GU Cancers 2019 | JAVELIN: post-hoc analysis of high-risk populations

Andrea Apolo

Andrea Apolo, MD, of the National Cancer Institute, Bethesda, MD, describes the post-hoc analysis of high-risk populations in the phase Ib JAVELIN trial (NCT01772004), outlining the inclusion criteria for this population. This interview was recorded at the 2019 Genitourinary Cancers Symposium, held in San Francisco, CA.

Transcript (edited for clarity):

So for the second abstract we looked at the 250 patients treated with Avelumab in the second line setting. These are metastatic bladder cancer patients that receive Avelumab after progressing on platinum-based chemotherapy, and we did a post-op analysis of high-risk groups. The high-risk groups included liver metastases, patients with high or low Avelumab, patients that were older, greater than or less than 75 years of age. Patients that had reno-insufficiency and depending on the site of disease, upper track or lower track disease. We look at the response rate and how they did in terms of overall. The overall response rate for the patient population was 16.5 months. However, when we looked at patients who are younger, they did a little bit better. Patients that were less than 75 years of age, the response rate was 25% versus 13%. When we looked at patients with liver metastases, the response rate was 6% versus 22%, so that was a big difference. Also patients that had low Avelumab, the response rate was 2.2% versus 19%. So these are big differences.

In terms of the progression free survival, there wasn’t a big difference in terms of the progression-free survival in these cohorts. In terms of the adverse events, we also looked at the adverse events to see if it was higher incidents of adverse events in the patients with higher risk groups and there wasn’t, so this was reassuring to us.

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