Brigatinib vs crizotinib in patients with ALK inhibitor-naive advanced ALK+ NSCLC: Updated results from the phase III ALTA-1L trial

Abstract

Background: Ph 1b data has shown promising efficacy and safety for atezo þ bev in unresectable HCC pts who have not received prior systemic therapy. Here, we report the primary analysis data from the Ph 3 IMbrave150 trial comparing atezo þ bev vs sor in this pt population. Methods: IMbrave150 enrolled systemic treatment (tx)-naı¨venaı¨ve pts with unresectable HCC. Pts were randomised 2:1 to receive either atezo 1200 mg IV q3w þ bev 15 mg/kg IV q3w or sor 400 mg BID until unacceptable toxicity or loss of clinical benefit per investigator. Coprimary endpoints were OS and PFS by independent review facility (IRF)-assessed RECIST 1.1. The key secondary endpoints IRF-ORR per RECIST 1.1 and IRF-ORR per HCC mRECIST were also part of the study statistical testing hierarchy. Results: The ITT population included 336 pts randomised to atezo þ bev and 165 randomised to sor. Baseline demographics were well balanced between arms. With a median follow up of 8.6 mo, OS HR was 0.58 (95% CI, 0.42, 0.79; P ¼ 0.0006) and PFS HR was 0.59 (95% CI, 0.47, 0.76; P < 0.0001; see table) for atezo þ bev vs sor. ORR was 27% vs 12% (P < 0.0001) per IRF RECIST 1.1 and 33% vs 13% (P < 0.0001) per IRF HCC mRECIST for atezo þ bev vs sor, respectively. Results were generally consistent