KEY TAKEAWAYS
- The JAVELIN Bladder 100 phase 3 trial aimed to assess the effectiveness of avelumab as 1L maintenance therapy in extending OS and PFS in patients with UC.
- The primary endpoint was to determine OS.
- Researchers observed that avelumab 1L maintenance therapy demonstrates comparable OS and PFS benefits with acceptable safety.
In the phase 3 JAVELIN Bladder 100 trial, researchers evaluated the efficacy of avelumab first-line (1L) maintenance therapy combined with best supportive care (BSC) versus BSC alone in patients with advanced urothelial carcinoma (UC) who had not progressed after 1L platinum-based chemotherapy.
Srikala S. Sridhar and the team aimed to demonstrate a significant prolongation in overall survival (OS) and progression-free survival (PFS) from the start of maintenance compared to BSC alone, with a median OS of 23.8 months versus 15.0 months, respectively (HR 0.76, 95% CI 0.63-0.91, P=0.0036).
They conducted an inclusive analysis focusing on patients diagnosed with unresectable locally advanced or metastatic UC who had not experienced progression after completing 4-6 cycles of 1L cisplatin or carboplatin combined with gemcitabine. The study enrolled a total of 700 patients, with the primary endpoint being OS measured from randomization.
At data cutoff (June 4, 2021), the median follow-up from randomization was≥38 months in both arms. In subgroups treated with 1L cisplatin + gemcitabine or carboplatin + gemcitabine, OS and PFS (measured from randomization) were longer with avelumab + BSC vs BSC alone. Safety findings were similar in both subgroups. In the overall population, the median OS (95% CI) measured from the start of 1L chemotherapy in this population without progression after 1L chemotherapy was 29.7 months (25.2-34.0) with avelumab + BSC and 20.5 months (19.0-23.5) with BSC alone (HR, 0.77 [95% CI, 0.635-0.921]).
The study concluded that long-term outcomes from the JAVELIN Bladder 100 trial confirm the efficacy of avelumab 1L maintenance therapy in providing similar OS and PFS benefits with acceptable safety for patients with advanced UC who have not progressed after 1L cisplatin- or carboplatin-based chemotherapy. The median OS measured from the start of chemotherapy further strengthens the rationale for using avelumab 1L maintenance as the standard of care in this patient population and sets a benchmark for future clinical trials.
The trial was sponsored by Pfizer.
Source: https://www.auajournals.org/doi/10.1097/01.JU.0001009424.64728.0c.02
Clinical Trial: https://clinicaltrials.gov/study/NCT02603432
Sridhar S.S., Powles T, Gupta S, et al. (2024). “AVELUMAB FIRST-LINE MAINTENANCE FOR ADVANCED UROTHELIAL CARCINOMA: LONG-TERM OUTCOMES FROM JAVELIN BLADDER 100 IN SUBGROUPS DEFINED BY FIRST-LINE CHEMOTHERAPY REGIMEN AND ANALYSIS OF OVERALL SURVIVAL FROM START OF FIRST-LINE CHEMOTHERAPY.” Presented at AUA 2024 (Abstract PD38-02).
