Becotatug Vedotin for Recurrent/Metastatic Nasopharyngeal Carcinoma (Magic-M001): A Multicenter, Randomized Trial
Mené sur 73 patients atteints d'un carcinome du rhinopharynx récidivant ou métastatique, cet essai multicentrique compare l'efficacité, du point de vue du taux de réponse objective et de la survie sans progression, et la toxicité d'une chimiothérapie (capécitabine ou docétaxel) et du bécotatug védotin (un conjugué anticorps-médicament ciblant EGFR)
Background: Patients with recurrent/metastatic nasopharyngeal carcinoma (NPC) had limited treatment option and dismal prognosis after failure to programmed cell death protein 1/programmed death ligand 1 (PD-1/PD-L1) inhibitors and chemotherapy.
Methods: This multicenter, open-label, randomized trial investigated 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. Eligible participants were randomized 1:1 to receive becotatug vedotin 2.3 mg/kg every 3 weeks or chemotherapy (capecitabine or docetaxel). The co-primary endpoints were the independent review committee-confirmed objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).
Results: Between April 6, 2023, and December 27, 2023, a total of 173 patients were randomized, with 86 assigned to becotatug vedotin and 87 to chemotherapy. As of June 30, 2024, the ORR was significantly higher with becotatug vedotin than with chemotherapy (30.2% vs 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 vs 2.83 months; hazard ratio, 0.63; 95% CI, 0.43-0.91; log-rank P = 0.01). As of December 30, 2024, the interim OS analysis showed a median OS of 17.08 months with becotatug vedotin and 11.99 months with chemotherapy (hazard ratio, 0.73; 95% CI, 0.48-1.12; log-rank P = 0.15), with a median follow-up of 13.47 months. The safety profiles were comparable between treatment groups.
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.
Annals of Oncology , résumé, 2026