Merck Presents Bladder and Kidney Cancer Data at 2026 ASCO GU Symposium

Merck announced that data across multiple genitourinary cancers from several approved and investigational medicines will be presented at the 2026 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium from February 26-28. Three studies will be featured in the symposium's press program.

Data presentations will feature new findings from Merck's broad portfolio of cancer medicines, including key data for Keytruda (pembrolizumab), Welireg (belzutifan) and Lenvima (lenvatinib), in collaboration with Eisai, as well as new results for the investigational antibody-drug conjugate (ADC) from Merck's innovative pipeline: sacituzumab tirumotecan (sac-TMT), a TROP2-directed ADC being developed in collaboration with Kelun-Biotech.

The presentations include first-time data from the phase 3 KEYNOTE-B15/EV-304 trial evaluating Keytruda plus Padcev (enfortumab vedotin-ejfv) as neoadjuvant and adjuvant treatment for patients with muscle-invasive bladder cancer who are eligible for cisplatin (abstract #LBA630). Results from the first interim analysis of the phase 3 LITESPARK-022 trial evaluating Keytruda in combination with Welireg as a treatment for patients with clear cell renal cell carcinoma (RCC) following nephrectomy will also be presented (abstract #LBA418).

The first presentation of data from the phase 3 LITESPARK-011 trial evaluating Welireg plus Lenvima as a treatment for patients with advanced RCC whose disease progressed on or after treatment with anti-PD-1/L1 therapy will be featured (abstract #LBA417). Additionally, first-time data presentation for the phase 2 MK-2870-002 study evaluating sac-TMT plus Keytruda for patients with advanced urothelial carcinoma will be presented (abstract #744).

Findings from the phase 2 SURE-02 trial (NCT05535218) suggest that the combination of sacituzumab govitecan (Trodelvy) and pembrolizumab may offer an organ-sparing strategy in patients with muscle-invasive bladder cancer (MIBC). Radical cystectomy preceded by chemotherapy is the established standard of care, yet approximately half of those patients diagnosed are either too frail to tolerate the chemotherapy or they refuse it.

Investigators enrolled 49 patients with MIBC who were ineligible for or declined the standard cisplatin-based chemotherapy. These patients, who had a median age of 66 years (IQR, 61-71), were instead treated with a combination of pembrolizumab and sacituzumab govitecan. Sixty-three patients were screened; 49 patients were enrolled, treated, and evaluated for safety and efficacy. The majority were male (84%) and White (98%). Thirty-three patients (67%) had a cT2 stage tumor, and 21 (43%) had a centrally confirmed variant histology.

Patients received 4 cycles of 200 mg intravenous pembrolizumab on day 1 and 7.5 mg/kg intravenous sacituzumab govitecan on day 1 and day 8, every 3 weeks, followed by radical cystectomy or re-TURBT and 13 cycles of postsurgical pembrolizumab at 200 mg every 3 weeks. The primary end point was clinical response rate, defined as negative imaging and no viable tumor at re-TURBT in patients not undergoing radical cystectomy.

After a median follow-up of 14 months, 39% of patients (19 of 49) achieved a clinical complete response. This stringent measure required both negative imaging and no evidence of viable cancer found during the re-TURBT procedure. All of these 19 patients successfully avoided radical cystectomy. Furthermore, every patient who achieved this clinical complete response remained metastasis-free. Investigators reported that 2 of these patients later experienced an intravesical relapse.

Although 8 patients, or 16%, experienced grade 3 treatment-related adverse events, with diarrhea being the most common, there were no grade 4 or 5 adverse events and no treatment-related deaths. Serious adverse events were reported in 3 patients, including 2 cases of bullous pemphigoid and 1 case of colitis.

Merck is advancing research aimed at helping transform the treatment landscape and broaden options for people with genitourinary (GU) cancers, including bladder, kidney and prostate cancers. Globally, GU cancers account for an estimated 2.6 million new cancer diagnoses each year, equalling 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 around the world, Merck is investigating the potential of several portfolio medicines and pipeline assets across various stages of disease.

Keytruda is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body's immune system to help detect and fight tumour cells. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells.