Highlighting Emerging Genitourinary Cancer Research at Columbia University

In an interview at the Columbia University Herbert Irving Comprehensive Cancer Center, Karie Daniella Keera Runcie, MD, assistant professor of Medicine at Columbia University Medical Center, discussed emerging research and future insights into genitourinary cancers.

First, she highlighted efficacy data from the phase 3 KEYNOTE-B15/EV-304 trial (NCT04700124), wherein patients experienced improvements in survival outcomes with the investigational combination of neoadjuvant and adjuvant enfortumab vedotin-ejfv (Padcev) and pembrolizumab (Keytruda) vs neoadjuvant chemotherapy among patients with muscle-invasive bladder cancer. Specifically, the median event-free survival (EFS), overall survival (OS), and pathologic complete response (pCR) rate in the respective arms were not reached (NR) vs 48.5 months (P <.0001), NR vs NR (P = .0029), and 55.8% vs 32.5% (P <.0001).¹ These findings made the investigational combination the new standard of care for this patient group, according to Runcie.

Then, she highlighted research she coauthored from the phase 2 Cyto-KIK trial (NCT04322955). Despite being a single-arm, small study assessing cabozantinib (Cabometyx) and nivolumab (Opdivo) in metastatic kidney cancer prior to cytoreductive nephrectomy, she explained that the study showed safety and feasibility, eliciting responses in a high-risk de novo metastatic group. It is currently being featured as an option in the NCCN guidelines.

Finally, she touched upon forward-looking insights in the field of kidney cancer, highlighting favorable efficacy of immunotherapy options for this disease. Furthermore, she highlighted a need to bolster cure rates for these patients, who historically have experienced pCR rates in the 10% to 15% range.

CancerNetwork: Following the most recent ASCO GU Cancer Symposium, which data do you think have the potential to impact clinical practice?

The biggest highlight of ASCO GU was EV-304, because that definitely changed the standard of care for our perioperative management of muscle-invasive bladder cancer. Enfortumab vedotin plus pembrolizumab in the neoadjuvant and adjuvant setting, on that Monday, became a standard of care.

Based on data from the phase 2 Cyto-KIK trial, what should others take away from your investigation of cytoreductive surgery plus nivolumab and cabozantinib in patients with kidney cancer?

Cyto-KIK was a single-arm, multi-center phase 2 study of cabozantinib and nivolumab, which is a standard of care in the metastatic setting prior to cytoreductive nephrectomy, and after that, they resumed systemic therapy. We had 38 patients who enrolled on this study, and this is still a small study compared with large phase 3 trials. The question of cytoreductive nephrectomy in the current standard of care is still an open question.

What we showed was that it's safe and feasible, and that 9% of patients in this high-risk, de novo metastatic population had a complete response to therapy, and some of these patients have been able to stop treatment and be monitored over time. It's safe and feasible, and it's in the NCCN guidelines for [this] select group of patients.

What other directions must the GU oncology field go in to further improve outcomes across different patient populations?

Trying to focus on kidney cancer, with the advent of immunotherapy, we've made great strides. We've improved progression-free survival [and] overall survival with immunotherapy. Recently, data was presented about adjuvant therapies at ASCO GU, [and] the goal is cure. Despite making all these advancements in the first-line setting, only about 10% to 15% of patients have a complete response to therapy. We need to focus on [bolstering cure rates], perhaps trying therapies in a neoadjuvant setting to see if we can improve the cure rates up front.

References

1. Galsky MD, Valderrama BP, Maruzzo M, et al. Neoadjuvant and adjuvant enfortumab vedotin (EV) plus pembrolizumab (pembro) for participants with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin: randomized, open-label, phase 3 KEYNOTE-B15 study. J Clin Oncol. 2026;44(suppl 7):LBA630. doi:10.1200/JCO.2026.44.7_suppl.LBA630
2. Runcie K, Ornstein MC, Saraiya B, et al. Cyto-KIK: a phase II trial of cytoreductive surgery in kidney cancer plus immunotherapy (nivolumab) and targeted kinase inhibition (cabozantinib). J Clin Oncol. 2026;44(suppl 7):513. doi:10.1200/JCO.2026.44.7_suppl.513