At the 2025 European Society of Medical Oncology (ESMO) Congress 2025, held from17 to 21 October in Berlin, Germany, results from the Phase III IMbrave152/SKYSCRAPER-14 study were presented. The study evaluated the triplet therapy of Roche’s TIGIT inhibitor tiragolumab with Tecentriq (atezolizumab) and Avastin (bevacizumab) in first-line metastatic liver cancer.
The control arm consisted of the current standard-of-care, the combination of Tecentriq with Avastin, and a placebo. The study failed to meet its primary endpoint of progression-free survival (PFS). The tiragolumab arm had a minimally higher median PFS of 8.3 months compared to 8.2 months in the control arm. Data from the co-primary endpoint of overall survival (OS) remains immature. The trio showed a small improvement over the control arm in response rates, the study’s secondary endpoint (29.9% vs 26.0%). Serious adverse events (AEs) were reported in 45.8% of patients in the tiragolumab arm and in 38.4% in the placebo arm. Grade ≥3 AEs occurred in 53.6% in the tiragolumab arm and 47.7% in the control arm.
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This is the second time in a matter of months that Roche’s potential first-in-class TIGIT product has failed a Phase III study. In 2024, the company announced that the SKYSCRAPER-01 study combining the TIGIT agent with Tecentriq in metastatic non-small cell lung cancer (NSCLC) had not met its OS endpoint. In 2022, a similar readout was announced in small cell lung cancer.
Roche is not the only company suffering from underwhelming TIGIT results. Merck’s Phase III KeyVibe-010 study combining their TIGIT asset, vibostolimab, with Keytruda in melanoma was discontinued due to AEs, prompting the company to end its TIGIT programme altogether. Similarly, BeOne Medicines terminated its Phase III AdvanTIG-302 study combining TIGIT ociperlimab and PD1 inhibitor tislelizumab in first-line NSCLC. These studies have shown that combining a TIGIT with a PD-(L)1 inhibitor may be synergistic in theory, but thus far has failed in clinic due to either efficacy or safety.
Gilead is still holding out hope that the combination could work, as its TIGIT inhibitor domvanalimab is in multiple Phase III studies in combination with PD1 inhibitor zimberelimab, primarily in first-line NSCLC. If approved, GlobalData anticipates sales for TIGIT products could reach $3 billion by 2031.
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