Becotatug vedotin plus pucotenlimab as first-line therapy in patients with recurrent or metastatic nasopharyngeal carcinoma: A phase II clinical trial.

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TPS6130 Background: Epidermal growth factor receptor (EGFR) is highly expressed in approximately 85% of nasopharyngeal carcinoma (NPC) cases and plays a critical role in tumor cell proliferation. Becotatug vedotin (MRG003) is a novel EGFR-targeted antibody-drug conjugate (ADC) with promising anti-tumor activity in NPC. Pucotenlimab is a recombinant humanized programmed cell death protein-1 (PD-1) inhibitor. Although platinum-based chemotherapy combined with a PD-1 inhibitor represents the current standard first-line treatment for recurrent or metastatic (R/M) NPC, treatment-related toxicities and suboptimal efficacy remain significant challenges. Preclinical and early clinical data have demonstrated synergistic anti-tumor activity of MRG003 combined with pucotenlimab in platinum-refractory R/M NPC. However, the efficacy and safety of this platinum-free combination as a first-line therapy for R/M NPC remain uncertain. This study aims to evaluate the efficacy and safety of becotatug vedotin plus pucotenlimab as a novel first-line treatment for patients with R/M NPC. Methods: This is an open-label, single-arm, phase II trial enrolling patients with R/M NPC eligible for first-line systemic therapy. Inclusion criteria include: age 18 to 75 years; ECOG performance status score of 0 or 1; histologically or cytologically confirmed NPC; stage IVB (UICC/AJCC 8th edition) or locoregional recurrence not amenable to curative local therapy; at least one measurable lesion per RECIST v1.1; and adequate organ function. Key exclusion criteria include severe uncontrolled pulmonary disease, active autoimmune disease, or a history of autoimmune disease requiring systemic immunosuppressive therapy. Eligible patients receive becotatug vedotin (2.0 mg/kg, IV, D1, Q3W) and pucotenlimab (200 mg, IV, D1, Q3W) until disease progression, unacceptable toxicity, or death. Dose adjustments are permitted based on toxicities. The primary endpoint is progression-free survival (PFS), defined as the time from treatment initiation to disease progression or death from any cause. Secondary endpoints include objective response rate (ORR), disease control rate (DCR), duration of response (DoR), overall survival (OS), treatment-related safety, and predictive biomarkers. Research Sponsor: Lepu Biopharma Co., Ltd. Clinical trial information: NCT07381699 .

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