QOL and Survival Outcomes Favor Avelumab Maintenance in Bladder Cancer

Petros Grivas, MD, PhD, professor in the Clinical Research Division and medical director of Local/Regional Outreach and the International Program at Fred Hutchinson Cancer Center and professor in the Division of Hematology and Oncology at University of Washington School of Medicine, discusses the overall survival (OS) and quality-of-life findings from the JAVELIN Bladder 100 trial (NCT02603432) of avelumab (Bavencio) as maintenance therapy for advanced bladder cancer.

According to Grivas, many trials have struggled to show OS benefit over time. JAVELIN Bladder 100 revealed progression-free survival [PFS] and OS benefit that persisted at later follow-up in 2023. Additionally, patients reported no reduction in quality of life with avelumab maintenance, with Q-TWiST analysis showing relative improvement in quality-adjusted time without symptoms or toxicity vs best supportive care alone. This benefit could be attributed to the reduced rate of disease progression and overall tolerability of avelumab.

Grivas noted that these outcomes placed this trial among 2 others that have changed practice in this setting. The CheckMate 901 trial (NCT03036098) showed the benefit of the addition of nivolumab (Opdivo) to chemotherapy whereas the EV-302 trial (NCT04223856) investigated enfortumab vedotin (Padcev) plus pembrolizumab (Keytruda) vs chemotherapy, leading to that combination being listed as the preferred regimen by the NCCN guidelines.

TRANSCRIPTION:

0:10 | We know that it has been very difficult to prolong OS overall in oncology, and particularly in patients with metastatic urothelial carcinoma. We have done trials for years, and we have not succeeded. So I think it’s very important to utilize evidence-based medicine and OS benefit is a huge milestone. Of course…that particular trial was presented in 2020 with subsequent follow-up that also even now, showed sustained PFS and OS benefit.

0:42 | So I think it’s very important for the patients, because not only prolonged survival delays progression, but I think that we also published that there’s also this survival benefit comes with no detriment in the quality of life, because patients tolerate avelumab maintenance quite well. And I think that’s an important point. When we make this decision with the patients, we have to think about the quality of life and patient-reported outcome. So we have publications, at least 2 of them looking at quality of life, patient-reported outcomes, and what we call Q-TWiST analysis, that looks at the particular time that patients spend with no progression or toxicity, and all those analyses [and] subset analyses, show that the benefit with survival comes with benefit, I would argue, in quality of life, because you delay progression.

1:29 | Of course…it’s important to know that JAVELIN Bladder 100 trial was one of the 3 practice-changing trials in this disease setting. And of course, we have seen the CheckMate 901 and EV-302 trials that have also shown significant benefit with gemcitabine/cisplatin [plus] nivolumab vs gemcitabine/cisplatin in the CheckMate 901 trial and pembrolizumab and enfortumab vs platinum-based chemotherapy that…now enfortumab/pembrolizumab has become the standard of care preferred [regimen] based on the NCCN guidelines in this frontline setting.