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Jeanny B. Aragon-Ching, MD, FACP, discusses the clinical implications of the phase 3 JAVELIN Bladder 100 trial in urothelial carcinoma.
Jeanny B. Aragon-Ching, MD, FACP, clinical program director, Genitourinary Cancers, the Inova Schar Cancer Institute, discusses the clinical implications of the phase 3 JAVELIN Bladder 100 (NCT02603432) trial in urothelial carcinoma.
JAVELIN Bladder 100 investigated avelumab (Bavencio) maintenance plus best supportive care vs best supportive care alone in patients with locally advanced or metastatic urothelial carcinoma who did not progress following first-line, platinum-based chemotherapy.
Patients who achieved a response or stable disease following first-line chemotherapy with either gemcitabine plus cisplatin, or gemcitabine plus carboplatin, were randomly assigned to the experimental arm or control arm of JAVELIN Bladder 100, Aragon-Ching says.
The addition of avelumab maintenance to best supportive care elicited an overall survival and progression-free survival benefit vs best supportive care alone in the intention-to-treat population and PD-L1–positive patients, Aragon-Ching notes.
In June 2020, the FDA approved avelumab as maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-based chemotherapy, based on data from JAVELIN Bladder 100, Aragon-Ching concludes.