Shots:

• The application is based on the P-III IMpower010 study evaluating the efficacy & safety of Tecentriq vs BSC in 1005 patients in a ratio (1:1) with Stage IB-IIIA NSCLC- following surgical resection and up to 4 cycles of adjuvant cisplatin-based CT
• The results from an interim analysis showed the reduction in the risk of disease recurrence or death by 34% in patients with Stage II-IIIA NSCLC whose tumors express PD-L1≥1%- m- DFS (not reached vs 35.3 mos.) while safety data were consistent with its known safety profile and no new safety signals were observed
• The application is being reviewed under the US FDA’s RTOR pilot program with anticipated FDA's decision on approval by Dec 01- 2021

Ref: Roche | Image: Roche