Oncology and Therapy最新文献

{"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":"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":"919-937"},"PeriodicalIF":3.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13575046/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148438369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Beyond the BCG Paradox: Biological Rationale and Clinical Evidence for Combining Intravesical BCG with Immune Checkpoint Inhibitors in High-Risk Non-muscle-Invasive Bladder Cancer.","authors":"Michele Musone, Biagio Barone, Stefano Chianese, Paolo Conforti, Antonio Madonna, Silvestro Imperatore, Fabrizio Dinacci, Raffaele Balsamo, Giuseppe Lucarelli, Roberto Falabella, Vincenzo Francesco Caputo, Antonio Luigi Pastore, Andrea Fuschi, Matteo Ferro, Lorenzo Romano, Marco Fabiano, Celeste Manfredi, Gian Maria Busetto, Valerio Santarelli, Francesco Del Giudice, Felice Crocetto","doi":"10.1007/s40487-026-00445-8","DOIUrl":"10.1007/s40487-026-00445-8","url":null,"abstract":"<p><p>Bladder cancer (BC) is the most common malignancy of the urinary tract, with more than 75% of cases diagnosed as non-muscle-invasive bladder cancer (NMIBC). Intravesical Bacillus Calmette-Guérin (BCG) remains the gold standard adjuvant treatment for high-risk NMIBC owing to its ability to induce a robust local immune response within the bladder tumor microenvironment. Nevertheless, a substantial proportion of patients experience disease recurrence or progression, highlighting the need for improved therapeutic strategies. This narrative review examines the biological rationale and available clinical evidence supporting the combination of intravesical BCG with immune checkpoint inhibitors (ICIs) in high-risk NMIBC. A literature review was conducted to analyze the immunological mechanisms underlying BCG-induced antitumor activity, adaptive immune resistance, and the potential role of ICIs in modulating the tumor microenvironment. Clinical trials were evaluated with particular attention to patient populations, study design, safety profiles, and efficacy end points. From a biological perspective, BCG acts as an immunological primer by recruiting and activating innate and adaptive immune cells, while immune checkpoint inhibitors may counteract functional exhaustion of BCG-induced antitumor responses. However, translation of this rationale into consistent clinical benefit remains challenging. Early-phase studies have reported variable response rates in selected patient populations, particularly in BCG-unresponsive disease. In contrast, recent phase III data have shown that upfront combination strategies do not necessarily translate into improved oncological outcomes. Overall, while the combination of BCG and immune checkpoint inhibition is supported by a strong immunological rationale, current clinical evidence remains heterogeneous and largely derived from early-phase or ongoing trials, precluding definitive conclusions regarding long-term oncological benefit and durable bladder preservation. Despite a strong immunological rationale, the combination of BCG with immune checkpoint inhibitors remains investigational. Its adoption into routine clinical practice will require mature phase III evidence, validated predictive biomarkers, and a clear demonstration of superiority over established bladder-preserving treatment strategies.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"869-893"},"PeriodicalIF":3.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13575091/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148228738","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Publisher Correction: Perioperative Treatment Patterns for Muscle-Invasive Bladder Cancer Patients Undergoing Radical Cystectomy in the Adjuvant Immunotherapy Era: A Retrospective Analysis of US Community Oncology Practice.","authors":"Patrick Squires, Ke Meng, Xiaohan Hu, Vladimir Turzhitsky, Yu-Han Kao, Jennifer Stuart, Chethan Ramamurthy, Haojie Li, Ronac Mamtani","doi":"10.1007/s40487-026-00451-w","DOIUrl":"10.1007/s40487-026-00451-w","url":null,"abstract":"","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"1125"},"PeriodicalIF":3.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13575032/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148206075","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"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":"1077-1090"},"PeriodicalIF":3.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13575076/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148608604","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Abemaciclib in HR+, HER2- Breast Cancer: A Narrative Review of the Clinical Evidence.","authors":"Miguel Martin, Alexandru Rosca, Alexandra Searles Vitko, Monique Coersmeyer, Katheryn Moreira, Huiping Li, Erica L Mayer","doi":"10.1007/s40487-026-00449-4","DOIUrl":"10.1007/s40487-026-00449-4","url":null,"abstract":"<p><p>Hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-) breast cancer comprises approximately 70% of all breast cancer cases. In early-stage breast cancer, adjuvant endocrine therapy (ET) reduces recurrence and mortality, while in advanced/metastatic breast cancer (MBC), ET prolongs survival and delays the use of chemotherapy. However, there remains a need for agents that further improve outcomes across the spectrum of breast cancer presentations. Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors, such as abemaciclib, ribociclib, and palbociclib, are used in combination with ET as a standard of care first-line option in HR+, HER2- advanced disease to improve survival outcomes. Moreover, the addition of abemaciclib and ribociclib to adjuvant ET reduces risk of cancer recurrence, with abemaciclib also improving overall survival. Here, we provide a comprehensive analysis of the clinical trials that have demonstrated the efficacy of abemaciclib across the HR+, HER2- breast cancer continuum, improving outcomes in both high-risk, node-positive early breast cancer as well as in advanced disease. Abemaciclib has also been shown to be effective when combined with a variety of ET options, including aromatase inhibitors, tamoxifen, fulvestrant, imlunestrant, or as monotherapy, and has shown efficacy regardless of prior CDK4/6 inhibitor exposure, ESR1 or PI3K pathway mutational status, menopausal status, and in both endocrine-sensitive and endocrine-resistant breast cancer. Importantly, the safety profile of abemaciclib has been consistent across trials and allows the administration of the drug over long periods of time when needed, particularly if dose-reduction strategies are employed. Together, the data summarized in this publication help inform clinical decision making regarding the role of abemaciclib in the treatment of patients with both early and metastatic HR+, HER2- breast cancer.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"895-918"},"PeriodicalIF":3.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13575028/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148253829","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"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":"10.1007/s40487-026-00461-8","url":null,"abstract":"","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"1091-1093"},"PeriodicalIF":3.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13574999/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148799163","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"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":"10.1007/s40487-026-00463-6","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;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":"939-966"},"PeriodicalIF":3.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13575083/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148819906","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Outcomes Among Medicare Beneficiaries Treated with Bruton Tyrosine Kinase Inhibitors for Treatment-Naïve CLL.","authors":"Daniel A Ermann, Deborah M Stephens, Xiaoliang Wang, Irene Varghese, Heidi De Souza, Caitlin Sheetz, Qianhong Fu, Gregory A Maglinte, Rhys Williams, Erlene K Seymour, Derrick van Beuge, Mazyar Shadman, Ryan Jacobs","doi":"10.1007/s40487-026-00452-9","DOIUrl":"10.1007/s40487-026-00452-9","url":null,"abstract":"<p><strong>Introduction: </strong>There is a dearth of head-to-head studies comparing covalent Bruton tyrosine kinase (cBTK) inhibitors in adults with chronic lymphocytic leukemia (CLL). Real-world evidence may complement clinical trial data by assessing relative effectiveness in routine practice. This retrospective observational study used a de-identified Medicare Fee-For-Service database to compare real-world outcomes associated with first-line cBTKi monotherapies in older adults with CLL.</p><p><strong>Methods: </strong>Patients aged ≥ 65 years with CLL initiating first-line ibrutinib, acalabrutinib, or zanubrutinib monotherapy between January 1, 2020 and September 30, 2025 were included. Real-world time to treatment discontinuation (rwTTD), time to next treatment (rwTTNT), and overall survival (rwOS) were evaluated using Kaplan-Meier analyses and Cox proportional hazards models. Subgroup analyses were performed by age group.</p><p><strong>Results: </strong>Among 10,523 patients included, 3006 (28.6%) received zanubrutinib (median follow-up 15.8 months), 4309 (40.9%) received acalabrutinib (20.7 months), and 3208 (30.5%) received ibrutinib (34.9 months). Median rwTTD was not reached (NR) for zanubrutinib, compared with 24 months for acalabrutinib and 14 months for ibrutinib. Median rwTTNT was NR for zanubrutinib, 40 months for acalabrutinib, and 20 months for ibrutinib. After adjustments for age, sex, race, CCI, and year of index, zanubrutinib had significantly longer rwTTD (hazard ratio [HR] 0.57 [95% CI 0.51-0.61]), rwTTNT (HR 0.63 [0.55-0.71]), and rwOS (HR 0.64 [0.54-0.77]) compared to ibrutinib. Zanubrutinib also had significantly improved rwTTD (HR 0.86 [0.78-0.94]), rwTTNT (HR 0.87 [0.78-0.96]), and rwOS (HR 0.77 [0.66-0.88]) compared to acalabrutinib. Similar patterns were observed when stratified by age group over 65.</p><p><strong>Conclusions: </strong>These findings demonstrate that zanubrutinib is associated with improved real-world outcomes compared with other cBTK inhibitors.</p>","PeriodicalId":44205,"journal":{"name":"Oncology and Therapy","volume":" ","pages":"995-1010"},"PeriodicalIF":3.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13574742/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148296707","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"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":"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":"1043-1057"},"PeriodicalIF":3.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13575021/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148580525","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"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":"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^-5) 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":"1025-1041"},"PeriodicalIF":3.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13575011/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148340639","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}