On May 13, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported new research across more than 25 types of cancer and multiple treatment settings from the company’s broad and differentiated portfolio and pipeline will be showcased at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (May 30–June 3) (Press release, Merck & Co, MAY 13, 2025, View Source [SID1234652981]). Data highlight Merck’s commitment to rapidly advance research across multiple tumor types and continue to build on its portfolio of established medicines.
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"The new data we are presenting at ASCO (Free ASCO Whitepaper) spotlight our commitment in oncology as we pioneer novel treatment approaches in our ongoing work to transform cancer care," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "Merck is fueling the next wave of innovation in cancer through research to help address significant unmet medical needs for even more patients."
Key data being presented on investigational candidates from Merck’s pipeline:
First-time data from the colorectal cancer cohort of the Phase 1 KANDLELIT-001 study evaluating MK-1084, an investigational, oral selective KRAS G12C inhibitor, as monotherapy and in combination therapies for patients with KRAS G12C-mutated advanced colorectal cancer (Abstract #3508; Oral abstract session: Gastrointestinal cancer—colorectal and anal).1
Additional data from the non-small cell lung cancer (NSCLC) cohorts of the Phase 1 KANDLELIT-001 study evaluating MK-1084 as monotherapy and in combination therapies for patients with KRAS G12C-mutated metastatic NSCLC (Abstract #8605; Poster session: Lung cancer—non-small cell metastatic).1
First-time data from the Phase 2/3 waveLINE-003 study evaluating zilovertamab vedotin, an investigational antibody-drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1), plus standard of care as a treatment for patients with relapsed or refractory diffuse large B-cell lymphoma (Abstract #7005; Oral abstract session: Hematologic malignancies—lymphoma and chronic lymphocytic leukemia).
Data from the randomized Phase 2 OptiTROP-Lung03 study conducted in China, independently led by Kelun-Biotech, evaluating sacituzumab tirumotecan (sac-TMT), an investigational TROP2-directed ADC, as a treatment for patients with previously treated advanced EGFR-mutated NSCLC (Abstract #8507; Oral abstract session: Lung cancer—non-small cell metastatic).2
Additionally, new or updated findings from Merck’s broad portfolio of cancer medicines will be presented, including longer-term results for KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, and WELIREG (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, as well as findings in earlier stages of cancer.
Key data being presented on existing medicines in Merck’s portfolio:
Primary results from the first interim analysis of the Phase 3 ASCENT-04/KEYNOTE-D19 trial evaluating KEYTRUDA plus the TROP2-directed ADC sacituzumab govitecan-hziy for patients with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer will be featured as part of the ASCO (Free ASCO Whitepaper) press program (Abstract #LBA109; Oral abstract session: Breast cancer—metastatic).3
Five-year follow-up results from the Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA monotherapy as an adjuvant treatment for patients with renal cell carcinoma at increased risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions (Abstract #4514; Rapid oral abstract session: Genitourinary cancer—kidney and bladder).
Five-year follow-up data from the Phase 2 LITESPARK-004 trial evaluating WELIREG as a treatment for von Hippel-Lindau (VHL) disease-associated tumors (Abstract #4507; Oral abstract session: Genitourinary cancer—kidney and bladder).
Results from the Phase 1b TROPION-Lung02 trial evaluating KEYTRUDA plus the TROP2-directed ADC datopotamab deruxtecan, with or without platinum-based chemotherapy, as a first-line treatment for patients with advanced NSCLC (Abstract #8501; Oral abstract session: Lung cancer—non-small cell metastatic).4
Data from the 4.5-year follow-up of the Phase 3 KEYNOTE-859 trial evaluating KEYTRUDA plus chemotherapy for the first-line treatment of advanced human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma (Abstract #4036; Poster session: Gastrointestinal cancer—gastroesophageal, pancreatic, and hepatobiliary).
Final analysis results from the Phase 3 KEYNOTE-A18 trial evaluating KEYTRUDA in combination with concurrent chemoradiotherapy (CRT) as a treatment for patients with high-risk locally advanced cervical cancer (Abstract #LBA5504; Oral abstract session: Gynecologic cancer).5
Exploratory efficacy analysis results from the Phase 3 KEYNOTE-689 trial evaluating KEYTRUDA as a neoadjuvant treatment for patients with resectable locally advanced head and neck squamous cell carcinoma, then continued as adjuvant treatment in combination with standard of care radiotherapy with or without cisplatin and then as a single agent (Abstract #6012; Rapid oral abstract session: Head and neck cancer).
Merck investor event
Merck will hold an Oncology Investor Event to coincide with the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting on Monday, June 2, 2025, 6 p.m. CT, during which senior management will provide an update on the company’s oncology strategy and program. The event will take place in Chicago, Ill., 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.
Details on abstracts listed above and additional key abstracts for Merck
Breast cancer
Sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in previously untreated PD-L1-positive advanced triple-negative breast cancer (TNBC): Primary results from the randomized Phase 3 ASCENT-04/KEYNOTE-D19 study. S. Tolaney.3
Abstract #LBA109, Oral abstract session: Breast cancer—metastatic
Sacituzumab tirumotecan (sac-TMT) as first-line treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/mTNBC): Initial results from the Phase II OptiTROP-Breast05 study. Y. Yin.2
Abstract #1019, Rapid oral abstract session: Breast cancer—metastatic
Gastrointestinal cancers
The KRAS G12C inhibitor MK-1084 for KRAS G12C–mutated advanced colorectal cancer (CRC): Results from KANDLELIT-001. I. Ługowska.1
Abstract #3508, Oral abstract session: Gastrointestinal cancer—colorectal and anal
KEYNOTE-859: 4.5-year median follow-up of pembrolizumab plus chemotherapy for previously untreated advanced HER2-negative gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. S. Rha.
Abstract #4036, Poster session: Gastrointestinal cancer—gastroesophageal, pancreatic, and hepatobiliary
Quality-adjusted time without symptoms of disease or toxicity (Q-TWiST) analysis of pembrolizumab (pembro) versus chemotherapy (chemo) in microsatellite instability–high (MSI-H)/mismatch repair–deficient (dMMR) metastatic colorectal cancer (mCRC) in the KEYNOTE-177 trial. E. Elez.
Abstract #3631, Poster session: Gastrointestinal cancer—colorectal and anal
Genitourinary cancers
Five-year follow-up results from the Phase 3 KEYNOTE-564 study of adjuvant pembrolizumab (pembro) for the treatment of clear cell renal cell carcinoma (ccRCC). N. Haas.
Abstract #4514, Rapid oral abstract session: Genitourinary cancer—kidney and bladder
Hypoxia-inducible factor-2α (HIF-2α) inhibitor belzutifan in von Hippel-Lindau (VHL) disease–associated neoplasms: 5-year follow-up of the phase 2 LITESPARK-004 study. V. Narayan.
Abstract #4507, Oral abstract session: Genitourinary cancer—kidney and bladder
Phase 1b/2 KEYNOTE-365 cohort I: Pembrolizumab (pembro) plus carboplatin and etoposide chemotherapy (chemo) or chemo alone for metastatic neuroendocrine prostate cancer (NEPC). G. Amsberg.
Abstract #5059, Poster session: Genitourinary cancer—prostate, testicular, and penile
Gynecologic cancers
Pembrolizumab with chemoradiotherapy in patients with high-risk locally advanced cervical cancer: Final analysis results of the Phase 3, randomized, double-blind ENGOT-cx11/GOG-3047/KEYNOTE-A18 study. L. Duska.5
Abstract #LBA5504, Oral abstract session: Gynecologic cancer
Head and neck cancer
Neoadjuvant and adjuvant pembrolizumab plus standard of care (SOC) in resectable locally advanced head and neck squamous cell carcinoma (LA HNSCC): Exploratory efficacy analyses of the Phase 3 KEYNOTE-689 study. D. Adkins.
Abstract #6012, Rapid oral abstract session: Head and neck cancer
Hematologic cancers
WaveLINE-003: Phase 2/3 trial of zilovertamab vedotin plus standard of care in relapsed/refractory diffuse large B-cell lymphoma. P. Armand.
Abstract #7005, Oral abstract session: Hematologic malignancies—lymphoma and chronic lymphocytic leukemia
Lung cancer
MK-1084 for KRAS G12C-mutated (mut) metastatic non–small-cell lung cancer (mNSCLC): Results from KANDLELIT-001. A. Sacher.1
Abstract #8605, Poster session: Lung cancer—non-small cell metastatic
Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study. L. Zhang.2
Abstract #8507, Oral abstract session: Lung cancer—non-small cell metastatic
Patritumab deruxtecan (HER3-DXd) in resistant EGFR-mutated (EGFRm) advanced non-small cell lung cancer (NSCLC) after a third-generation EGFR TKI: The Phase 3 HERTHENA-Lung02 study. T. Mok.4
Abstract #8506, Oral abstract session: Lung cancer—non-small cell metastatic
TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) as first-line (1L) therapy for advanced non-small cell lung cancer (aNSCLC). B. Levy.4
Abstract #8501, Oral abstract session: Lung cancer—non-small cell metastatic
Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated locally advanced or metastatic (LA/M) non-small cell lung cancer (NSCLC) harboring uncommon EGFR mutations: Preliminary results from a Phase 2 study. L. Zhang.2
Abstract #8615, Poster session: Lung cancer—non-small cell metastatic
Sacituzumab tirumotecan (sac-TMT) in combination with tagitanlimab (anti-PD-L1) in first-line (1L) advanced non-small-cell lung cancer (NSCLC): Non-squamous cohort from the Phase II OptiTROP-Lung01 study. W. Fang.2
Abstract #8529, Poster session: Lung cancer—non-small cell metastatic
Melanoma and other skin cancers
First-line lenvatinib plus pembrolizumab versus placebo plus pembrolizumab in Chinese patients with unresectable or metastatic melanoma: Results from LEAP-003. J. Guo.6
Abstract #9553, Poster session: Melanoma/skin cancers
Multi-tumor
Pembrolizumab monotherapy for melanoma or non-small cell lung cancer in India: Results of the Phase IV KEYNOTE-593 study. S. Limaye.
Abstract #e21518, Publication only: Melanoma/skin cancers