Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that its Phase II/III SKYSCRAPER-06 study did not achieve its primary endpoints in evaluating tiragolumab in combination with Tecentriq® (atezolizumab) and chemotherapy compared to pembrolizumab and chemotherapy as initial treatment for previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (nSq NSCLC).
The study did not meet its primary endpoint of progression-free survival (PFS) at its primary analysis, with a hazard ratio (HR) of 1.27 [95% CI: 1.02, 1.57]. Additionally, overall survival (OS) at the first interim analysis also did not meet expectations, with a HR of 1.33 [95% CI: 1.02, 1.73], which was considered immature.
The combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy in both PFS and OS compared to the comparator arm in the intent-to-treat population, encompassing Phase II and Phase III cohorts. However, the safety profile observed remained consistent with previous findings for this combination, with no new or unexpected safety concerns identified.
Following these results, the study will be halted, and patients and investigators will be unblinded. Genentech plans to communicate these findings to investigators and share results with health authorities, with intentions to present at an upcoming medical meeting.
“This outcome is disappointing, as we had hoped this combination could offer improved outcomes for people with metastatic non-squamous lung cancer,” commented Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “We extend our gratitude to all patients and healthcare professionals involved in the study and will leverage these insights to advance our understanding.
