KEY TAKEAWAYS
- The phase 3 JAVELIN Bladder 100 trial studied the impact of avelumab 1L maintenance + BSC in improving prolonged OS vs. BSC alone in pts with advanced UC.
- Enrolled pts were randomized 1:1 to receive Avelumab+BSC or BSC.
- The study showed prolonged OS and PFS with avelumab+BSC over BSC alone, regardless of response to 1L chemotherapy.
In the phase-3 JAVELIN Bladder 100 trial, exploratory analyses were done on subgroups based on their response to 1L chemotherapy (complete response [CR], partial response [PR], or stable disease [SD]) after ≥ two years of follow-up.
The study included unresectable locally advanced or metastatic urothelial carcinoma (UC) patients (pts) who received 4-6 cycles of 1L gemcitabine+cisplatin or carboplatin without advancement. They were randomized 1:1 to receive avelumab 1L maintenance+best supportive care (BSC) (n=350) or BSC alone (n=350) based on their most suitable response to 1L chemo (CR/PR vs. SD) and whether they had visceral or nonvisceral disease at the beginning of 1L chemotherapy.
As of the data cutoff on June 4, 2021, both groups had a median follow-up of 38 months. The avelumab+BSC group had better OS and PFS results than the BSC alone group, regardless of the subgroup. The avelumab+BSC arm showed a higher percentage of CR, PR, and SD subgroups administering following second-line anticancer drug treatment as compared to the BSC alone arm, with percentages of 50.0% vs. 74.2%, 58.3% vs. 71.8%, and 46.4% vs. 70.4%, respectively.
The study confirmed that avelumab+BSC is effective in prolonging OS and PFS compared to BSC alone, regardless of response to 1L chemotherapy, even with subsequent therapy. The long-term safety was constant in all subgroups, supporting that avelumab first-line (1L) maintenance should be the standard of care for advanced UC pts not progressed with 1L platinum-based chemotherapy.
Source: https://www.auajournals.org/doi/10.1097/JU.0000000000003240.10
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT02603432
Valderrama, Begoña; Powles, Thomas; Sridhar, Srikala; Caserta, Claudia; Loriot, Yohann; Gupta, Shilpa; Bellmunt, Joaquim; Sternberg, Cora; Wang, Jing; Costa, Nuno; Laliberte, Robert; di Pietro, Alessandra; Park, Se Hoon; Grivas, Petros PD09-10 AVELUMAB FIRST-LINE (1L) MAINTENANCE FOR ADVANCED UROTHELIAL CARCINOMA (UC): LONG-TERM OUTCOMES FROM JAVELIN BLADDER 100 IN SUBGROUPS DEFINED BY RESPONSE TO 1L CHEMOTHERAPY, Journal of Urology: April 2023 – Volume 209 – Issue Supplement 4 doi: 10.1097/JU.0000000000003240.10.
