Treatment Rationale and Study Design for the RELAY Study: A Multicenter, Randomized, Double-Blind Study of Erlotinib With Ramucirumab or Placebo in Patients With Epidermal Growth Factor Receptor Mutation-Positive Metastatic Non–Small-Cell Lung Cancer

Garon, Edward B.; Reck, Martin; Paz‐Ares, Luis; Ponce, Santiago; Jaime, Jesús Corral; Juan, Óscar; Nadal, Ernest; Lee, Pablo; Dalal, Rita P.; Liu, Jingyi; He, Song; Treat, Joseph; Nakagawa, Kazuhiko

doi:10.1016/j.cllc.2016.05.023

Cited by 9 publications

(5 citation statements)

References 16 publications

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“…Ramucirumab, as a single drug or in combination with different chemotherapy regimens, has also been approved for second-line gastric or gastro-oesophageal junction adenocarcinoma, colorectal cancer, and hepatocellular carcinoma. 26 The RELAY trial investigating the effect of dual inhibition of EGFR and VEGFR2 in patients with untreated, metastatic, EGFRmutated NSCLC, initiated in December, 2014, is a global study in three parts: a phase 1b single-arm safety lead-in (part A); 27 a phase 3, randomised, double-blind, placebocontrolled study (part B); 28 and an open-label, single-arm, exploratory east Asian cohort (part C; 29 appendix p 10). This report focuses on the phase 3 primary analysis.…”

Section: Implications Of All the Available Evidencementioning

confidence: 99%

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

Nakagawa¹,

Garon²,

Seto³

et al. 2019

The Lancet Oncology

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Section: Implications Of All the Available Evidencementioning

confidence: 99%

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

Nakagawa¹,

Garon²,

Seto³

et al. 2019

The Lancet Oncology

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443

465

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“…Lung cancer is the most common cause of cancer related death in the world, with approximately 2.09 million new cases and 1.76 million deaths predicted in 2018 [1]. Approximately 80 to 85% of all patients with lung cancer are diagnosed with non-small-cell lung cancer (NSCLC), and most patients with NSCLC present with advanced disease [2], with a 5-year survival rate of about 1% for patients with stage IV NSCLC [2,3]. First-line platinum-based therapy, including platinumbased chemoimmunotherapy combinations [4,5], is considered the standard of care for the majority of patients who have advanced NSCLC (aNSCLC) without actionable mutations [6][7][8].…”

Section: Introductionmentioning

confidence: 99%

Healthcare resource utilization in advanced non-small-cell lung cancer: post hoc analysis of the randomized phase 3 REVEL study

Garon¹,

Winfree

Molife

et al. 2020

Support Care Cancer

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Purpose In REVEL, patients with advanced non-small-cell lung cancer (aNSCLC) and patients with increased tumor aggressiveness (rapid disease progression (RDP), platinum-refractory disease (PRD), and high symptom burden (HSB)) benefited from second-line treatment with ramucirumab plus docetaxel over placebo plus docetaxel. This post hoc analysis describes healthcare resource utilization (HCRU) associated with the treatment. Methods aNSCLC patients who had progressed during or after first-line platinum-based chemotherapy were randomized to receive docetaxel and either ramucirumab or placebo until disease progression, unacceptable toxicity, withdrawal, or death. HCRU included hospitalizations, transfusions, and concomitant medications. Categorical variables (counts and percentages) were compared using Fisher's exact test. Continuous variables (mean, standard deviation (SD), median, minimum, and maximum) were compared using the Wilcoxon rank sum test. Results Patient characteristics were largely similar between treatment arms. Within the intent-to-treat (ITT) population (n = 1253), the mean treatment duration was 19.7 and 16.9 weeks in the ramucirumab and control arms, respectively; 51.0% versus 54.9% of patients received subsequent anticancer therapy, respectively. Hospitalization rates were 41.9% versus 42.6% (p = 0.863), mean length of hospital stay was 14.5 days versus 11.3 days (p = 0.066), transfusion rates were 9.9% versus 12.3% (p = 0.206), and use of granulocyte colony-stimulating factors was 41.8% versus 36.6% (p = 0.063), respectively. No significant difference was observed in HCRU between treatment arms in both ITT population and in aggressive disease subgroups including RDP (n = 209), PRD (n = 360), and HSB (n = 497). Conclusion In REVEL, the addition of ramucirumab to docetaxel did not increase HCRU among patients with aggressive aNSCLC disease. These results may help inform economic evaluation of treatment for patients with aNSCLC.

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“…Vascular endothelial growth factor (VEGF) and EGFR pathways are intimately related. The upregulation of VEGF receptors may be responsible for EGFR resistance and combination studies are ongoing (86) (Table 2). Early trials have already confirmed the benefit of dual inhibition with bevacizumab and erlotinib (87, 88).…”

Section: Resistance To Third-generation Tkis and Combination Treatmentmentioning

confidence: 99%

Third-Generation Tyrosine Kinase Inhibitors Targeting Epidermal Growth Factor Receptor Mutations in Non-Small Cell Lung Cancer

Barnes

O’Kane

Vincent³

2017

Front. Oncol.

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Sensitizing mutations in the epidermal growth factor receptor (EGFR) predict response to EGFR tyrosine kinase inhibitors (TKIs) and both first- and second-generation TKIs are available as first-line treatment options in patients with advanced EGFR-mutant non-small cell lung cancer. Eventual resistance develops with multiple mechanisms identifiable both upon repeat biopsy and in plasma circulating tumor DNA. The T790M gatekeeper mutation is responsible for almost 60% of cases. A number of third-generation TKIs are in clinical development, and osimertinib has been approved by the US Food and Drug Administration for the treatment of patients with EGFR T790M mutant lung cancer after failure of initial EGFR kinase therapy. Resistance mechanisms are being identified to these novel agents, and the treatment landscape of EGFR-mutant lung cancer continues to evolve. The sequence of EGFR TKIs may change in the future and combination therapies targeting resistance appear highly promising.

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Treatment Rationale and Study Design for the RELAY Study: A Multicenter, Randomized, Double-Blind Study of Erlotinib With Ramucirumab or Placebo in Patients With Epidermal Growth Factor Receptor Mutation-Positive Metastatic Non–Small-Cell Lung Cancer

Cited by 9 publications

References 16 publications

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

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

Healthcare resource utilization in advanced non-small-cell lung cancer: post hoc analysis of the randomized phase 3 REVEL study

Third-Generation Tyrosine Kinase Inhibitors Targeting Epidermal Growth Factor Receptor Mutations in Non-Small Cell Lung Cancer

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