Dear colleagues, dear, friends thank you for joining in this webcast. So Virtual ACSO 2020-- new format. Still, we had the chance to follow some of the most recent developments in GU oncology, and there were some game-changers.
Let me start with my personal highlight, and this was the Tom Powles's presentation on Javelin BLADDER 100 trial. So Tom showed us the results as a late-breaking abstract number one on avelumab maintenance in a group of 700 patients. Those 700 patients where recruited and randomized one-to-one fashion to best supportive care, and then experimental arm avelumab and best supportive care.
All patients had a metastatic urothelial carcinoma treated with either cisplatin combination therapy with gemcitabine or carboplatin with gemcitabine treatment. So standard treatment, according to renal function, and then one arm with supportive care until progress of disease, and the other arm avelumab maintenance.
This treatment resulted in a remarkable overall survival benefit of 21 months versus 14 months for the best supportive care arm. So the delta was six months when continuing or using maintenance PD-L1 inhibition In this cohort of patients. So I think this is really important. We have to discuss some points in the further course once we really see all the data. For example, how long should the avelumab treatment be continued? Would it be, for example, four cycles be enough?
On the other hand, the best response were in the PD-L1 positive patients with the non-visceral disease. So what do we do with a visceral disease? In the future, hopefully, biomarkers will somehow guide the treatment decision. And also, we don't know what's going to happen when the trials, the chemo trials and upfront chemo combination IO therapy-- In this case, pembrolizumab-- reads out. So in case we start up-front IO treatment, this maintenance would probably make no sense at all.
However, I think this is really a game-changer. This is a well-selected late breakout presented by Tom Powles. And I really think the investigators for shedding light in this situation where we haven't had any evidence. So I think, personally, we should use avelumab in the situation, post-four to six cycles chemotherapy in metastatic urothelial carcinoma.
When it comes to renal cell carcinoma, there was the 23-month update of the axi/pembro KEYNOTE presentation. And here, this combination really has proven to be of benefit. It was the favored sunitinib treatment in the all-comer population. Especially, I think, looking at the 8.8% percent complete response in this whole study group after 23 months of follow up, this is encouraging data, and this supports the guidelines recommendation to use axi/pembro as a first-line treatment in the metastatic renal cell carcinoma.
An alternative is the ipi/nivo in this indication for the intermediate and poor prognosis patients. So you have to choose, and really depending on the patient profile, which makes sense.
And also in this article, we had some information on the use of ipilimumab. So here, one abstract looked at deferred use of ipilimumab. And this doesn't make sense, though. We should use it as shown in the initial publication with upfront four cycles and then nivolumab in combination.
So when it comes to prostate cancer, there are three very similar presentations, but important in the indication of non-metastatic CRPC. So rising PSA on ADT, no disease in conventional imaging. And here, we have seen last year the MFS benefit of about two years for the SPARTAN, PROSPER, and ARAMIS trials-- so for apalutamide and enzalutamide, and darolutamide. And now the three presentations were focusing on the follow-up results on those three trials. They were, as you know, randomized phase III trials looking at the standard of care and standard of care like ADT in combination with the tests or the substance apalu, enza, or darolutamide.
So both three trials have shown an overall survival benefit with regards to the statistical design, with regards to the hazard ratio. So really, we have some data supporting the use of all three of them. And in some countries, already, three are approved, and we have to choose which one to use.
And there are several factors that might lead our decision of which one to use. In some countries, the costs. In some countries, we have to look at reimbursements. Then, the patient factors like the side effects. For example, enzalutamide is more associated with fatigue. With apalutamide, you might expect in some patients the rash as one of the AEs of special interest. With darolutamide, the AE profile seems not to differ a lot from the placebo. However, it's not quite fair to do a trial-trial comparison, since also, the timing of when looking at the SAEs and AEs was different among the three trials.
So we have to wait for head-to-head trials, which will never happen. So then we need to see real-world data. And in summary, it makes sense-- MFS prolongation of two years and an overall survival benefit. So for me, personally, my take-home message is to really intensify the treatment in non-metastatic CRPC. And it is not enough when you have a fast PSA doubling time of less than 10 months. So I really think it is important to intensify treatment in this indication for the man with non-metastatic CRPC.
So last abstract which caught my attention was the TAPUR trial, which looked at olaparib in advanced metastatic CRPC in men with BRCA1 an BRCA2 alterations. And we've seen the first phase III data on olaparib shown and presented at last year's ESMO. Now we have learned from the New England Journal publication which was released a couple of weeks ago that olaparib also results in an overall survival benefit compared to when switching to enza or abiraterone in the situation.
So here, a lot of discussions were virtually in the room on PARP inhibition in advanced prostate cancer, there are colleagues that vote for and also guidelines that support the genetic counseling from the beginning of metastatic disease in prostate cancer. And we have two FDA-approved drugs-- namely rucaparib and olaparib-- in a little different indications. One is in the indication of BRCA1 and BRCA2-alterated and ATM-alterated patients, and one is for second-line in all genetic alterations.
So I think here, a really tailored approach makes sense. And we have to look at the subgroups. For example, for olaparib, the ATM population doesn't really benefit a lot. However, BRCA1 and BRCA2 has shown in TAPUR, this ASCO presentation makes very much difference, and the response rates are the highest when you have genetic aberrations in those checkpoints.
So the future is now. The future is genetic counseling for our men with metastatic prostate cancer. And in most academic centers and around, there are established molecular tumor boards. And I think this will be the future. We have to see how future trials read out, like the TRITON3 trial, which looks at rucaparib post enza or abi. So this is something I'm personally very interested in, how this will develop in the next years.
So thanks a lot for your attention. Hopefully, I was able to summarize my personal highlights of this year's ASCO, virtual ASCO 2020. Looking forward to see you all in person next year, hopefully. Stay safe, and all the best. Thanks a lot.