Targeted Oncology最新文献

{"title":"Vibostolimab Coformulated with Pembrolizumab Plus Chemotherapy as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer.","authors":"Jacob Sands, Shun Lu, Joachim G Aerts, Martin Reck, Alejandro Navarro, Talia Shentzer Kutiel, Nir Peled, Ignacio Casarini, Samuel J Kerr, Toshiaki Takahashi, Ahmet Bilici, Ying Cheng, Mengzhao Wang, Shin Yup Lee, Anna Łowczak, Julien Mazieres, Haixia Hu, Jianyu Wu, Himani Aggarwal, Hazem El-Osta, Luis Paz-Ares","doi":"10.1007/s11523-026-01237-w","DOIUrl":"https://doi.org/10.1007/s11523-026-01237-w","url":null,"abstract":"<p><strong>Background: </strong>Vibostolimab, an anti-T-cell immunoreceptor with immunoglobulin and ITIM domains (TIGIT) antibody, showed antitumor activity with pembrolizumab in non-small-cell lung cancer.</p><p><strong>Objective: </strong>The KEYVIBE-008 study evaluated vibostolimab coformulated with pembrolizumab (vibostolimab/pembrolizumab) plus etoposide and platinum-based chemotherapy (EP) versus atezolizumab plus EP as first-line therapy for extensive-stage small-cell lung cancer.</p><p><strong>Methods: </strong>Participants aged ≥18 years with untreated extensive-stage small-cell lung cancer were randomized 1:1 to vibostolimab/pembrolizumab (200 mg each) or atezolizumab (1200 mg) every 3 weeks, with EP and cisplatin/carboplatin for the first four cycles. The primary endpoint was overall survival. The prespecified interim analysis included a non-binding futility analysis of overall survival (futility threshold for actual number of events, P = 0.4816).</p><p><strong>Results: </strong>Four hundred and sixty participants were randomized (both arms, n = 230). Median time from randomization to data cutoff (4 June, 2024) was 16.6 (range 11.3‒26.1) months. The prespecified futility criterion for overall survival was met (hazard ratio 1.26; 95% confidence interval 1.00‒1.59; P = 0.9762). There was no difference in progression-free survival (hazard ratio 1.01; 95% confidence interval 0.82‒1.23) or objective response rates (71.7% with vibostolimab/pembrolizumab vs 74.8% with atezolizumab). Grade ≥3 treatment-related adverse events occurred in 66.8% of participants treated with vibostolimab/pembrolizumab and 57.2% treated with atezolizumab. Immune-mediated adverse events and infusion reactions occurred in 39.3% and 29.7% of participants, respectively.</p><p><strong>Conclusions: </strong>In this interim analysis of vibostolimab/pembrolizumab plus EP versus atezolizumab plus EP as first-line therapy for extensive-stage small-cell lung cancer, the prespecified futility criterion for overall survival was met. Grade ≥3 treatment-related adverse events and immune-mediated adverse events were more frequent with vibostolimab/pembrolizumab versus atezolizumab. Given the overall benefit/risk profile, treatment with vibostolimab/pembrolizumab was discontinued.</p><p><strong>Clinical trial registration: </strong>Clinicaltrials.gov, NCT05224141.</p>","PeriodicalId":22195,"journal":{"name":"Targeted Oncology","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2026-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149228559","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":"Adjuvant Systemic Therapies After Nephrectomy for Renal Cell Carcinoma: A Bayesian Network Meta-Analysis and Multi-Criteria Benefit-Risk Assessment.","authors":"Shugo Yajima, Gaku Okumura, Soichiro Yoshida, Hiroshi Fukushima, Hiroyuki Sato, Akihiro Hirakawa, Toshiki Kijima, Hitoshi Masuda, Yasuhisa Fujii","doi":"10.1007/s11523-026-01260-x","DOIUrl":"https://doi.org/10.1007/s11523-026-01260-x","url":null,"abstract":"<p><strong>Background: </strong>Adjuvant pembrolizumab has improved disease-free survival after nephrectomy for high-risk renal cell carcinoma, and pembrolizumab plus belzutifan has further expanded the treatment landscape.</p><p><strong>Objective: </strong>We compared efficacy and treatment burden across adjuvant systemic therapies and examined the benefit-risk trade-off of the combination.</p><p><strong>Methods: </strong>Randomized trials of systemic therapy after nephrectomy were synthesized using a Bayesian network meta-analysis. Disease-free survival hazard ratios were converted to illustrative 2-year estimates using a common pembrolizumab baseline. Observed differences in 2-year disease-free survival, grade 3 or higher adverse events, and treatment discontinuation came from LITESPARK-022. Using these data, a multi-criteria decision analysis examined how outcome weighting affected the balance between the two regimens.</p><p><strong>Results: </strong>Six randomized datasets formed a tree-shaped network of eight regimens. In LITESPARK-022, adding belzutifan yielded approximately seven additional disease-free patients per 100 treated, but also approximately 22 additional patients with grade 3 or higher adverse events and 15 additional treatment discontinuations. Under the primary decision-analytic assumptions, the combination had the higher net-benefit score only when disease-free survival received roughly two thirds of the decision weight (threshold 0.68; range 0.47-0.79 across sensitivity analyses). Most comparisons relied on a single dataset, and overall survival and patient-reported outcomes remained immature.</p><p><strong>Conclusions: </strong>Adding belzutifan to pembrolizumab improved disease-free survival but increased toxicity and treatment discontinuation. The decision analysis illustrates a model-dependent trade-off rather than identifying a preferred regimen. Because overall survival data are immature, the decision to intensify treatment remains risk and preference sensitive.</p><p><strong>Prospero registration: </strong>CRD420261454205.</p>","PeriodicalId":22195,"journal":{"name":"Targeted Oncology","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2026-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149216716","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":"Association of TP53 Truncating Mutations with Time to Treatment Failure after First-Line Chemoimmunotherapy in HER2-Mutant Non-Small Cell Lung Cancer.","authors":"Akihiro Yoshimura, Juichiro Yoshida, Chieko Takumi, Koichi Takayama","doi":"10.1007/s11523-026-01263-8","DOIUrl":"https://doi.org/10.1007/s11523-026-01263-8","url":null,"abstract":"<p><strong>Background: </strong>Biomarkers associated with first-line chemoimmunotherapy outcomes in HER2-mutant non-small cell lung cancer (NSCLC) remain incompletely characterized.</p><p><strong>Objective: </strong>To evaluate whether TP53 truncating mutations are associated with clinical outcomes after first-line pembrolizumab plus pemetrexed-platinum in patients with HER2-mutant NSCLC.</p><p><strong>Patients and methods: </strong>We conducted a retrospective clinicogenomic study using the nationwide Center for Cancer Genomics and Advanced Therapeutics (C-CAT) database. Patients with advanced or recurrent HER2-mutant NSCLC who received first-line pembrolizumab plus pemetrexed-platinum were included. The primary endpoint was time to treatment failure (TTF).</p><p><strong>Results: </strong>Among 69 patients, 21 (30.4%) harbored TP53 truncating mutations. Patients with TP53 truncating mutations had shorter TTF than those without TP53 truncating mutations (median, 6.0 versus 7.6 months; hazard ratio [HR], 1.97; 95% confidence interval [CI] 1.11-3.49; log-rank P = 0.018). The 9-month TTF rates were 4.8% and 40.6%, respectively. After adjustment for age, Eastern Cooperative Oncology Group performance status, and programmed death-ligand 1 tumor proportion score, TP53 truncating mutations remained associated with shorter TTF (HR, 1.98; 95% CI 1.08-3.63; P = 0.026). No significant differences were observed in overall survival or objective response rate.</p><p><strong>Conclusions: </strong>TP53 truncating mutations were associated with shorter TTF during first-line pembrolizumab plus pemetrexed-platinum in HER2-mutant NSCLC, without significant differences in overall survival or objective response rate. These findings suggest a potential association with shorter treatment durability and require validation in independent cohorts.</p>","PeriodicalId":22195,"journal":{"name":"Targeted Oncology","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2026-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149216676","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":"A Podcast on Osimertinib After CRT in Unresectable Stage III EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC): Current and Future Perspectives.","authors":"Thanyanan Reungwetwattana, Kristin A Higgins, Ignacio Casarini, Suresh S Ramalingam","doi":"10.1007/s11523-026-01250-z","DOIUrl":"https://doi.org/10.1007/s11523-026-01250-z","url":null,"abstract":"<p><p>Epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) disease biology may differ from EGFR-wild type NSCLC, with an increased risk of distant metastases in unresectable stage III EGFRm NSCLC. Osimertinib is an established first treatment for patients with EGFRm advanced NSCLC, effectively treating EGFRm tumours. The phase III LAURA study, which assessed the efficacy and safety of osimertinib for patients with locally advanced, unresectable stage III EGFRm NSCLC who completed chemoradiotherapy (CRT) without disease progression, demonstrated a statistically significant improvement with osimertinib in progression-free survival (PFS), with a median PFS of 39.1 months, versus 5.6 months with placebo. The safety profile was as expected based on the known profiles of osimertinib and CRT. On the basis of the LAURA results, osimertinib has now been approved for the treatment of unresectable stage III EGFRm NSCLC. Given the implementation of the LAURA regimen in multiple countries, this podcast highlights the potential challenges that must be considered by healthcare professionals when administering osimertinib in clinical practice, and how these may be mitigated. Considerations of the impact of the 'treat-to-progression' approach, a paradigm shift for the treatment of stage III unresectable NSCLC, and patient-centred care, including the importance of shared decision-making, will also be discussed. Overall, continuous systemic treatment post-CRT may be key to improving long-term outcomes and represents a mindset shift for both healthcare professionals and patients. Therefore, we may need to consider unresectable stage III EGFRm NSCLC as a chronic disease, requiring long-term treatment to maintain suppression of disease.The podcast and transcript can be viewed below the abstract of the online version of the manuscript. Alternatively, the podcast can be downloaded here:  https://doi.org/ https://doi.org/10.6084/m9.figshare.33191613 . Supplementary file1 (MP4 306769 KB).</p>","PeriodicalId":22195,"journal":{"name":"Targeted Oncology","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2026-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149184442","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":"Comment on: \"First-in-Human Phase I Study of KPT-9274, a First-in-Class Dual Inhibitor of PAK4 and NAMPT, in Patients with Advanced Solid Malignancies\".","authors":"Reza Izadpanah, Eckhard U Alt","doi":"10.1007/s11523-026-01258-5","DOIUrl":"https://doi.org/10.1007/s11523-026-01258-5","url":null,"abstract":"","PeriodicalId":22195,"journal":{"name":"Targeted Oncology","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149128715","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":"Perspectives on 10 years of Immune Checkpoint Inhibitors in Merkel Cell Carcinoma: A Podcast.","authors":"Shailender Bhatia, Sandra D'Angelo, Paul Nghiem","doi":"10.1007/s11523-026-01256-7","DOIUrl":"https://doi.org/10.1007/s11523-026-01256-7","url":null,"abstract":"<p><p>Merkel cell carcinoma (MCC) is a rare and aggressive skin cancer with a poor prognosis, particularly in patients with advanced disease. The introduction of immune checkpoint inhibitors (ICIs) approximately 10 years ago has dramatically improved outcomes for patients with advanced MCC. Current US Food and Drug Administration-approved ICIs in this setting include the PD-L1 inhibitor avelumab and PD-1 inhibitors pembrolizumab and retifanlimab. In this podcast, we summarize key studies of ICIs in advanced MCC, including clinical trials and real-world studies, and discuss clinical evidence related to practical considerations, such as elective discontinuation of ICI treatment, and treatment of patients with immunocompromised or immunosuppressed status. We also discuss initial findings from studies of ICI-based combinations in patients with advanced MCC and ICI treatment in earlier stages of MCC, and highlight the emerging role of circulating tumor DNA for predicting disease recurrence. Overall, these developments demonstrate the positive impact of ICIs in the treatment of MCC and illustrate ongoing efforts to further improve patient outcomes.</p>","PeriodicalId":22195,"journal":{"name":"Targeted Oncology","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149128818","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":"Beyond Contraindication-Based Selection: The Unmet Need for Predictive Biomarkers in First-Line Immunotherapy for Advanced HCC.","authors":"Alireza Tojjari, Anwaar Saeed","doi":"10.1007/s11523-026-01259-4","DOIUrl":"https://doi.org/10.1007/s11523-026-01259-4","url":null,"abstract":"<p><p>Three immunotherapy-based regimens are now approved for first-line treatment of advanced hepatocellular carcinoma: atezolizumab plus bevacizumab, durvalumab plus tremelimumab (STRIDE), and nivolumab plus ipilimumab. Although each has demonstrated an overall survival benefit in a pivotal phase III trial, no randomized study has directly compared these regimens and no validated clinical or molecular biomarker identifies which patients derive differential benefit from one strategy over another. Current selection therefore remains driven primarily by hepatic and functional reserve, regimen-specific safety constraints, and treatment feasibility. In this Current Opinion, we propose a practical selection framework, examine emerging evidence in patients with Child-Pugh B liver function, and emphasize that current sequencing evidence does not establish a preferred first-line immunotherapy combination. We further discuss why predictive biomarker development in advanced hepatocellular carcinoma has repeatedly failed to translate, including limited tissue availability, tumor and liver-disease heterogeneity, prognostic confounding, and reliance on single-treatment cohorts rather than treatment-by-biomarker interaction analyses. We propose that the most promising future selection tools will integrate tumor immune state with angiogenic, myeloid, and circulating molecular features and be prospectively tested across competing regimens and treatment sequences.</p>","PeriodicalId":22195,"journal":{"name":"Targeted Oncology","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2026-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149115095","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":"Correction: Regorafenib as Second-Line Versus Later-Line Therapy in Advanced Hepatocellular Carcinoma: A Multicenter Real-World Study with Exploratory Analysis of Prior Immune Checkpoint Inhibitor Exposure.","authors":"Kwon Yong Tak, Hee Sun Cho, Jaejun Lee, Kyeungmo Yang, Ahlim Lee, Ji Won Han, Soon Kyu Lee, Hyun Yang, Heechul Nam, Hee Yeon Kim, Sung Won Lee, Seok-Hwan Kim, Do Seon Song, Myeong Jun Song, Jung Hyun Kwon, UIm Chang, Soon Woo Nam, Chang Wook Kim, Jeong Won Jang, Si Hyun Bae, Hae Lim Lee, Pil Soo Sung","doi":"10.1007/s11523-026-01255-8","DOIUrl":"https://doi.org/10.1007/s11523-026-01255-8","url":null,"abstract":"","PeriodicalId":22195,"journal":{"name":"Targeted Oncology","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2026-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149115093","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":"Prevalence of PD-L1-High Tumor Expression and Association with First-Line Treatment Outcomes in Patients with Metastatic Urothelial Carcinoma: Results from a Prospective Observational Cohort Study.","authors":"Petros Grivas, Piyush K Agarwal, Hikmat Al-Ahmadie, Terence Friedlander, Daniel M Geynisman, Yair Lotan, Alicia K Morgans, Fernando J Bianco, Sreenivasa Chandana, Bruno Fang, Michael Large, Joshua J Meeks","doi":"10.1007/s11523-026-01257-6","DOIUrl":"https://doi.org/10.1007/s11523-026-01257-6","url":null,"abstract":"<p><strong>Background: </strong>Programmed death-ligand 1 (PD-L1) expression has been studied extensively in clinical trials of metastatic urothelial carcinoma.</p><p><strong>Objective: </strong>We aimed to provide information on the prevalence of tumor PD-L1 expression and treatment outcomes in patients with metastatic urothelial carcinoma in a real-world setting.</p><p><strong>Methods: </strong>PREVAIL (NCT03788746) enrolled patients with metastatic urothelial carcinoma undergoing systemic first-line treatment at US community oncology practices. The primary endpoint was the prevalence of pretreatment tumor PD-L1-high expression using an immunohistochemistry antibody for PD-L1 (SP263) [Roche Diagnostics]. Secondary endpoints included treatment patterns and association between PD-L1 expression and objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).</p><p><strong>Results: </strong>Among 139 patients, the pretreatment prevalence of PD-L1-high expression was 53.2% (95% confidence interval 44.6-61.7). Forty-seven patients (33.8%) received anti-PD-L1/anti-programmed death 1 agents alone as first-line therapy. In all evaluable patients, ORR was 50.9%, median PFS was 15.1 months, and median OS was 25.4 months from the first dose of first-line therapy. There was no significant difference in PFS (hazard ratio 0.72; 95% confidence interval 0.34-1.52; p = 0.385) or OS (hazard ratio 0.71; 95% confidence interval 0.44-1.15; p = 0.164) in patients with pretreatment PD-L1-high versus PD-L1-low expression. Objective response rate was similar between patients with PD-L1-high (17/33; 51.5%) and PD-L1-low (12/24; 50.0%) expression.</p><p><strong>Conclusions: </strong>In this observational study, more than half of patients had high pretreatment tumor PD-L1 expression. There was no significant association between PD-L1 status and ORR, PFS, or OS with any first-line therapy, although definitive conclusions cannot be made because of the limited sample size.</p>","PeriodicalId":22195,"journal":{"name":"Targeted Oncology","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2026-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149115048","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":"Outcomes by Body Mass Index in Patients With B-Cell Precursor Acute Lymphoblastic Leukemia Treated with Inotuzumab Ozogamicin.","authors":"Wendy Stock, Ryan D Cassaday, Daniel J DeAngelo, Anjali Advani, Nicola Gokbuget, Josep Ribera, Wei Jiang, Susana Pulido, Erik Vandendries, Nathan Braniff, Elias Jabbour, Hagop Kantarjian","doi":"10.1007/s11523-026-01253-w","DOIUrl":"10.1007/s11523-026-01253-w","url":null,"abstract":"<p><strong>Background: </strong>Inotuzumab ozogamicin (lnO) is approved for the treatment of adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia. Elevated body mass index (BMI) could be associated with worse outcomes.</p><p><strong>Objective: </strong>To conduct post hoc BMI-stratified efficacy/safety analyses of lnO.</p><p><strong>Patients and methods: </strong>Pooled data from phase 1-4 InO trials were analyzed, with patients grouped by BMI: < 25 kg/m² (normal), 25-30 kg/m² (overweight), and > 30 kg/m² (obese), including a subset of morbidly obese (> 40 kg/m²) patients. Descriptive analyses included efficacy, safety, and pharmacokinetic simulations for InO.</p><p><strong>Results: </strong>Across 338 patients, complete remission (CR) or CR with incomplete count recovery (CRi) was achieved in 69.7%, 75.9%, 68.7%, and 84.6% patients in the < 25, 25-30, > 30, and > 40 kg/m² subgroups, respectively. The 24-month probability of progression-free survival was 19.9%, 12.8%, 10.9%, and 23.1%; the 24-month overall survival probability was 28.1%, 22.1%, 17.5%, and 23.1% in these subgroups, respectively. Most deaths were due to progressive disease. Most patients experienced treatment-emergent adverse events (TEAEs), with similar incidence across subgroups. The most common grade ≥ 3 TEAE was neutropenia (36.1%), with sinusoidal obstruction syndrome (SOS) observed in 8.3%. 143 patients (42%) proceeded to hematopoietic stem cell transplant (HSCT) after lnO treatment, with 31 (21.7%) experiencing post-HSCT SOS; the BMI > 40 kg/m² subgroup (n = 7 receiving HSCT) had the numerically highest post-HSCT non-relapse mortality. In simulations for dose capping (capped maximum dose), exposure metrics were similar across subgroups with/without dose capping.</p><p><strong>Conclusion: </strong>Efficacy/safety outcomes with InO were consistent across BMI subgroups. Dose-capping does not appear to be required.</p>","PeriodicalId":22195,"journal":{"name":"Targeted Oncology","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148983141","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}