Roche (SIX: RO, ROG; OTCQX: RHHBY) has announced disappointing results from the phase II/III SKYSCRAPER-06 study, aimed at evaluating the efficacy of tiragolumab plus Tecentriq (atezolizumab) and chemotherapy in treating non-squamous non-small cell lung cancer. The study did not meet its primary endpoints of progression-free survival (PFS) and overall survival (OS), signaling a setback in the development of this combination therapy.

The trial, which compared the tiragolumab combination against pembrolizumab and chemotherapy, reported a hazard ratio (HR) of 1.27 for PFS and 1.33 for OS in its interim analyses. These results indicate reduced efficacy of the tiragolumab combination in improving survival outcomes for patients with previously untreated, locally advanced unresectable or metastatic lung cancer.

Despite the study’s outcomes, the safety profile of the tiragolumab combination with Tecentriq and chemotherapy remained consistent with previous observations, and no new safety concerns were identified. Roche has decided to halt the study based on these results, and plans to unblind patients and investigators, with detailed findings to be presented 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, 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 acknowledged the contributions of patients and healthcare professionals involved in the study and emphasized that the findings would inform future research into the anti-TIGIT pathway and cancer treatment strategies.

SKYSCRAPER-06 is a global, randomized, placebo-controlled, and double-blinded study that involved 542 participants with non-squamous non-small cell lung cancer. The study’s primary endpoints were to assess OS and PFS in patients receiving first-line treatment with either the tiragolumab combination or pembrolizumab and chemotherapy. Tiragolumab, a novel immune checkpoint inhibitor targeting the TIGIT pathway, is designed to amplify immune responses when combined with other cancer therapies like Tecentriq.

Tecentriq, a foundational cancer immunotherapy developed by Roche, is approved for various forms of cancer, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and hepatocellular carcinoma (HCC). It works by inhibiting the PD-L1 protein expressed on tumor cells and tumor-infiltrating immune cells, potentially activating T-cells to fight cancer.

The failure of the SKYSCRAPER-06 study to meet its primary endpoints is a significant development in the field of cancer immunotherapy, particularly in the treatment of non-small cell lung cancer. It highlights the challenges and complexities of developing effective cancer treatments and the importance of ongoing research to understand and harness the immune system’s potential in oncology.

  cancer research, cancer therapy, chemotherapy, clinical research, clinical trial, Lung cancer, lung cancer trial, Oncology, Roche, SKYSCRAPER-06, Tecentriq, tiragolumab