medwireNews: Early data from the SAKK 06/17 trial point to the feasibility of incorporating durvalumab into the perioperative treatment regimen of patients with resectable muscle-invasive urothelial carcinoma (MIUC).
The findings were presented at the 2021 Genitourinary Cancers Symposium in a poster by Richard Cathomas (Cantonal Hospital Graubünden, Chur, Switzerland) and colleagues.
The open-label phase 2 study enrolled 61 patients with nonmetastatic MIUC of clinical stage T2–T4a, N0–N1 who received four 3-weekly cycles of neoadjuvant cisplatin 70 mg/m2 (given on day 1 of each cycle) plus gemcitabine 1000 mg/m2 (on days 1 and 8) alongside durvalumab 1500 mg (on day 1) before undergoing radical surgery. This was followed by up to 10 cycles of adjuvant durvalumab 1500 mg every 4 weeks.
Of the 58 participants who received at least one dose of durvalumab (ie, the full analysis set), the majority (69%) had T2 disease, while 21% had T3 and 10% had T4 disease. The median age of the cohort was 67.5 years and over three-quarters (79%) were men.
In all, the large majority (95%) of patients received all four doses of neoadjuvant durvalumab, albeit with a dose delay in 24%, 81% received all four cisplatin doses, and 72% received all eight gemcitabine doses.
Cathomas and team presented data on several secondary endpoints of the trial, including pathologic response (<ypT2,N0), which was achieved by 60% of the 53 patients who underwent surgery, and pathologic complete remission (ypT0,N0), which was observed in 34%.
They noted that the pathologic response and complete remission rates “confirm results from similar phase II trials,” such as of neoadjuvant nivolumab plus cisplatin-based chemotherapy.
With regard to the safety profile, 43% of patients experienced adverse events (AEs) of grade 3 during neoadjuvant chemoimmunotherapy, while grade 4 events were reported in 25%. The rates of grade 3 and 4 AEs during adjuvant durvalumab treatment were 12% and 2%, respectively.
All but one participant had an R0 resection, and high-grade postoperative complications (Clavien–Dindo grade ≥IIIa) occurred in 34%, which the researchers said is comparable to the rate observed in the PURE-01 trial of neoadjuvant pembrolizumab in a similar patient population.
This durvalumab-containing perioperative regimen “is feasible and can be completed in [the] vast majority of patients,” said the investigators, adding that the final analysis for the primary endpoint of event-free survival at 2 years is expected in the first quarter of 2022.
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