Roche has reported that the phase II/III SKYSCRAPER-06 study, investigating tiragolumab in combination with Tecentriq (atezolizumab) and chemotherapy as a first-line treatment for previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer, did not achieve its primary endpoints in its initial analysis.
The study did not demonstrate statistically significant improvements in progression-free survival (PFS) or overall survival (OS) compared to the comparator arm, which included pembrolizumab and chemotherapy. Specifically, the primary analysis showed a hazard ratio (HR) of 1.27 for PFS and an immature HR of 1.33 for OS. Consequently, the combination therapy with tiragolumab and Tecentriq showed reduced efficacy in both PFS and OS within the intent-to-treat population, comprising both phase II and phase III cohorts.
Despite these outcomes, the safety profile of tiragolumab plus Tecentriq and chemotherapy remained consistent with previously observed data, with no new safety concerns identified. Based on these results, the study will be halted, and participants and investigators will be unblinded. Roche plans to communicate these findings to health authorities and present the results at an upcoming medical conference.
Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche, expressed disappointment in the results, acknowledging the hope for improved outcomes in metastatic non-squamous lung cancer. He highlighted the study’s role in advancing scientific understanding of the anti-TIGIT pathway and underscored Roche’s commitment to leveraging these learnings for future cancer research endeavors.
Moving forward, Roche will assess potential adjustments to its ongoing tiragolumab program in light of the SKYSCRAPER-06 outcomes. The global phase II/III study involved 542 participants and aimed to evaluate tiragolumab plus Tecentriq and chemotherapy against pembrolizumab and chemotherapy, with OS and PFS as primary endpoints.
Tiragolumab, an investigational immune checkpoint inhibitor targeting TIGIT, is designed to enhance immune responses in combination with Tecentriq, which blocks PD-L1 interactions to activate T-cells. Tecentriq, already approved for various cancers globally, including certain forms of lung cancer and melanoma, represents a cornerstone of Roche’s immunotherapy portfolio, available in both intravenous and subcutaneous formulations across multiple indications.
Roche continues to explore the potential of tiragolumab and Tecentriq in various treatment settings, aiming to advance innovative therapies in oncology.