and the majority (85.7%) had received > 4 prior lines of therapy. Most patients (13/14; 92.9%) had an adverse event, which were grade ≥ 3 in 7 (50.0%) patients. No dose-limiting toxicities occurred (12 evaluable patients; six in each cohort). Pharmacokinetics for ceralasertib were comparable to that reported in other studies for monotherapy or in combination with durvalumab. Among 13 response-evaluable patients, 3/13 had a confirmed partial response (one with lung adenocarcinoma, one with squamous cell carcinoma of the cervix uteri, and one with lung squamous cell carcinoma); the objective response rate was 23.1% [80% CI 8.8‒44.4%]).</p><p><strong>Conclusions: </strong>Ceralasertib plus durvalumab had antitumor activity in Chinese patients with advanced solid tumors; safety and pharmacokinetics were consistent with studies in Western patient populations.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT05514132.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2026-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148608604","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mario Escobar Gómez, Ana Maria Rodríguez-Leboeuf, Selene Camargo-Correa, Ida Caterina García-Appendini, Arti Dhar, Isabela Rivas, Juan Guillermo Ariza, Pedro A Madero-Morales
{"title":"Clinicians' Perspectives on the Impact of Different Attributes of Androgen Receptor Pathway Inhibitors on Prostate Cancer Treatment Preferences and Compliance in Mexico.","authors":"Mario Escobar Gómez, Ana Maria Rodríguez-Leboeuf, Selene Camargo-Correa, Ida Caterina García-Appendini, Arti Dhar, Isabela Rivas, Juan Guillermo Ariza, Pedro A Madero-Morales","doi":"10.1007/s40487-026-00457-4","DOIUrl":"https://doi.org/10.1007/s40487-026-00457-4","url":null,"abstract":"<p><strong>Introduction: </strong>Androgen receptor pathway inhibitors (ARPIs) are a critical prostate cancer (PC) treatment option. Previous research has suggested that the physical attributes of ARPI medications (e.g., pill formulation, pill shape, pill size, dosing) may influence patients' treatment satisfaction, adherence, and persistence, which may impact patient outcomes and quality of life. The objective of this study was to describe Mexican clinical experts' perspectives on how different attributes of pill forms of ARPIs may affect treatment preferences and compliance in patients with PC.</p><p><strong>Methods: </strong>This study employed a mixed-methods sequential design. In the first phase, we conducted a targeted literature review (TLR) to frame discussions with clinical experts. In phase 2, we conducted a structured expert elicitation (SEE) comprised of a survey, semi-structured individual interviews, and two focus groups with oncologists and urologists to gather insights about the influence of different ARPI attributes on patient preferences and compliance. In the third phase, we constructed a series of probabilistic mathematical models to analyze the likelihood of patients' treatment preferences and adherence.</p><p><strong>Results: </strong>The TLR identified pill size, shape, number, frequency, and form as key attributes that influence patients' experiences and treatment compliance. Simpler regimens and smaller, easier-to-swallow formulations were consistently linked to greater comfort and adherence. In the SEE, participants ranked dosing frequency and pill count as the factors with the greatest influence on patient adherence when efficacy was comparable. During the interviews and focus groups, participants highlighted the importance of ≤ 2 pills/day, once-daily dosing, and small pill size alternatives. Findings from the Monte Carlo models were consistent with the earlier phases, supporting the importance of patient-preferred formulations.</p><p><strong>Conclusions: </strong>Findings from this mixed-methods study indicate that patient-preferred formulations may support better treatment adherence and support consideration of patient preferences in treatment decision-making between clinicians and patients to optimize adherence and outcomes in PC management.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2026-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148580525","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yaqi Jia, Yanbing Li, Siyan Zhan, Jeff Jianfei Guo, Yan-Jun Zhang, Ziheng Guo, Xian Cao
{"title":"A Comprehensive Mapping of Real-World Studies and Data Sources for Oncology in China: Insights into Landscape, Challenges, and Future Direction.","authors":"Yaqi Jia, Yanbing Li, Siyan Zhan, Jeff Jianfei Guo, Yan-Jun Zhang, Ziheng Guo, Xian Cao","doi":"10.1007/s40487-026-00456-5","DOIUrl":"https://doi.org/10.1007/s40487-026-00456-5","url":null,"abstract":"<p><strong>Introduction: </strong>Cancer remains a major public health concern in China, with approximately 2.57 million cancer-related deaths reported in 2022. Real-world studies (RWS), which leverage high-quality real-world data (RWD), can generate robust real-world evidence (RWE) to enhance clinical decision-making and improve patient outcomes across diverse oncology settings.</p><p><strong>Methods: </strong>A comprehensive literature search of four bibliographic databases (PubMed, Embase, China National Knowledge Infrastructure, and Wanfang) was conducted to identify oncology-related RWS articles and RWD sources covering Chinese populations from 2015 to 2025.</p><p><strong>Results: </strong>2606 RWS articles were identified. The findings indicate a growing trend in RWS publications, with a predominant focus on disease epidemiology. A total of 126 databases were extracted. Registries were observed as the main source of RWD. The top three investigated cancer types were digestive system, thoracic, and breast neoplasms. RWD sources are predominantly concentrated in coastal regions, reflecting disparities in the geographical distribution of oncology research.</p><p><strong>Conclusion: </strong>Enhancing data quality and promoting the aggregation of RWD are essential for maximizing the utility of RWD in advancing oncology care in China. Moving forward, standardized regulatory procedures, improved data accessibility, and collaboration across the healthcare ecosystem are essential to unlock the value of RWD and improve patient outcomes.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2026-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148438369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sridevi Rajeeve, Saurabh P Nagar, Sabyasachi Ghosh, Victoria Alegria, Justin Hayne, Bruno Emond, Jessica Maitland, Zaina P Qureshi, Larry D Anderson
{"title":"IMMPACT-MM: Insights into Multiple Myeloma Patient Outcomes following Early-Line Cilta-cel Treatment.","authors":"Sridevi Rajeeve, Saurabh P Nagar, Sabyasachi Ghosh, Victoria Alegria, Justin Hayne, Bruno Emond, Jessica Maitland, Zaina P Qureshi, Larry D Anderson","doi":"10.1007/s40487-026-00455-6","DOIUrl":"https://doi.org/10.1007/s40487-026-00455-6","url":null,"abstract":"<p><strong>Introduction: </strong>Ciltacabtagene autoleucel (cilta-cel) has demonstrated deep and durable responses in patients with relapsed/refractory multiple myeloma (RRMM), supporting the goal of sustained minimal residual disease (MRD) negativity as a marker for potential functional cure, characterized by prolonged treatment-free disease control. Initially, cilta-cel was approved in the US for RRMM after ≥ 4 prior lines of therapy (LOT), and after 1-3 prior LOT in April 2024. This study describes real-world clinical outcomes, including MRD negativity, of cilta-cel after 1-3 prior LOT.</p><p><strong>Methods: </strong>Electronic medical records from Loopback Analytics (April 2024-May 2025) were used, supplemented with physician notes. Adults with RRMM treated with cilta-cel after 1-3 prior LOT were included. Post-infusion outcomes (cilta-cel response, MRD negativity, disease progression, and overall survival) were assessed overall and by bridging therapy (BT) regimen.</p><p><strong>Results: </strong>Overall, 120 patients were included (median age 67 years, 43.3% female). Prior to infusion, 87.5% received BT, including alkylator-based (28.6%), IMiD ± mAb-based (25.7%), PI-based (20.0%), talquetamab (14.3%), and other regimens (11.4%). Over a median follow-up of 5.8 months, among patients with a response assessment (81.7%), the overall response rate (ORR) to cilta-cel was 98.0%, including 72.4% with complete response. Among 36 MRD-evaluable patients, MRD negativity (10<sup>-5</sup>) was achieved in 35 (97.2%), with a median time to MRD negativity of 80.0 days. At last follow-up, 94.2% of patients remained progression-free, 95.8% had not initiated subsequent treatment, and 99.2% remained alive. Across BT regimens, ORR to cilta-cel was 95-100% and MRD negativity was achieved in 80-100%.</p><p><strong>Conclusions: </strong>This real-world study demonstrates the effectiveness of cilta-cel in RRMM after 1-3 prior LOT. High rates of response and MRD negativity were reported overall and across BT regimens, including talquetamab. Longer follow-up with repeated MRD measurements may provide further insights into response durability and survival outcomes, helping to contextualize the potential for a functional cure.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2026-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148340639","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Podcast on the Emerging Role of PD-(L)1/VEGF Bispecific Antibodies in the Evolving Advanced Renal Cell Carcinoma Treatment Landscape.","authors":"Brian I Rini, Benjamin Garmezy","doi":"10.1007/s40487-026-00450-x","DOIUrl":"https://doi.org/10.1007/s40487-026-00450-x","url":null,"abstract":"<p><p>Combinations of an immune checkpoint inhibitor (ICI) + anti-programmed cell death 1 protein (PD-1) or anti-programmed cell death ligand 1 (PD-L1) or an ICI + tyrosine kinase inhibitor (TKI; anti-vascular endothelial growth factor [VEGF]) are the current standard first-line treatments for advanced renal cell carcinoma (RCC). However, novel therapies are needed as treatments for RCC have relied on the same mechanisms for decades, with only modest advancements made in the field compared with other genitourinary diseases. Therefore, a considerable unmet need remains for additional treatment options with enhanced activity and minimal toxicity for patients with advanced RCC. Simultaneous bispecific targeting of PD-1 and VEGF may improve efficacy and safety compared with combination therapy of PD-1- and VEGF-targeting single agents. In this podcast, authors discuss the evolving treatment landscape for patients with RCC and describe how bispecific antibodies, as monotherapy or combination therapy, have the potential to transform the treatment of these patients. Preclinical evidence shows that bispecific co-targeting of PD-(L)1 and VEGF may result in cooperative binding, which can enhance both PD-1 binding affinity and anti-angiogenic activity. Bispecific targeting can also potentially confer safety advantages owing to a reduction in immune-related adverse events. PD-(L)1/VEGF bispecifics under development include PF-08634404, ivonescimab, and BNT327, all of which have distinct structural configurations and mechanistic differences. These bispecific antibodies, among others, are being evaluated for the treatment of patients with advanced RCC. The authors discuss existing clinical evidence with bispecific antibodies in other cancers and explore the rationale for evaluating the antitumor activity of PD-(L)1/VEGF bispecifics, either as monotherapy or in conjunction with other treatments in patients with RCC.Podcast and Infographic available for this article. Podcast (MP4 107526 KB) Infographic.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2026-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148340606","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}