Roche updates their phase II/III SKYSCRAPER-06 study in metastatic non-squamous non-small cell lung cancer

Roche announces that their phase II/III SKYSCRAPER-06 study which is evaluating tiragolumab plus Tecentriq and chemotherapy versus pembrolizumab and chemotherapy as an initial treatment for people with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer, did not meet its primary endpoints of progression-free survival at its primary analysis with a hazard ratio (HR) of 1.27 and overall survival at its first interim analysis with a HR of 1.33, which was immature. This combination showed reduced efficacy in both PFS and OS compared to the comparator arm in the intent-to-treat population, which includes the phase II and phase III cohorts. The overall safety profile remains consistent with the safety profile previously observed for the combination of tiragolumab plus Tecentriq and chemotherapy, and no new or unexpected findings were identified. Based on these results, patients and investigators will be unblinded and we intend to halt the study.

“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,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “We are thankful to all of the patients and healthcare professionals involved in the study, and we will leverage the learnings to inform our scientific understanding of the anti-TIGIT pathway and new avenues in cancer research.”

The ongoing phase III studies are currently investigating treatment settings and indications distinct from SKYSCRAPER-06. Based on today’s results, we will evaluate any relevant changes needed to the ongoing tiragolumab programme.

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