Tiragolumab

Phase 3 trial of tiragolumab plus atezolizumab for advanced lung cancer failed to meet OS endpoint.

Final analysis of SKYSCRAPER-01 trial showed no significant OS improvement with tiragolumab plus atezolizumab vs atezolizumab alone in PD-L1–high NSCLC. Safety profile consistent with prior reports. Roche to review study programs and present detailed data in 2025.

Roche's Phase III SKYSCRAPER-01 trial for tiragolumab, an immune checkpoint inhibitor, failed to meet the primary endpoint of overall survival in lung cancer patients. The study, evaluating tiragolumab with Tecentriq, showed no new safety signals but did not improve survival outcomes. This follows previous setbacks for Roche's anti-TIGIT candidate in other trials.

Roche's phase III SKYSCRAPER-01 study, evaluating tiragolumab plus Tecentriq versus Tecentriq alone in PD-L1-high NSCLC patients, did not meet its primary endpoint of overall survival. The study involved 534 previously untreated, locally advanced unresectable or metastatic NSCLC patients. Safety profile remained consistent with no new safety signals. Detailed data to be presented at a medical meeting in 2025.

Genentech's Phase III SKYSCRAPER-01 study, testing tiragolumab + Tecentriq vs. Tecentriq alone in PD-L1-high NSCLC, did not meet its primary endpoint of overall survival. The study involved 534 previously untreated patients with locally advanced unresectable or metastatic NSCLC. Safety profile remained consistent, with no new signals identified; detailed data to be presented in 2025.

Genentech reports Phase III SKYSCRAPER-01 study did not meet primary endpoint of overall survival for tiragolumab plus Tecentriq vs. Tecentriq alone in PD-L1-high NSCLC patients. Safety profile remained consistent with no new signals. Data to be presented in 2025.

Cell therapy is evolving from autologous to allogeneic, aiming for ready-made treatments. Challenges include immune rejection and costly clinical trials. AI could predict optimal cell combinations, but FDA approval processes need modernization for broader access. Off-the-shelf therapies promise affordability and accessibility, potentially revolutionizing precision medicine.

Recent Phase II data from iTeos and GSK's anti-TIGIT therapy belrestotug plus anti-PD-1 Jemperli shows promising response rates in NSCLC patients, despite high-profile failures in the TIGIT space. Despite setbacks, companies like Roche and Merck continue TIGIT studies, emphasizing trial design's impact on outcomes. Insights suggest anti-TIGIT therapy may benefit patients with high CD-155 expression, potentially as combination therapy. Recent positive results from iTeos/GSK and Gilead/Arcus indicate a possible turning tide in TIGIT therapeutics.

GSK and iTeos Therapeutics' Phase II GALAXIES Lung-201 study showed Jemperli and belrestotug, an anti-TIGIT therapy, achieved a 60% objective response rate in non-small cell lung cancer patients, with a 30% improvement over Jemperli alone. The combination also led to significant reductions in circulating tumor DNA and was presented at ESMO 2024.