- The approval is based on P-III IMpower110 study assessing the efficacy and safety of Tecentriq vs CT in 572 PD-L1-selected, CT-naïve participants in a ratio (1:1) with stage IV non-squamous or squamous NSCLC
- Results: improvement in OS in people with high PD-L1 expression (20.2 vs 13.1mos.), safety was consistent with its known safety profile with no new safety signals identified, grade 3–4 treatment-related AEs (12.9% vs 44.1%)
- An exploratory OS analysis in the PD-L1 high population showed a continued OS benefit @median follow-up of 31.mos. (20.2 vs 14.7). Tecentriq is the first single-agent cancer immunotherapy with 3 dosing options allowing administration every 2,3,& 4wks.
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