Long-term follow-up results from the JAVELIN Bladder 100 study further support the standard-of-care role of avelumab as frontline maintenance in patients with urothelial carcinoma.
Prolonged overall survival (OS) with avelumab plus best supportive care (BSC) vs BSC alone in patients with advanced urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy has been demonstrated, according to long-term follow-up data from the phase 3 JAVELIN Bladder 100 trial (NCT02603432).1
These results further support the standard-of-care role of avelumab as frontline maintenance in this patient population.
The multicenter, multinational, randomized, open-label, parallel-arm JAVELIN Bladder 100 trial examined avelumab plus the BSC vs BSC alone in patients with advanced UC that had not progressed with first-line platinum-containing chemotherapy.
A total of 700 patients with unresectable locally advanced or metastatic UC without disease progression with 4-6 cycles of first-line gemcitabine plus cisplatin or carboplatin were randomized in a 1:1 ratio to receive avelumab in addition to BSC or BSC alone. There were 350 participants per arm, 358 of which had PD-L1-positive tumors (51.1%).2
In the experimental arm, arm A, patients were administered a 1-hour intravenous (IV) infusion of avelumab every 2 weeks in 4-week cycles along with the BSC which was administered as deemed appropriate by the treating physician, while arm B administered patients the BSC alone.
The primary end point of the study was OS as assessed from randomization to discontinuation from the study, death, or date of censoring, whichever occurred first, in all patients. Secondary end points included progression-free survival (PFS), safety, objective response, time to tumor response, duration of response, percentage of participants with disease control, and more.
With extended follow-up of a median 38 months in both arms for all patients and at a data cutoff of June 4, 2021, the OS was significantly longer in the avelumab plus BSC vs BSC alone arm in all randomized patients, as well as in patients with PD-L1-positive tumors. These findings remained consistent with previous conclusions, and an OS benefit was observed across prespecified subgroups.1
PFS assessed by investigators was longer in patients administered avelumab plus BSC compared to those given BSC alone in all randomized patients and in patients with PD-L1-positive tumors. A total of 185 patients (52.9%) within the avelumab plus BSC arm and 185 patients (52.9%) in the BSC alone arm received a subsequent anticancer drug therapy, including a PD-L1 inhibitor in 40 (11.4%) vs 186 (53.1%) patients.
In regard to safety, long-term data was consistent with previous avelumab monotherapy studies, with no new safety signals.