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ASCO 2021: Post Hoc Subgroup Analyses With Avelumab in Advanced Urothelial Carcinoma

By: Vanessa A. Carter, BS
Posted: Thursday, June 17, 2021

Thomas Powles, MD, of Barts Cancer Institute, London, and colleagues presented post hoc analyses of clinical and genomic subgroups from the JAVELIN Bladder 100 during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 4520). This phase III trial evaluated the survival outcomes of patients treated with the PD-1 inhibitor avelumab as first-line maintenance combined with best supportive care in patients with advanced urothelial carcinoma. An overall survival benefit was observed with avelumab-based treatment across subgroups with upper or lower tract tumors, metastatic or locally advanced and unresectable disease (prior to chemotherapy), and lymph node–only disease after chemotherapy.

This trial enrolled 700 participants with unresectable, locally advanced or metastatic urothelial carcinoma, who did not experience disease progression after four to six cycles of carboplatin or gemcitabine plus cisplatin. Patients were randomly assigned 1:1 to receive either avelumab and best supportive care (n = 350) or best supportive care alone (n = 350).

Patients in the avelumab-plus-best-supportive-care arm had a prolonged overall survival over those who received best supportive care alone. This improvement was seen specifically in participants with upper tract tumors, lower tract tumors, and metastatic disease, with survivals increasing from 17.4 to 19.9 months, 14.1 to 22.5 months, and 14.1 to 18.2 months, respectively. Although not yet estimable, an overall survival benefit was also seen in individuals with locally advanced and unresectable disease, as well as lymph node–only disease after chemotherapy.

Individuals who received previous first-line gemcitabine plus carboplatin and had PD-L1–positive tumors had longer overall survival with avelumab-based care versus best supportive care alone (16.1 vs. 24.0 months). Of note, an improved overall survival benefit was also observed for those given avelumab across all The Cancer Genome Atlas subtypes except luminal.

Disclosure: For full disclosures of the study authors, visit coi.asco.org.



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