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Merck, known as MSD outside of the United States and Canada, 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. These data, including three studies that will be featured in the symposium’s press program, 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,” said Dr. Marjorie Green, 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.”
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.
Key data from Merck’s portfolio and pipeline to be presented at the 2026 ASCO GU Cancers Symposium:
- 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.
- 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-2a) 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.
- 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).
Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of Keytruda in later-stage cancers, Merck is evaluating our portfolio of medicines and pipeline candidates in earlier disease states, with more than 30 ongoing registrational studies across multiple types of cancer.
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, leveraging multiple novel combination strategies, across various stages of disease, to help address unmet needs in GU cancers.
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.
Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying Keytruda across a wide variety of cancers and treatment settings. The Keytruda clinical programme seeks to understand the role of Keytruda across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with Keytruda, including exploring several different biomarkers.
Welireg, Merck’s first-in-class hypoxia-inducible factor 2 alpha (HIF-2a) inhibitor, is an orally administered small-molecule designed to reduce transcription and expression of HIF-2a target genes associated with cellular proliferation, angiogenesis and tumour growth. By inhibiting HIF-2a signalling, Welireg aims to disrupt key pathways certain tumours may use to adapt to low-oxygen conditions, including those that help promote abnormal blood vessel formation and support tumour survival.
Welireg has received regulatory approvals in patients with certain von Hippel-Lindau (VHL) disease-associated tumours, renal cell carcinoma (RCC) and in pheochromocytoma or paraganglioma (PPGL). As part of a broader clinical programme, Merck continues to research Welireg monotherapy and combination approaches for people with RCC and selected solid tumours across a range of treatment settings, to further define where HIF-2a inhibition may provide clinical benefit.
Lenvima, discovered and developed by Eisai, is an orally available multiple receptor tyrosine kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). Lenvima inhibits other kinases that have been implicated in pathogenic angiogenesis, tumour growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRa), KIT, and RET. In syngeneic mouse tumour models, Lenvima decreased tumour-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone. The combination of Lenvima and everolimus showed increased antiangiogenic and antitumor activity as demonstrated by decreased human endothelial cell proliferation, tube formation, and VEGF signalling in vitro and tumour volume in mouse xenograft models of human renal cell cancer greater than each drug alone.
Merck previously entered a clinical collaboration agreement with Seagen and Astellas to evaluate the combination of Merck’s Keytruda (pembrolizumab) and Seagen’s and Astellas’ Padcev (enfortumab vedotin-ejfv) in patients with MIBC who are not eligible for or declined cisplatin-based chemotherapy. Padcev and the Padcev device are trademarks jointly owned by Agensys, Inc., and Seagen Inc. Pfizer Inc. completed its acquisition of Seagen on December 14, 2023.
Daiichi Sankyo and Merck (known as MSD outside of the United States and Canada) entered into a global collaboration in October 2023 to jointly develop and commercialize patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply. In August 2024, the global co-development and co-commercialization agreement was expanded to include gocatamig (MK-6070/DS3280), which the companies will jointly develop and commercialize worldwide, except in Japan where Merck & Co., Inc., Rahway, N.J., USA will maintain exclusive rights. Merck & Co., Inc., Rahway, N.J., USA will be solely responsible for manufacturing and supply for gocatamig.
In March 2018, Eisai and Merck, known as MSD outside of the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of Lenvima. Under the agreement, the companies jointly develop, manufacture and commercialize Lenvima, both as monotherapy and in combination with Merck’s anti-PD-1 therapy, Keytruda, and HIF-2a inhibitor, Welireg.
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