Annals of Oncology最新文献

{"title":"SKYSCRAPER-03: a phase III study of tiragolumab plus atezolizumab versus durvalumab in locally advanced, unresectable, stage III NSCLC after platinum-based concurrent chemoradiation☆","authors":"H.A. Wakelee,&nbsp;M.-J. Ahn,&nbsp;J. Bradley,&nbsp;S. Popat,&nbsp;K. Kelly,&nbsp;A.-M. Baird,&nbsp;O. Ozyilkan,&nbsp;J. Yu,&nbsp;S.Y. Lee,&nbsp;N. Yanagitani,&nbsp;M. Johnson,&nbsp;A. Sánchez-Hernández,&nbsp;A. Szczesna,&nbsp;K. Cuppens,&nbsp;E. Yao,&nbsp;C. Parsons,&nbsp;C. Matheny,&nbsp;Z. Zhang,&nbsp;M.N. White,&nbsp;J.J. Hsu,&nbsp;R. Dziadziuszko","doi":"10.1016/j.annonc.2026.07.414","DOIUrl":"10.1016/j.annonc.2026.07.414","url":null,"abstract":"<div><h3>Background</h3><div>SKYSCRAPER-03 (NCT04513925) was a phase III, open-label, randomized study that evaluated consolidation therapy with tiragolumab plus atezolizumab versus durvalumab in patients with locally advanced, unresectable, stage III, non-small-cell lung cancer (NSCLC) after platinum-based concurrent chemoradiation.</div></div><div><h3>Patients and methods</h3><div>Eligible patients were randomly assigned (1 : 1) to receive either atezolizumab [1680 mg every 4 weeks (Q4W)] plus tiragolumab (840 mg Q4W) on day 1 of each cycle or durvalumab (10 mg/kg every 2 weeks or 1500 mg Q4W for those ≥30 kg body weight) on days 1 and 15 of each cycle for 13 × 28-day cycles. The primary endpoint was Independent Review Facility (IRF)-assessed progression-free survival (PFS) in patients with programmed death-ligand 1 (PD-L1)-positive (tumor cells ≥1%) NSCLC. Key secondary endpoints were overall survival (OS) and safety.</div></div><div><h3>Results</h3><div>The PD-L1 all-comers population included 413 patients randomly assigned to tiragolumab plus atezolizumab and 416 to durvalumab; the PD-L1-positive population included 209 and 210 patients in each arm, respectively. After a median follow-up of 33.0 months, median IRF-assessed PFS in PD-L1-positive patients was 19.4 months with tiragolumab plus atezolizumab compared with 16.6 months with durvalumab [stratified hazard ratio (HR) 0.96, 95% confidence interval (CI) 0.75-1.23, <em>P</em> = 0.76]; median PFS in PD-L1 all-comers was 14.2 compared with 13.8 months, respectively (stratified HR 1.00, 95% CI 0.84-1.19). The median OS in PD-L1-positive patients was not estimable with tiragolumab plus atezolizumab compared with 54.8 months with durvalumab (stratified HR 0.99, 95% CI 0.73-1.34); in PD-L1 all-comers, the median OS was 45.6 compared with 45.8 months, respectively (stratified HR 0.98, 95% CI 0.80-1.20). The safety profile of the combination was consistent with prior observations and there were no new or unexpected findings.</div></div><div><h3>Conclusions</h3><div>The primary endpoint of the SKYSCRAPER-03 study was not met. Tiragolumab plus atezolizumab was tolerated but did not offer additional benefit over durvalumab.</div></div>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":"37 11","pages":"Pages 1513-1523"},"PeriodicalIF":80.4,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148682743","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adjuvant olaparib in germline BRCA carriers: new certainties and remaining open questions from the updated OlympiA results","authors":"L. Arecco,&nbsp;M. Lambertini","doi":"10.1016/j.annonc.2026.09.006","DOIUrl":"10.1016/j.annonc.2026.09.006","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":"37 11","pages":"Pages 1453-1456"},"PeriodicalIF":80.4,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148987709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Eight-year outcomes of testosterone suppression plus enzalutamide or a nonsteroidal antiandrogen for metastatic hormone-sensitive prostate cancer (ENZAMET; ANZUP 1304)","authors":"A.Y. Zhang,&nbsp;H. Thomas,&nbsp;S. Begbie,&nbsp;L. Cheung,&nbsp;K.N. Chi,&nbsp;S. Chowdhury,&nbsp;M. Frydenberg,&nbsp;C. Herberstein,&nbsp;L.G. Horvath,&nbsp;A.M. Joshua,&nbsp;N.J. Lawrence,&nbsp;G. Marx,&nbsp;J. McCaffrey,&nbsp;R. McDermott,&nbsp;R.A. McLaughlin,&nbsp;S.A. North,&nbsp;F. Parnis,&nbsp;W. Parulekar,&nbsp;D.W. Pook,&nbsp;M.N. Reaume,&nbsp;C.J. Sweeney","doi":"10.1016/j.annonc.2026.07.412","DOIUrl":"10.1016/j.annonc.2026.07.412","url":null,"abstract":"<div><h3>Background</h3><div>We previously reported that, at median follow-ups of 34 and 68 months, enzalutamide improved overall survival (OS) compared with a first-generation nonsteroidal antiandrogen (NSAA) when used with testosterone suppression for metastatic hormone-sensitive prostate cancer (mHSPC). We now report longer-term outcomes with a focus on adverse events (AEs) and causes of death.</div></div><div><h3>Patients and methods</h3><div>Participants with mHSPC were randomly assigned (1 : 1) to receive daily enzalutamide or NSAA in addition to testosterone suppression; concurrent early docetaxel was permitted at clinician discretion. OS was the primary endpoint; secondary endpoints included progression-free survival (PFS), cause-specific survival, duration of treatment, and AEs.</div></div><div><h3>Results</h3><div>At a median follow-up of 8.1 years (97 months), deaths occurred in 285 of 563 (51%) participants assigned enzalutamide versus 337 of 562 (60%) assigned NSAA. OS was longer with enzalutamide than with NSAA [median 7.9 versus 5.8 years; OS at 8 years 50% versus 40%; hazard ratio (HR) 0.73, 95% confidence interval (CI) 0.63-0.86, <em>P</em> = 0.0001]. Clinical PFS at 8 years also favoured enzalutamide (43% versus 20%; HR 0.49, 95% CI 0.42-0.57, <em>P</em> &lt; 0.0001). Of the 622 deaths, 468 were attributed to prostate cancer, of which fewer were associated with enzalutamide than with NSAA (207 versus 261), whereas deaths attributed to other causes occurred with similar frequency in the two groups (78 versus 76). Median treatment duration was 4.8 years with enzalutamide and 1.9 years with NSAA. Of 185 of 563 (33%) participants still receiving enzalutamide at data cut-off, most (163 of 185, 88%) remain on the full 160-mg dose. Rates of grade 3-5 AEs per 100 person-years were similar between groups for cardiac (2.2 versus 2.2) and nervous system disorders (2.3 versus 2.0), with more falls observed with enzalutamide (0.70 versus 0.24).</div></div><div><h3>Conclusion</h3><div>Enzalutamide continues to provide substantial long-term OS benefit at 8 years, with sustained efficacy, maintenance of full dose in most participants, and no increase in non–prostate cancer mortality.</div></div>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":"37 11","pages":"Pages 1537-1548"},"PeriodicalIF":80.4,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148787444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Five-year outcomes of perioperative pembrolizumab for early-stage non-small-cell lung cancer from the randomized KEYNOTE-671 study","authors":"H. Wakelee,&nbsp;J.D. Spicer,&nbsp;S. Gao,&nbsp;M. Liberman,&nbsp;M. Tsuboi,&nbsp;T. Kato,&nbsp;K.-N. Chen,&nbsp;C. Dooms,&nbsp;M. Majem,&nbsp;G.L. Martinengo,&nbsp;O. Bylicki,&nbsp;D. Rodríguez-Abreu,&nbsp;B. Halmos,&nbsp;D.R. Jones,&nbsp;J.E. Chaft,&nbsp;M. Reck,&nbsp;E. Jensen,&nbsp;S.M. Keller,&nbsp;A. Samkari,&nbsp;M.C. Garassino","doi":"10.1016/j.annonc.2026.08.005","DOIUrl":"10.1016/j.annonc.2026.08.005","url":null,"abstract":"<div><h3>Background</h3><div>Adding perioperative pembrolizumab to neoadjuvant chemotherapy significantly improved event-free survival (EFS; <em>P</em> &lt; 0.001) and overall survival (OS; <em>P</em> = 0.0052) compared with neoadjuvant chemotherapy and surgery alone in participants with early-stage non-small-cell lung cancer (NSCLC) in the phase III, randomized KEYNOTE-671 study. We report results from KEYNOTE-671 after 5 years of follow-up.</div></div><div><h3>Patients and methods</h3><div>Eligible participants with previously untreated, resectable stage II, IIIA, or IIIB (N2) NSCLC were randomly assigned 1 : 1 to 4 cycles of pembrolizumab 200 mg or placebo every 3 weeks, plus platinum-doublet chemotherapy, followed by surgery, then adjuvant pembrolizumab or placebo every 3 weeks for up to 13 cycles. Dual primary endpoints were EFS per RECIST version 1.1 by investigator assessment and OS.</div></div><div><h3>Results</h3><div>Seven hundred ninety-seven participants were randomly assigned to receive pembrolizumab (<em>n</em> = 397) or placebo (<em>n</em> = 400). Median time from randomization to data cut-off (3 July 2025) was 60.4 (range 42.6-85.8) months. Five-year EFS was 49.9% [95% confidence interval (CI) 44.6-55.0] in the pembrolizumab arm and 26.5% (95% CI 21.7-31.5) in the placebo arm [hazard ratio (HR) 0.58, 95% CI 0.48-0.69]; 5-year OS was 64.6% (95% CI 59.5-69.2) and 53.6% (95% CI 48.3-58.6), respectively (HR 0.74, 95% CI 0.59-0.92). No detriment to health-related quality of life was identified in the pembrolizumab versus placebo arm with longer follow-up. Safety was consistent with the known profiles of each treatment.</div></div><div><h3>Conclusions</h3><div>After 5 years of follow-up, EFS was nearly double with perioperative pembrolizumab plus neoadjuvant chemotherapy, along with continued improvement in OS compared with neoadjuvant chemotherapy and surgery alone. The durable and clinically meaningful benefits observed support use of this treatment as a standard of care for patients with resectable, early-stage NSCLC (<span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, NCT03425643).</div></div>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":"37 11","pages":"Pages 1524-1536"},"PeriodicalIF":80.4,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148787511","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"TIGIT at a crossroads: lessons from SKYSCRAPER-03 in unresectable stage III NSCLC","authors":"Y. Zenke","doi":"10.1016/j.annonc.2026.09.004","DOIUrl":"10.1016/j.annonc.2026.09.004","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":"37 11","pages":"Pages 1461-1462"},"PeriodicalIF":80.4,"publicationDate":"2026-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148928796","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prospective circulating tumour DNA surveillance in patients with early high-risk hormone receptor positive, HER2-negative breast cancer in the TRAK-ER study.","authors":"N Cunningham, C Swift, R J Cutts, K Thomas, S Sardo Infirri, F Dalenc, F Le Du, I R Macpherson, C O'Brien, C Palmieri, P Schmid, F Legrand, J Lemonnier, R D Daber, J Zhao, E Gauthier, Afc Okines, D Lee, I Garcia-Murillas, M Robert, F Andre, N C Turner","doi":"10.1016/j.annonc.2026.10.1292","DOIUrl":"https://doi.org/10.1016/j.annonc.2026.10.1292","url":null,"abstract":"<p><strong>Background: </strong>CtDNA detection during adjuvant endocrine therapy (ET) strongly associates with recurrence in oestrogen receptor (ER) positive early breast cancer (EBC), with potential to direct switches in adjuvant treatment.</p><p><strong>Patients and methods: </strong>TRAK-ER is a multicentre study for patients with high-risk, ER-positive, HER2-negative EBC, who undergo 3 monthly ctDNA surveillance for up to 3 years during adjuvant ET. High-risk included ≥4 involved lymph nodes; tumour >5 cm; 1-3 involved lymph nodes with additional high-risk features. Upon ctDNA detection, patients have staging scans and in the absence of radiological recurrence, are randomised to receive palbociclib plus fulvestrant or standard ET. ctDNA analysis was performed using a tumour informed assay (Labcorp). We report a protocol-specified analysis of ctDNA detection during surveillance, and results of contemporaneous radiological recurrence.</p><p><strong>Results: </strong>1133 patients were registered by September 2025, 928 had panels designed (design failed in 16.1% (178/1106), and 912 started ctDNA surveillance including results from 5810 tests (median 7 per patient). ctDNA detection rate was 5.0% (45/897) in the first test, and 1.3% (66/4913) in subsequent tests (P<0.001). Patient level detection rate was 12.0% (109/912), with 1.1% (10/912) of patients having a clinical recurrence without prior ctDNA detection. Detection positively associated with nodal burden (P<0.001) and grade (P=0.04) and negatively associated with increasing time from surgery (P=0.01). Estimated cumulative ctDNA detection rate at 5 years post-surgery was 23.7% (95%CI 14.5-31.9%). In patients with ctDNA detected on the first test, 65.9% (29/44) had radiological recurrence compared to 26.6% (17/64) in patients first detected on subsequent tests (P<0.001).</p><p><strong>Conclusion: </strong>Results from TRAK-ER inform implementation of ctDNA surveillance in ER-positive EBC, including molecular relapse rates, factors associating with ctDNA detection and contemporaneous radiological recurrence. Ultrasensitive assays detecting ctDNA at low levels, are required to robustly identify patients prior to clinical recurrence. TRAK-ER is ongoing to assess the impact of treatment after molecular relapse detection.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149285005","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"CheckMate 8HW: One Checkmate, Several Moves Left.","authors":"Julien Taieb","doi":"10.1016/j.annonc.2026.10.1287","DOIUrl":"https://doi.org/10.1016/j.annonc.2026.10.1287","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149284936","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Final analysis of the Neotorch study: perioperative toripalimab in combination with chemotherapy for patients with stage Ⅱ/Ⅲ resectable non-small-cell lung cancer.","authors":"Z M Li, L Wu, W X Wang, L H Sun, P Zhang, W T Fang, Y Zheng, Q X Chen, L Yang, L J Tan, J D Mei, J L Shan, S D Xu, X H Sun, N Yang, X H Hu, G H Yu, D L Yu, Y P Chen, L G Xing, Y P Liu, H Tian, K N Chen, N Wu, L J Cao, M Zhou, H H Fang, X Zhang, J Jiang, X Y Li, M Q Kang, M H Ye, Q Sun, S Q Li, G W Wu, H P Xu, K S Zhu, A H Zhong, L M Zhu, C L Wang, Y Zhang, K C Cai, H T Ma, J Chen, H Hu, Z X Yang, W G Zhang, X S Hang, X C Zhang, J Hu, Y C Huang, J Yao, Z Y Zhang, L W Zhang, L X Liu, W H Wang, S H Wei, D Z Cao, J J Zou, S Lu","doi":"10.1016/j.annonc.2026.10.094","DOIUrl":"10.1016/j.annonc.2026.10.094","url":null,"abstract":"<p><strong>Background: </strong>Interim analysis of the Neotorch study demonstrated significant benefit in event-free survival (EFS) and major pathological response (MPR) rate for perioperative toripalimab plus chemotherapy in patients with resectable stage Ⅲ non-small-cell lung cancer (NSCLC). In this article, we report the overall final analysis results of the stage Ⅱ and Ⅲ patients in this study.</p><p><strong>Patients and methods: </strong>Eligible patients with treatment-naïve resectable stage II or stage IIIA, IIIB (N2) NSCLC were randomly assigned to receive toripalimab or placebo plus chemotherapy as neoadjuvant treatment (three cycles), adjuvant treatment (one cycle), and toripalimab or placebo monotherapy as maintenance treatment (up to 13 cycles). The primary endpoints of this study were EFS assessed by investigators and MPR evaluated by blinded independent pathologic review in stage Ⅲ patients, as well as the overall outcome in stage Ⅱ and Ⅲ patients.</p><p><strong>Results: </strong>A total of 501 patients in China were included in this randomized study (toripalimab arm: N = 250, placebo arm: N = 251). Baseline characteristics were generally balanced between the 2 arms. At the final analysis (median follow-up of 48.2 months), the investigator-assessed EFS was significantly improved in the toripalimab arm, with a stratified hazard ratio (HR) of 0.52 [95% confidence interval (CI) 0.39-0.68, stratified P < 0.0001]. The median EFS in the toripalimab arm was not reached, while it was 20.2 months in the placebo arm. The between-arm difference in MPR rate was statistically significant and clinically meaningful (47% compared with 9%, P < 0.0001). Overall survival (OS) prolongation was also statistically significant in the toripalimab arm (HR 0.66, 95% CI 0.49-0.89, P = 0.0072), with median survival not reached in either arm. The safety profile was consistent with that of the interim analysis, with no new safety signals identified.</p><p><strong>Conclusions: </strong>Perioperative toripalimab plus chemotherapy demonstrated durable and significant benefits in EFS, MPR, and OS in patients with resectable stage Ⅱ and Ⅲ NSCLC, with a manageable safety profile. GRAPHICAL ABSTRACT.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149261166","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Extended follow-up of tarlatamab in patients with small-cell lung cancer after platinum-based chemotherapy in the randomized phase III DeLLphi-304 study.","authors":"C M Rudin, M-J Ahn, M Schuler, F H Blackhall, G Mountzios, T Yoshida, L Sun, B C Cho, A Lugini, S Arulananda, S R Punekar, P Rocha, L Paz-Ares, J Mazières, M Gümüş, U Demirci, S Huang, B Abidi, U Patil, B Zhu","doi":"10.1016/j.annonc.2026.10.095","DOIUrl":"10.1016/j.annonc.2026.10.095","url":null,"abstract":"<p><strong>Background: </strong>In the DeLLphi-304 trial, at a median follow-up of <12 months, tarlatamab significantly improved overall survival (OS; P < 0.001), progression-free survival (PFS; P = 0.002), and patient-reported outcomes (PROs), and demonstrated a favorable safety profile versus chemotherapy. We report efficacy and safety outcomes after extended follow-up in patients with small-cell lung cancer (SCLC).</p><p><strong>Patients and methods: </strong>In this phase III, open-label trial, patients with SCLC whose disease had progressed on or after platinum-based chemotherapy were randomly assigned (1 : 1) to receive either tarlatamab or chemotherapy (topotecan, lurbinectedin, or amrubicin) until disease progression, unacceptable toxicity, or death. The primary endpoint was OS. Secondary endpoints included investigator-assessed PFS, objective response, disease control, duration of response per RECIST v1.1, PROs, and safety.</p><p><strong>Results: </strong>As of data cut-off (18 February 2026), median OS was 13.6 and 8.4 months with tarlatamab and chemotherapy, respectively (median follow-up, 23.3 and 22.8 months). Median PFS was 4.2 and 3.2 months, respectively (median follow-up, 22.2 and 21.9 months). Kaplan-Meier estimated OS rates at 12 and 24 months were 55.9% and 30.3% with tarlatamab versus 39% and 14.9% with chemotherapy; corresponding PFS rates at 12 and 24 months were 20.6% and 14.2% versus 5.9% and 2.3%. Objective response rate was 35.4% with tarlatamab, including six confirmed complete responses versus 20.4% with chemotherapy; at data cut-off, ongoing responses were observed in 31.1% (28 of 90) versus 3.8% (2 of 52) of responders, respectively. Sustained disease control for ≥52 weeks was observed in 24.4% versus 4.3%. Treatment-related adverse events (TRAEs) led to treatment discontinuation in 3.2% versus 6.6%; grade ≥3 events decreased over time, with no serious TRAEs with onset ≥12 months. Cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome occurred early in treatment and were predominantly low grade.</p><p><strong>Conclusions: </strong>With extended follow-up, tarlatamab continues to demonstrate sustained and durable clinical benefit and a favorable long-term tolerability profile versus chemotherapy, in patients with SCLC after first-line platinum-based chemotherapy, supporting its use as the standard of care in this setting.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13718749/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149261161","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of risvutatug rezetecan versus gemcitabine plus docetaxel in relapsed/refractory advanced osteosarcoma: Primary results from the ARTEMIS-011 phase 3 trial.","authors":"L Xie, W Yao, Y Hua, W Luo, C Tu, J Wang, J Chen, B Li, D Zhu, X Li, Y Xiao, J Ma, H Hu, M Fang, Z Huang, H Wang, Q Liu, Y Jin, X Zhang, X Niu, X Tang","doi":"10.1016/j.annonc.2026.10.1284","DOIUrl":"https://doi.org/10.1016/j.annonc.2026.10.1284","url":null,"abstract":"<p><strong>Background: </strong>Patients with relapsed/refractory (R/R) osteosarcoma have a poor prognosis and high unmet needs for effective therapies. Herein, we report primary results from ARTEMIS-011, the multicenter, open-label, randomized phase 3 trial of risvutatug rezetecan (Ris-Rez), a B7-H3-directed antibody-drug conjugate, in Chinese patients with R/R osteosarcoma after ≥2 prior lines of systemic treatment.</p><p><strong>Patients and methods: </strong>Patients (≥12 years) were randomized 2:1 to Ris-Rez 12.0 mg/kg or gemcitabine plus docetaxel (GD), every 3 weeks, stratified by age and lung metastasis. The primary endpoint was progression-free survival (PFS) by blinded independent central review (BICR); secondary endpoints included overall survival (OS) and safety.</p><p><strong>Results: </strong>At data cutoff (June 17, 2026), 80 patients were treated with Ris-Rez and 42 with GD; median follow-up was 7.1 months. Median age was 21 years (IQR, 17-34) with 31 (25%) adolescents (12 to <18 years). BICR-assessed PFS significantly improved with Ris-Rez compared with GD (median, 5.5 vs 1.4 months; HR, 0.33; 95% CI, 0.20-0.55; P<0.0001). OS data were immature, with a HR of 0.51 (95% CI, 0.21-1.23). With longer treatment duration with Ris-Rez than GD (median, 4.5 vs 1.5 months), adverse events (AEs) were reported in all patients. No treatment-related AEs (TRAEs) led to death. Grade ≥ 3 TRAEs occurred in 93% of patients with Ris-Rez and 83% with GD, and serious TRAEs in 64% versus 29%, which were predominantly hematologic. TRAEs led to dose reductions in 71% versus 26% of patients with Ris-Rez versus GD, respectively, and permanent discontinuation was infrequent (3.8% vs 2.4%).</p><p><strong>Conclusions: </strong>In ARTEMIS-011, Ris-Rez demonstrated a statistically significant and clinically meaningful improvement in BICR-assessed PFS compared to GD, alongside a numerical trend toward improved OS and manageable safety profile with dose modifications and supportive care, offering a promising new treatment option for patients with R/R advanced osteosarcoma.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149261070","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}