Rohit Jain, MD, MPH, medical oncologist, assistant member, Department of Genitourinary Oncology, Moffitt Cancer Center, discusses the data from the phase 3 JAVELIN Bladder 100 trial (NCT02603432) examining avelumab (Bavencio) as maintenance therapy following response or stable disease with first-line platinum-based chemotherapy in patients with advanced or metastatic urothelial cancer.

The landmark trial randomized 700 patients to receive either avelumab plus best supportive care (BSC) vs BSC alone. The primary end point was overall survival (OS), according to Jain. Results showed that the median OS in all comers was 21.4 months in the avelumab arm vs 14.3 months in the BSC-alone arm, with a hazard ratio of 0.69, Jain explains. Additionally, in patients who were PD-L1 positive, the OS with avelumab plus BSC was not yet reached vs 17.1 months with BSC alone.

These data provide significant evidence that patients who receive avelumab maintenance therapy live longer, which is why JAVELIN Bladder 100 is a practice-changing trial, according to Jain. Furthermore, in a subgroup analysis that examined responses by different chemotherapy regimens received by the patient, the responses and OS benefit were maintained, Jain says. Moreover, the study showed that patients with urothelial cancer should be started on maintenance treatment as soon as possible when they have a response, Jain concludes.

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Rohit Jain, MD, MPH, discusses the data from the phase 3 JAVELIN Bladder 100 trial examining avelumab as maintenance therapy following response or stable disease with first-line platinum-based chemotherapy in patients with advanced or metastatic urothelial cancer.

Rohit Jain, MD, MPH

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