Roche Updates on SKYSCRAPER-06 Study in Metastatic Non-Squamous NSCLC

Roche recently revealed results from its phase II/III SKYSCRAPER-06 clinical trial, which assessed the efficacy of combining tiragolumab with Tecentriq® (atezolizumab) and chemotherapy as an initial treatment for patients with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). The trial aimed to compare this combination therapy against pembrolizumab and chemotherapy. Unfortunately, the study did not meet its primary endpoints during the primary analysis of progression-free survival (PFS) and the first interim analysis of overall survival (OS).

The SKYSCRAPER-06 trial involved 542 patients and was global, randomized, placebo-controlled, and double-blinded. The primary endpoints were overall survival and progression-free survival. Results showed that the combination of tiragolumab plus Tecentriq and chemotherapy had a hazard ratio (HR) of 1.27 [95% CI: 1.02, 1.57] for PFS and a HR of 1.33 [95% CI: 1.02, 1.73] for OS, which was immature at the time of analysis. The combination therapy demonstrated reduced efficacy compared to the comparator arm, which influenced the decision to halt the trial.

The safety profile of tiragolumab plus Tecentriq and chemotherapy was consistent with prior studies, showing no new or unexpected adverse effects. Despite this, Roche decided to unblind patients and investigators and to discontinue the trial due to the reduced efficacy observed. Results will be communicated to health authorities and shared at an upcoming medical conference.

Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Roche, expressed his disappointment in the outcomes, noting that there was hope that the combination might provide better results for patients with metastatic non-squamous lung cancer. He emphasized the value of the patients' and healthcare professionals' contributions and stated that the findings would enhance the company's understanding of the anti-TIGIT pathway to inform future cancer research.

The SKYSCRAPER-06 trial is part of a broader research initiative to explore tiragolumab, a novel immune checkpoint inhibitor that targets TIGIT, a protein that suppresses the immune response to cancer. Tiragolumab is thought to work synergistically with other immunotherapies like Tecentriq, which targets the PD-L1/PD-1 pathway. Dual blockade of these pathways is believed to potentially overcome immune suppression and restore immune activity against tumors.

Tecentriq, a monoclonal antibody, has already been approved for various aggressive cancer types, including specific forms of early-stage and metastatic non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer, BRAF V600 mutation-positive advanced melanoma, and alveolar soft part sarcoma. It functions by binding to the PD-L1 protein on tumor cells, blocking its interaction with PD-1 and B7.1 receptors, which may activate T-cells to attack cancer cells. Tecentriq is approved for use alone or in combination with other cancer treatments.

Founded in 1896, Roche has evolved into a leading biotechnology company and a global leader in in-vitro diagnostics. The company is committed to scientific excellence to develop medicines and diagnostics that improve and save lives. Roche is recognized for its commitment to sustainability and has been named one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Indices for fifteen consecutive years. The company's efforts also focus on improving access to healthcare in collaboration with local partners worldwide.

Genentech, a member of the Roche Group in the United States, and Roche’s majority stake in Chugai Pharmaceutical in Japan underscores its global presence and influence in the pharmaceutical and diagnostics industries.