Lance C. Pagliaro, MD, Mayo Clinic, discusses the efficacy of first-line avelumab (Bavencio) maintenance therapy, as seen in the phase 3 JAVELIN Bladder 100 trial (NCT02603432) in patients with advanced urothelial carcinoma.

The randomized JAVELIN Bladder 100 trial enrolled patients with advanced urothelial carcinoma who were progression free following first-line gemcitabine plus cisplatin or carboplatin. This trial randomly assigned patients to receive either avelumab first-line maintenance therapy plus best supportive care (BSC) or BSC alone. Overall survival (OS) served as the primary end point for the study, and secondary end points included progression-free survival (PFS) and safety. At a median follow-up of at least 38 months for all patients in both arms, the median OS in the overall population (n = 700) was 23.8 months (95% CI, 19.9-28.8) with avelumab vs 15.0 months (95% CI, 13.5-18.2) with BSC alone (HR, 0.76; 95% CI, 0.631-0.915; 2-sided 

 = .0036). In the subgroup of patients with PD-L1–positive tumors (n = 358), the median OS was 30.9 months (95% CI, 24.0-39.8) in the avelumab arm vs 18.5 months (95% CI, 14.1-24.2) in the BSC alone arm (HR, 0.69; 95% CI, 0.521-0.901; 2-sided 

Furthermore, the investigator-assessed median PFS in the overall population was longer in the avelumab arm than in the BSC alone arm, at 5.5 months (95% CI, 4.2-7.2) vs 2.1 months (95% CI, 1.9-3.0), respectively (HR, 0.54; 95% CI, 0.457-0.645; 2-sided 

 < .0001). The investigator-assessed median PFS in the PD-L1–positive subgroup was 7.5 months (95% CI, 5.5-11.1) in the avelumab arm vs 2.8 months (95% CI, 2.0-3.7) in the BSC alone arm (HR, 0.46; 95% CI, 0.360-0.588; 2-sided 

At disease progression, patients in either arm were eligible to go on to receive salvage therapy, Pagliaro explains. More patients in the BSC alone arm received subsequent anticancer therapy, including a PD-L1 inhibitor, than those in the avelumab arm, at 72.0% vs 52.9% of patients, respectively.

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Lance C. Pagliaro, MD, discusses the efficacy of first-line avelumab maintenance therapy, as seen in the phase 3 JAVELIN Bladder 100 trial in patients with advanced urothelial carcinoma.

Lance C. Pagliaro, MD

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Dr Pagliaro on the Use of First-Line Avelumab Maintenance Therapy in Urothelial Carcinoma