Tokyo-172 BCG is Noninferior to TICE BCG in High-Risk Non-Muscle Invasive Bladder Cancer
Key Clinical Summary:
- Design/Population: The phase 3 SWOG S162 study randomized 984 BCG-naïve patients with high-risk non-muscle invasive bladder cancer (high-grade Ta/T1 ± CIS or CIS alone) 1:1:1 to receive intravesical TICE BCG, intravesical Tokyo-172 BCG, or intradermal priming followed by intravesical Tokyo-172.
- Key Outcomes: At a median follow-up of 4.6-years, Tokyo-172 demonstrated noninferior high-grade recurrence-free survival compared with TICE. Complete response rates in CIS, 4-year complete response durability, and PFS were similar across arms. Intradermal priming did not improve outcomes. Grade 3/4 adverse events were higher with Tokyo-172; no treatment-related deaths were reported.
- Clinical Relevance: Tokyo-172 BCG is a noninferior alternative to TICE BCG for patients with high-risk non-muscle invasive bladder cancer, supporting its use amid supply constraints. Intradermal priming offers no added benefit and may increase toxicity.
Results from the phase 3 SWOG S162 study demonstrated that Tokyo-172 bacillus Calmette-Guérin (BCG) was noninferior to TICE BCG among BCG-naïve patients with high-risk non-muscle-invasive bladder cancer.
These results were presented by Robert Svatek, MD, UT Health San Antonio, San Antonio, Texas, at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in San Francisco, California.
In this multicenter study, 984 patients with high-grade Ta/T1 disease with or without carcinoma in situ (CIS), or CIS alone, and a negative purified protein derivative (PPD) test were randomized 1:1:1 to receive intravesical TICE BCG, intravesical Tokyo-172 BCG, or intradermal priming followed by intravesical Tokyo-172 BCG. Patients received standard induction consisting of 6 weekly instillations, followed by maintenance over 3 years.
The primary end point was high-grade recurrence-free survival (RFS). Key secondary end points included progression-free survival (PFS), complete response rate, duration of response, and safety.
At a median follow-up of 4.6 years, high-grade RFS was 58% in the TICE BCG arm, 64% in the Tokyo-172 BCG arm, and 63% in the intradermal priming plus Tokyo-172 BCG arm.PFS was 79% in both the TICE and Tokyo-172 BCG arms and 77% in the intradermal priming arm. Complete response rates were 62%, 60%, and 63%, respectively. Duration of response was 80% in both the TICE BCG and intradermal priming arms and 83% in the Tokyo-172 BCG arm. PPD conversion occurred in 29% of patients and was not associated with RFS.
Grade 1/2 adverse events occurred in 67% of patients in the TICE BCG arm, 71% of patients in the Tokyo-172 BCG arm, and 67% of patients in the intradermal priming arm. Grade 3/4 events occurred in 6%, 11%, and 14% of patients, respectively. No treatment-related deaths were reported.
“Tokyo-172 is noninferior to TICE BCG in terms of RFS and CIS [complete response] and is similar for PFS,” concluded Dr Svatek. “Priming with Tokyo-172 BCG does not improve RFS [and] PPD conversion is not prognostic.”
Source:
Svatek R, Tangen C, Meeks JJ, et al. SWOG S1602: A phase III randomized trial to evaluate BCG strain differences and priming with intradermal BCG before intravesical therapy for BCG-naïve high-grade non-muscle invasive bladder cancer (NCT #03091660). Presented at ASCO GU. February 26-28, 2026. San Francisco, California. LBA629.
