Lilly Announces Positive Phase 3 RELAY Trial Results for CYRAMZA® (ramucirumab) Combined with Erlotinib as First-Line Treatment in Metastatic EGFR-Mutated NSCLC

Source: Sina Medical News 　2019-03-13                                                        A-A+

3Month12On [date], Eli Lilly and Company announced that its drugCYRAMZA®（ramucirumab) clinical3Phase StudyRELAYMet the primary endpoint of progression-free survival. This clinical3A global, randomized, double-blind trial is currently evaluatingCYRAMZAIn combination with erlotinib asEGFRGenetically Mutated Metastatic Non-Small Cell Lung Cancer (NSCLC) Efficacy of first-line treatment in patients. The results showed that, statistically, there was a significant prolongation of the time during which patients experienced no cancer growth or spread after initiating treatment.

RELAYSafety Information from Previous StudiesCYRAMZAclinical3consistent with the safety profile of erlotinib established in phase clinical trials. InCYRAMZA+Most Common in the Erlotinib Group(>5%)≥3Grade adverse events include hypertension, acneiform dermatitis, and diarrhea. Detailed efficacy and safety results will be submitted to2019Annual Medical Conference.

Ramucirumabis an anti-angiogenic therapy, and the drug acts as a vascular endothelial growth factor(VEGF)Receptor2Antagonists, by specifically blockingVEGFReceptors and LigandsVEGF-a、VEGF-candVEGF-dcombination, blockadeVEGFReceptor2activation, thereby achieving the effect of inhibiting tumor growth. Eli Lilly and Company plans to2019Initiate the marketing authorization registration process for this treatment regimen in mid-year.

President, Late-Stage Oncology Development, Eli Lilly and CompanyMaura Dicklerstated: “Despite metastatic in recent yearsEGFRProgress has been made in the treatment of mutated non-small cell lung cancer, but the prognosis remains poor, and additional first-line treatment options are still needed to help patients suffering from this fatal disease. We are excited about the results of this study, which showCYRAMZACombination with erlotinib significantly delayed disease progression in patients.RELAY“This trial is another example of Eli Lilly and Company’s commitment to providing new treatment options for patients with lung cancer. We thank the patients, investigators, and clinical trial sites that participated in the study, and we look forward to collaborating with regulatory authorities worldwide on the submission for registration.”

There is currently no cure for metastatic lung cancer. This disease is associated with low survival rates, and disease progression following the acquisition of drug resistance remains a challenge. Most patients will undergo multiple lines of therapy, and first-line treatment regimens may influence subsequent treatment options. Tyrosine kinase inhibitors(TKIs)is currentlyEGFRMutant TypeNSCLCstandard treatment regimen,RELAYErlotinib, the medication used in the study protocol, is the globally recognized standard of care for this type of lung cancer.

RELAYYesCYRAMZAThe Second Positive Result in the Treatment of Metastatic Non-Small Cell Lung Cancer3Phase trial. In another studyREVELIn China,CYRAMZA+Docetaxel versus Placebo+Docetaxel was compared in patients with metastatic non-small cell lung cancer whose disease had progressed during or after platinum-based chemotherapy.REVELThe study met the primary endpoint of overall survival, as well as the key secondary endpoints of progression-free survival and response rate, with results supportingCYRAMZACurrently indicated for second-line treatment of non-small cell lung cancer.

Meanwhile, the previously completedCYRAMZAClinical3Phase study results also support the approval of this drug for second-line treatment of gastric cancer and colorectal cancer. According to another studyREACH-2the results, Eli Lilly and Company has also submitted applications in the United States, the European Union, and Japan regardingCYRAMZARegistration Submission for Second-Line Treatment of Hepatocellular Carcinoma. (Compiled by Sina Medicine)/David）

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Lilly's CYRAMZA® (ramucirumab) Phase 3 RELAY Trial Met Primary Endpoint, Significantly Improving Progression-Free Survival in First-Line Treatment of Patients with Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

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