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Thomas Flaig, MD


Durvalumab Plus Olaparib in Metastatic Urothelial Carcinoma: Phase II BAYOU Trial

By: Cordi Craig, MS
Posted: Friday, August 12, 2022

The standard of care for metastatic urothelial carcinoma is cisplatin-based chemotherapy; however, about 40% of patients are unfit for this treatment due to renal impairment, poor performance, or comorbidities. Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues evaluated the safety and efficacy of adding the monoclonal antibody durvalumab to the PARP inhibitor olaparib in patients with metastatic urothelial cancer. Although the phase II BAYOU study found the combination did not improve survival outcomes in an unselected population with metastatic urothelial carcinoma, PARP inhibitors may be effective among the subset of patients who harbor homologous recombination repair (HRR) mutations. The study was published in the Journal of Clinical Oncology.

The study authors randomly assigned untreated, platinum-ineligible patients with metastatic urothelial cancer (n = 154) 1:1 to receive durvalumab plus olaparib or durvalumab plus placebo. Of those patients, 20% had HRR gene mutations. The primary endpoint was progression-free survival. Secondary endpoints included overall survival in all patients and progression-free survival in the patient subgroup.

The survival results were not significantly different between the treatment group and the control group. The progression-free survival was 4.2 months with the addition of olaparib and 3.5 months for those treated with the addition of placebo (P = .79). The median overall survival was 10.2 months and 10.7 months, respectively. However, among the subgroup of patients with HRR gene mutations, the median progression-free survival was 5.6 months and 1.8 months with durvalumab plus olaparib and durvalumab plus placebo, respectively.

The treatment combination had a manageable safety profile, according to the investigators. Grade 3 and 4 treatment-related adverse events were reported in 18% of the treatment group and 9% of the control group.

Disclosure: For full disclosure of the study authors, visit

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