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Overall survival (OS) data for KEYTRUDA ® (pembrolizumab) in earlier stages of women’s cancers, including high-risk early-stage triple-negative breast cancer (KEYNOTE-522) and high-risk locally advanced cervical cancer (KEYNOTE-A18), selected for Presidential Symposium sessions
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Ten-year OS data from KEYNOTE-006 and final OS data from KEYNOTE-811 reinforce important role of KEYTRUDA for certain patients with advanced melanoma and HER2-positive gastric or gastroesophageal junction adenocarcinoma
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Data presented at ESMO highlight progress in Merck’s pipeline of antibody-drug conjugates (ADCs), including patritumab deruxtecan (HER3-DXd), sacituzumab tirumotecan (sac-TMT) and ifinatamab deruxtecan (I-DXd)
September 4, 2024 6:45 am ET--RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that new data for four approved medicines and six pipeline candidates in more than 20 types of cancer will be presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, from Sept. 13-17. Study findings from the Phase 3 KEYNOTE-522 trial (#LBA4) in high-risk early-stage triple-negative breast cancer (TNBC), the Phase 3 KEYNOTE-A18 trial (#709O) in high-risk locally advanced cervical cancer and the Phase 3 LEAP-012 trial (#LBA3) in unresectable, non-metastatic hepatocellular carcinoma, in collaboration with Eisai, have been selected for the ESMO Presidential Symposium Sessions. Data being shared at the Congress showcase the company’s continued progress in advancing clinical research for Merck’s broad portfolio and diverse pipeline of investigational candidates, with a total of 80 abstracts being presented.
“Over the past decade, data on KEYTRUDA have contributed to paradigm shifts in the treatment of some of the deadliest forms of cancer and the rewriting of medical textbooks. We are very proud that today marks ten years since KEYTRUDA received its first approval in the U.S.,” said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “The compelling data for KEYTRUDA at this year’s ESMO are demonstrative of KEYTRUDA’s impressive journey, from 10-year survival data in unresectable or metastatic melanoma to new overall survival data in earlier stages of two types of women’s cancers. We’re also excited to show how we’re building on our leadership in oncology with data from our broad and diverse pipeline as we work toward improved outcomes for as many patients as possible.”
Presentations at the Congress will feature new or updated findings from Merck’s broad portfolio of cancer medicines: KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy; WELIREG ® (belzutifan); LENVIMA ® (lenvatinib), in collaboration with Eisai; and LYNPARZA ® (olaparib), in collaboration with AstraZeneca.
Key data from Merck’s portfolio to be presented at ESMO Congress 2024:
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First-time overall survival (OS) results from the Phase 3 KEYNOTE-522 trial evaluating KEYTRUDA in combination with chemotherapy as neoadjuvant treatment and then continuing as single agent as adjuvant treatment in patients with high-risk early-stage TNBC (Presentation #LBA4; Presidential Symposium II: Practice-changing trials).
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OS data from the Phase 3 KEYNOTE-A18 trial evaluating KEYTRUDA in combination with concurrent chemoradiotherapy (CRT) as treatment for patients with high-risk locally advanced cervical cancer (Presentation #709O; Presidential Symposium I: Practice-changing trials). 1
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First presentation of results from the first interim analysis of the Phase 3 LEAP-012 trial evaluating KEYTRUDA plus LENVIMA in combination with transarterial chemoembolization (TACE) in patients with unresectable, non-metastatic hepatocellular carcinoma (Presentation #LBA3; Presidential Symposium I: Practice-changing trials). 2
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Ten-year OS data from the Phase 3 KEYNOTE-006 trial evaluating KEYTRUDA compared to ipilimumab as first-line treatment for patients with advanced melanoma (Presentation #LBA44; Mini oral session: Melanoma and other skin tumours).
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OS data from the per protocol final analysis of the Phase 3 KEYNOTE-811 trial evaluating KEYTRUDA plus trastuzumab and chemotherapy as first-line treatment for patients with advanced human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma (Presentation #1400O; Proffered paper session 2: GI tumours, upper digestive).
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Data from the per protocol final analysis of the Phase 3 LITESPARK-005 trial evaluating WELIREG as treatment for adult patients with advanced renal cell carcinoma that progressed following PD-1/L1 inhibitor and vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI) therapies (Presentation #LBA74; Proffered paper session 1: GU tumours, non-prostate).
Additionally, new data on investigational candidates from Merck’s pipeline will be presented at the Congress, including for: patritumab deruxtecan (HER3-DXd), a HER3-directed antibody-drug conjugate (ADC), and ifinatamab deruxtecan (I-DXd; also known as MK-2400) being developed in collaboration with Daiichi Sankyo; sacituzumab tirumotecan (sac-TMT; also known as MK-2870/SKB264), an investigational anti-TROP2 ADC being developed in collaboration with Kelun-Biotech; and opevesostat (also known as MK-5684/ODM-208), an investigational steroid synthesis inhibitor in collaboration with Orion.
Key data on investigational candidates from Merck’s pipeline to be presented at ESMO Congress 2024:
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Data from the Phase 2 ICARUS-BREAST01 trial evaluating HER3-DXd as treatment for patients with hormone-receptor (HR)-positive/HER2-negative advanced breast cancer (Presentation #340O; Proffered paper session: Breast cancer, metastatic). 3
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First-time data from a Phase 2 study conducted in China, independently led by Kelun-Biotech, evaluating sac-TMT as treatment for patients with previously treated advanced endometrial carcinoma and ovarian cancer (Presentation #715MO; Mini oral session 2: Gynaecological cancers). 4
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Findings from a Phase 2 study conducted in China, independently led by Kelun-Biotech, evaluating sac-TMT plus KEYTRUDA as treatment for patients with recurrent or metastatic cervical cancer (Presentation #716MO; Mini oral session 2: Gynaecological cancers). 4
About Merck’s early-stage cancer clinical program
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.
About KEYTRUDA ® (pembrolizumab) injection, 100 mg
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 tumor 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 tumor 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 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.
About LENVIMA ® (lenvatinib); available as 10 mg and 4 mg capsules
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, tumor 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 (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, LENVIMA decreased tumor-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.
About LYNPARZA ® (olaparib)
LYNPARZA is a first-in-class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells. Inhibition of PARP with LYNPARZA leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. LYNPARZA is being tested in a range of tumor types with defects and dependencies in the DDR.
LYNPARZA, which is being jointly developed and commercialized by AstraZeneca and Merck, has a broad clinical trial development program, and AstraZeneca and Merck are working together to understand how it may affect multiple PARP-dependent tumors as a monotherapy and in combination across multiple cancer types.
About the Merck and Eisai strategic collaboration
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. Eisai and Merck are studying the KEYTRUDA plus LENVIMA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in various tumor types across multiple clinical trials.
About the AstraZeneca and Merck strategic oncology collaboration
In July 2017, AstraZeneca and Merck, known as MSD outside of the United States and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialize certain oncology products including LYNPARZA, the world’s first PARP inhibitor, for multiple cancer types. Working together, the companies will develop these products in combination with other potential new medicines and as monotherapies. Independently, the companies will develop these oncology products in combination with their respective PD-L1 and PD-1 medicines.
About the Astellas, Pfizer and Merck collaboration
Astellas and Seagen entered a clinical collaboration agreement with Merck to evaluate the combination of Astellas’ and Seagen’s Padcev ® (enfortumab vedotin-ejfv) and Merck’s KEYTRUDA ® (pembrolizumab) in patients with previously untreated metastatic urothelial cancer. 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.
About the Daiichi Sankyo and Merck collaboration
Daiichi Sankyo and Merck 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.
About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We 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. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn .