Becotatug Vedotin Plus Pucotenlimab Shows Responses in Previously Treated Nasopharyngeal Carcinoma

Patients with recurrent or metastatic nasopharyngeal carcinoma progressing after platinum and anti–PD-1/PD-L1 therapy have limited treatment options. The ongoing, open-label, multicohort Magic-C001 phase I/II study evaluated the EGFR-directed antibody-drug conjugate becotatug vedotin plus the PD-1 inhibitor pucotenlimab in EGFR-positive solid tumors. The nasopharyngeal carcinoma analysis included 31 previously treated patients receiving the recommended phase II dose: becotatug vedotin 2.0 mg/kg plus pucotenlimab 3.0 mg/kg every three weeks. The phase II primary endpoint was objective response rate.

The confirmed response rate was 71.0% (95% CI, 52.0–85.8), and disease control rate was 93.5% (95% CI, 78.6–99.2). Median response duration was 14.0 months (95% CI, 5.7–not estimated), and median progression-free survival was 12.0 months (95% CI, 6.8–15.4). Overall survival data were immature.

Reported treatment-related adverse events included pruritus (71.9%), hypoesthesia (65.6%), anemia (59.4%), and rash (56.3%); grade 3 or higher events occurred in 40.6%. No treatment-related deaths occurred. The abstract does not specify the safety-analysis denominator. These findings suggest antitumor activity, but the small, uncontrolled cohort cannot establish benefit over alternative treatments or isolate the contribution of PD-1 rechallenge. An ongoing multicenter randomized phase III study is evaluating the regimen.