Imfinzi (durvalumab)

Muscle-invasive bladder cancer(MIBC)carries a high risk of recurrence.The standard treatment has been cisplatin-based neoadjuvant chemotherapy(NAC)followed by radical cystectomy(RC), but nearly half of patients are cisplatin-ineligible and unable to receive optimal NAC.Furthermore, recurrence after NAC plus RC remains common, highlighting the need for effective adjuvant strategies.Recent advances in immune checkpoint inhibitors(ICIs)have revolutionized perioperative treatment paradigms.The phase Ⅲ CheckMate 274 trial demonstrated that adjuvant nivolumab significantly prolonged disease-free survival(DFS), particularly in PD-L1-positive patients.In the IMvigor010 trial, adjuvant atezolizumab did not improve DFS in the overall population, but a biomarker-driven subanalysis revealed marked benefit in patients with postoperative circulating tumor DNA(ctDNA)positivity.Based on these findings, the ongoing IMvigor011 trial restricts adjuvant atezolizumab to ctDNA-positive patients.The NIAGARA trial evaluated a comprehensive perioperative approach using neoadjuvant gemcitabine-cisplatin plus durvalumab followed by adjuvant durvalumab for 1 year.This regimen significantly improved DFS, overall survival(OS), and pathological complete response(pCR)rates without increasing Grade ≥3 toxicities.ctDNA has emerged as a promising biomarker for risk stratification and treatment monitoring, potentially enabling precision perioperative immunotherapy.This review summarizes pivotal phase Ⅲ trials of perioperative ICI therapy in MIBC and discusses the role of ctDNA-guided strategies, envisioning a shift from universal ICI administration to biomarker-driven, individualized perioperative approaches.

P1, N=50, Recruiting, Inimmune Corporation | Not yet recruiting --> Recruiting | Trial completion date: Apr 2026 --> Mar 2027 | Trial primary completion date: Aug 2024 --> Oct 2026

Early postoperatively, he developed a single S3 metastasis in the left lung and started combination therapy with atezolizumab plus bevacizumab...He was treated with lenvatinib for a short period of time postoperatively, but recurred multiple metastases in both lungs on CT scan 3 months later. He has been treated with a combination of durvalumab plus tremelimumab while submitting to cancer genome testing, which revealed TMB-high and MSI-high. Tissue sampling is essential for the diagnosis of inter-hepatic metastasis or multicentric occurrence, and in the case of ipsilateral hepatopulmonary metastasis, trans-diaphragmatic approach surgery is effective for less incision surgery. Combined immunoadjuvant therapy for resected HCC has shown efficacy in short-term results.

In recurrent ovarian cancer, niraparib+pembrolizumab showed modest activity with durable responses in homologous recombination-deficient (HRD) tumors; olaparib+durvalumab demonstrated high activity in gBRCA platinum-sensitive relapse, and adding bevacizumab broadened benefit in non-BRCA cohorts. In the newly diagnosed disease, rucaparib+nivolumab maintenance failed to improve PFS versus rucaparib alone. Endometrial trials (olaparib+durvalumab; talazoparib+avelumab in mismatch repair-proficient disease) showed limited activity overall, with signals restricted to biomarker-selected subgroups...PARP+PD-1/PD-L1 combinations are most compelling in ovarian cancer, particularly in BRCA/HRD tumors and, in selected settings, with the addition of bevacizumab, while frontline maintenance benefit remains unproven and endometrial activity is modest. Biomarker-guided selection, rational triplets with non-cytotoxic partners, and optimized sequencing warrant further evaluation.

P3, N=252, Recruiting, NRG Oncology | Not yet recruiting --> Recruiting

This case suggests that an integrated approach, combining aggressive local therapy with systemic immunotherapy informed by biomarkers, can achieve a favorable outcome in selected patients with ICC. The identification of a high tumor mutational burden was crucial in guiding treatment and supports its potential as a predictive biomarker. This precision oncology strategy may improve the poor prognosis associated with this condition.

P=N/A, N=236, Completed, AstraZeneca | Active, not recruiting --> Completed | Trial completion date: Jul 2026 --> Nov 2025 | Trial primary completion date: Jul 2026 --> Nov 2025

P2, N=60, Recruiting, John Sfakianos | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2026

Durvalumab-containing combination therapy showed promising efficacy in patients with R/M PSC, irrespective of PD-L1 expression. A lower CD4+/CD8+ ratio may be associated with favorable disease control.

Adjuvant durvalumab following complete resection was not associated with improvement in DFS compared with placebo in EGFR-/ALK- NSCLC, regardless of PD-L1 status.

P3, N=625, Recruiting, AstraZeneca | Trial completion date: Apr 2029 --> Sep 2030 | Trial primary completion date: Oct 2026 --> Jul 2027

P2, N=33, Not yet recruiting, University of Washington