PMID- 37976444
OWN - NLM
STAT- MEDLINE
DCOM- 20240129
LR  - 20240201
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 42
IP  - 3
DP  - 2024 Jan 20
TI  - SKYSCRAPER-02: Tiragolumab in Combination With Atezolizumab Plus Chemotherapy in 
      Untreated Extensive-Stage Small-Cell Lung Cancer.
PG  - 324-335
LID - 10.1200/JCO.23.01363 [doi]
AB  - 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.
FAU - Rudin, Charles M
AU  - Rudin CM
AUID- ORCID: 0000-0001-5204-3465
AD  - Memorial Sloan Kettering Cancer Center, New York, NY.
FAU - Liu, Stephen V
AU  - Liu SV
AUID- ORCID: 0000-0002-4852-3914
AD  - Georgetown University, Washington, DC.
FAU - Soo, Ross A
AU  - Soo RA
AUID- ORCID: 0000-0002-3053-3997
AD  - National University Cancer Institute, Singapore, Singapore.
FAU - Lu, Shun
AU  - Lu S
AUID- ORCID: 0000-0001-8833-7262
AD  - Shanghai Chest Hospital, School of Medicine, Shanghai JiaoTong University, 
      Shanghai, China.
FAU - Hong, Min Hee
AU  - Hong MH
AUID- ORCID: 0000-0003-3490-2195
AD  - Yonsei Cancer Center, Severance Hospital, Seoul, South Korea.
FAU - Lee, Jong-Seok
AU  - Lee JS
AD  - Seoul National University Bundang Hospital, Seongnam, South Korea.
FAU - Bryl, Maciej
AU  - Bryl M
AD  - Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu, Poznan, Poland.
FAU - Dumoulin, Daphne W
AU  - Dumoulin DW
AUID- ORCID: 0000-0001-5578-7902
AD  - Erasmus MC, Rotterdam, the Netherlands.
FAU - Rittmeyer, Achim
AU  - Rittmeyer A
AUID- ORCID: 0000-0002-5280-6052
AD  - Lungenfachklinik Immenhausen, Immenhausen, Germany.
FAU - Chiu, Chao-Hua
AU  - Chiu CH
AUID- ORCID: 0000-0001-8401-2356
AD  - Taipei Veterans General Hospital, Taipei, Taiwan.
AD  - Taipei Medical University Hospital, Taipei, Taiwan.
FAU - Ozyilkan, Ozgur
AU  - Ozyilkan O
AD  - Adana Baskent University Hospital, Ankara, Turkey.
FAU - Johnson, Melissa
AU  - Johnson M
AUID- ORCID: 0000-0001-9874-1314
AD  - Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.
FAU - Navarro, Alejandro
AU  - Navarro A
AD  - Hospital Univ Vall d'Hebron, Barcelona, Spain.
FAU - Novello, Silvia
AU  - Novello S
AUID- ORCID: 0000-0001-7653-9748
AD  - University of Turin, AOU San Luigi Orbassano (TO), Turin, Italy.
FAU - Ozawa, Yuichi
AU  - Ozawa Y
AUID- ORCID: 0000-0003-3798-3488
AD  - Wakayama Medical University, Wakayama, Japan.
AD  - Hamamatsu Medical Center, Shizuoka, Japan.
FAU - Tam, Sammi Hiu
AU  - Tam SH
AD  - Genentech Inc, South San Francisco, CA.
FAU - Patil, Namrata S
AU  - Patil NS
AUID- ORCID: 0000-0001-6156-684X
AD  - Genentech Inc, South San Francisco, CA.
FAU - Wen, Xiaohui
AU  - Wen X
AD  - Genentech Inc, South San Francisco, CA.
FAU - Huang, Meilin
AU  - Huang M
AD  - Genentech Inc, South San Francisco, CA.
FAU - Hoang, Tien
AU  - Hoang T
AD  - Genentech Inc, South San Francisco, CA.
FAU - Meng, Raymond
AU  - Meng R
AD  - Genentech Inc, South San Francisco, CA.
FAU - Reck, Martin
AU  - Reck M
AUID- ORCID: 0000-0002-5336-9739
AD  - Airway Research Center North, German Center for Lung Research, LungenClinic, 
      Grosshansdorf, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT04256421
GR  - P30 CA008748/CA/NCI NIH HHS/United States
GR  - R35 CA263816/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20231117
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Antibodies, Monoclonal)
RN  - 52CMI0WC3Y (atezolizumab)
RN  - 6PLQ3CP4P3 (Etoposide)
SB  - IM
MH  - Humans
MH  - Antibodies, Monoclonal/therapeutic use
MH  - *Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Brain Neoplasms/drug therapy
MH  - Etoposide
MH  - *Lung Neoplasms/drug therapy/pathology
MH  - *Small Cell Lung Carcinoma/drug therapy
PMC - PMC10824371
COIS- The following represents disclosure information provided by authors of this 
      manuscript. All relationships are considered compensated unless otherwise noted. 
      Relationships are self-held unless noted. I = Immediate Family Member, Inst = My 
      Institution. Relationships may not relate to the subject matter of this 
      manuscript. For more information about ASCO's conflict of interest policy, please 
      refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center. Open 
      Payments is a public database containing information reported by companies about 
      payments made to US-licensed physicians (Open Payments).
EDAT- 2023/11/17 18:42
MHDA- 2024/01/19 06:42
PMCR- 2023/11/17
CRDT- 2023/11/17 16:03
PHST- 2024/01/19 06:42 [medline]
PHST- 2023/11/17 18:42 [pubmed]
PHST- 2023/11/17 16:03 [entrez]
PHST- 2023/11/17 00:00 [pmc-release]
AID - JCO.23.01363 [pii]
AID - 10.1200/JCO.23.01363 [doi]
PST - ppublish
SO  - J Clin Oncol. 2024 Jan 20;42(3):324-335. doi: 10.1200/JCO.23.01363. Epub 2023 Nov 
      17.