Latin American Perspective on Bladder Cancer Clinical Trials - Fabio Kater
May 24, 2022
Fabio Kater, MD, Clinical Oncologist, A Beneficência Portuguesa, São Paulo, Brazil
Phillip J. Koo, MD, FACS Division Chief of Diagnostic Imaging at the Banner MD Anderson Cancer Center in Arizona.
ESMO 2021: Results of the GETUG/AFU VESPER V05 Phase III Trial (ddMVAC vs GC in MIBC) and the Phase II Trial of Pembrolizumab plus sEphB4-HSA in Metastatic Urothelial Carcinoma
ASCO GU 2022: TROPHY-U-01 Cohort 4: Sacituzumab Govitecan in Combination with Cisplatin in Platinum-Naïve Patients with Metastatic Urothelial Cancer
ASCO GU 2022: Study EV-103 Cohort L: Evaluating Perioperative Enfortumab Vedotin Monotherapy in Cisplatin-Ineligible MIBC
Phillip Koo: Hi, my name is Philip Koo, and welcome back to UroToday's exclusive coverage of the 13th International Uro-Oncology Congress here in São Paulo, Brazil. We have with us today, Dr. Fabio Kater, who is a medical oncologist at the Portuguese Beneficence hospital of São Paulo. Welcome.
Fabio Kater: Thank you, Dr. Koo, it's a pleasure to be here in this wonderful conference and with you with everybody here, my colleagues that are joining this conference.
Phillip Koo: Great. So today you're going to be speaking about giving some highlights from the various bladder cancer trials. Can you give us a little taste of what you'll be speaking on?
Fabio Kater: That's it, Dr. Koo. I'm trying just to update about the news from ESMO 2021 and the ASCO GU 2022 news from bladder cancer, and I'm going to focus on some details that I found that is important for us. I don't think there are practice changing, except one that I would talk most, but there are some hints that are going to move from what we do different from now.
So, firstly, I'm going to talk about the VESPER trial that was a trial that was presented at ESMO last year. This may be a trial that may change practice in bladder cancer in the neoadjuvant scenario, because the author is compared to different schemes from neoadjuvant therapy, one MVAC dose-dense and the other one is gemcitabine and cisplatin, which is not the most conventional arm that we use in the practice, but it's a practical one and most of our technicians are used to GC times four in the neoadjuvant setting. In this VESPER trial, MVAC dose-dense times-six was compared to gemcitabine-cisplatin in times-four, and we see much higher proportion of patients having PCR, pathological complete response, and disease-free survival at 3 years.
So the question is, is the scheme more efficient than the other? Or is it just simply giving more platin to these patients? So, we don't know, but maybe the information, I think, they're trying to bring to us is maybe we have to do more chemo than we are just thinking of nowadays. So, probably the patient is going to need more chemotherapy before the operation. Urologists are not, in my view, they don't see this as a good option, because in practical clinic, we see the complaining about some side effects from chemotherapy. When the patient reaches the point of surgery, they used to warn us about some toxicities that can reflect on the post-operative scenario.
The other trials that I'm going to focus about, it's going to be the use of enfortumab vedotin in the neoadjuvant setting for patients who are ineligible to cisplatin. We know that this antibody conjugate is something very new in our clinical routine and enfortumab vedotin is already approved in the US, but not here in Brazil already, but we are very anxious to have this kind of option in later lines. So, can we use this antibody conjugate in earlier scenarios? Yes. Obviously we have only phase II trials of the drug showing responses, about 30-35%, which is very interesting because it's just similar as what cisplatin can offer us. So, for those people, for those patients who are cisplatin ineligible, maybe enfortumab vedotin can be a good choice.
I'm going to talk about the later lines in the metastatic scenario and I'm going to talk about the combination of cetrelimab plus erdafitinib in patients harboring the FGFR alterations. So the rationale is combining target therapy plus a checkpoint inhibitor. This is very ambitious, because we know that, probably, patients who harbor the FGFR alterations are tumors that are not so immunogenic. So what are the rational for combining the two strategies together? But in this trial, it's only a one-arm, phase II trial of NORSE trial, showed that the response with a combination of cetrelimab plus erdafitinib gives about 60% of response rate in metastatic bladder cancer. It's something controversial. I think we should have more, a phase III trial to confirm this news, these findings.
At last, I'm going to talk about sacituzumab govitecan, which is another antibody conjugate for people who are chemo refractory at all, that reaches metastatic disease in later lines, showing again, a response rate about 35%, which is in line with other options in this scenario. So, what I foresee in bladder cancer is the up-come of new strategies for people who are really, maybe, orphaned of some therapies in later lines, for example, or even the use of this new agent in earlier lines, also.
Phillip Koo: Great. So if you think about Brazil and Latin American in general and the future of clinical trials, where do you think the opportunities lie in bladder cancer? Yeah,
Fabio Kater: Yeah. As I told you, we don't have much of these drugs approved here, so we are just waiting for the approval of these drugs. We know that Brazilian scenario is not so fast as we have in other countries around the world, but I think we have some unmet needs, such as later lines, for example. We do need enfortumab vedotin or sacituzumab govitecan to use for these patients who are chemo refractory or even progressed after immunotherapy.
Phillip Koo: Great. Well, thank you very much for spending some time with us. We really appreciate your insight and we look forward to your lecture.
Fabio Kater: It's a great time. Thank you, Dr. Koo, and it's a great pleasure to have this opportunity here in our conference. Thank you.