Roche Updates on Phase II/III SKYSCRAPER-06 Study in Metastatic Non-Squamous NSCLC

Basel, 04 July 2024 - Roche has announced that the phase II/III SKYSCRAPER-06 study, which was designed to evaluate the combination of tiragolumab plus Tecentriq (atezolizumab) and chemotherapy against pembrolizumab and chemotherapy for patients with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer, did not achieve its primary endpoints. The primary analysis revealed a hazard ratio (HR) for progression-free survival (PFS) of 1.27 [95% CI: 1.02, 1.57], and the first interim analysis for overall survival (OS) showed a HR of 1.33 [95% CI: 1.02, 1.73], with the data still being immature. This combination therapy demonstrated lower efficacy in both PFS and OS compared to the comparator arm in the intent-to-treat population, which encompasses both phase II and phase III cohorts.

Despite the disappointing efficacy results, the overall safety profile of the tiragolumab and Tecentriq combination remained consistent with previous observations, revealing no new or unexpected findings. Consequently, Roche has decided to unblind the patients and investigators involved in the study and plans to halt further progress. The company will communicate with investigators and share the results with health authorities before presenting the findings at an upcoming medical meeting.

Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Roche, expressed his disappointment, stating, "These results are disappointing as it was our hope that this combination might yield improved outcomes for people living with metastatic non-squamous lung cancer." He extended gratitude to the patients and healthcare professionals who participated in the study and emphasized the importance of leveraging these learnings to advance scientific understanding of the anti-TIGIT pathway and explore new avenues in cancer research.

Roche is continuing its investigation into tiragolumab through other ongoing phase III studies that explore different treatment settings and indications compared to the SKYSCRAPER-06 study. The company plans to evaluate necessary adjustments to the ongoing tiragolumab program based on the current study's results.

The SKYSCRAPER-06 study is a global phase II/III, randomized, placebo-controlled, double-blinded trial. It compared tiragolumab plus Tecentriq and chemotherapy against pembrolizumab and chemotherapy in 542 patients with non-squamous non-small cell lung cancer. The primary endpoints were overall survival and progression-free survival.

Tiragolumab, a novel immune checkpoint inhibitor, selectively binds to TIGIT, an inhibitory checkpoint that suppresses the immune response to cancer. Preclinical research suggests that tiragolumab can act as an immune amplifier when used with other cancer immunotherapies, such as Tecentriq. The TIGIT pathway is distinct yet complementary to the PD-L1/PD-1 pathway, and dual blockade with tiragolumab and Tecentriq may help overcome immune suppression and restore immune response.

Tecentriq (atezolizumab) is a cancer immunotherapy that has been approved for some of the most challenging types of cancer. It was the first cancer immunotherapy approved for adjuvant treatment in certain types of early-stage non-small cell lung cancer, small cell lung cancer, and hepatocellular carcinoma. Additionally, Tecentriq is approved globally, either alone or in combination with other therapies, for various forms of metastatic non-small cell lung cancer, metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer, BRAF V600 mutation-positive advanced melanoma, and alveolar soft part sarcoma.

Tecentriq works by binding to the programmed death ligand-1 (PD-L1) protein on tumor cells and tumor-infiltrating immune cells, blocking its interactions with PD-1 and B7.1 receptors. This inhibition may activate T-cells, and Tecentriq can be used as a foundational combination partner with other immunotherapies, targeted therapies, and chemotherapies across a wide range of cancers. Tecentriq is available as both an intravenous infusion and a subcutaneous formulation approved in over 40 countries, with the same indications as the intravenous version.

Roche, founded in 1896 in Basel, Switzerland, is a leading biotechnology company and a global leader in in-vitro diagnostics. The company focuses on scientific excellence to develop medicines and diagnostics that improve and save lives. Roche is a pioneer in personalized healthcare and aims to transform healthcare delivery for better patient outcomes. Roche has been recognized as one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for 15 consecutive years.