Adding durvalumab to standard treatment for resectable, muscle-invasive urothelial carcinoma (MUIC) produces “promising” outcomes, according to researchers.

In a phase 2 trial, patients who received neoadjuvant gemcitabine, cisplatin, and durvalumab, as well as adjuvant durvalumab, had a 3-year event-free survival (EFS) rate of about 73% and a 3-year overall survival (OS) rate of about 81%.

These results, from the SAKK 06/17 trial ( identifier: NCT03406650), were published in the Journal of Clinical Oncology.

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This trial included 57 evaluable patients with MIUC. At baseline, their median age was 68 (range, 33-81) years, and 21% were women.

Patients received 4 neoadjuvant cycles of durvalumab plus gemcitabine and cisplatin. After radical surgery, all patients received 10 cycles of adjuvant durvalumab. The median follow-up was 40 months.

About one-third of resected patients (33%) had a pathologic complete response, and R0 resection was achieved in 51 of the 52 patients who underwent surgery. Among patients with R0 resection, the relapse-free survival rate was 83.4% at 2 years and 80.9% at 3 years.

The 2-year EFS rate was 75.7%, and the 3-year EFS rate was 73.4%. The median EFS has not been reached. The 2-year OS rate was 85.0%, and the 3-year OS rate was 80.8%.

All patients had at least 1 treatment-related adverse event (TRAE) during neoadjuvant therapy. The most common TRAEs were fatigue (63%), nausea (53%), thrombocytopenia (49%), neutropenia (47%), and anemia (40%). The rate of grade 3-4 TRAEs was 67%.

Immune-related adverse events related to adjuvant durvalumab occurred in 62% of patients. The most common were diarrhea (13%), dry skin (11%), and lipase or amylase increase (11%).

“It is feasible to add the PD-L1 inhibitor durvalumab to neoadjuvant cisplatin/gemcitabine chemotherapy and to continue with adjuvant durvalumab after radical surgery,” Michael Anthony Carducci, MD, an associate editor of the Journal of Clinical Oncology, wrote in a comment.

“This approach can achieve high rates of event-free survival and overall survival at 2 and 3 years and is currently being tested in a large randomized phase III trial,” he added.

Disclosures: This study was supported by AstraZeneca. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Cathomas R, Rothschild SI, Hayoz S, et al. Perioperative chemoimmunotherapy with durvalumab for muscle-invasive urothelial carcinoma: Primary analysis of the single-arm phase II trial SAKK 06/17. J Clin Oncol. Published online August 17, 2023. doi:10.1200/JCO.23.00363

This article originally appeared on Cancer Therapy Advisor