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Treatment Patterns and Overall Survival for Patients With Metastatic Urothelial Carcinoma Following FDA Approval of Avelumab Maintenance Therapy

Grace Taylor

The NCCN Clinical Practice Guidelines in Oncology for Bladder Cancer recommend that patients with locally advanced/metastatic urothelial carcinoma (mUC) receive the following treatment regimens: platinum-based chemotherapy (PBC) followed by avelumab maintenance therapy (maintA), but only if there is no disease progression after first-line PBC; pembrolizumab (P) for patients who are platinum eligible; and P combined with enfortumab vedotin (P+EV) for patients who are cisplatin ineligible. At the 2024 ASCO Genitourinary Cancers Symposium, Haojie Li, MD, PhD, Merck & Co, Inc, Rahway, New Jersey, and colleagues presented data on their retrospective cohort study, which evaluated real-world treatment patterns and overall survival (OS) for patients with mUC during the period between the US Food and Drug Administration’s approval of maintA and P+EV to treat the disease.

For their study, the researchers used data from The US Oncology Network’s electronic health record database iKnowMed (iKM) and looked at patients with mUC who were diagnosed between April 30, 2020, and June 30, 2021. Dr Li and colleagues tracked these patients from the index date—in this case the date they received first-line anticancer treatment—through March 31, 2023, until their last patient record, or until the death of the patient, whichever occurred first. If the patient received avelumab after being treated with first-line PBS and did not have documented disease progression before starting avelumab, this was defined as maintA. It was also considered maintA if a physician’s notes indicated the use of avelumab as maintenance therapy after the patient received first-line PBC.

The majority (80.2%) of the patients included in the study were male, and the median age was 74 (range 46-90+) years. The results showed that 207 patients received first-line treatment for mUC, and of these patients, 107 (51.7%) were treated with immune checkpoint inhibitor (ICI) monotherapy, 80 (38.6%) were treated with PBC, and 20 (9.7%) had other treatments. The percentage of patients who received first-line monotherapy was higher among older patients (those 75 years or older) at 53.3% vs 14% for younger patients who were in the age range of 57-65.

The median (95% confidence interval) OS for patients who received first-line treatment was 12.6 (8.5, 15.1) months. In total, 32.5% of the study’s participants received first-line PBC. Of this group, 28 (35%) received ICI maintenance therapy, with the majority (n = 26, 92.9%) also receiving maintA. During the follow-up, 71 (34.3%) patients received second-line treatment. Within this group, 30 (42.2%) received antibody drug conjugates and 27 (38%) received ICI monotherapy. The number of patients who received third-line treatment was 25 (12.1%).

The findings revealed that the patients with mUC had poor rates of OS even after the approval of  avelumab maintenance therapy. According to the authors, “many first-line patients did not have the opportunities to receive second-line treatment, which demonstrated continuing unmet need for mUC patients.”


Source: Li H, Sura S, Babcock A, et al. Evolving treatment landscape in metastatic urothelial carcinoma (mUC) post-avelumab maintenance approval: Real-world insights from The US Oncology Network. Presented at: the 2024 ASCO GU Cancers Symposium; January 25-27, 2024; San Francisco, CA, and virtual; Abstract 560.

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