This year at GU ASCO we’re presenting the long-term results from the JAVELIN Bladder 100 study. This was a study in which patients with metastatic urothelial carcinoma who received platinum-based chemotherapy, either gemcitabine and cisplatin or gemcitabine and carboplatin, were then randomised 1:1 to receive either avelumab or best supportive care. The primary endpoint on this study was median overall survival and this was tested in all patients and in those who were PD-L1 positive.
This study has reported out previously positive results and this has led to the widespread approval of avelumab in the maintenance setting for this patient population. We are presenting some long-term data from this study. The data cut-off was June 4th 2021 and the median follow-up was 38 months in the group who received avelumab and about 39 months in the group that received best supportive care.
In the study we were really looking at outcomes according to what chemotherapy regimen patients received upfront, whether they received gemcitabine and cisplatin or gemcitabine and carboplatin. We know that patients receiving gemcitabine/carboplatin tend to generally be a bit older, a bit frailer and their kidney function is often not as good as patients who receive cisplatin, and we saw this in this study. What’s important to note is the fact that regardless of whether patients received gemcitabine/cisplatin or gemcitabine/carboplatin, the long-term follow-up data shows that they both derived benefit from maintenance avelumab. So that was an important finding of the study.
We also did another analysis where we took all of the patients who were candidates for this study, which means they had all had some semblance of a response on frontline chemotherapy and went on to receive either avelumab or best supportive care, and we looked at survival from the time they started chemotherapy. So, remember, this is a subset of patients, only those who had had a response to frontline chemotherapy. We found that overall survivals are now starting to approach 30 months, so it just gives us a sense that we are really doing a lot better in this disease than we were before, many new treatments and our patients are really benefiting from all the trials and the new developments.
So, looking ahead, what it tells us is a couple of things. First off, avelumab maintenance is an important strategy that we use in our patients and we should really try to offer this to any patients that do have a response to frontline platinum-based chemotherapy. That’s important. Secondly, we do see that patients receiving gemcitabine/cisplatin perhaps do a little bit better than those who receive gemcitabine and carboplatin. So maybe we need to think a little bit more carefully about trying to get the cisplatin into more of our patients. We’ve typically used the Galsky criteria but many of us are now starting to be a little bit more liberal, allowing patients to have cisplatin when their creatinine clearance is 50ml/min or higher. So we’re being a little bit more liberal, perhaps, because cisplatin is a little bit more effective than carboplatin. So that’s going to be important that for patients with metastatic urothelial cancer currently the standard of care is platinum-based chemotherapy, maybe cisplatin over carboplatin, followed by maintenance avelumab. And the long-term data are supportive of what we saw at the outset.
The message here is that we are continuing to see improvements in outcomes in our patients with advanced bladder cancer. We need to continue doing trials, continue collaborations going forwards.