Roche (SWX: ROG; SWX: RO; OTCMKTS: RHHBY), the Swiss pharmaceutical giant, has announced that a Phase II/III clinical trial for its TIGIT-targeted antibody tiragolumab, designed for non-small cell lung cancer (NSCLC), did not outperform Keytruda (pembrolizumab), a PD-1 inhibitor. The trial, known as SKYSCRAPER-06, was evaluating the efficacy of tiragolumab combined with the PD-L1 drug Tecentriq (atezolizumab) and chemotherapy against Keytruda plus chemotherapy as a first-line treatment for locally advanced unresectable or metastatic non-squamous NSCLC.
An interim analysis indicated that the tiragolumab regimen did not meet either of its primary endpoints, showing no improvement in progression-free survival (PFS) with a hazard ratio (HR) of 1.27 or overall survival (OS; HR of 1.33). As a result, Roche plans to unblind and discontinue the study and is also set to reconsider the broader development plans for tiragolumab.
In 2023, data from the SKYSCRAPER-01 study for PD-L1-high NSCLC suggested no improvement to PFS with tiragolumab, but potential OS benefits were observed. In March 2023, Roche halted the development of tiragolumab for extensive stage small-cell lung cancer, but reported positive Phase II data at last year’s ASCO meeting for the combination of tiragolumab, Tecentriq, and the VEGF inhibitor Avastin (bevacizumab) in liver cancer.
TIGIT remains a challenging immunotherapy target. Merck, Sharp & Dohme (MSD; NYSE: MRK) stopped development of its anti-TIGIT antibody vibostolimab for melanoma in May 2024, while Bristol-Myers Squibb (BMS) canceled a Phase II anti-TIGIT molecule in February 2023 due to safety issues. Novartis also decided to withdraw from a global co-development deal with China’s BeiGene Inc., focused on the anti-TIGIT ociperlimab. Gilead Sciences’ domvanalimab is among the few to have shown positive data for lung and gastric cancers.- Fineline.com
