ASCO GU: How Merck & Co/MSD is Advancing Treatment of Bladder and Kidney Cancers

During the 2026 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, held February 26-28, 2026, Merck & Co., known as MSD outside of the United States and Canada, presented results from several approved and investigational medicines for multiple genitourinary cancers.

Globally, GU cancers account for an estimated 2.6 million new cancer diagnoses each year, equaling over 1 in 8 of all cancer incidences. Through a robust clinical development program with more than 50 clinical trials evaluating more than 22,000 patients worldwide.  Merck is investigating the potential of several portfolio medicines and pipeline assets, leveraging multiple novel combination strategies across various stages of disease, to help address unmet needs in GU cancers. The results presented at ASCO GU underscore Merck’s commitment to advancing research across its broad portfolio to improve patient outcomes.

“We’re excited to share new results from our portfolio and pipeline for more patients with certain types of bladder and kidney cancers, with new data in muscle invasive bladder cancer and earlier stages of renal cell carcinoma,” noted Marjorie Green, MD, senior vice president and head of oncology, global clinical development, Merck Research Laboratories.

“The results we’re presenting at ASCO GU underscore our leadership across the genitourinary cancer landscape and our commitment to advance standards of care for these patients,” Green added.

Data presentations included key data for pembrolizumab (Keytruda®), belzutifan (Welireg®), and lenvatinib (Lenvima®), in collaboration with Eisai, as well as new results for the investigational antibody-drug conjugate sacituzumab tirumotecan (sac-TMT), a TROP2-directed ADC being developed in collaboration with Kelun-Biotech.

Key data from Merck’s portfolio and pipeline

• First-time data from the Phase 3 KEYNOTE-B15/EV-304 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus Padcev ^®(enfortumab vedotin-ejfv) as neoadjuvant and adjuvant treatment (before and after surgery) for patients with muscle-invasive bladder cancer who are eligible for cisplatin (abstract #LBA630, Oral abstract session B: Urothelial carcinoma), which will be featured in the official ASCO GU Press Program. ¹
• Results from the first interim analysis of the Phase 3 LITESPARK-022 trial evaluating KEYTRUDA in combination with WELIREG, Merck’s first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, as a treatment for patients with clear cell renal cell carcinoma (RCC) following nephrectomy (abstract #LBA418, Oral abstract session C: Renal cell cancer and testicular cancer), which will be featured in the official ASCO GU Press Program.
• First presentation of data from the Phase 3 LITESPARK-011 trial evaluating WELIREG plus LENVIMA, an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, as a treatment for patients with advanced RCC whose disease progressed on or after treatment with anti-PD-1/L1 therapy (abstract #LBA417, Oral abstract session C: Renal cell cancer and testicular cancer), which will be featured in the official ASCO GU Press Program. ²
• First-time data presentation for the Phase 2 MK-2870-002 study evaluating sac-TMT plus KEYTRUDA for patients with advanced urothelial carcinoma (abstract #744, Poster session B: Prostate cancer and urothelial carcinoma). ³

Abstracts

Clinical trials
Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/​ KEYNOTE-B15 /​ EV-304) (KEYNOTE-B15) – ClinicalTrials.gov ID NCT04700124
A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/​KEYMAKER-U04) – ClinicalTrials.gov ID NCT06483334
A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician’s Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/​TroFuse-020/​Gog-3101/​ENGOT-cx20) – ClinicalTrials.gov ID NCT06459180
A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022) – ClinicalTrials.gov ID NCT05239728
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011) ClinicalTrials.gov ID NCT04586231
A Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma (MK-6482-024/​LITESPARK-024) – ClinicalTrials.gov ID NCT05468697

Highlights of prescribing information
Pembrolizumab (Keytruda®; Merck & Co/MSD)[Prescribing Information]
Belzutifan (Welireg®; Merck & Co/MSD)[Prescribing Information]
Lenvatinib (Lenvima®; Eisai)[Prescribing information]
Enfortumab vedotin (Padcev®; Astellas Pharma and Pfizer)[Prescribing information]

Featured image: Merck & Co/MSD. Photo courtesy © 2020 – 2026 Wendt/Sunvalley Communication. Used with permission

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