Merck Showcases First — Time Pivotal Phase 3 Results From Oncology Pipeline and Continued Innovative Potential of Existing Portfolio at ESMO 2026

For best results when printing this announcement, please click on link below: Merck Showcases First-Time Pivotal Phase 3 Results From Oncology Pipeline and Continued Innovative Potential of Existing Portfolio at ESMO 2026 INTerpath-001 data to be presented in Presidential Symposium, featuring the first Phase 3 results for investigational intismeran autogene plus KEYTRUDA(®) (pembrolizumab), demonstrating improvements in recurrence-free survival and distant metastasis-free survival versus KEYTRUDA alone in patients with completely resected stage IIB-IV melanoma in the adjuvant setting Investigational sacituzumab tirumotecan (sac-TMT) data from TroFuse-005, the first and only Phase 3 trial of a TROP2-directed antibody-drug conjugate to improve overall survival and progression-free survival in certain patients with advanced or recurrent endometrial cancer, will be presented in a Presidential Symposium KEYNOTE-C93 data to be presented in Presidential Symposium suggesting important role of first-line KEYTRUDA monotherapy for certain patients with mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that first-time results from three pivotal clinical trials will be presented during late-breaking Presidential Symposia at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain from Oct.

23-27. Additionally, more than 90 additional abstracts across more than 20 tumor types from the company’s pipeline and portfolio will be presented throughout the meeting. “New data at ESMO, including three Presidential Symposia from three pivotal trials, reflect the strength and depth of Merck’s industry-leading oncology portfolio and pipeline,” said Dr. Marjorie Green, senior vice president and head of oncology global clinical development, Merck Research Laboratories.

m. m. ET, during which senior management will provide an update on the company’s oncology strategy and program. The event will take place in Madrid, Spain, and will be accessible via webcast.

Investors, analysts, members of the media and the general public are invited to listen to a webcast of the presentation via this weblink ( ). S. and Canada Toll-Free) or (517) 308-9422 and using the access code 8984239. Details on presentations listed above and additional key presentations for Merck Breast cancer Final OS analysis of sacituzumab tirumotecan versus chemotherapy in previously Presentation #4639RO, Rapid oral session 2: Breast cancer, advanced stage treated locally recurrent or metastatic triple-negative breast cancer: Phase III OptiTROP-Breast01.

M. (4) Results from KEYNOTE-B49: A Phase 3, randomized, double-blind study of Presentation #LBA51, Proffered paper session 2: Breast cancer, early and pembrolizumab (pembro) vs placebo (pbo) plus chemotherapy (CT) in participants advanced stage (pts) with HR+/HER2− advanced breast cancer (ABC). H. S.

Rugo. Association between disease control and patient-reported functioning and Presentation #4659P, Poster session: Triple negative breast cancer quality of life in the ASCENT-04/KEYNOTE-D19 study. K. (6) Gastrointestinal cancers Adjuvant intismeran autogene plus FOLFIRINOX in resectable pancreatic ductal Presentation #3151P, Poster session: Pancreatic cancer adenocarcinoma: Results from a Phase I study.

D. J. (1) Genitourinary cancers Final analysis of the Phase 3 LITESPARK-011 study: Belzutifan (bel) plus Presentation #3587O, Proffered paper session 2: Genitourinary tumours, renal lenvatinib (len) versus cabozantinib (cabo) for advanced renal cell carcinoma and urothelial (RCC) after anti-PD-(L)1 therapy. D.

Y. (5) Final protocol-prespecified analysis of the Phase 3 KEYNOTE-564 trial of Presentation #3589RO, Rapid oral session 2: Genitourinary tumours, renal and adjuvant pembrolizumab versus placebo in clear cell renal cell carcinoma urothelial (ccRCC). T. K.

Choueiri. Enfortumab vedotin (EV) with or without pembrolizumab (P) as first-line (1L) Presentation #4740RO, Rapid oral session 1: Genitourinary tumours, renal and treatment for cisplatin (cis)-ineligible locally advanced or metastatic urothelial urothelial carcinoma (la/mUC): Long-term follow-up analysis from EV-103 cohorts DE/A and K. J. P.

(7) ctDNA analysis of the Phase 3 KEYNOTE-B15 trial: Neoadjuvant and adjuvant Presentation #4734O, Proffered paper session 1: Genitourinary tumour, renal (neoadj-adj) enfortumab vedotin (EV) + pembrolizumab (pembro) for participants and urothelial (pts) with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin. J. A.

(7) Health-related quality of life (HRQoL) with neoadjuvant and adjuvant Presentation #4738RO, Rapid oral session 1: Genitourinary tumours, renal and (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in urothelial participants (pts) with muscle-invasive bladder cancer (MIBC) eligible for cisplatin in the Phase 3 KEYNOTE-B15 study. A. (7) Perioperative pembrolizumab (pembro) or enfortumab vedotin (EV) plus pembro in Presentation #4733O, Proffered paper session 1: Genitourinary tumour, renal pts with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: and urothelial Ad hoc analysis from KEYNOTE-905. A.

(7) Sacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) for locally Presentation #4739RO, Rapid oral session 1: Genitourinary tumours, renal and advanced or metastatic urothelial carcinoma (la/mUC): Results from a Phase 2 urothelial Study (2870-002/SKB264-II-06). X. (4) Updated results from the Phase 1b/2 KEYNOTE-365 cohort I: Pembrolizumab Presentation #2217RO, Rapid oral session: Genitourinary tumours, prostate, (pembro) + carboplatin and etoposide chemotherapy (chemo) or chemo alone for penile and testis neuroendocrine prostate cancer (NEPC). G.

von Amsberg. Gynecologic cancers Sacituzumab tirumotecan in previously treated advanced or recurrent Presentation #LBA11, Proffered paper session: Presidential Symposium III endometrial cancer: Results from the Phase 3 TroFuse-005/ENGOT-en23/GOG-3095 study. D. (2,3) KEYNOTE-C93/GOG-3064/ENGOT-en15: Phase 3, randomized, open-label study of Presentation #LBA12, Proffered paper session: Presidential Symposium III first-line (1L) pembrolizumab (pembro) vs carboplatin (C) + paclitaxel (P) in mismatch repair-deficient (dMMR) advanced or recurrent endometrial carcinoma (a/rEC).

B. M. (3) Raludotatug deruxtecan (R-DXd) + bevacizumab (bev) in participants (pts) with Presentation #1247RO, Rapid oral session 2: Gynaecological cancers platinum-resistant recurrent ovarian cancer (PROC): Results for cohort B-1 of the Phase 1b/2 REJOICE-Ovarian02 study. A.

(8) Raludotatug deruxtecan (R-DXd) in patients (pts) with platinum-resistant Presentation #1331P, Poster session: Gynaecological cancers ovarian cancer (PROC): An updated analysis of efficacy and tolerability from the Ph 2 part of REJOICE-Ovarian01. K. (8) NRG-GY020: Phase III randomized trial of radiation +/- MK-3475 (pembrolizumab) Presentation #1239O, Proffered paper session: Gynaecological cancers for newly diagnosed early-stage high intermediate risk (HIR) mismatch repair deficient (dMMR) endometrioid endometrial cancer. F.

(9) Sacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) in post-platinum Presentation #1259P, Poster session: Gynaecological cancers advanced mismatch repair proficient (pMMR) endometrial cancer (EC): Results from a Phase 2 study (2870-002/SKB264-II-06). L. (4) Head and neck cancer Practical considerations for adopting perioperative pembrolizumab in locally Presentation #1580P, Poster session: Head and neck cancer, excluding thyroid advanced head and neck squamous cell carcinoma (LA HNSCC) in Europe: Insights from KEYNOTE-689. M.

Oliva. Lung cancer Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (P) versus chemotherapy Presentation #LBA66, Proffered paper session 1: NSCLC, metastatic (chemo) plus pembrolizumab (P) as first-line (1L) treatment for PD-L1 negative advanced non-squamous (nsq) NSCLC: Randomized Phase 3 OptiTROP-Lung06 study. C. (4) Final OS analysis of sacituzumab tirumotecan (sac-TMT) versus platinum-based Presentation #LBA67, Proffered paper session 1: NSCLC, metastatic chemotherapy in EGFR-mutated non-small cell lung cancer (NSCLC) after progression on EGFR-TKI: Phase III OptiTROP-Lung04 study.

F. (4) Calderasib (MK-1084), alone or in combination, for KRAS G12C-mutant metastatic Presentation #2680RO, Rapid oral session 2: NSCLC, metastatic non-small cell lung cancer (mNSCLC). M. A.

N. (10) Final analysis of adjuvant pembrolizumab (pembro) in resected early-stage Presentation #2511O, Proffered paper session: Non-metastatic NSCLC and other non—small-cell lung cancer (NSCLC): Phase 3 PEARLS/KEYNOTE-091 study. M. E.

thoracic malignancies O’Brien. Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer Presentation #3842P, Poster session: SCLC (ES-SCLC): IDeate-Lung01 updated results. M. (8) Melanoma INTerpath-001: Phase 3 study of the mRNA-based individualized neoantigen Presentation #LBA1, Proffered paper session: Presidential Symposium I therapy (INT) intismeran autogene (intismeran) plus pembrolizumab (pembro) vs pembro alone for adjuvant treatment of resected stage IIB-IV melanoma (MEL).

G. V. (1) STARBOARD Phase 3: A randomized, double-blind study of first-line (1L) Presentation #2071O, Proffered paper session: Melanoma and other skin tumours encorafenib (enco), binimetinib (bini) and pembrolizumab (pembro) vs placebo (pbo) and pembro for unresectable locally advanced or metastatic BRAF V600-mutant melanoma. D.

(7) Physician perspectives on defining cure in early-stage melanoma. H. M. Shaw.

Presentation #2173eP, ePoster session: Melanoma Patritumab deruxtecan (HER3-DXd) in melanoma after anti-PD-(L)1 therapy: Presentation #2073RO, Rapid oral session: Melanoma and other skin tumours Primary analysis from HERTHENA-PanTumor01. M. (8) Multi-tumor Final results of the TUXEDO-3 Phase II trial of patritumab deruxtecan Presentation #690O, Proffered paper session: CNS tumours (HER3-DXd) in active brain metastases (BMs) and leptomeningeal disease (LMD). M.

(8) Calderasib monotherapy in various KRAS G12C-mutated advanced solid tumors: Presentation #1039P, Poster session: Developmental therapeutics Results from the Phase 1 KANDLELIT-001 study. (10) (1) In collaboration with Moderna (2) In collaboration with Kelun-Biotech (3) In collaboration with the European Network for Gynaecological Oncology Trial (ENGOT) groups and the GOG Foundation, Inc. S. National Cancer Institute (NCI)/led by NRG Oncology (10) In collaboration with Taiho Pharmaceutical Co.

, Ltd About intismeran autogene Intismeran autogene (intismeran; V940 or mRNA-4157) is a novel, potential first-in-class investigational messenger RNA (mRNA)-based individualized neoantigen therapy (INT) jointly developed by Merck and Moderna. Intismeran is designed and produced using a patient's tumor sample to identify the unique mutational signature, or "fingerprint," of their cancer and generate an anti-tumor immune response. Each therapy consists of a synthetic mRNA coding for up to 34 neoantigens and is tailored to the unique biology of an individual patient's tumor.

Upon administration, the RNA-encoded neoantigen sequences are translated in the body and presented to the immune system, a key step in generating specific T-cell responses against cancer cells. Individualized neoantigen therapies are designed to train and activate an anti-tumor immune response based on the unique mutational signature of a patient's tumor. Merck and Moderna are advancing the robust INTerpath clinical development program evaluating the safety and efficacy of intismeran in combination with KEYTRUDA and other anti-cancer therapies, and as a monotherapy.

About sacituzumab tirumotecan (sac-TMT) Sac-TMT is an investigational TROP2-directed ADC with a belotecan-derived topoisomerase I inhibitor payload and a unique bifunctional linker designed with the potential to maximize payload delivery to tumor cells and minimize payload loss while circulating in the body. TROP2 is overexpressed on tumor cells compared to healthy cells in many common cancers, and through the TroFuse clinical development program, Merck is evaluating sac-TMT in 18 ongoing global Phase 3 trials across multiple tumor 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. About calderasib Calderasib (MK-1084) is an investigational, highly potent and specific next-generation KRAS G12C covalent inhibitor. Mutations in KRAS are among the most prevalent mutations found in cancer, occurring with high frequency in non-small cell lung cancer (NSCLC), pancreatic, urogenital and colorectal cancers.

The KRAS G12C mutation is the most frequently observed KRAS mutation in patients, occurring in approximately 14% of patients with NSCLC (adenocarcinoma). Despite decades of research and recognition of the therapeutic importance of targeting KRAS, the development of small molecule inhibitors targeting KRAS mutations has been challenging. About KEYTRUDA(®) (pembrolizumab) injection for intravenous use, 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 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.

S. for KEYTRUDA(®) (pembrolizumab) Melanoma KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.