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2024-11-30

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cc-by-nc-nd (c) International Association for the Study of Lung Cancer, 2024
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/221675

RELAY: Final Overall Survival for Erlotinib Plus Ramucirumab or Placebo in Untreated, EGFR-Mutated Metastatic NSCLC

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https://doi.org/10.1016/j.jtho.2024.11.032

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Introduction: RELAY, a global double-blind, placebo-controlled phase 3 study (NCT02411448) found statistically significant improvement in progression-free survival (primary end point) for ramucirumab (RAM) plus erlotinib (ERL) (RAM & thorn; ERL) in patients with untreated EGFR-mutated metastatic NSCLC (hazard ratio [HR] 1/4 0.59, 95% confidence interval [CI]: 0.46-0.76, p < 0.0001; median progression-free survival: 19.4 versus 12.4 mo). Here, we report the final overall survival (OS; secondary end point) outcomes for the intention-to-treat population. Methods: Between January 2016 and February 2018, 449 eligible patients with an EGFR exon 19del or L858R mutation and no central nervous system metastases were randomized (1:1) to ERL (150 mg/day) with RAM (10 mg/kg every two weeks, N = 224) or placebo (N = 225). Results: At data cutoff, 297 deaths were reported (overall event rate = 66%), with a median follow-up of 45.1 months (interquartile range: 26.7-71.2), an OS HR of 0.98 (95% CI: 0.78-1.24, p = 0.864), and median OS of 51.1 months (RAM + ERL) and 46.0 months (placebo + ERL). Outcomes in subsets of patients with poor prognosis (L858R or TP53 co-mutation) suggest a directional improvement in OS (L858R: HR = 0.87, 95% CI: 0.62-1.22; exon 19del: HR = 1.13, 95% CI: 0.83-1.55; TP53 co-mutation: HR = 0.83, 95% CI: 0.58-1.19; TP53-wild-type: HR = 1.22, 95% CI: 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). The safety profile for RAM + ERL was consistent with previous reports with no increased toxicity over time or new safety signals observed. Conclusion: In RELAY, OS was not significantly improved with similar long OS durations in both treatment arms. Clinical Trial Information: ClinicalTrials.gov Identifier: NCT02411448 (c) 2024 International Association for the Study of Lung Cancer. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).

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Càncer de pulmó, Assaigs clínics de medicaments

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Lung cancer, Drug testing

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Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

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NAKAGAWA, Kazuhiko, GARON, Edward b., SETO, Takashi, NISHIO, Makoto, PONCE AIX, Santiago, PAZ ARES, Luis, CHIU, Chao-hua, PARK, Keunchil, NOVELLO, Silvia, NADAL, Ernest, NISHINO, Kazumi, YOH, Kiyotaka, SHIH, Jin-yuan, CHIK, Jeannie y. k., MORO SIBILOT, Denis, PURI, Tarun, VARUGHESE, Sunoj chacko, FRIMODT MOLLER, Bente, VISSEREN GRUL, Carla, RECK, Martin. RELAY: Final Overall Survival for Erlotinib Plus Ramucirumab or Placebo in Untreated, EGFR-Mutated Metastatic NSCLC. _Journal of Thoracic Oncology_. 2025. Vol. 20, núm. 4, pàgs. 487-499. [consulta: 10 de gener de 2026]. ISSN: 1556-1380. [Disponible a: https://hdl.handle.net/2445/221675]

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