(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL between April 28 and May 1st, 2023, was host to an invasive bladder cancer podium session. Dr. Shilpa Gupta presented the long-term outcomes from JAVELIN Bladder 100, which evaluated avelumab first-line maintenance for advanced urothelial carcinoma. This report included subgroup analysis stratified by the response to 1st line chemotherapy.
The JAVELIN Bladder 100 trial has previously demonstrated that avelumab 1st line maintenance plus best supportive care (BSC) significantly prolonged OS versus BSCe alone in patients with locally advanced or metastatic urothelial carcinoma that had not progressed with 1st line platinum containing chemotherapy (gemcitabine + cisplatin or carboplatin). In the initial analysis (data cut-off: October 21, 2019), the median OS was 21.4 versus 14.3 months in favor of the intervention arm (HR: 0.69, 95% CI: 0.56 – 0.86, p=0.001).1 Results from this trial have led to the approval of avelumab 1st line maintenance in various countries worldwide. Avelumab 1st line maintenance is now recommended as standard of care in international treatment guidelines based on level 1 evidence.
In this updated analysis, the authors report long-term outcomes (data cutoff: June 4, 2021; median follow-up ≥38 months in both arms) from exploratory analyses in subgroups defined by response to 1st line chemotherapy.
When use of avelumab + BSC versus BSC alone was assessed by best response to 1st line chemotherapy, benefits were seen in the complete response, partial response, and stable disease patients, although the magnitude of the effect was most pronounced in the patients with complete response (median OS 40 versus 27 months; HR: 0.72, 95% CI: 0.48 to 1.08), as seen below.
Similar results were noted with the investigator-assessed PFS outcomes with benefits observed across all response outcome groups, with, again, the highest magnitude of effect in the complete response group (HR: 0.58, 95% CI: 0.41 – 0.82).
As expected, subsequent 2nd line anticancer therapy was required at a higher frequency rate in patients in the best supportive care arms, as demonstrated below:
No new safety signals were observed with this extended follow-up, with the rate of Grade 3+ adverse events at about 50% in complete and partial response intervention arms, compared to 60% in the stable disease intervention arm. We also note a higher proportion of patients in the complete response group (23%) versus the partial response (10%) or stable disease (13%) subgroups who reported an AE that led to treatment discontinuation.
Dr. Gupta concluded that:
- Long-term follow-up from the JAVELIN Bladder 100 trial (median ≥38 months in both arms) continues to show prolonged OS and PFS with avelumab + BSC versus BSC alone, irrespective of best response to 1st line chemotherapy (CR, PR, or SD)
- Long-term safety of avelumab 1st line maintenance was consistent across subgroups, including incidence of adverse events and treatment-related adverse events
- These findings further support 1st line maintenance as the standard of care for all patients with locally advanced or metastatic urothelial carcinoma that has not progressed with 1st line platinum-containing chemotherapy
Presented by: Shilpa Gupta, MD, Associate Professor, Director of the Genitourinary Medical Oncology at Taussig Cancer Institute and Co-Leader of the Genitourinary Oncology Program at Cleveland Clinic, Cleveland, OH
Written by: Rashid K. Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2023 American Urological Association (AUA) Annual Meeting, Chicago, IL, April 27 – May 1, 2023
Reference:- Powles T, Park SH, Voog E, et al. Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. N Engl J Med 2020 Sept 24;383(13):1218-1230.