Multicenter randomized trial of becotatug vedotin for recurrent or metastatic nasopharyngeal carcinoma

Patients with recurrent or metastatic nasopharyngeal carcinom (R/M NPC) have limited treatment options and dismal prognosis after failure of PD-(L)1 inhibitors and chemotherapy. The multicenter Magic-M001 trial in China evaluated the EGFR-targeted antibody drug conjugate becotatug vedotin in patients with R/M NPC after failure of at least two previous lines of systemic therapy including chemotherapy and PD-(L)1 inhibitor. The patients were randomized 1:1 to receive becotatug vedotin 2.3 mg/kg every 3 weeks (n=86) or capecitabine or docetaxel chemotherapy (n=87). The co-primary endpoints were independent review committee-confirmed objective response rate (ORR) and progression-free survival (PFS) and overall survival (OS). The ORR was significantly higher with becotatug vedotin than with chemotherapy (30.2% versus 11.5%; p=0.003). With a median follow-up of 7.39 months, the median PFS was 5.82 versus 2.83 months (HR 0.63; p=0.01), and interim OS analysis with a median follow-up of 13.47 months found a median OS of 17.08 months with becotatug vedotin and 11.99 months with chemotherapy (HR 0.73; p=0.15). Safety profiles were comparable between groups. The authors conclude that among patients with pretreated immunotherapy-exposed R/M NPC, betotatug vedotin significantly improved ORR and PFS compared with chemotherapy, with comparable toxicity and encouraging, although immature, OS results.