ASCO GU recap: Vignesh Packiam, MD, on key bladder cancer highlights

Recent data presented at the 2026 ASCO Genitourinary Cancers Symposium in San Francisco, California, highlighted several developments in bladder cancer management, including efforts to address treatment shortages, refine bladder-preservation strategies, and expand the role of circulating biomarkers, according to Vignesh T. Packiam, MD, associate professor of urology at the Rutgers Cancer Institute of New Jersey. In the following video, Packiam reviews several studies presented at the meeting that he described as clinically meaningful for practicing urologists, particularly as the field continues to navigate limitations in standard therapies and explore new multimodal treatment strategies.

One notable update came from the SWOG S1602 trial (NCT03091660), which examined potential strategies to mitigate the long-standing shortage of intravesical BCG. The study compared the widely used TICE strain of BCG with the Tokyo-172 strain and also evaluated whether immune “priming” with an intradermal BCG injection before intravesical therapy could improve outcomes. In the trial of more than 900 patients with non–muscle invasive bladder cancer, the Tokyo-172 strain demonstrated noninferiority to the TICE strain. Among patients with carcinoma in situ, the 6-month complete response rates were 70.2% with TICE and 66.4% with Tokyo-172, with similar outcomes seen in 2-year recurrence-free survival analyses (HR, 0.82; 95.8% CI, 0.63 to 1.08). Investigators also found no meaningful benefit from intradermal priming, with the data indicating no difference between primed and non-primed approaches (HR, 1.0; 95.8% CI, 0.76 to 1.33).¹ Packiam noted that the findings could support broader availability of the Tokyo-172 strain in the US, which could help alleviate persistent supply challenges.

Another trial discussed was the SUNRISE‑2 trial, which evaluated a bladder-preservation strategy for patients with muscle-invasive bladder cancer who were either ineligible for or declined radical cystectomy. The study compared standard chemoradiation with an investigational regimen consisting of the gemcitabine intravesical system combined with the checkpoint inhibitor cetrelimab. The trial enrolled more than 500 patients, but it was stopped early after an interim analysis determined the experimental regimen was unlikely to demonstrate superiority over the control arm. While the results were negative for the primary end point of bladder intact event-free survival,² Packiam said the study still contributes important information about the role of device-based drug delivery strategies and immunotherapy combinations in bladder-preservation approaches.

More encouraging findings emerged from the INDIBLADE trial (NCT05200988), a single-arm study evaluating sequential immunotherapy followed by chemoradiation in patients pursuing bladder preservation. In this trial, patients received neoadjuvant checkpoint inhibition with ipilimumab (Yervoy) and nivolumab (Opdivo) prior to definitive chemoradiation. Among the 50 patients enrolled, the 2-year bladder-intact event-free survival rate reached 78%, and overall survival at 2 years was 96%. The trial also incorporated analysis of circulating tumor DNA (ctDNA), demonstrating that ctDNA negativity following neoadjuvant immunotherapy was associated with significantly better outcomes after chemoradiation.³ According to Packiam, these results suggest that dynamic biomarker assessment after systemic therapy—rather than baseline measurements alone—may offer meaningful prognostic insight for patients undergoing bladder-preserving treatment.

Finally, Packiam highlighted a biomarker analysis from the NIAGARA trial (NCT03732677), which previously evaluated neoadjuvant chemotherapy with or without perioperative durvalumab in patients undergoing radical cystectomy. The updated analysis examined the combined prognostic value of ctDNA and urinary tumor DNA prior to surgery. Investigators found that patients who were negative for both biomarkers had a 24-month event-free survival rate of 90%, compared with 55% among those who were positive for both (HR, 0.25; 95% CI, 0.12 to 0.49).⁴ Packiam noted that the dual-biomarker approach appeared more predictive than either biomarker alone, underscoring the growing interest in integrating blood- and urine-based assays into treatment decision-making. As research advances, he said, urinary tumor DNA in particular is likely to become an increasingly important tool in bladder cancer management.

For more insights into data presented at ASCO GU, catch up with Urology Times’ coverage here.

REFERENCES

1. Svatek RS, Tangen C, Meeks JJ, et al. SWOG 1602: 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: 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium. February 26-28, 2026. San Francisco, California. Abstract LBA629. https://www.asco.org/abstracts-presentations/257313

2. Necchi A, Williams SB, Tran P, et al. Gemcitabine intravesical system (Gem-iDRS) in combination with cetrelimab (CET) versus chemotherapy (CRT) in muscle-invasive bladder (MIBC): SunRISe-2 final results. Presented at: 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium. February 26-28, 2026. San Francisco, California. Abstract 635. https://www.asco.org/abstracts-presentations/256842

3. Mellema JJJ, Stockem CF, Herberts C, et al. Induction ipilimumab plus nivolumab followed by consolidating chemoradiotherapy as bladder-sparing treatment in stage II/III urothelial carcinoma of the bladder: The phase 2 Indi-Blade trial. Presented at: 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium. February 26-28, 2026. San Francisco, California. Abstract LBA637. https://www.asco.org/abstracts-presentations/257348/abstract

4. van der Heijden MS, Galsky MD, Joshi R, et al. Urinary tumor DNA (utDNA) and circulating tumor DNA (ctDNA) in patients (pts) with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA. Presented at: 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium. February 26-28, 2026. San Francisco, California. Abstract 636. https://www.asco.org/abstracts-presentations/256840/abstract