Roche's New Immunotherapy Fails To Show Benefit Over Merck's Blockbuster Keytruda In Lung Cancer Patients

On Thursday, Roche Holdings AG RHHBY said that the Phase 2/3 SKYSCRAPER-06 study of tiragolumab plus Tecentriq (atezolizumab) and chemotherapy versus pembrolizumab and chemotherapy as first-line treatment for locally advanced unresectable or metastatic non-squamous non-small cell lung cancer, did not meet its primary endpoints of progression-free survival (PFS) at its primary analysis.

The hazard ratio (HR) was 1.27, and overall survival (OS) at its first interim analysis, with an HR of 1.33, was immature.

Merck & Co Inc MRK markets pembrolizumab as Keytruda.

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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, which includes the phase 2 and phase 3 cohorts.

The overall safety profile remains consistent with those 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 Roche intends 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, Chief Medical Officer and Head of Global Product Development.

Ongoing phase 3 studies are investigating treatment settings and indications distinct from SKYSCRAPER-06. Based on the results, Roche said it would evaluate any relevant changes needed to the ongoing tiragolumab program.

On Friday, the FDA approved Roche’s Vabysmo (faricimab) 6.0 mg single-dose prefilled syringe for neovascular or ‘wet’ age-related macular degeneration, diabetic macular edema, and macular edema following retinal vein occlusion.

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