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Avelumab Plus Axitinib Under Study in Urothelial Cancer

By: Celeste L. Dixon
Posted: Wednesday, January 13, 2021

The combination of monoclonal-antibody avelumab and the VEGFR inhibitor axitinib showed both antitumor activity and a manageable safety profile in patients with advanced or metastatic urothelial cancer, according to the results of a phase II trial, JAVELIN Medley VEGF, presented during the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting (Abstract 281) and also in the Journal for ImmunoTherapy of Cancer. This finding was consistent with study results with each drug alone and in combination, noted Gabriella Galffy, MD, of Pulmonology Hospital Törökbálint in Hungary, and colleagues.

The 20 participating patients were naive to immune checkpoint inhibitor therapy, ineligible for cisplatin-containing chemotherapy, and treatment-naive in the locally advanced or metastatic setting. They received avelumab at 800 mg intravenously every 2 weeks plus axitinib at 5 mg orally twice daily. The trial’s primary endpoint was confirmed objective response per investigator assessment, and secondary endpoints included progression-free survival and safety.

“Responses were observed regardless of PD-L1 expression status,” stated Dr. Galffy and co-investigators. The confirmed overall response rate was 10.0%, composed exclusively of partial responses. Five patients (25%) had stable disease, and the median progression-free survival for the entire cohort was 2.3 months. Nine patients (45%) experienced treatment-related adverse events, including one patient who died of a urinary bladder hemorrhage.

Currently, avelumab is approved for certain patients with locally advanced or metastatic urothelial cancer: those who have experienced disease progression after one or more previous platinum-based chemotherapy lines and those who have not had disease progression with platinum-based chemotherapy and will take avelumab as a maintenance treatment.

Disclosure: For full disclosures of the study authors, visit jitc.bmj.com.



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