RAD-SG Trial Evaluates RADiation Therapy and Sacituzumab Govitecan in MIBC

Omar Mian, MD, PhD, radiation oncologist and physician scientist at Cleveland Clinic's Lerner Research Institute, discusses adaptive RADiation therapy given with sacituzumab govitecan (Trodelvy) for bladder preservation in patients with muscle-invasive bladder cancer (MIBC) and provides an overview of the RAD-SG trial, which is currently in progress.

Transcription:

0:10 | One of the presentations I'm very excited about at ASTRO this year is a trial and progress presentation. The trial is called RAD-SG. It is a radiation and targeted antibody-drug conjugate combination. [It is] really a first of its kind of clinical trial, you might call it a smart missile type of radiosensitization.

Your standard of care is currently combining radiation with radiosensitizing chemotherapy. And of course, chemotherapy goes all over the body. A new and emerging class of systemic therapies are called antibody-drug conjugates, and this binds the chemotherapy to an antibody that goes right to the cancer. In this case, we're using a drug called sacituzumab govitecan. This is an antibody that targets cancer cell surface moiety, called Trop-2, and delivers a type of chemotherapy that's potently radiosensitizing.

The whole idea of the study is combining these 2 things together, with radiation and this antibody-drug conjugate, to give us targeted radiosensitization. Of course, the radiation is targeted, but now the chemotherapy is going to go right to the tumor. The benefit of this is more potent sensitization at the tumor, but also decreased [adverse] effects, we hope, from not having off-target effects into chemotherapy or minimizing those.

We anticipate accruing about 20 people to the initial, pilot, phase 1 component of this study. It's a small study, we're doing a lot of correlative analysis looking at safety and early signals of efficacy, but also studying the biology of how this immunomodulatory drug combined with radiation works together to clear cancer. I'm very excited about it. There's an NIH grant for which these trials are a component of the analysis and of the correlative and translational science studies. That's work that a number of investigators in medical oncology and translational scientists at the Cleveland Clinic are doing.