Dr. Sridhar on long-term follow-up from the JAVELIN Bladder 100 trial

Srikala S. Sridhar, MD, discusses long-term follow-up data from the phase 3 JAVELIN Bladder 100 trial, which she presented at the 2023 ASCO Genitourinary Cancers Symposium.¹

Based on findings from the JAVELIN Bladder 100 trial, the FDA approved avelumab (Bavencio) in 2020 as maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line, platinum-based chemotherapy.²

Sridhar is a medical oncologist and head of the Genitourinary Site Group at Princess Margaret Cancer Center, University Health Network, Toronto, ON, and Chair of GU Medical Oncologists of Canada.

Video Transcript:

The JAVELIN Bladder 100 trial was published a few years ago in the New England Journal of Medicine. In this study, we took patients with metastatic urothelial carcinoma who had received frontline platinum-based chemotherapy—either gemcitabine and cisplatin or gemcitabine and carboplatin—and as long as they'd had a response, which is either having stable disease, a partial response, or complete response, they were then enrolled on the study and randomized to receive either maintenance avelumab or best supportive care. The primary end point on this study was median overall survival. And we looked at all patients and in those who were PD-L1 positive.

What we presented at ASCO GU this year was our long-term results from this study; it was a post-hoc analysis looking at outcomes in groups defined by the type of chemotherapy they received—so whether they received gemcitabine and cisplatin, or gemcitabine and carboplatin. Not surprisingly, patients who receive gemcitabine and carboplatin tended to be a little bit older, had a worse performance status, and wore kidney function. Again, the group that we would typically give gemcitabine and carboplatin to.

What we found when we looked at the long-term results, and this was after about 38 months of follow-up, was that avelumab maintenance had a benefit, regardless of whether patients received gemcitabine and cisplatin, or gemcitabine and carboplatin. And just for a moment, if we look at the numbers, we can see that the overall survival in the group that received the gemcitabine/cisplatin plus avelumab was about 25 months compared to 18 months in the group that received gemcitabine/cisplatin plus best supportive care. If we look at the group that received gemcitabine and carboplatin, those numbers are slightly lower, at about 21 months vs 13 months, respectively.

So the message here is two-fold. First, regardless of whether they received gemcitabine and cisplatin or gemcitabine and carboplatin, there was a benefit with the use of maintenance of avelumab. Looking at the numbers, potentially gemcitabine and cisplatin did do a little bit better than gemcitabine and carboplatin. Typically in my practice, I do try to give cisplatin to my patients, if at all possible…The second analysis that we presented at the meeting this year was really looking at the overall group of patients who went on to this study. So, of course, these are patients who did not have evidence of disease progression on frontline chemotherapy, and then went on to receive the avelumab or the best supportive care. And we were really curious to know how their survival was from the beginning of chemotherapy. And in the overall population of patients who received avelumab, the overall survival was looking at around 30 months or so compared to 21 months in those who received Best supportive care. It's important to remember that this does not represent all patients who get chemotherapy, but simply those who had had disease response on frontline and were subsequently enrolled on this study. But I think it goes to show us that we are really making inroads in this disease. Patients are definitely living longer up until quite recently, the survivals were in the range of just over a year, a year and a half or so. And so I think it really tells us that we're making good progress

This transcript has been edited for clarity.

References

1. Sridhar SS, Powles T, Gupta S, et al. Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): Long-term follow-up from the JAVELIN Bladder 100 trial in subgroups defined by 1L chemotherapy regimen and analysis of overall survival (OS) from start of 1L chemotherapy. J Clin Oncol 41, 2023 (suppl 6; abstr 508). doi: 10.1200/JCO.2023.41.6_suppl.508

2. FDA approves Bavencio as first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma. News release. Pfizer. June 30, 2020. Accessed February 20, 2023. https://www.pfizer.com/news/press-release/press-release-detail/fda-approves-bavencio-first-line-maintenance-treatment