Roche reports update on Phase III SKYSCRAPER-01 study results

2024-11-26

Basel, 26 November 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) reports an update on the phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq® (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC).

SKYSCRAPER-01 is a global phase III, randomised, double-blind study evaluating tiragolumab plus Tecentriq compared to Tecentriq alone in 534 patients with PD-L1-high previously untreated, locally advanced unresectable or metastatic NSCLC. 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. The study did not reach the primary endpoint of overall survival at the final analysis. The overall safety profile observed remained consistent with longer follow-up, and no new safety signals were identified. The detailed data will be presented at a medical meeting in 2025.

Roche continuously reviews its study programmes to determine if any adjustments are necessary for the purposes of ongoing research. Roche will apply the same principles to this programme, with additional data from phase III studies across different settings or tumour types anticipated next year.

About tiragolumab
Tiragolumab is an investigational 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.

About Tecentriq
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.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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