Neeraj Agarwal: Hi, my name is Dr. Neeraj Agarwal. I'm a medical oncologist and director of genitourinary cancers program at the University of Utah Huntsman Cancer Institute. It's such a pleasure to have Dr. Albert Jang, who I know for a long time when he was a fellow in Case Western University and now pursuing advanced GU oncology fellowship at the Mayo Clinic. So Albert, first of all, congratulations for presenting at such early stage of your career, the primary result of a phase two trial of Masofaniten, a N-terminal inhibitor. And it was combined with Enzalutamide in patients with metastatic hormone-sensitive prostate cancer. So first of all, thank you for joining us today.

Albert Jang: Thank you for having me, Dr. Agarwal. It's such a pleasure to be here.

Neeraj Agarwal: So please tell us, Albert, about the study. Why did you design this study and what are the results for our audience today?

Albert Jang: Yeah. So I'm presenting this study on behalf of my mentor, Dr. Pedro Barata, who's the GU medical oncologist at University Hospitals Cleveland Case Western. So it was a single-institution investigator-initiated trial looking to combine Masofaniten, which is an N-terminal domain inhibitor of the androgen receptor in combination with Enzalutamide with androgen deprivation therapy for patients with metastatic hormone-sensitive prostate cancer. The thought behind this is that as we know, patients who have metastatic prostate cancer will develop resistance on androgen receptor pathway inhibitors over time. We've seen this such as the AR-V7 splice variant. We have also seen this with ligand-binding domain mutations. So the thought of combining another agent on top of an androgen receptor pathway inhibitor might slow down patients' disease in developing resistance and moving on to castration-resistant prostate cancer.

Neeraj Agarwal: How many patients were there in this study? And what were the results?

Albert Jang: So there were 13 patients on this trial. Unfortunately, this combination was tested in the metastatic castration-resistant setting. That study ended up becoming negative. So the production of Masofaniten was discontinued, but we did manage to enroll 13 patients on it.

Neeraj Agarwal: And tell us about the results.

Albert Jang: Yeah. So the goal of this study was originally to enroll 35 patients. This was a Simon two-stage design. So the first stage was to enroll 13 patients. If we saw a biochemical response, which we defined as a PSA of less than 0.2 by six months, and if we saw that in nine patients or more, this will be determined as satisfying stage one and moving on to stage two, where we would enroll 22 more patients to get a total of 35 patients on the study. Because we only had 13 patients, we only have follow-up for those 13, and we actually saw a biochemical response of PSA of less than 0.2 by six months in 10 of these 13 patients. So it did meet the benchmark for moving on to part two before it closed.

Neeraj Agarwal: Which is quite impressive. Out of 13 patients with metastatic hormone-sensitive prostate cancer, 10 achieved a PSA level, which was undetectable after a pre-specified time point. That is much higher than what we have seen with the registration phase three trials of these androgen receptor pathway inhibitors. So I certainly think there is these preliminary data definitely are promising. And I really hope that N-terminal inhibition story doesn't stop here and continues to be pursued. For now, it looks like Masofaniten is not being pursued for further clinical investigation, but I still like to congratulate you for presenting this study so early in your career, as I said, and congratulations to you and your mentor, Dr. Pedro Barata and the entire team. It takes a village to do these studies.

Albert Jang: Yes. I am very thankful that I was able to present this poster today on behalf of Dr. Pedro Barata and the entire University Hospitals Cleveland crew of providers and patients and their families.

Neeraj Agarwal: Thank you for joining us today.

Albert Jang: Thank you.