Tokyo-172 vs TICE BCG: Eugene Cone, MD, discusses SWOG S1602 findings

In this video, Eugene B. Cone, MD, of Urology of Indiana, discusses the limitations of TICE BCG, the rationale for evaluating alternative BCG strains, and findings from the phase 3 SWOG S1602 trial (NCT03091660) comparing Tokyo-172 and TICE BCG in BCG-naïve non–muscle invasive bladder cancer (NMIBC).

Cone explains that BCG availability has remained a significant challenge in the US, where TICE BCG is the only strain with FDA approval. He notes that production constraints have contributed to uneven access across practices, prompting some clinicians to consider alternative intravesical therapies. In addition to supply limitations, BCG’s toxicity profile, which commonly includes lower urinary tract symptoms, has contributed to interest in approaches that could maintain or improve efficacy while reducing treatment-related adverse effects.

SWOG S1602 was designed to evaluate whether the Tokyo-172 strain could provide comparable efficacy to TICE BCG and potentially expand the available BCG supply. The phase 3 trial randomly assigned patients with BCG-naïve high-risk NMIBC to intravesical TICE, intravesical Tokyo-172, or intradermal BCG priming followed by intravesical Tokyo-172. At a median follow-up of 4.6 years, high-grade recurrence-free survival (RFS), complete response, duration of response, and progression-free survival were similar across the 3 groups. Tokyo-172 met the prespecified criteria for noninferiority to TICE, with 5-year high-grade RFS of 58% with TICE vs 64% with Tokyo-172. Grade 3 to 4 adverse events were more frequent with Tokyo-172.

The study also evaluated whether intradermal BCG priming could enhance the response to subsequent intravesical therapy. Although the strategy was hypothesized to improve antitumor immunity, the trial did not demonstrate a benefit in high-grade RFS with priming.

Overall, Cone says the findings support Tokyo-172 as a potential alternative to TICE BCG if it becomes available in the US.

“The take-home here is that if the Tokyo strain becomes available in the US, urologists can administer it interchangeably with TICE without concern about lack of efficacy or clinical benefit,” he concluded.