SKYSCRAPER-01: Tiragolumab Plus Atezolizumab Fails to Improve Overall Survival in PD-L1-High NSCLC
核心洞察
Roche's SKYSCRAPER-01 phase 3 trial evaluating tiragolumab plus atezolizumab did not meet its primary endpoint of overall survival in PD-L1 (搜索)-high NSCLC (搜索) patients.
The combination therapy's safety profile remained consistent with previous reports, and no new safety signals were identified during the study.
Detailed data from the SKYSCRAPER-01 trial will be presented at an upcoming medical meeting in 2025, according to Roche.
The phase 3 SKYSCRAPER-01 trial evaluating tiragolumab (MTIG7192A) in combination with atezolizumab (Tecentriq) as a first-line treatment for patients with PD-L1 (搜索)–high, locally advanced or metastatic non–small cell lung cancer (NSCLC (搜索)) has failed to demonstrate a statistically significant improvement in overall survival (OS) compared to atezolizumab alone, Roche announced. The global, randomized, double-blind study enrolled 534 patients. The company plans to present detailed data from the final analysis at a medical meeting in 2025.
SKYSCRAPER-01 Study Details
The SKYSCRAPER-01 trial enrolled patients with histologically or cytologically confirmed PD-L1 (搜索)–high locally advanced, unresectable, or metastatic NSCLC (搜索) who were not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiation. Patients were randomized 1:1 to receive either 600 mg of tiragolumab plus 1200 mg of intravenous atezolizumab every 3 weeks or placebo plus atezolizumab. Treatment continued until disease progression, loss of clinical benefit, or unacceptable toxicity.
The co-primary endpoints of the study were OS and progression-free survival (PFS). Key secondary endpoints included OS and PFS in the secondary analysis set, confirmed objective response rate, duration of response, PFS rate at 6 and 12 months, OS rate at 12 and 24 months, and time to confirmed deterioration.
Previous Findings and Other Trials
In May 2022, Roche reported that the combination of tiragolumab and atezolizumab did not significantly improve PFS compared to atezolizumab alone. Tiragolumab plus atezolizumab also failed to significantly improve OS or PFS vs pembrolizumab (Keytruda) and chemotherapy in the phase 2/3 SKYCRAPER-06 study (NCT04619797). Consequently, Roche discontinued the SKYCRAPER-06 trial in July 2024.
In extensive-stage small cell lung cancer, tiragolumab was evaluated alongside atezolizumab, carboplatin, and etoposide in the phase 3 SKYSCRAPER-02 trial (NCT04256421) and did not meet the study’s co-primary endpoint of improved PFS vs atezolizumab plus chemotherapy alone.
Safety Profile
The safety profile of tiragolumab plus atezolizumab in the SKYSCRAPER-01 final analysis was consistent with prior reports, and no new safety signals were observed.