Avelumab maintenance shows long-term safety in patients with advanced urothelial carcinoma
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Key takeaways:
- Grade 3 or higher adverse events occurred in a lower proportion of patients after a year of treatment.
- Results support using avelumab first-line maintenance until progression as standard of care in certain patients.
CHICAGO — Post-hoc analyses of the JAVELIN Bladder 100 trial confirmed the acceptable long-term safety of avelumab first-line maintenance for advanced urothelial carcinoma, according to a presentation at ASCO Annual Meeting.
In the phase 3 JAVELIN Bladder 100 trial, avelumab (Bavencio; EMD Serono, Pfizer) first-line maintenance plus best supportive care significantly prolonged OS and PFS compared with best supportive care alone in patients with advanced urothelial carcinoma that had not progressed with first-line platinum-based therapy. The safety profile of avelumab first-line maintenance was consistent with prior avelumab monotherapy studies, with no new safety signals observed.
At ASCO 2023, Joaquim Bellmunt, MD, PhD, associate professor at Harvard Medical School and director of the bladder cancer center at Dana-Farber Cancer Institute's genitourinary oncology program, presented on the long-term safety analyses with a minimum of 2 years follow-up in patients who received avelumab first-line maintenance plus best supportive care, as well as a subgroup of patients who had received at least 12 months of treatment in the trial. Treatment continued in the trial until confirmed progression, unacceptable toxicity or withdrawal of consent.
Median follow-up was 38 months at data cutoff (June 4, 2021). In 344 patients who received one or more doses of avelumab, median treatment duration was 5.8 months and median number of infusions was 11.5.
“Long-term safety data showed that immune-related and treatment-related adverse events of grade 3 and above occurred in a lower proportion of patients after 12 months of treatment, and no new safety signals were identified with longer treatments,” Bellmunt said in the presentation.
Treatment-related adverse events (TRAEs) occurred in 269 patients (78.2%), with grade 3 or above in 67 patients (19.5%). The most common TRAEs included increased lipase (3.5%) and increased amylase (2.3%), and a TRAE led to discontinuing avelumab in 40 patients (11.6%).
Immune-related adverse events (irAEs) occurred in 111 patients (32.3%), with grade 3 or above occurring in 26 (7.6%).
“Most patients only had a single immune-related adverse event,” Bellmunt said in the presentation.
The most common irAE categories were thyroid disorders (12.8%) and immune-related rash (10.8%), while the most common categories of grade 3 or above included immune-related rash and hepatitis (1.5% each). Overall, 18 patients (5.2%) experienced serious irAEs, with immune-related nephritis/renal dysfunction (1.2%) being most commonly observed. In total, 21 patients (6.1%) had an irAE that led to discontinuing avelumab.
In the subgroup of patients (n = 118) who received avelumab for at least 12 months, any grade TRAEs occurred after 12 months in 50% of patients and grade 3 or above events occurred in 11.9%. Overall, 10.2% of patients had a TRAE occurring after 12 months that led to treatment discontinuation. IrAEs occurred after 12 months in 22.9% of patients, with 4.2% being grade 3 or above; immune-related rash occurred most commonly (10.2%). None of the categories of grade 3 or above irAEs occurred in more than one patient, according to Bellmunt.
“These results further support the use of avelumab first-line maintenance until disease progression as a standard of care for patients with advanced urothelial carcinoma that has not progressed with first-line platinum-based chemotherapy,” Bellmunt said.
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Bellmunt J, et al. Abstract 4516. Presented at: ASCO Annual Meeting; June 2-6, 2023; Chicago.
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