Tiragolumab and atezolizumab: median progression-free survival 7.00 vs 5.55 months

Among participants with high PD-L1 expression in the global cohort of the Phase III SKYSCRAPER-01 trial, median progression-free survival (PFS) was 7.00 months with tiragolumab plus atezolizumab and 5.55 months with placebo plus atezolizumab (hazard ratio 0.78, 95% confidence interval 0.63 to 0.97), the study record shows. Median overall survival, another primary outcome, was 23.13 months and 16.85 months (hazard ratio 0.87, 95% confidence interval 0.71 to 1.08). Hoffmann-La Roche, the sponsor, now has randomized results posted for the 620 participants with previously untreated non-small cell lung cancer (NSCLC) who took part.

Why it matters

The record says the study was designed to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected NSCLC. The TECENTRIQ (atezolizumab) label, version published Oct 16, 2026, lists atezolizumab as a single agent for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained at least 50% of tumor cells or PD-L1 stained tumor-infiltrating immune cells covering at least 10% of the tumor area), with no EGFR or ALK genomic tumor aberrations. The trial population, as the record lists it, had high tumor PD-L1 expression, no EGFR mutation and no ALK fusion oncogene, and had received no prior systemic treatment for metastatic NSCLC. The record lists the same measures for a separate China cohort.

Results posted November 9, 2026

The record lists results first posted on November 9, 2026. The primary analysis set held participants with high PD-L1 expression by a PD-L1 assay (tumor proportion score of at least 50%). The global cohort had 259 participants on placebo plus atezolizumab and 262 on tiragolumab plus atezolizumab.

Investigator-assessed PFS by RECIST v1.1: 5.55 months (95% confidence interval 4.37 to 7.03) on placebo plus atezolizumab, 7.00 months (5.62 to 9.79) on tiragolumab plus atezolizumab. The hazard ratio was 0.78 (0.63 to 0.97), log rank p value 0.0226.
Overall survival: 16.85 months (14.59 to 21.32) on placebo plus atezolizumab, 23.13 months (17.71 to 28.78) on tiragolumab plus atezolizumab. The hazard ratio was 0.87 (0.71 to 1.08), log rank p value 0.2165.
Confirmed objective response rate, a secondary outcome: 35.1 percent (29.39 to 41.33) on placebo plus atezolizumab, 45.8 percent (39.69 to 52.04) on tiragolumab plus atezolizumab. The difference was 10.67 percentage points (1.97 to 19.15), p value 0.0114.

China cohort

The China cohort included participants enrolled at sites in China during the extended China enrollment phase. As the record states, participants enrolled from China during the global enrollment phase were included in the China analysis too, so 15 participants from the global cohort appear in both. In the primary analysis set, 48 participants took placebo plus atezolizumab and 52 took tiragolumab plus atezolizumab.

PFS: 7.16 months (5.68 to 13.17) on placebo plus atezolizumab, 7.82 months (5.09 to 15.15) on tiragolumab plus atezolizumab. The hazard ratio was 0.94 (0.58 to 1.51).
Overall survival: 29.67 months (21.88 to not estimable) on placebo plus atezolizumab, 28.29 months (15.70 to not estimable) on tiragolumab plus atezolizumab. The hazard ratio was 1.13 (0.60 to 2.14).

Trial design

SKYSCRAPER-01 was a Phase III, randomized, placebo-controlled study that ran from March 4, 2020. Primary completion was December 30, 2025. Participants were randomized 1:1 and received either tiragolumab 600 mg or matching placebo by intravenous infusion every 3 weeks on Day 1 of each 21-day cycle, after atezolizumab 1200 mg, until disease progression, loss of clinical benefit or unacceptable toxicity. Randomization was stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1) and tumor histology (non-squamous vs. squamous).

Eligible participants had an ECOG performance status of 0 or 1, no prior systemic treatment for metastatic NSCLC, high tumor PD-L1 expression and measurable disease per RECIST v1.1. In all, 620 participants were randomized.

Safety measures

The record counts participants, not events. In the global cohort, 241 of 263 participants on placebo plus atezolizumab and 256 of 267 on tiragolumab plus atezolizumab had an adverse event, over up to 65.1 months. The adverse events tables list serious adverse events in 108 of 263 and 117 of 267 participants, and deaths in 179 of 263 and 175 of 267. Cytokine release syndrome affected 0 of 263 and 2 of 267 participants. Two participants randomized to placebo plus atezolizumab received tiragolumab, and the record counts them in the tiragolumab arm for safety.

In the China cohort, 48 of 48 participants on placebo plus atezolizumab and 51 of 52 on tiragolumab plus atezolizumab had an adverse event.

What remains uncertain

The record states that the upper limit of the 95% confidence interval for overall survival in the China cohort was not estimable, because too few participants had events (study record).