Calderasib

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 RAHWAY, N.J.--(BUSINESS WIRE)-- $MRK #MRK --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. "We are proud to share Phase 3 data for the first time from intismeran and sac-TMT, alongside new research from our oncology portfolio, reflecting our commitment to advancing research across a range of cancer types." Key data from Merck’s pipeline and portfolio to be presented: First presentation of data from the pivotal Phase 3 INTerpath-001 trial evaluating intismeran autogene (intismeran; V940/mRNA-4157), a novel investigational mRNA-based individualized neoantigen therapy, in combination with KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, as adjuvant treatment for patients with completely resected stage IIB-IV melanoma, which will be featured in an ESMO Presidential Symposium (Presentation #LBA1, Proffered paper session: Presidential Symposium I). 1 First presentation of data from the pivotal Phase 3 TroFuse-005 trial evaluating sacituzumab tirumotecan (sac-TMT), an investigational trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate, for patients with advanced or recurrent endometrial cancer who have progressed after platinum-based chemotherapy and a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, which will be featured in an ESMO Presidential Symposium (Presentation #LBA11, Proffered paper session: Presidential Symposium III). 2,3 First presentation of data from the Phase 3 KEYNOTE-C93 trial evaluating KEYTRUDA monotherapy as a first-line treatment for patients with mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer who had not previously received systemic chemotherapy or who experienced recurrence after receiving prior adjuvant therapy, which will be featured in an ESMO Presidential Symposium (Presentation #LBA12, Proffered paper session: Presidential Symposium III). 3 Data from Phase 3 OptiTROP studies evaluating sac-TMT in non-small cell lung cancer (NSCLC), including results from the OptiTROP-Lung06 study (Presentation #LBA66) in first-line PD-L1-negative advanced non-squamous NSCLC and final overall survival data from the OptiTROP-Lung04 study (Presentation #LBA67) in epidermal growth factor receptor (EGFR)-mutated NSCLC following progression on EGFR tyrosine kinase inhibitors (TKIs) (Proffered paper session 1: NSCLC, metastatic). 4 Final analysis results from the Phase 3 LITESPARK-011 study evaluating WELIREG ® (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, in combination with LENVIMA ® (lenvatinib), an orally available multiple receptor TKI discovered by Eisai, for patients with advanced renal cell carcinoma with a clear cell component following a PD-1 or PD-L1 inhibitor (Presentation #3587O, Proffered paper session 2: Genitourinary tumours, renal and urothelial). 5 Merck investor event Merck will hold an Oncology Investor Event to coincide with the ESMO 2026 Congress on Monday, October 26, 7:30 p.m. CET/2:30 p.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 . All participants may join the call by dialing (800) 369-2154 (U.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 treated locally recurrent or metastatic triple-negative breast cancer: Phase III OptiTROP-Breast01. M. Li. 4 Presentation #4639RO, Rapid oral session 2: Breast cancer, advanced stage Results from KEYNOTE-B49: A Phase 3, randomized, double-blind study of pembrolizumab (pembro) vs placebo (pbo) plus chemotherapy (CT) in participants (pts) with HR+/HER2− advanced breast cancer (ABC). H. S. Rugo. Presentation #LBA51, Proffered paper session 2: Breast cancer, early and advanced stage Association between disease control and patient-reported functioning and quality of life in the ASCENT-04/KEYNOTE-D19 study. K. Kalinsky. 6 Presentation #4659P, Poster session: Triple negative breast cancer Gastrointestinal cancers Adjuvant intismeran autogene plus FOLFIRINOX in resectable pancreatic ductal adenocarcinoma: Results from a Phase I study. D. J. Pinato. 1 Presentation #3151P, Poster session: Pancreatic cancer Genitourinary cancers Final analysis of the Phase 3 LITESPARK-011 study: Belzutifan (bel) plus lenvatinib (len) versus cabozantinib (cabo) for advanced renal cell carcinoma (RCC) after anti-PD-(L)1 therapy. D. Y. Heng. 5 Presentation #3587O, Proffered paper session 2: Genitourinary tumours, renal and urothelial Final protocol-prespecified analysis of the Phase 3 KEYNOTE-564 trial of adjuvant pembrolizumab versus placebo in clear cell renal cell carcinoma (ccRCC). T. K. Choueiri. Presentation #3589RO, Rapid oral session 2: Genitourinary tumours, renal and urothelial Enfortumab vedotin (EV) with or without pembrolizumab (P) as first-line (1L) treatment for cisplatin (cis)-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC): Long-term follow-up analysis from EV-103 cohorts DE/A and K. J. P. Maroto Rey. 7 Presentation #4740RO, Rapid oral session 1: Genitourinary tumours, renal and urothelial ctDNA analysis of the Phase 3 KEYNOTE-B15 trial: Neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) + pembrolizumab (pembro) for participants (pts) with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin. J. A. Chatzkel. 7 Presentation #4734O, Proffered paper session 1: Genitourinary tumour, renal and urothelial Health-related quality of life (HRQoL) with neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) eligible for cisplatin in the Phase 3 KEYNOTE-B15 study. A. Gomez de Liano Lista. 7 Presentation #4738RO, Rapid oral session 1: Genitourinary tumours, renal and urothelial Perioperative pembrolizumab (pembro) or enfortumab vedotin (EV) plus pembro in pts with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: Ad hoc analysis from KEYNOTE-905. A. Ullén. 7 Presentation #4733O, Proffered paper session 1: Genitourinary tumour, renal and urothelial Sacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) for locally advanced or metastatic urothelial carcinoma (la/mUC): Results from a Phase 2 Study (2870-002/SKB264-II-06). X. Bian. 4 Presentation #4739RO, Rapid oral session 1: Genitourinary tumours, renal and urothelial Updated results from the Phase 1b/2 KEYNOTE-365 cohort I: Pembrolizumab (pembro) + carboplatin and etoposide chemotherapy (chemo) or chemo alone for neuroendocrine prostate cancer (NEPC). G. von Amsberg. Presentation #2217RO, Rapid oral session: Genitourinary tumours, prostate, penile and testis Gynecologic cancers Sacituzumab tirumotecan in previously treated advanced or recurrent endometrial cancer: Results from the Phase 3 TroFuse-005/ENGOT-en23/GOG-3095 study. D. Lorusso. 2,3 Presentation #LBA11, Proffered paper session: Presidential Symposium III KEYNOTE-C93/GOG-3064/ENGOT-en15: Phase 3, randomized, open-label study of first-line (1L) pembrolizumab (pembro) vs carboplatin (C) + paclitaxel (P) in mismatch repair-deficient (dMMR) advanced or recurrent endometrial carcinoma (a/rEC). B. M. Slomovitz. 3 Presentation #LBA12, Proffered paper session: Presidential Symposium III Raludotatug deruxtecan (R-DXd) + bevacizumab (bev) in participants (pts) with platinum-resistant recurrent ovarian cancer (PROC): Results for cohort B-1 of the Phase 1b/2 REJOICE-Ovarian02 study. A. Oaknin. 8 Presentation #1247RO, Rapid oral session 2: Gynaecological cancers Raludotatug deruxtecan (R-DXd) in patients (pts) with platinum-resistant ovarian cancer (PROC): An updated analysis of efficacy and tolerability from the Ph 2 part of REJOICE-Ovarian01. K. Hasegawa. 8 Presentation #1331P, Poster session: Gynaecological cancers NRG-GY020: Phase III randomized trial of radiation +/- MK-3475 (pembrolizumab) for newly diagnosed early-stage high intermediate risk (HIR) mismatch repair deficient (dMMR) endometrioid endometrial cancer. F. Backes. 9 Presentation #1239O, Proffered paper session: Gynaecological cancers Sacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) in post-platinum advanced mismatch repair proficient (pMMR) endometrial cancer (EC): Results from a Phase 2 study (2870-002/SKB264-II-06). L. Chen. 4 Presentation #1259P, Poster session: Gynaecological cancers Head and neck cancer Practical considerations for adopting perioperative pembrolizumab in locally advanced head and neck squamous cell carcinoma (LA HNSCC) in Europe: Insights from KEYNOTE-689. M. Oliva. Presentation #1580P, Poster session: Head and neck cancer, excluding thyroid Lung cancer Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (P) versus chemotherapy (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. Zhou. 4 Presentation #LBA66, Proffered paper session 1: NSCLC, metastatic Final OS analysis of sacituzumab tirumotecan (sac-TMT) versus platinum-based chemotherapy in EGFR-mutated non-small cell lung cancer (NSCLC) after progression on EGFR-TKI: Phase III OptiTROP-Lung04 study. W.F. Fang. 4 Presentation #LBA67, Proffered paper session 1: NSCLC, metastatic Calderasib (MK-1084), alone or in combination, for KRAS G12C-mutant metastatic non-small cell lung cancer (mNSCLC). M. A. N. Sendur. 10 Presentation #2680RO, Rapid oral session 2: NSCLC, metastatic Final analysis of adjuvant pembrolizumab (pembro) in resected early-stage non–small-cell lung cancer (NSCLC): Phase 3 PEARLS/KEYNOTE-091 study. M. E. O’Brien. Presentation #2511O, Proffered paper session: Non-metastatic NSCLC and other thoracic malignancies Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer (ES-SCLC): IDeate-Lung01 updated results. M. Ahn. 8 Presentation #3842P, Poster session: SCLC Melanoma INTerpath-001: Phase 3 study of the mRNA-based individualized neoantigen therapy (INT) intismeran autogene (intismeran) plus pembrolizumab (pembro) vs pembro alone for adjuvant treatment of resected stage IIB-IV melanoma (MEL). G. V. Long. 1 Presentation #LBA1, Proffered paper session: Presidential Symposium I STARBOARD Phase 3: A randomized, double-blind study of first-line (1L) encorafenib (enco), binimetinib (bini) and pembrolizumab (pembro) vs placebo (pbo) and pembro for unresectable locally advanced or metastatic BRAF V600-mutant melanoma. D. Schadendorf. 7 Presentation #2071O, Proffered paper session: Melanoma and other skin tumours 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: Primary analysis from HERTHENA-PanTumor01. M. McKean. 8 Presentation #2073RO, Rapid oral session: Melanoma and other skin tumours Multi-tumor Final results of the TUXEDO-3 Phase II trial of patritumab deruxtecan (HER3-DXd) in active brain metastases (BMs) and leptomeningeal disease (LMD). M. Preusser. 8 Presentation #690O, Proffered paper session: CNS tumours Calderasib monotherapy in various KRAS G12C-mutated advanced solid tumors: Results from the Phase 1 KANDLELIT-001 study. M Kwiatkowski. 10 Presentation #1039P, Poster session: Developmental therapeutics 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. (GOG) 4 Led by Kelun-Biotech, conducted in China 5 In collaboration with Eisai 6 In collaboration with Gilead 7 In collaboration with Astellas/Pfizer 8 In collaboration with Daiichi Sankyo 9 Sponsored by U.S. National Cancer Institute (NCI)/led by NRG Oncology 10 In collaboration with Taiho Pharmaceutical Co. Ltd and Astex Pharmaceuticals (UK), a wholly owned subsidiary of Otsuka 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. Selected Indications in the U.S. for KEYTRUDA ® (pembrolizumab) Melanoma KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. Head and Neck Squamous Cell Cancer KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent. KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin-ejfv, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: who are not eligible for any platinum-containing chemotherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. KEYTRUDA, in combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC). KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC. KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. KEYTRUDA, in combination with belzutifan, is indicated for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Endometrial Carcinoma KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Contacts Media Contacts: Julie Cunningham julie.cunningham@merck.com Justine Moore justine.moore@merck.com Investor Contacts: Peter Dannenbaum (732) 594-1579 Steven Graziano (732) 594-1583 Read full story here