Long-term Follow-up Results From the JAVELIN Bladder 100 Trial on First-line Avelumab

The JAVELIN Bladder 100 trial analyzed the efficacy of first-line (1L) avelumab maintenance for advanced urothelial carcinoma (UC). New long-term follow-up results, presented during the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium, examined the drug’s effect on overall survival (OS) from the start of 1L chemotherapy.

The phase 3 trial results show that in platinum-eligible patients with advanced UC, 1L cisplatin- or carboplatin-based chemotherapy regimens followed by avelumab maintenance in patients without progression have become the standard of care. The results also demonstrated significantly longer OS and progression-free survival (PFS) from the start of avelumab maintenance paired with best supportive care (BSC) versus BSC alone.

Patients with unresectable locally advanced or metastatic UC who did not progress on 4 to 6 cycles of 1L cisplatin plus gemcitabine or carboplatin plus gemcitabine were randomized 1:1 to receive avelumab plus BSC (n=350) or BSC alone (n=350). The primary end point was OS measured from randomization, and secondary end points included PFS and safety.

At the time of data cutoff (June 2, 2021), median follow-up from randomization was ≥38 months in both arms. In subgroups treated with 1L cisplatin plus gemcitabine or carboplatin plus gemcitabine, OS and PFS (measured from start of maintenance [randomization]) were longer in the avelumab plus BSC arm than in the BSC alone arm. Both subgroups had similar safety findings. In the overall population, median OS measured from the start of 1L chemotherapy was 29.7 months (95% CI, 25.2-34.0) in the avelumab plus BSC arm and 20.5 months (95% CI, 19.0-23.5) in the BSC alone arm (hazard ratio, 0.77; 95% CI, 0.635-0.921).

The long-term follow-up results of the JAVELIN Bladder 100 trial confirmed that avelumab 1L maintenance has similar OS and PFS benefits in patients with advanced UC who are progression-free after standard-of-care 1L cisplatin- or carboplatin-based chemotherapy, with an acceptable safety profile. The median OS measured from the start of chemotherapy supports the use of avelumab 1L maintenance as a standard-of-care treatment and serves as a point of reference for future clinical trials.