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SKYSCRAPER-02: Tiragolumab in Combination With Atezolizumab Plus Chemotherapy in Untreated Extensive-Stage Small-Cell Lung Cancer

 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 
 JOURNAL OF CLINICAL ONCOLOGY, Vol.42(3) : 324-335, 2024-01 
Journal Title
Issue Date
Antibodies, Monoclonal / therapeutic use ; Antineoplastic Combined Chemotherapy Protocols* / adverse effects ; Brain Neoplasms / drug therapy ; Etoposide ; Humans ; Lung Neoplasms* / drug therapy ; Lung Neoplasms* / pathology ; Small Cell Lung Carcinoma* / drug therapy
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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Hong, Min Hee(홍민희) ORCID logo https://orcid.org/0000-0003-3490-2195
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