Johnson & Johnson  announced longer follow-up data from the landmark Phase III MARIPOSA study which showed first-line treatment with Rybrevant (amivantamab-vmjw) combined with Lazcluze (lazertinib) provided consistent benefit across long-term outcomes compared to osimertinib monotherapy in adult patients with advanced nonsmall cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.

强生公司宣布了具有里程碑意义的III期MARIPOSA研究的更长时间的随访数据，该研究显示，与奥西替尼单药治疗成人晚期非小细胞肺癌（NSCLC）伴表皮生长因子受体（EGFR）外显子19缺失（ex19del）或L858R替代突变的患者相比，雷布万特（阿米万塔单抗vmjw）联合拉兹鲁兹（拉泽替尼）的一线治疗在长期结局中提供了一致的益处。

The data show a strong and improving overall survival (OS) trend favoring Rybrevant plus Lazcluze at approximately three years of follow-up. These results were presented in a late-breaking oral presentation at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer (WCLC) (Abstract #1146)..

。这些结果在国际肺癌研究协会（IASLC）2024年世界肺癌会议（WCLC）上发表的最新口头报告（摘要#1146）。。

At three years (a median follow-up of 31.1 months), 61 percent of patients receiving Rybrevant plus Lazcluze were alive compared to 53 percent of those treated with osimertinib based on an analysis performed at the request of a health authority (Median OS not estimable vs 37.3 months; hazard ratio [HR], 0.77; [95 percent confidence interval [CI], 0.61-0.96]; nominal P=0.019).

根据卫生部门的要求进行的分析，在三年（中位随访时间为31.1个月）时，61%接受瑞勃列万特联合拉兹克鲁兹治疗的患者存活，而接受奥西替尼治疗的患者存活率为53%（中位OS不可估计vs 37.3个月；风险比[HR]，0.77；[95%置信区间[CI]，0.61-0.96]；标称P=0.019）。

Overall survival will continue to be assessed with longer term follow-up as a key secondary endpoint. The primary efficacy outcome measure was progression-free survival (PFS) as assessed by blinded independent central review (BICR)..

总体生存率将继续通过长期随访作为关键的次要终点进行评估。。。

“By combining the multi-targeted mechanism of Rybrevant with Lazcluze a central nervous systempenetrant third-generation tyrosine kinase inhibitor, we are advancing a chemotherapy-free regimen for the first-line treatment of patients with EGFR-mutant NSCLC. This approach blocks EGFR and MET pathways and leverages the immune system, offering patients an opportunity for prolonged benefits,” said Shirish M.

Shirish M。

Gadgeel, M.D., Chief of Division of Hematology and Oncology, Associate Director at Henry Ford Cancer Institute and presenting author.* “Even more encouraging is the marked improvement in the hazard ratio and the ongoing separation of survival curves, showing an eight percent improvement at three years for Rybrevant  plus Lazcluze compared to osimertinib.

医学博士，血液学和肿瘤学系主任，亨利福特癌症研究所副主任兼报告作者。*“更令人鼓舞的是风险比的显着改善和生存曲线的持续分离，显示Rybrevant plus Lazcluze与osimertinib相比，三年后改善了8%。

This supports the long-term benefit of the combination as a first-line treatment option in this setting.”.

这支持了在这种情况下作为一线治疗选择的组合的长期益处。”。

Results further showed Rybrevant  plus Lazcluze demonstrated a trend toward improved central nervous system disease control compared to osimertinib at three years (HR, 0.82; [95 percent CI, 0.62- 1.09]; nominal P=0.165). At the three-year landmark, intracranial PFS was double for Rybrevant plus Lazcluze versus osimertinib (38 percent vs 18 percent, respectively).

结果进一步显示，与osimertinib相比，Rybrevant加Lazcluze在三年内表现出改善中枢神经系统疾病控制的趋势（HR，0.82；[95%CI，0.62-1.09]；标称P=0.165）。在这三年的里程碑事件中，Rybrevant plus Lazcluze与osimertinib的颅内PFS是前者的两倍（分别为38%和18%）。

More patients remained on treatment at three years with the Rybrevant combination compared to osimertinib (40 percent vs 29 percent, respectively; HR, 0.80; [95 percent CI, 0.68-0.96]; nominal P=0.014). Additionally, more patients receiving Rybrevant  and Lazcluze at the three-year follow-up had not started a subsequent therapy versus osimertinib (45 percent vs 32 percent, respectively; HR, 0.77; [95 percent CI, 0.65-0.93]; nominal P=0.005).

与osimertinib相比，更多的患者在三年后仍接受瑞勃列万特联合治疗（分别为40%和29%；HR为0.80；[95%CI为0.68-0.96]；标称P=0.014）。此外，在三年的随访中，更多接受Rybrevant和Lazcluze治疗的患者与osimertinib相比没有开始后续治疗（分别为45%和32%；HR为0.77；[95%CI为0.65-0.93]；标称P=0.005）。

Progression-free survival after first subsequent therapy was 57 percent for the Rybrevant combination compared to 49 percent for osimertinib (HR, 0.73; [95 percent CI, 0.59-0.91]; nominal P=0.004)..

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As previously reported in the MARIPOSA study, the safety profile was consistent with the safety profiles of the individual treatments. The rate of discontinuation of all study treatments due to treatment-related adverse events for Rybrevant plus Lazcluze was 10 percent. The rate of interstitial lung disease (including pneumonitis) was less than three percent in both arms.rs 1 and 2, fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration.

正如先前在MARIPOSA研究中报道的那样，安全性与个体治疗的安全性一致。Rybrevant plus Lazcluze因治疗相关不良事件而停止所有研究治疗的比率为10%。两组间质性肺病（包括肺炎）的发生率均不到3%。rs 1和rs 2与人IgG1的Fc部分融合，并配制为玻璃体内给药的等渗溶液。

Aflibercept acts as a soluble decoy receptor that binds VEGF-A and Placental Growth Factor (PGF) and thereby can inhibit the binding and activation of their cognate VEGF receptors..

阿柏西普作为可溶性诱饵受体，结合VEGF-a和胎盘生长因子（PGF），从而抑制其同源VEGF受体的结合和激活。。

Condition: NSCLC / EGFR

条件：NSCLC/EGFR

Type: drug

类型：药物