Avelumab first-line maintenance therapy for locally advanced/metastatic urothelial carcinoma: Results from the real-world US PATRIOT-II study.
Petros Grivas, Pedro C. Barata, Helen Moon, Shilpa Gupta, Thomas E. Hutson, Cora N. Sternberg, Jason R. Brown, Vaidehi Dave, Chad Downey, Alicia C. Shillington, Howard M. Katzenstein, Melissa Kirker, Sarah Hanson, Frank X. Liu, Valerie Morris, Abhijeet Bhanegaonkar, Guru Sonpavde
Abstract
697 Background: In the JAVELIN Bladder 100 phase 3 trial, avelumab first-line maintenance (AVE 1LM) + best supportive care (BSC) improved overall survival (OS) and progression-free survival (PFS) vs BSC alone in patients (pts) with locally advanced/metastatic urothelial carcinoma (la/mUC) with no disease progression following 4-6 cycles of platinum-based chemotherapy (PBC). PATRIOT-II aimed to describe real-world outcomes in pts with la/mUC treated with AVE 1LM who were progression-free after 1L PBC. We hypothesized that outcomes would be similar to those of JAVELIN Bladder 100. Methods: PATRIOT-II is an observational, retrospective study in US pts with la/mUC treated in geographically dispersed community and academic centers. Pts receiving AVE 1LM were eligible. Data were collected via medical records for a minimum of 52 weeks (wks) from AVE 1LM initiation. This analysis focuses on ≥24 wks post AVE 1LM initiation. Survival and safety outcomes were assessed; analyses are descriptive in nature. Results: 160 pts from 37 sites, a mix of oncology practices and community/academic centers, were included with median age, 70 (range, 40-90) years; 123 (77%) male; 118 (74%) White, non-Hispanic; 77 (49%) lower tract and 49 (31%) upper tract tumors; 119 (74%) ECOG PS 0/1; 70 (44%) and 51 (32%) known visceral (excluding bone) or non-visceral metastases (mets), respectively; 31 (19%) liver mets; and 64 (40%) creatinine clearance >60 mL/min. 100 (62.5%) and 60 (37.5%) pts had received 1L cisplatin or carboplatin, respectively. 130 pts (objective response rate, 81% [complete response, 21; partial response, 109]) had an investigator-assessed response to 1L PBC. Pts initiated AVE 1LM at a median of 4 wks (IQR, 3-6) after PBC completion. At data cutoff, 120 pts (75%) had discontinued AVE 1LM, 89 (74% of 120) due to progression/adverse events (AEs)/other non-death related reasons. Median time on AVE 1LM was 4.1 months (mo) (IQR, 2.3-8.7); median follow-up time post AVE 1LM initiation was 11.5 mo (IQR, 7.5-16.3). Table shows OS and PFS data. Most common documented treatment-related AEs (any grade) included hypothyroidism (n=7 [4%]), anemia (n=6 [4%]), blood creatinine increased (n=6 [4%]), fatigue (n=6 [4%]), and nausea (n=6 [4%]). Grade 3+ AEs occurred in 19 (12%), with no Grade 5 AEs. No new safety signals were noted. Conclusions: Results complement JAVELIN Bladder 100 and align with other AVE 1LM real-world studies. Limitations include retrospective data, lack of randomization and central scan review, missing data, selection bias, and confounders. PATRIOT-II further supports the level I evidence for AVE 1LM as standard of care in la/mUC not progressing on 1L PBC. [Table: see text]