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María Natalia Gandur Quiroga: Adjuvant Pembrolizumab in Muscle-Invasive Urothelial Carcinoma

María Natalia Gandur Quiroga/LinkedIn

Nov 3, 2024, 09:22

María Natalia Gandur Quiroga: Adjuvant Pembrolizumab in Muscle-Invasive Urothelial Carcinoma

María Natalia Gandur Quiroga posted on X:

“AMBASSADOR Study: Adjuvant Pembrolizumab in Muscle-Invasive Urothelial Carcinoma

Background

Muscle-invasive urothelial carcinoma is an aggressive cancer with high relapse rates.
Until now, the effectiveness of pembrolizumab as an adjuvant therapy following radical surgery was unknown.

Study Design

Phase 3, randomized, open-label trial.
702 patients divided into two groups: pembrolizumab (200 mg every 3 weeks for 1 year) vs. observation.

Key Results

Disease-Free Survival (DFS): Median of 29.6 months with pembrolizumab vs. 14.2 months with observation (HR 0.73; p=0.003).
DFS benefit across all subgroups, regardless of PD-L1 expression or previous neoadjuvant therapy.

Safety

Grade ≥3 adverse events occurred in 50.7% of the pembrolizumab group and 31.6% of the observation group.
Most common side effects: fatigue, pruritus, diarrhea, and hypothyroidism.

Conclusion

Pembrolizumab significantly prolongs DFS in high-risk patients after radical surgery.
While overall survival data is pending, these findings suggest a promising new adjuvant treatment option for this patient population.

Clinical Implications

Potential shift in the standard of care for patients with muscle-invasive urothelial carcinoma.
Reinforces the value of PD-1 inhibitors in the adjuvant management of aggressive cancers.”

María Natalia Gandur Quiroga is a Medical Oncologist and Chief of the Division of Genitourinary Medical Oncology at the Ángel H. Roffo Oncology Institute in Buenos Aires, Argentina. She is a Professor of Medicine at the University of Buenos Aires at the Oncologists Post Graduates Studies. Her research focuses on clinical trials with aims to improve the treatment of patients with urologic tumors. She is an active member of the European Association for Cancer Research, Argentinian Medical Association and American Society of Clinical Oncology.