Genitourinary Cancers Symposium 2021 Trials in Progress TROPiCS-04 - Petros Grivas

February 8, 2021

Petros Grivas discusses the upcoming ASCO GU 2021 meeting that opens on Thursday, February 11, 2021.  Dr. Grivas will be presenting a "Trials in Progress" on the study of sacituzumab govitecan (IMMU-132) in metastatic or locally advanced unresectable urothelial cancer (TROPiCS-04).  This is a Phase III, global, multicenter, open-label randomized controlled trial in which approximately 600 subjects with metastatic or locally advanced unresectable UC who have progressed after prior therapy with platinum-based regimen and anti-programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy will be randomized to either sacituzumab govitecan arm or Treatment of Physician's Choice (TPC) arm.


Petros Grivas, MD, Ph.D., Associate Professor, Clinical Director of Genitourinary Cancers Program, University of Washington, Associate Member, Clinical Research Division, Fred Hutchinson Cancer Research Center.

Alicia Morgans, MD, MPH Associate Professor of Medicine in the Division of Hematology/Oncology at the Northwestern University Feinberg School of Medicine in Chicago, Illinois.

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Alicia Morgans: Hi, my name is Alicia Morgans. I'm a GU medical oncologist and Associate Professor of Medicine at Northwestern University in Chicago. I'm so delighted to have here with me today a good friend and colleague, Dr. Petros Grivas, who's an Associate Professor of Medicine and a GU medical oncologist at the University of Washington and the Fred Hutchinson Cancer Center in Seattle, Washington. Thank you so much for being here with me today, Petros.

Petros Grivas: Thank you so much, Alicia and I'm very excited about ASCO GU as well. Thanks for inviting me.

Alicia Morgans: Wonderful. Well, as we look towards ASCO GU, this virtual meeting, I know you are super excited about a trial in progress you're going to be talking about. Can you give us a little sense of that as we get excited about the meeting?

Petros Grivas: Absolutely. I'm going to have the opportunity to present the trial in progress of the TROPiCS-04 trial. This is a Phase III randomized clinical trial in patients with pre-treated advanced urothelial cancer and with metastatic or locally advanced unresectable disease. And it was previously treated with platinum-based chemotherapy and immunotherapy and possibly other therapies, there is no limitation in the number of prior therapies. These patients will be randomized one-to-one to either sacituzumab govitecan. Sacituzumab govitecan is an antibody-drug conjugate against TROP-2. It's linked to a payload which is called SN-38, which is a metabolite of irinotecan and this antibody-drug conjugate will be compared to standard of care chemotherapy that is used in the salvage setting, which can be their single-agent paclitaxel or docetaxel, or vinflunine in Europe. And this Phase III trial is based on the very promising results of the Cohort 1 of the TROPHY-U-01 trial, a Phase II study that showed an overall response rate of 27% with this antibody-drug conjugate, sacituzumab govitecan, in patients pre-treated advanced urothelial cancer. So, we're very excited about this study, it's up and running. And as I mentioned to you, we're aiming to enroll patients in this [inaudible 00:02:00] setting, and it's up to 600 patients, so a big Phase IiI trial that we need in the field of urothelial cancer.

Alicia Morgans: Absolutely. And I remember using that agent, I participated in some of the early studies with that, and I know Scott Tagawa was really involved in that work as well. Very, very exciting. I think anytime we can use an antibody-drug conjugate in this population that is both effective and tolerable, we are going to be making strides because these agents seem to do actually quite well in urothelial cancer. So we all look forward to hearing more. Thank you so much for that teaser before GU ASCO.

Petros Grivas: Thank you so much, Alicia, and thanks to all the co-authors, all the co-investigators, and all the families and patients who will participate, [inaudible 00:02:42] overall survival and more to come in the near future.

Alicia Morgans: Wonderful. Thank you.