SKYSCRAPER-02: Tiragolumab in Combination With Atezolizumab Plus Chemotherapy in Untreated Extensive-Stage Small-Cell Lung Cancer
Year: 2023
Type: article
Study design: Clinical Trial
Abstract: PURPOSE The phase III SKYSCRAPER-02 study determined whether the benefits of atezolizumab plus carboplatin and etoposide (CE) could be enhanced by the addition of tiragolumab in untreated extensive-stage small-cell lung cancer (ES-SCLC). We report final progression-free survival (PFS) and overall survival (OS) analyses. METHODS Patients received tiragolumab 600 mg/placebo, plus atezolizumab 1,200 mg and CE (four cycles), then maintenance tiragolumab/placebo plus atezolizumab. Primary end points were investigator-assessed PFS and OS in patients without history/presence of brain metastases (primary analysis set [PAS]). Additional end points included PFS and OS in all patients regardless of brain metastases status (full analysis set [FAS]), response, and safety. RESULTS Four hundred ninety patients were randomly assigned (FAS): 243 to tiragolumab arm and 247 to control arm. At the cutoff date (February 6, 2022; median duration of follow-up, 14.3 months [PAS] and 13.9 months [FAS]), final analysis of PFS in the PAS (n = 397) did not reach statistical significance (stratified hazard ratio [HR], 1.11; P = .3504; median, 5.4 months tiragolumab v 5.6 months control). At the cutoff date (September 6, 2022; median duration of follow-up, 21.2 months [FAS]), median OS in the PAS at final OS analysis was 13.1 months in both arms (stratified HR, 1.14; P = .2859). Median PFS and OS in the FAS were consistent with the PAS. The proportion of patients with immune-mediated adverse events (AEs) in the tiragolumab and control arms was 54.4% and 49.2%, respectively (grade 3/4: 7.9% and 7.7%). AEs leading to treatment withdrawal occurred in 8.4% and 9.3% of tiragolumab- and control-treated patients, respectively. CONCLUSION Tiragolumab did not provide additional benefit over atezolizumab and CE in untreated ES-SCLC. The combination was well tolerated with no new safety signals.
Source: Journal of Clinical Oncology
DOI: 10.1200/jco.23.01363
Authors: Charles M. Rudin, Stephen V. Liu, Ross A. Soo, Shun Lu, Min Hee Hong, Jong-Seok Lee, Maciej Bryl, Daphne W. Dumoulin, Achim Rittmeyer, Chao-Hua Chiu, Ozgur Ozyilkan, Melissa Johnson, Alejandro Navarro, Silvia Novello, Yuichi Ozawa, Sammi Hiu Tam, Namrata S. Patil, Xiaohui Wen, Meilin Huang, Tien Hoang, Raymond Meng, Martin Reck
Institutions: Memorial Sloan Kettering Cancer Center, Georgetown University, National University Cancer Institute, Singapore, Shanghai Jiao Tong University, Shanghai Chest Hospital, Severance Hospital, Yonsei Cancer Hospital, Seoul National University Bundang Hospital, Erasmus MC, Taipei Medical University Hospital, Taipei Veterans General Hospital, Başkent University Hospital, Sarah Cannon, Tennessee Oncology, Vall d'Hebron Hospital Universitari, University of Turin, Wakayama Medical University, Hamamatsu Medical Center, Genentech, German Center for Lung Research, LungenClinic Grosshansdorf
Language: English
Topic: Lung Cancer Research Studies
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4388753162