Roche begins another pivotal Skyscraper study

Whatever you think about the chances TIGIT blockade still has to become a success, Roche shows no sign on giving up on it. Yesterday clinicaltrials.gov disclosed that the company had started enrolment into the ninth phase 3 study of its anti-TIGIT MAb tiragolumab: Skyscraper-15 will test a Tecentriq combo versus Tecentriq in adjuvant NSCLC. The primary endpoint is disease-free survival, where in a broadly similar setting Tecentriq monotherapy beat best supportive care with a hazard ratio of 0.66 in its registrational Impower-010 trial. This brings the tally of pivotal tiragolumab trials Roche is running in NSCLC to four, the most important being the front-line Skyscraper-01 study, which has failed for PFS but for which some hope of hitting a statistical benefit for OS still remains. However, final OS analysis was delayed from 2023 to the first quarter of 2024, and most recently to the second half of this year. Roche’s enthusiasm might be driven by two qualified successes: results of the mid-stage Morpheus-liver study in liver cancer prompted the start of Skyscraper-14, while the Asia-based Skyscraper-08 trial recently read out positively in oesophageal cancer. Pivotal trials of tiragolumabStudySettingDesignDataSkyscraper-011st-line PD-L1+ve NSCLC+ Tecentriq, vs TecentriqFailed for PFS; OS numerically positive at second interimSkyscraper-021st-line SCLC+ Tecentriq + chemo, vs Tecentriq + chemoFailed for PFS & OSSkyscraper-02C1st-line SCLC (China)+ Tecentriq + chemo, vs Tecentriq + chemoFeb 2024Skyscraper-031st-line maintenance in stage III NSCLC+ Tecentriq, vs ImfinziOct 2024Skyscraper-061st-line non-squam NSCLC+ Tecentriq + chemo, vs Keytruda + chemoMay 2027Skyscraper-071st-line maintenance in oesophageal squam cell cancerTecentriq +/- tiragolumab, vs placeboMar 2027Skyscraper-081st-line oesophageal cancer (Asia)+ Tecentriq + chemo, vs chemoPositive for OS & PFS, but used outdated comparatorSkyscraper-14/ Imbrave-1521st-line liver cancer+ Tecentriq + Avastin, vs Tecentriq + AvastinSep 2026Skyscraper-15Adjuvant PD-L1+ve stage IIB-IIIB NSCLC+ Tecentriq, vs TecentriqMar 2031Source: OncologyPipeline.