A Pooled Analysis of Datopotamab Deruxtecan in Patients With EGFR-Mutated NSCLC.

Methods

Data were pooled from the phase II TROPION-Lung05 (NCT04484142) and phase III TROPION-Lung01 (NCT04656652) trials.

数据来自第二阶段的TROPION-Lung05试验（NCT04484142）和第三阶段的TROPION-Lung01试验（NCT04656652）。

Patients with EGFR-mutated advanced or metastatic NSCLC, who had received previous targeted therapies and platinum-based chemotherapy, received Dato-DXd 6 mg/kg (TROPION-Lung05) or were randomized to Dato-DXd 6 mg/kg or docetaxel 75 mg/m2 (TROPION-Lung01) once every 3 weeks.

接受过靶向治疗和含铂化疗的EGFR突变晚期或转移性非小细胞肺癌患者，接受了Dato-DXd 6 mg/kg (TROPION-Lung05)治疗，或被随机分配接受Dato-DXd 6 mg/kg或docetaxel 75 mg/m2 (TROPION-Lung01)治疗，每3周一次。

End points included objective response rate, duration of response, and progression-free survival, all per blinded independent central review, overall survival, and safety.

终点包括客观缓解率、缓解持续时间、无进展生存期，所有这些都是通过盲法独立中央审查评估的，总生存期和安全性。

Results

In total, 117 patients with EGFR mutations who received Dato-DXd were included in the pool.

总共纳入了117名接受Dato-DXd治疗的EGFR突变患者。

The population was heavily pretreated (median three lines of previous therapies; range, 1-5) and predominantly Asian (69%).

该队列患者接受过多次治疗（中位数为三线治疗；范围1-5），并且以亚洲人为主（占69%）。

The most common mutations were exon 19 deletion (51%), L858R (32%), and T790M (27%); more than one EGFR mutation could be present.

最常见的突变是外显子19缺失（51%），L858R（32%）和T790M（27%）；可能存在一种以上的EGFR突变。

The confirmed objective response ratewas 43% (95% confidence interval[CI]: 34-52), including five complete responses (4%).

确认的客观缓解率为43%（95%置信区间[CI]：34-52），包括五例完全缓解（4%）。

Median duration of response was 7.0 months (95% CI: 4.2-9.8).

反应持续时间的中位数为7.0个月（95%置信区间：4.2-9.8）。

Median progression-free survivaland overall survivalwere 5.8 (95% CI: 5.4-8.2) and 15.6 months (95% CI: 13.1-19.0), respectively.

无进展生存期和总生存期的中位数分别为5.8个月（95%置信区间：5.4-8.2）和15.6个月（95%置信区间：13.1-19.0）。

The safety profile of Dato-DXd was consistent with the individual studies.

Dato-DXd的安全性特征与各个独立研究保持一致。

No new safety signals were observed.

未观察到新的安全信号。

Rates of grade greater than or equal to 3 treatment-related adverse events and serious adverse events were 23% and 6%, respectively.

3级或以上治疗相关不良事件和严重不良事件的发生率分别为23%和6%。

Conclusions

Dato-DXd demonstrated meaningful clinical activity in patients with EGFR-mutated advanced or metastatic NSCLC who had progressed on EGFR-directed therapies and chemotherapy, with an acceptable safety profile.

Dato-DXd在EGFR突变的晚期或转移性非小细胞肺癌患者中显示出有意义的临床活性，这些患者在EGFR靶向治疗和化疗后进展，具有可接受的安全性特征。