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Background <p>In the phase 3 EV-302 study, enfortumab vedotin–pembrolizumab (EV + P) significantly prolonged overall survival (OS) and progression-free survival (PFS) versus chemotherapy in patients with untreated locally advanced/metastatic urothelial carcinoma (la/mUC). We present a post&#xa0;hoc analysis in a pan-Asian population.</p> Methods <p>Patients from China, Japan, Singapore, South Korea, Taiwan, and Thailand received 3-week cycles of EV (1.25&#xa0;mg/kg; intravenously; Days 1 and 8) plus P (200&#xa0;mg; intravenously; Day 1) or chemotherapy (gemcitabine [Days 1 and 8] plus cisplatin/carboplatin [Day 1]). Primary endpoints were PFS and OS. Secondary endpoints included objective response rate (ORR) and safety.</p> Results <p>Overall, 176 patients were included (EV + P, <i>n</i> = 94; chemotherapy, <i>n</i> = 82). Median follow-up was 28.9&#xa0;months for EV + P recipients and 26.6&#xa0;months for chemotherapy recipients. EV + P prolonged PFS and OS versus chemotherapy, reducing the risk of disease progression or death by 63% (hazard ratio [HR], 0.37; 95% confidence interval [CI], 0.24–0.57) and death by 67% (HR, 0.33; [95% CI, 0.20–0.54]), respectively. Confirmed ORR was 72.2% versus 35.0%. Grade ≥ 3 treatment-related adverse events occurred in 66.0% of EV + P recipients and 68.4% of chemotherapy recipients. Most commonly maculopapular rash (11.7%) and hyperglycemia (10.6%) for EV + P and neutropenia (25.0%), anemia (19.7%), and neutrophil count decreased (18.4%) for chemotherapy.</p> Conclusion <p>EV + P demonstrated a clinically meaningful survival benefit in Asian patients with untreated la/mUC, with no new safety signals observed, consistent with the global EV-302 study. Results support guideline recommendations for EV + P as preferred first-line therapy in la/mUC.</p> Clinical trial registration <p>NCT04223856 (registered January 8, 2020).</p> Graphical abstract <p></p>

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Pan-Asian subgroup analysis of EV-302/KEYNOTE-A39: a phase 3 study to evaluate enfortumab vedotin and pembrolizumab in patients with untreated advanced urothelial carcinoma

  • 期刊论文

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  • 发表日期：

    2026年1月21日

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  • Eiji Kikuchi,
  • Michiel S. Van der Heijden,
  • Begoña P. Valderrama,
  • Shilpa Gupta,
  • Jens Bedke,
  • Sang Joon Shin,
  • Jian-Ri Li,
  • Jun Guo,
  • Pongwut Danchaivijitr,
  • Ravindran Kanesvaran,
  • Se Hoon Park,
  • Wen-Pin Su,
  • Shuya Kandori,
  • Woo Kyun Bae,
  • Alvin Wong,
  • Seema Gorla,
  • Abhishek Bavle,
  • Xuesong Yu,
  • Yi-Tsung Lu,
  • Thomas Powles

摘要

Background

In the phase 3 EV-302 study, enfortumab vedotin–pembrolizumab (EV + P) significantly prolonged overall survival (OS) and progression-free survival (PFS) versus chemotherapy in patients with untreated locally advanced/metastatic urothelial carcinoma (la/mUC). We present a post hoc analysis in a pan-Asian population.

Methods

Patients from China, Japan, Singapore, South Korea, Taiwan, and Thailand received 3-week cycles of EV (1.25 mg/kg; intravenously; Days 1 and 8) plus P (200 mg; intravenously; Day 1) or chemotherapy (gemcitabine [Days 1 and 8] plus cisplatin/carboplatin [Day 1]). Primary endpoints were PFS and OS. Secondary endpoints included objective response rate (ORR) and safety.

Results

Overall, 176 patients were included (EV + P, n = 94; chemotherapy, n = 82). Median follow-up was 28.9 months for EV + P recipients and 26.6 months for chemotherapy recipients. EV + P prolonged PFS and OS versus chemotherapy, reducing the risk of disease progression or death by 63% (hazard ratio [HR], 0.37; 95% confidence interval [CI], 0.24–0.57) and death by 67% (HR, 0.33; [95% CI, 0.20–0.54]), respectively. Confirmed ORR was 72.2% versus 35.0%. Grade ≥ 3 treatment-related adverse events occurred in 66.0% of EV + P recipients and 68.4% of chemotherapy recipients. Most commonly maculopapular rash (11.7%) and hyperglycemia (10.6%) for EV + P and neutropenia (25.0%), anemia (19.7%), and neutrophil count decreased (18.4%) for chemotherapy.

Conclusion

EV + P demonstrated a clinically meaningful survival benefit in Asian patients with untreated la/mUC, with no new safety signals observed, consistent with the global EV-302 study. Results support guideline recommendations for EV + P as preferred first-line therapy in la/mUC.

Clinical trial registration

NCT04223856 (registered January 8, 2020).

Graphical abstract