Data from Pharmawand - Curated by EPG Health - Date added 08 October 2019
Eli Lilly and Company announced that results from the global Phase III RELAY trial of Cyramza (ramucirumab) in combination with erlotinib in previously untreated patients with metastatic EGFR-mutated non-small cell lung cancer (NSCLC) were published in The Lancet Oncology. In the RELAY study, treatment with Cyramza in combination with erlotinib demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) – the time patients lived without their cancer growing or spreading after starting treatment – compared to erlotinib alone. The Cyramza-erlotinib combination achieved a median PFS of 19.4 months, corresponding to a seven-month improvement over erlotinib alone. There were no new safety signals and the safety profile observed in the trial was consistent with what has been previously observed for Cyramza in other Phase III clinical trials and the established safety profile of erlotinib.
On the primary endpoint of investigator-assessed PFS, Cyramza plus erlotinib (N=224) demonstrated a statistically significant and clinically meaningful improvement in median PFS by seven months compared to placebo plus erlotinib (N=225) [19.4 months with the Cyramza-containing arm compared to 12.4 months with the placebo-containing arm (HR 0.59; 95% CI, 0.46-0.79; P=<0.0001)]. Improvements with Cyramza plus erlotinib were also consistently observed across secondary and exploratory endpoints including duration of response, PFS2 and time on targeted therapy. Improvements were also consistently seen across all specified subgroups, including patients with tumors that had exon 19 and 21 mutations. Historically, patients receiving single-agent EGFR-TKIs with exon 21 (L858R) point mutations typically have had lower PFS benefit than those with exon 19 mutations. Overall survival (OS) was immature at the time of analysis. No detriment to OS was observed at this interim assessment, and the trial will continue until it reaches its final number of OS events.
The most common Grade at least 3 adverse events occurring at a rate of five percent or greater in the CYRAMZA-containing arm were hypertension (N=52 [24%, Grade 3 only]), dermatitis acneiform (an acne-like rash) (N=33 [15%, Grade 3 only)], and diarrhea (N=16 [7%, Grade 3 only]). Results from this study are the basis for global regulatory submissions. Lilly has made submissions in the U.S. and the EU, and a submission in Japan is planned by year-end.
See: "Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial/" Kazuhiko Nakagawa et al. The Lancet Oncology Online first October 04, 2019DOI:https://doi.org/10.1016/S1470-2045(19)30634-50>