Maintenance Avelumab Maintains Survival Benefit as First-Line Maintenance Across Subgroups in Advanced Urothelial Cancer

Joaquim Bellmunt, MD, PhD

The addition of maintenance avelumab (Bavencio) to best supportive care (BSC) demonstrated improved outcomes for patients with advanced urothelial carcinoma including those who went on to receive second-line therapy, according to results of an exploratory analysis of the JAVELIN Bladder 100 trial (NCT02603432) presented in a poster at the 2022 ASCO Annual Meeting.¹

The median overall survival (OS) was not reached in patients still receiving avelumab and was 19.9 months (95% CI, 18.2-23.0) in patients who discontinued avelumab and received second-line treatment. Further, the median OS was 18.2 months (95% CI, 10.0-34.4) in patients who discontinued avelumab and did not receive second-line treatment.

“Exploratory analyses of OS and time from randomization to end of second-line treatment were performed in the avelumab plus BSC arm in subgroups defined by second-line treatment administered by investigators after discontinuation of study treatment,” wrote the authors, led by Joaquim Bellmunt, MD, PhD, associate professor of medicine at Harvard Medical School and director of the Bladder Cancer Program at Beth Israel Deaconess Medical Center in Boston, Massachusetts.

The JAVELIN Bladder 100 trial previously demonstrated that avelumab first-line maintenance and BSC significantly prolonged OS compared with BSC alone in patients with advanced urothelial carcinoma that had not progressed with first-line platinum-containing chemotherapy.^2,3 For the current study, the investigators performed an exploratory analysis of outcomes in patients in the avelumab plus BSC arm based on receipt of second-line treatment, according to the study’s poster.

Median follow-up in the avelumab arm was 38.0 months at the data cutoff. Of the 350 patients randomized to avelumab plus BSC, 43 (12.3%) were still receiving avelumab first-line maintenance, with a median duration of treatment of 35.6 months (range, 24.5 to 49.7 months); 185 (52.9%) had discontinued treatment with avelumab and moved on to second-line treatment, with a median duration of avelumab treatment of 5.1 months (range, 0.5 to 44.6 months); and 122 (34.9%) had discontinued avelumab and did not receive second-line treatment, with a median duration of avelumab treatment of 5.0 months (range, 0.5 to 43.7 months).

Patients in the trial had unresectable locally advanced or metastatic urothelial carcinoma that had not progressed with 4 to 6 cycles of first-line platinum-containing chemotherapy. Patients were randomized 1:1 to receive avelumab maintenance plus BSC or BSC alone after an interval of 4 to 10 weeks from the end of first-line chemotherapy. The study’s primary end point was OS.

The investigators reported that baseline characteristics were similar between patients in the avelumab arm who did or did not receive second-line treatment.

Additional data showed that among patients receiving second-line treatment, the median time from the end of avelumab maintenance to the start of second-line treatment was 1.35 months (range, 0.3 to 30.9 months). Median time from randomization to the end of second-line treatment was 11.7 months (95% CI, 9.7-13.8).

“Overall, these data…provide new insights about survival in patients receiving avelumab first-line maintenance in the JAVELIN Bladder 100 trial with or without second-line treatment, and these data further support the benefits of the sequence of first-line platinum-based chemotherapy followed by avelumab maintenance,” Bellmunt said.

References

1. Bellmunt J, Powles T, Climent Durán MÁ, et al. Long-term outcomes in patients with advanced urothelial carcinoma (UC) who received avelumab first-line (1L) maintenance with or without second-line (2L) treatment: Exploratory analyses from JAVELIN Bladder 100. J Clin Oncol 2022;40(suppl 16):4560. doi:10.1200/JCO.2022.40.16_suppl.4560
2. Powles T, Park SH, Voog E, et al. Avelumab maintenance therapy for advanced or metastatic urothelial carcinoma. N Engl J Med. 2020;383(13):1218-1230. doi:10.1056/NEJMoa2002788
3. Powles T, Park SH, Voog E, et al. Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): Long-term follow-up results from the JAVELIN Bladder 100 trial. J Clin Oncol 2022;40(suppl 6):487. doi:10.1200/JCO.2022.40.6_suppl.487