First-Line Serplulimab in Extensive-Stage Small Cell Lung Cancer: Secondary Analysis of the ASTRUM-005 Phase 3 Randomized Clinical Trial.
Key Points: Question: What are the long-term efficacy and safety outcomes of adding serplulimab to first-line chemotherapy for previously untreated extensive-stage small cell lung cancer (ES-SCLC)? Findings: In this secondary analysis of an international, double-blind, phase 3 randomized clinical tr...
| Publicado en: | JAMA Oncology Vol. 12; no. 8; pp. 810 - 819 |
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| Autores principales: | , , , , , , , , , , , , , , , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
American Medical Association
Aug2026
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=196379883&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 196379883 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 23742437 I6NW jtl: JAMA Oncology issn: 23742437 maglogo: N pubinfo: dt: Aug2026 vid: 12 iid: 8 pid: 30 pub: American Medical Association place: Chicago, Illinois artinfo: ui: 196379883 196379883 196379883 10.1001/jamaoncol.2026.1645 196379883 ppf: 810 ppct: 9 formats: tig: atl: First-Line Serplulimab in Extensive-Stage Small Cell Lung Cancer: Secondary Analysis of the ASTRUM-005 Phase 3 Randomized Clinical Trial. aug: au: Liu, Jingjing Han, Liang Wu, Lin Chen, Jun Sun, Hongmei Wen, Guilan Ji, Yinghua Shi, Jianhua Pan, Zhijie Shi, Jinsheng Wang, Xicheng Bai, Yuansong Pan, Yueyin Min, Xuhong Viguro, Maksym Li, Xingya Zhao, Yanqiu Yang, Junquan Makharadze, Tamta Arkania, Ekaterine affil: Department of Oncology, Jilin Cancer Hospital, Changchun, Jilin, China sug: subj: Carcinoma, Small Cell Drug Therapy Lung Neoplasms Drug Therapy Antibodies, Monoclonal Therapeutic Use Antineoplastic Agents, Combined Therapeutic Use Drug Efficacy Evaluation Patient Safety Evaluation Patient-Reported Outcomes Tumor Markers, Biological Chemotherapy, Cancer Scales Human Cancer Patients Secondary Analysis Male Female Adult Middle Age Aged Questionnaires China Russia Ukraine Poland Turkiye Georgia Prospective Studies Administration, Intravenous Antibodies, Monoclonal Administration and Dosage Placebos Administration and Dosage Comparative Studies Carboplatin Administration and Dosage Etoposide Administration and Dosage Overall Survival Odds Ratio Adverse Drug Event Progression-Free Survival Funding Source Descriptive Statistics Data Analysis Software Kaplan-Meier Estimator Confidence Intervals Neoplasm Metastasis Recovery Alopecia Immunotherapy Adult: 19-44 years Middle Aged: 45-64 years Aged: 65+ years Male Female ab: Key Points: Question: What are the long-term efficacy and safety outcomes of adding serplulimab to first-line chemotherapy for previously untreated extensive-stage small cell lung cancer (ES-SCLC)? Findings: In this secondary analysis of an international, double-blind, phase 3 randomized clinical trial of 585 patients with ES-SCLC, serplulimab plus chemotherapy substantially improved overall survival compared with placebo plus chemotherapy, with longer median overall survival and higher 4-year survival rates. Long-term safety was manageable, with no new safety signals. Meaning: The findings of this secondary analysis support serplulimab combined with chemotherapy as an effective first-line, standard of care option that provides a durable survival benefit in ES-SCLC. Importance: The ASTRUM-005 phase 3 randomized clinical trial showed substantial survival benefit from adding serplulimab to chemotherapy for previously untreated extensive-stage small cell lung cancer (ES-SCLC). However, the long-term outcomes are unclear. Objective: To investigate the efficacy, safety, patient-reported outcomes (PROs), and exploratory biomarker findings from ASTRUM-005 at an extended follow-up. Design, Setting, and Participants: This international, double-blind, phase 3 randomized clinical trial enrolled patients from September 12, 2019, to April 27, 2021 in China, Russia, Ukraine, Poland, Turkey, and Georgia. Eligible patients had histologically or cytologically confirmed ES-SCLC with no prior systemic therapy. Patients were followed up through May 7, 2024, and the data analysis of this prespecified, secondary analysis lasted from August to September 2024. The median follow-up duration was 42.4 months (range, 0.2-55.2). Exposures: Patients were randomized in a 2:1 ratio to receive intravenous serplulimab (4.5 mg/kg; serplulimab group) or placebo (placebo group), which was combined with up to 4 cycles of carboplatin and etoposide every 3 weeks. Main outcomes and measures: The primary end point was overall survival (OS). Secondary end points included other efficacy end points, safety, and PROs. Results: A total of 585 patients (median [range] age was 63 [28-76] years in the serplulimab group and 62 [31-83] years in the placebo group) with previously untreated ES-SCLC, and 389 (66.5%) were randomly assigned to the serplulimab group and 196 (33.5%) to the placebo group. Baseline characteristics were balanced across treatment groups. At data cutoff, 280 OS events (72.0%) in the serplulimab group and 166 (84.7%) in the placebo group were observed. Compared with the placebo group, the serplulimab group showed more favorable efficacy (median OS, 15.8 [95% CI, 13.9-17.4] vs 11.1 [95% CI, 10.0-12.4] months; hazard ratio, 0.60; 95% CI, 0.49-0.73; P <.001). The serplulimab group showed improved OS rates at 4 years compared with the placebo group (21.9% vs 7.2%). Grade 3 or higher serplulimab-related or placebo-related treatment-emergent adverse events occurred for 136 (35.0%) and 57 patients (29.1%) in the respective groups. A PRO analysis revealed consistent trends of improved overall health, dyspnea, and pain in both groups and faster recovery from alopecia in the serplulimab group. Conclusions and Relevance: This secondary analysis of a randomized clinical trial demonstrated long-term benefit from adding serplulimab to chemotherapy for previously untreated patients with ES-SCLC, supporting this therapy as a first-line standard of care for this patient population. Trial Registration: ClinicalTrials.gov Identifier: NCT04063163 This randomized clinical trial examines the efficacy, safety, and patient-reported outcomes of adding serplulimab to chemotherapy for patients with extensive-stage small cell lung cancer. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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