Abstract
BackgroundRELAY, a global double-blind, placebo-controlled Phase 3 study (NCT02411448) demonstrated statistically significant improvement in progression-free survival (PFS; primary endpoint) for ramucirumab (RAM)+erlotinib (ERL) in patients with untreated EGFR-mutated metastatic NSCLC: HR 0.59 (95%CI: 0.46–0.76, p<0.0001; median [m]PFS 19.4 versus 12.4 months). Here, we report final overall survival (OS; secondary endpoint) outcomes for the intention-to-treat (ITT) population. MethodsBetween Jan.2016 and Feb.2018, 449 eligible patients with an EGFR exon 19del or L858R mutation and no CNS metastases were randomized (1:1) to ERL (150 mg/day) with RAM (10 mg/kg q2w, n=224) or placebo (PBO, n=225). ResultsAt data cut-off, 297 deaths were reported (overall event-rate 66%), median follow-up; 45.1 months (IQR: 26.7–71.2), OS HR; 0.98 (95%CI: 0.78-1.24, p=0.864), mOS; 51.1 (RAM+ERL) and 46.0 (PBO+ERL) months. Outcomes in subsets of poor prognostic patients (L858R or TP53 co-mutation) suggest a directional improvement in OS (L858R; HR [95%CI] 0.87 [0.62-1.22], exon 19del; 1.13 [0.83-1.55], TP53 co-mutation; 0.83 [0.58-1.19], TP53-wild-type; 1.22 [0.87-1.72]). Treatment-emergent T790M rates were similar between arms. Over 80% of patients received post-study discontinuation therapy (>50% received osimertinib in comparable numbers between arms). Safety profile for RAM+ERL was consistent with previous reports with no increased toxicity over time or new safety signals observed. ConclusionIn RELAY, OS was not significantly improved with similar long OS durations in both treatment arms.
Published Version
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