On August 23, 2023 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that it has been made aware of an inadvertent disclosure of the second interim analysis of the Phase III SKYSCRAPER-01 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for people with PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, AUG 23, 2023, View Source [SID1234634646]).
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SKYSCRAPER-01 is ongoing and the study remains blinded to patients and investigators. We are continuing the study until the final analysis for overall survival. All other studies in the tiragolumab programme will continue as planned.
The interim results for the primary endpoint of overall survival were not mature at the time of the second interim analysis, with median overall survival estimates of 22.9 months [95% CI: 17.5, NE] in the tiragolumab plus Tecentriq arm, and 16.7 months [95% CI: 14.6, 20.2] in the Tecentriq monotherapy arm, yielding a hazard ratio (HR) of 0.81 [95% CI: 0.63, 1.03]. This second interim analysis took place in February 2023 and was based on a data cut-off in November 2022, with a median follow-up of 15.5 months. The data showed that tiragolumab plus Tecentriq was well-tolerated and no new safety signals were identified when adding tiragolumab to Tecentriq.
About the SKYSCRAPER-01 study
SKYSCRAPER-01 is a global Phase III, randomised double-blinded study evaluating tiragolumab plus Tecentriq (atezolizumab) versus Tecentriq alone in 534 patients with first-line PD-L1-high locally advanced, unresectable or metastatic non-small cell lung cancer. Patients were randomised 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until disease progression, loss of clinical benefit or unacceptable toxicity. Co-primary endpoints are overall survival (OS) and progression-free survival (PFS) in the primary analysis set.
About tiragolumab
Tiragolumab is a novel immune checkpoint inhibitor with an intact Fc region. Tiragolumab selectively binds to TIGIT, a novel inhibitory immune checkpoint, which suppresses the immune response to cancer. Based on preclinical research, tiragolumab is thought to work as an immune amplifier with other cancer immunotherapies such as Tecentriq (atezolizumab). The TIGIT pathway is distinct, but complementary to the PD-L1/PD-1 pathway. Dual blockade with tiragolumab and Tecentriq may help overcome immune suppression and restore the immune response.
About Tecentriq (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.