Becotatug vedotin for recurrent/metastatic nasopharyngeal carcinoma (Magic-M001): a multicenter, randomized trial.

patients_and_methods

This multicenter, open-label, randomized trial investigated the anti-epidermal growth factor receptor antibody-drug conjugate becotatug vedotin in patients with recurrent/metastatic NPC after failure to ≥2 lines of systemic therapies, including chemotherapy and PD-1/PD-L1 inhibitors.

这项多中心、开放标签、随机试验研究了抗表皮生长因子受体抗体药物偶联物becotatug vedotin，用于在≥2线系统治疗失败后复发/转移性NPC患者，包括化疗和PD-1/PD-L1抑制剂。

Eligible participants were randomly assigned 1:1 to receive becotatug vedotin 2.3 mg/kg every 3 weeks or chemotherapy (capecitabine or docetaxel).

符合条件的参与者被随机分配为1:1，接受每3周一次的becotatug vedotin 2.3 mg/kg或化疗（卡培他滨或多西他赛）。

The coprimary endpoints were the independent review committee-confirmed objective response rate(ORR), progression-free survival(PFS), and overall survival(OS).

主要终点是独立审查委员会确认的客观缓解率（ORR）、无进展生存期（PFS）和总生存期（OS）。

Results

Between 6 April 2023 and 27 December 2023, a total of 173 patients were randomly assigned, with 86 assigned to becotatug vedotin and 87 to chemotherapy.

从2023年4月6日到2023年12月27日，共有173名患者被随机分配，其中86名被分配到becotatug vedotin，87名被分配到化疗。

As of 30 June 2024, the ORR was significantly higher with becotatug vedotin than with chemotherapy (30.2% versus 11.5%, P = 0.003).

截至2024年6月30日，becotatug vedotin的ORR显著高于化疗（30.2%对11.5%，P = 0.003）。

With a median follow-up of 7.39 months, becotatug vedotin was associated with a significantly reduced risk of disease progression or death compared with chemotherapy [median PFS, 5.82 versus 2.83 months; hazard ratio(HR) 0.63, 95% confidence interval(CI) 0.43-0.91, log-rank P = 0.01].

中位随访7.39个月，becotatug vedotin与化疗相比，疾病进展或死亡风险显著降低[中位PFS，5.82个月对2.83个月；风险比（HR）0.63，95%置信区间（CI）0.43-0.91，对数秩P = 0.01]。

As of 30 December 2024, the interim OS analysis showed a median OS of 17.08 months with becotatug vedotin and 11.99 months with chemotherapy (HR 0.73, 95% CI 0.48-1.12, log-rank P = 0.15), with a median follow-up of 13.47 months.

截至2024年12月30日，中期OS分析显示，becotatug vedotin的中位OS为17.08个月，化疗为11.99个月（HR 0.73，95% CI 0.48-1.12，对数秩P = 0.15），中位随访时间为13.47个月。

The safety profiles were comparable between treatment groups.

各治疗组之间的安全特性是可比较的。

Conclusions

Among patients with heavily pretreated and immunotherapy-exposed recurrent or metastatic NPC, becotatug vedotin significantly improved ORR and PFS compared with chemotherapy, with comparable toxicity and encouraging but immature OS results.

在接受过多次治疗和免疫治疗的复发或转移性鼻咽癌患者中，比卡替尼单抗显著改善了客观缓解率和无进展生存期，与化疗相比毒性相当，总生存期数据虽然令人期待但尚未成熟。