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

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 P = .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 P = .0064).

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 P < .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 P < .0001).

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.