The approval of Imfinzi is based on the positive PFS data from the Phase 3 PACIFIC trial.
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Genentech announced that the Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities.
LOXO-292 is being evaluated in the ongoing Phase 1/2 LIBRETTO-001 clinical trial.
Data showed ORR was 14.3% (95% CI, 7.4-24.1) with 2.6% achieving complete response and 11.7% achieving partial response. Of the 11 responders, median DOR was not yet reached at the time of analysis; 91% of patients, however, had a DOR of ≥6 months.
Study data showed 57% of evaluable patients (N=23) had a partial response and 4% achieved a complete response. Among the 14 responders, 64% did not have significant tumor growths for ≥6 months.
The approvals for nivolumab and ipilimumab were based on CheckMate 214, a randomized open-label trial.
The overall response rate based on modified RECIST was 18.2% with complete response rate of 3.2% and partial response rate of 14.9%.
The overall response rate among patients was 13.3% (95% CI: 8.2, 20.0) with a complete response seen in 1.4% and partial response in 11.9%.
In the Phase 2, multicenter, open-label, single-arm CheckMate -142 trial (n=74), qualified patients received Opdivo 3mg/kg intravenously (IV) every 2 weeks.
The sBLA submission was based on results from the Phase 1/2 CheckMate -040 study.