Research on Novel Treatment Approaches and Scientific Advances From Merck’s Broad and Differentiated Oncology Portfolio and Pipeline to be Presented at ASCO 2025

• New and updated data for MK-1084, an investigational KRAS G12C inhibitor, from the colorectal cancer and non-small cell lung cancer cohorts of the Phase 1 KANDLELIT-001 study will be presented
• Zilovertamab vedotin and sacituzumab tirumotecan data to highlight progress in Merck’s pipeline of innovative antibody-drug conjugates
• Follow-up data for KEYTRUDA® (pembrolizumab) and WELIREG® (belzutifan), as well as new and updated analyses for KEYTRUDA in earlier stages of cancer, add to the body of evidence supporting the role of these medicines

“The new data we are presenting at ASCO 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.”

• First-time data from the colorectal cancer cohort of the Phase 1 KANDLELIT-001 study evaluating MK-1084, an investigational, oral selectiveKRASG12C inhibitor, as monotherapy and in combination therapies for patients withKRASG12C-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 KRASG12C-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.

• 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 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).

1. In collaboration with Taiho Pharmaceutical Co. Ltd and Astex Pharmaceuticals (UK), a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd
2. Led by Kelun-Biotech
3. In collaboration with Gilead
4. In collaboration with Daiichi Sankyo
5. In collaboration with the European Network for Gynaecological Oncology Trial (ENGOT) groups and the GOG Foundation, Inc. (GOG)