Real-World Data With Avelumab Maintenance Therapy in Metastatic Urothelial Carcinoma

Transcript:

Shilpa Gupta, MD: Petros, give us a brief overview of what’s happening in the real world with maintenance therapies. We saw a plethora of abstracts at this ASCO GU [American Society of Clinical Oncology Genitourinary Cancers Symposium], including the PATRIOT-II study, which you’re leading. Briefly summarize the real-world maintenance avelumab uptake and what we’re seeing.

Petros Grivas, MD, PhD: Thanks, Shilpa. It’s very interesting to see the first attempts to evaluate real-world outcomes in patients who get avelumab maintenance in real-world practice. It’s always important to follow with real-world data to corroborate data from clinical trials. Obviously, clinical trials can’t be substituted. These are important. But it’s an effort to get a sense of what’s happening in clinical practice. We saw a number of abstracts in posters at ASCO GU looking at real-world maintenance avelumab.

I can focus a little on the multicenter study that we led. We used 26 centers to create a database of patients who received checkpoint inhibition in advanced urothelial cancer across the different settings in metastatic disease. In particular, we looked for patients who got switch maintenance avelumab, and we had about 100 in our analysis. We looked at patient characteristics, treatment patterns, and utilization of chemotherapy time to avelumab. What we saw was consistent with what we see in clinical practice: about two-thirds of patients get cisplatin-based chemotherapy. In a selection of academic centers you see a little higher-than-expected utilization of cisplatin. At academic centers, we try a little more to get cisplatin in our patients. We also saw that the response rates to platinum-based chemotherapy were consistent with what we know historically. Those patients went on to maintenance avelumab showing a significant utilization of that, at least in the centers we’re working with.

We looked at outcomes. The median PFS [progression-free survival] was consistent with what we saw in the JAVELIN Bladder 100 trial. With our current follow-up, more than half the patients were alive, so we have to do a longer follow-up to look at the median overall survival [OS]. The response rate with avelumab maintenance was around 30%, which was much higher compared with what we saw in JAVELIN Bladder 100. That may reflect the investigator-based assessment, not a formal RECIST 1.1 independent blinded scan review. The response rate was presented in JAVELIN Bladder 100. However, I don’t think response rate is the main end point in that maintenance setting. PFS and OS are the main end points. We saw a number of other real-world experiences.

Shilpa, you’ve been part of the PATRIOT-II study with real-world experience in the first-line setting. The early data in PATRIOT-II represent patterns of treatment with chemotherapy. We saw similar data. About two-thirds of patients had cisplatin-based chemotherapy, and you see the range of chemotherapy was 3 to 6 cycles. Then you see patients get avelumab, on average 1 to 2 months after finishing chemotherapy, which is similar to what you saw in JAVELIN Bladder 100. In PATRIOT-II, we’re going to do a second data cut with longer follow-up to look at outcomes with avelumab maintenance.

My sense is that what we see in practice is what we saw in JAVELIN Bladder 100. There may be individual numerical differences, but this supports the standard of care that JAVELIN Bladder 100 established and supports federal clinical trials in the maintenance setting, like MAIN-CAV, JAVELIN MEDLEY, and TROPHY-U-01 cohort 5. We should keep building on the backbone of avelumab maintenance in these spaces.

Shilpa Gupta, MD: Thank you, Petros. It’s reassuring to see that the real-world pickup is also very successful.

Transcript edited for clarity.