Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial.

Here we report on stage 1, which aimed to confirm the dose and assess the preliminary efficacy (primary outcome: overall survival; secondary outcomes: progression‑free survival, objective response rateand duration of response) and safety of gotistobart compared to docetaxel.

在这里，我们报告了第一阶段的结果，该阶段旨在确认剂量并评估 gotistobart 与多西他赛相比的初步疗效（主要结果：总生存期；次要结果：无进展生存期、客观缓解率和缓解持续时间）以及安全性。

Patients with sqNSCLC were randomized (1:1) to gotistobart (6 mg kg-1 with two 10 mg kg-1 loading doses every 3 weeks (N = 45)) or docetaxel (75 mg m-2 every 3 weeks (N = 42)).

将 sqNSCLC 患者随机分为两组（1:1），一组接受 gotistobart 治疗（每3周一次，起始剂量为两个10 mg kg-1，随后维持剂量为6 mg kg-1，共45例），另一组接受 docetaxel 治疗（每3周一次，剂量为75 mg m-2，共42例）。

After a median follow-up of 14.5 months, median overall survivalwas not reached with gotistobart (95% confidence interval(CI) 9.3 to not evaluable) versus 10.0 months (95% CI 6.2 to 11.9 months) with docetaxel (hazard ratio0.46, 95% CI 0.25 to 0.84, nominal two-sided P = 0.0102).

经过中位随访14.5个月后，使用 gotistobart 治疗的患者的中位总生存期尚未达到（95% 置信区间为9.3至不可评估），而使用 docetaxel 治疗的患者的中位总生存期为10.0个月（95% 置信区间为6.2至11.9个月），两组的危险比为0.46（95% 置信区间为0.25至0.84，名义双侧P值为0.0102）。

Safety was manageable, with grade ≥3 treatment-related adverse events in 42% and 49% of patients receiving gotistobart and docetaxel, respectively.

安全性可控，接受gotistobart和docetaxel治疗的患者中，分别有42%和49%出现了3级或更高级别的治疗相关不良事件。

Stage 1 results suggest that gotistobart monotherapy can provide clinically meaningful benefit for patients with programmed cell death protein/programmed death ligand 1-resistant and chemotherapy-resistant metastatic sqNSCLC.

第一阶段的结果表明，对于那些对程序性细胞死亡蛋白/程序性死亡配体1和化疗耐药的转移性鳞状非小细胞肺癌患者，gotistobart单药治疗可以提供临床意义上的益处。

ClinicalTrials.gov identifier: NCT05671510 .

临床试验注册号：NCT05671510。