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Merck, known as MSD outside of the United States and Canada, announced new research from more than 100 abstracts across over 25 types of cancer from the company’s comprehensive oncology portfolio and pipeline will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (May 29-June 2). The data reinforce the long-term impact of Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, and Merck’s rapidly advancing pipeline across multiple tumour types and stages of disease, highlighting the company’s leadership in oncology and commitment to advancing innovative oncology research.
“During ASCO, we will present data that showcase the strong momentum in our oncology pipeline, including long-term data for intismeran autogene, our investigational individualized neoantigen therapy (INT),” said Dr Marjorie Green, senior vice president and head of oncology global clinical development, Merck Research Laboratories. “We look forward to sharing new research for our oncology medicines and novel treatment approaches, such as our INT and antibody-drug conjugates, which may help address significant unmet medical needs for patients living with cancer.”
Key data from Merck’s portfolio and pipeline to be presented:
- Five-year follow-up data from the phase 2b KEYNOTE-942 trial evaluating intismeran autogene in combination with Keytruda for patients with high-risk melanoma following complete resection (Abstract #9500, Oral abstract session: Melanoma/skin cancers).
- Final analysis results from the Phase 3 KEYNOTE-522 trial evaluating Keytruda in combination with chemotherapy as pre-operative treatment and then continuing as a single agent after surgery for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) (Abstract #507, Oral abstract session: Breast cancer – local/regional/adjuvant).
- Data from the phase 3 OptiTROP-Lung05 trial conducted in China, led by Kelun-Biotech, evaluating sac-TMT plus Keytruda in advanced non-small cell lung cancer (Abstract #8506, Oral abstract session: Lung cancer – non-small cell metastatic).
- Progression-free survival data from the phase 3 ASCENT-04/KEYNOTE-D19 study evaluating Keytruda plus Trodelvy (sacituzumab govitecan-hziy) in previously untreated PD-L1-positive metastatic TNBC (Abstract #LBA1000, Oral abstract session: Breast cancer – metastatic).
Intismeran autogene is a novel investigational messenger RNA (mRNA)-based individualized neoantigen therapy (INT) consisting of a synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the DNA sequence of the patient’s tumour. Upon administration into the body, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation, a key step in adaptive immunity. Individualized neoantigen therapies are designed to train and activate an antitumor immune response by generating specific T-cell responses based on the unique mutational signature of a patient’s tumour.
Sac-TMT is an investigational TROP2-directed ADC with a belotecan-derived topoisomerase I inhibitor payload and a bifunctional linker designed with the potential to maximize payload delivery to tumour cells and minimize payload loss while circulating in the body. Sac-TMT is the only TROP2 ADC designed with a focus on both ends of the linker.
TROP2 is overexpressed on tumour cells compared to healthy cells in many common cancers, and through the TroFuse clinical development program, Merck is evaluating sac-TMT in 17 ongoing global phase 3 trials across multiple tumour types, the broadest range of disease and treatment settings compared to any TROP2-directed ADC to date. The TroFuse development program spans early-to-late-stage disease in more than nine disease areas and includes more than 15,000 patients worldwide. Numerous phase 3 trials are exploring sac-TMT as monotherapy and in combination with immunotherapies, aiming to improve survival and quality of life for patients with advanced and earlier-stage cancers.
Raludotatug deruxtecan is an investigational, potential first-in-class CDH6 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, raludotatug deruxtecan is comprised of a humanized anti-CDH6 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.
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 2,800 trials studying Keytruda across a wide variety of cancers and treatment settings. The Keytruda clinical program 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 tumors, renal cell carcinoma (RCC) and in pheochromocytoma or paraganglioma (PPGL). As part of a broader clinical program, 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.
Sac-TMT was developed by Kelun-Biotech. Kelun-Biotech is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Under a collaboration agreement, Kelun-Biotech has granted Merck the exclusive rights to develop, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macau and Taiwan).
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 muscle-invasive bladder cancer (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 entered into a global collaboration in October 2023 to jointly develop and commercialize ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-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 will maintain exclusive rights. Merck will be solely responsible for manufacturing and supply for gocatamig.
Merck, known as MSD outside of the United States and Canada, the company unified around our purpose: It use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines.
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