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 tiragolumab
Study | Setting | Design | Data |
---|---|---|---|
Skyscraper-01 | 1st-line PD-L1+ve NSCLC | + Tecentriq, vs Tecentriq | Failed for PFS; OS numerically positive at second interim |
Skyscraper-02 | 1st-line SCLC | + Tecentriq + chemo, vs Tecentriq + chemo | Failed for PFS & OS |
Skyscraper-02C | 1st-line SCLC (China) | + Tecentriq + chemo, vs Tecentriq + chemo | Feb 2024 |
Skyscraper-03 | 1st-line maintenance in stage III NSCLC | + Tecentriq, vs Imfinzi | Oct 2024 |
Skyscraper-06 | 1st-line non-squam NSCLC | + Tecentriq + chemo, vs Keytruda + chemo | May 2027 |
Skyscraper-07 | 1st-line maintenance in oesophageal squam cell cancer | Tecentriq +/- tiragolumab, vs placebo | Mar 2027 |
Skyscraper-08 | 1st-line oesophageal cancer (Asia) | + Tecentriq + chemo, vs chemo | Positive for OS & PFS, but used outdated comparator |
Skyscraper-14/ Imbrave-152 | 1st-line liver cancer | + Tecentriq + Avastin, vs Tecentriq + Avastin | Sep 2026 |
Skyscraper-15 | Adjuvant PD-L1+ve stage IIB-IIIB NSCLC | + Tecentriq, vs Tecentriq | Mar 2031 |
Source: OncologyPipeline.
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