John Taylor III, MD, shares preliminary findings from phase 2 LEGEND trial

In this video, John A. Taylor III, MD, MS, shares the design and preliminary findings of the phase 2 LEGEND trial, which is exploring detalimogene voraplasmid (EG-70) in patients with BCG-unresponsive non-muscle invasive bladder cancer. The results were presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California.

Taylor is a professor and director of basic urologic research and the coleader of the D3ET Program at the University of Kansas Medical Center.

Video Transcript:

Could you describe the design of the phase 2 LEGEND trial?

The phase 2 is a standard single-arm open-label trial. It was modeled after the FDA guidelines for non-muscle invasive disease in 2018 and I think that was updated in 2024. Let's go to the phase 1 trial. That was a standard dose escalation. I believe it was a 3x3, which showed good tolerability and gave us the direct to phase 2 dose. So, the phase two with that dose is, it's up to 4 treatment cycles in year 1, so they're 3-month treatment cycles where the patients receive study drug on weeks 1, 2, 5, and 6, on a 12-week cycle. They're evaluated after 4 cycles at year one. If they have a complete response at year 1, they can continue on trial through year 2. And then I believe they're beginning to initiate a maintenance phase beyond if they continue to respond.

What were the key findings?

The most important thing is tolerability, one of the most important things. Remember, this is a heavily pre-treated population, so they come in with bad functioning bladders and poor tolerance to intravesical therapy. The treatment related AEs were no more than grade 1 or 2, there were no grade 3 or 4 AEs. In hindsight, the majority of these AEs, any AE is around 40% and grade 1 or 2 is around 20%. These mostly can be attributed to intravesical administration rather than study drug-related. So, it's tolerated really well, which is important for this patient population.

The efficacy findings reported to date are 71% any time response. Three-month response rate of 67%. Six-month response rate [is] 41%. I believe that the Kaplan Meier, which we didn't present, but the Kaplan-Meier estimates for the 1 year is around 50%. So, it's good tolerability in this BCG-refractory population. That's one of the most important things, but also, the patients tolerate it well; they're able to handle the treatment.

This transcript was AI generated and edited by human editors for clarity.