JAVELIN Bladder 100: Avelumab Maintenance for Advanced Urothelial Carcinoma
Posted: Thursday, December 17, 2020
Results from the phase III JAVELIN Bladder 100 study support the approval of maintenance therapy with the anti–PD-L1 antibody avelumab for patients with locally advanced or metastatic urothelial carcinoma. The study researchers found that maintenance avelumab in addition to best supportive care significantly prolonged overall survival when compared with best supportive care alone. This international, randomized, open-label, parallel-arm trial was published in The New England Journal of Medicine.
“It is notable that the longer overall survival with avelumab maintenance therapy was observed across all prespecified subgroups examined and that this prolonged overall survival was gained without a detrimental impact on patients’ quality of life,” stated Thomas Powles, MD, of Queen Mary University of London and Barts Cancer Centre, in a press release.
A total of 700 patients with unresectable locally advanced or metastatic urothelial cancer who did not have disease progression with first-line chemotherapy were enrolled. Patients were randomly assigned to groups that either received best supportive care in conjunction with avelumab maintenance treatment (10 mg/kg, administered every 2 weeks) or best supportive care alone. For each participant, tumors were biopsied to assess PD-L1 expression.
Patients who received avelumab maintenance treatment had significantly higher overall survival at 1 year (71.3%) compared with the control group (58.4%, P = .001). Additionally, overall survival was increased with avelumab (79.1%) compared with the control (60.4%) in patients who tested positive for PD-L1 (P < .001). In the overall population, the median progressive-free survival was 3.7 months with avelumab compared with 2.0 months without it. In PD-L1–positive participants, median progression-free survival was 5.7 months with avelumab maintenance as compared with 2.1 months with best supportive care alone.
The safety profile in this trial was similar to previous studies examining avelumab therapy. Adverse events of grade 3 or higher were present in 16.6% of the avelumab group and 0% of in the control group.
Disclosure: For full disclosures of the study authors, visit nejm.org.