Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
Enfortumab Vedotin plus Pembrolizumab as First-line Treatment in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Results from EV-202 Cohort 9.
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Swiecicki Paul L, Hanna Glenn J, Geiger Jessica L, Fujisawa Takao, Haigentz Missak, Honma Yoshitaka, Bruce Justine Y, Tanaka Kaoru, Muro Kei, Bhateja Priyanka, Kaplan Jason, Liu Shubin, Gorla Seema, Wozniak Michele, Dillon Ryan, Hamed Salaheldin, Meng Changting, Chaney Marya F, Rosenberg Ari J
Аннотация
PURPOSE: To assess the safety and efficacy of enfortumab vedotin (EV) and pembrolizumab as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).
PATIENTS AND METHODS: In this open-label, multicohort, phase II study (NCT04225117), the R/M HNSCC cohort (cohort 9) received EV (1.25 mg/kg IV) on days 1 and 8 and pembrolizumab (200 mg IV) on day 1 in 21-day cycles. Eligible patients had R/M HNSCC, programmed cell death ligand 1 (PD-L1) combined positive score (CPS) ≥1, and no prior systemic therapy in the R/M setting. The primary endpoint was the investigator-assessed confirmed objective response rate (cORR) per Response Evaluation Criteria in Solid Tumors version 1.1. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.
RESULTS: The primary analysis included 41 patients. Of these, 39% had PD-L1 CPS 1-19, and 61% had CPS ≥20. The median interquartile range nectin-4 expression H score was 185 (110-255). In patients with oropharyngeal squamous cell carcinoma (n = 14), 78.6% had p16-positive disease. The median follow-up for OS was 11 months. Sixteen patients achieved a response, and cORR was 39% [95% confidence interval (CI), 24.2-55.5]. The complete response rate was 9.8%. Median DOR was not estimable, and the estimated 6-month DOR rate was 81.7% (95% CI, 42-95.4). The median PFS was 5.1 months (95% CI, 3.5-not estimable). Grade ≥3 treatment-related adverse events were reported in 41.5% of patients, most commonly maculopapular rash (7.3%).
CONCLUSIONS: EV with pembrolizumab demonstrated promising clinical activity as first-line treatment in patients with PD-L1 CPS ≥1 R/M HNSCC. Safety results reinforced the manageable tolerability profile of EV with pembrolizumab.
PATIENTS AND METHODS: In this open-label, multicohort, phase II study (NCT04225117), the R/M HNSCC cohort (cohort 9) received EV (1.25 mg/kg IV) on days 1 and 8 and pembrolizumab (200 mg IV) on day 1 in 21-day cycles. Eligible patients had R/M HNSCC, programmed cell death ligand 1 (PD-L1) combined positive score (CPS) ≥1, and no prior systemic therapy in the R/M setting. The primary endpoint was the investigator-assessed confirmed objective response rate (cORR) per Response Evaluation Criteria in Solid Tumors version 1.1. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.
RESULTS: The primary analysis included 41 patients. Of these, 39% had PD-L1 CPS 1-19, and 61% had CPS ≥20. The median interquartile range nectin-4 expression H score was 185 (110-255). In patients with oropharyngeal squamous cell carcinoma (n = 14), 78.6% had p16-positive disease. The median follow-up for OS was 11 months. Sixteen patients achieved a response, and cORR was 39% [95% confidence interval (CI), 24.2-55.5]. The complete response rate was 9.8%. Median DOR was not estimable, and the estimated 6-month DOR rate was 81.7% (95% CI, 42-95.4). The median PFS was 5.1 months (95% CI, 3.5-not estimable). Grade ≥3 treatment-related adverse events were reported in 41.5% of patients, most commonly maculopapular rash (7.3%).
CONCLUSIONS: EV with pembrolizumab demonstrated promising clinical activity as first-line treatment in patients with PD-L1 CPS ≥1 R/M HNSCC. Safety results reinforced the manageable tolerability profile of EV with pembrolizumab.