Preface
Recently, an important breakthrough has been made in the MARIPOSA study led by Professor Lu Shun from the Chest Hospital of Shanghai Jiao Tong University School of Medicine, and its results were published in the New England Journal of Medicine, which is expected to open up a new pattern for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations.
For patients with EGFR-mutated advanced NSCLC, third-generation EGFR-TKI monotherapy is the current standard first-line treatment option. However, there are still many unmet clinical needs, and there is still room for improvement in the efficacy of EGFR-TKI monotherapy. Amivantamab is a bispecific antibody targeting EGFR and MET, which can be used in combination with EGFR-TKI to enhance tumor inhibition and delay the time of drug resistance. In order to further verify the efficacy of the combination of the two, Professor Lu Shun led the MARIPOSA study.
The MARIPOSA study is an international, multicenter, randomized, controlled Phase III clinical trial to evaluate the efficacy and safety of amivantamab in combination with lazertinib versus osimertinib alone or lazertinib alone in the first-line treatment of EGFR-mutated locally advanced or metastatic NSCLC. Enrolled patients were randomized in a 2:2:1 ratio to receive amivantamab plus lazertinib, osimertinib monotherapy, or lazertinib monotherapy. The primary endpoint of the study was progression-free survival (PFS) as assessed by an independently blinded center. Secondary endpoints included objective response rate (ORR), duration of response (DoR), and safety.
A total of 1074 patients with advanced NSCLC with EGFR mutations were enrolled in the study. Among them, there were 429 patients in the combination treatment group, 429 patients in the osimertinib group, and 216 patients in the Lazertinib group. Median PFS was 23.7 months in the combination group and 16.6 months in the osimertinib arm (HR=0.70; 95% CI, 0.58-0.85; P<0.001). In addition, the objective response rate (ORR) was 86 and 85 percent, respectively. Among patients with confirmed response, the median duration of response (DoR) was 25.8 months and 16.8 months, respectively. In an interim overall survival (OS) analysis, amivantamab plus Lazertinib was shown to be beneficial over osimertinib.
In the safety analysis, discontinuation due to treatment-related adverse events (TRAEs) occurred in 10% and 3% of patients in the combination and osimertinib arms, respectively. The most common AEs in the combination group included paronychia (68%; ≥11% for grade 3) and infusion-related reactions (63%; ≥6% for level 3). Venous thromboembolism (VTE) is an AE of particular concern, mostly grade 1 to 2, and most VTE occurs within 4 months of initiation of amivantamab plus Lazertinib and is effectively controlled with anticoagulation.
Overall, the MARIPOSA study has shown promising prospects for the treatment of amivantamab in combination with Lazertinib in EGFR-mutated advanced NSCLC, providing a new treatment option for these patients.
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