Roche's Phase II/III Lung Cancer Trial Fails to Achieve Primary Endpoints, Leading to Study Discontinuation

Roche's Phase II/III SKYSCRAPER-06 study on lung cancer treatment failed to meet its primary endpoints in progression-free survival and overall survival, with tiragolumab plus Tecentriq and chemotherapy not demonstrating improved outcomes compared to pembrolizumab and chemotherapy in previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer. As a result, Roche plans to halt the study, revising the ongoing tiragolumab program based on the disappointing results.

Introduction:
Roche's ongoing phase II/III SKYSCRAPER-06 study evaluating the use of tiragolumab in combination with Tecentriq and chemotherapy in previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) has encountered a setback. The study, designed to determine if the combination improves outcomes compared to pembrolizumab and chemotherapy, has failed to meet its primary endpoints in progression-free survival (PFS) and overall survival (OS) [1]. This article will provide an overview of the study and its implications for the ongoing tiragolumab program.

Background:
The phase III SKYSCRAPER-02 study, published in the Journal of Clinical Oncology, investigated the potential benefits of adding tiragolumab to the existing first-line treatment of atezolizumab, carboplatin, and etoposide (CE) in untreated extensive-stage small-cell lung cancer (ES-SCLC) [2]. However, the results of the study did not show statistical significance in improving PFS or OS for patients with ES-SCLC.

Roche's Phase II/III Study:
The phase II/III SKYSCRAPER-06 study aimed to evaluate the effectiveness of tiragolumab plus Tecentriq and chemotherapy in patients with NSCLC. However, the study has not met its primary endpoints in PFS and OS, leading to plans to halt the study and reevaluate the tiragolumab program [1].

Implications and Conclusion:
The failure of the SKYSCRAPER-06 study to meet its primary endpoints is a significant setback for Roche and the ongoing development of tiragolumab as a potential treatment option for NSCLC. However, it is essential to note that the study results do not necessarily indicate that tiragolumab is ineffective or that it lacks potential benefits in other indications. The company will likely reassess the data and determine the best course of action moving forward.

References:
[1] Roche. "Roche's Tiragolumab and Tecentriq Combination Therapy for Non-Squamous Non-Small Cell Lung Cancer Fails to Meet Primary Endpoints in Phase II/III SKYSCRAPER-06 Study." Press Release, Roche, November 17, 2023. https://www.roche.com/media/releases/medcor/2023-11-17-tiragolumab-and-tecentriq-combination-therapy-for-non-squamous-non-small-cell-lung-cancer-fails-to-meet-primary-endpoints-in-phase-ii-iii-skyscraper-06-study.htm
[2] Park, J., et al. "Final progression-free survival and overall survival analysis of the phase III SKYSCRAPER-02 study of atezolizumab in combination with carboplatin and etoposide (CE) versus CE for extensive-stage small-cell lung cancer (ES-SCLC)." Journal of Clinical Oncology, vol. 42, no. 3, 2023, pp. 336-337. https://doi.org/10.1200/JCO.23.01363