Ifinatamab Deruxtecan in Patients With Extensive-Stage Small Cell Lung Cancer: Primary Analysis of the Phase II IDeate-Lung01 Trial.

This phase II trial evaluated the efficacy and safety of ifinatamab deruxtecan (I-DXd), a B7 homolog 3-directed antibody-drug conjugate, in patients with previously treated ES-SCLC.

这项II期试验评估了在之前接受过治疗的ES-SCLC患者中，B7同源蛋白3导向的抗体药物偶联物伊菲那妥单抗德曲妥单抗（I-DXd）的有效性和安全性。

Methods

Patients were randomly assigned to receive I-DXd 8 or 12 mg/kg intravenously once every 3 weeks in part 1 (dose optimization) and received I-DXd 12 mg/kg in part 2 (extension).

患者被随机分配接受 I-DXd 8 或 12 mg/kg 静脉注射，每3周一次，在第1部分（剂量优化）中，而在第2部分（扩展）中接受 I-DXd 12 mg/kg。

The primary end point was objective response rate(ORR) by blinded independent central review per RECIST, version 1.1.

主要终点是根据 RECIST 版本 1.1，通过盲法独立中央审查的客观缓解率（ORR）。

Results

Overall, 183 patients received I-DXd: 88 in part 1 (8 mg/kg, n = 46; 12 mg/kg, n = 42) and 95 in part 2.

总体而言，183名患者接受了I-DXd治疗：其中88名患者在第1部分（8 mg/kg，n=46；12 mg/kg，n=42），另外95名患者在第2部分。

The median number of previous lines of treatment was two.

先前治疗线的中位数为两线。

In the total 12-mg/kg group from parts 1 and 2 (n = 137), the confirmed ORR was 48.2% (95% CI, 39.6 to 56.9), median duration of response was 5.3 (95% CI, 4.0 to 6.5) months, median time to response was 1.4 (range, 1.0-8.1) months, median progression-free survivalwas 4.9 (95% CI, 4.2 to 5.5) months, and the 9-month overall survivalestimate was 59.1%.

在第1部分和第2部分的总12-mg/kg组中（n = 137），确认的客观缓解率（ORR）为48.2%（95%置信区间，39.6至56.9），反应持续时间的中位数为5.3（95%置信区间，4.0至6.5）个月，反应时间的中位数为1.4（范围，1.0-8.1）个月，无进展生存期的中位数为4.9（95%置信区间，4.2至5.5）个月，9个月总生存率估计为59.1%。

Any-grade treatment-related adverse events (TRAEs) occurred in 89.8% of patients (grade ≥3, 36.5%).

任何级别的治疗相关不良事件（TRAEs）发生在89.8%的患者中（3级或以上，36.5%）。

The most common TRAEs were nausea (43.1%), anemia (34.3%), and neutropenia (34.3%).

最常见的治疗相关不良事件是恶心（43.1%）、贫血（34.3%）和中性粒细胞减少症（34.3%）。

TRAEs associated with treatment discontinuation and death were reported in 9.5% and 4.4% of patients, respectively.

分别有9.5%和4.4%的患者报告了与治疗中断和死亡相关的不良事件。

Treatment-related interstitial lung disease (ILD) as determined by the ILD adjudication committee was reported in 12.4% of patients (grade ≥3, 4.4%).

治疗相关性间质性肺病（ILD）由ILD裁定委员会确定，在12.4%的患者中报告（3级或以上，4.4%）。

Conclusions

I-DXd 12 mg/kg once every 3 weeks showed promising efficacy in patients with previously treated ES-SCLC.

I-DXd 12 mg/kg每3周一次在既往治疗过的广泛期小细胞肺癌（ES-SCLC）患者中显示出有希望的疗效。

The observed safety profile was consistent with previous reports, with no new safety signals identified.

观察到的安全性特征与先前报告一致，未发现新的安全信号。