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FDA Approves Avelumab for Advanced Urothelial Carcinoma

Urothelial carcinoma.

First-line cisplatin-based chemotherapy prolongs survival in patients with advanced urothelial carcinoma (UC), but disease progression usually occurs within 8 months, and currently no standard second-line therapies are available. Avelumab (Bavencio®, EMD Serono, Inc.), a fully human anti-PD-L1 IgG1 antibody, has shown to have an acceptable safety profile and success in treating this patient population. Based on this evidence, the FDA has now approved avelumab to treat patients with locally advanced or metastatic UC whose cancer has not progressed with first-line platinum-containing chemotherapy.

Approval was based on a phase 3, international, open-label trial, JAVELIN Bladder 100 (NCT02603432). Seven hundred patients with unresectable, locally advanced, or metastatic UC were enrolled. To be eligible for the study, patients had to have disease that did not progress after first-line treatment with 4-6 cycles of gemcitabine/cisplatin or gemcitabine/carboplatin, measurable disease prior to chemotherapy, and adequate hematologic/organ function. In a randomized 1:1 ratio, patients were administered either avelumab intravenously at a dose of 10 mg/kg every 2 weeks as a 1-hour infusion plus best supportive care (BSC) or BSC alone. Treatment was received within 4 to 10 weeks after last chemotherapy dose was given.

Results revealed that median overall survival (OS) was significantly increased in the avelumab/BSC arm compared with the BSC alone arm (21.4 months vs 14.3 months).

In greater than 20% of patients who received avelumab, the most common side effects included fatigue, musculoskeletal pain, urinary tract infection, and rash.

Avelumab is recommended to be administered at a dose of 800 mg as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

For More Information

Bavencio® (avelumab) prescribing information (2020). EMD Serono. Available at: https://www.bavencio.com/

Clinicaltrials.gov (2020). A study of avelumab in patients with locally advanced or metastatic urothelial cancer (JAVELIN Bladder 100). NLM Identifier: NCT02603432.

Powles T, Grivas P, Aragon-Ching JB, et al (2016). A multicenter, international, randomized, open-label phase 3 trial of avelumab + best supportive care (BSC) vs BSC alone as maintenance therapy after first-line platinum-based chemotherapy in patients with advanced urothelial cancer (JAVELIN Bladder 100). Annal of Oncol, 27(6):266-295. Abstract 596. DOI:10.1093/annonc/mdw373

Image Courtesy of CoRus13. Licensed under CC-Zero

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