MSD Oncology Pipeline Advances With First Phase 3 Data for Intismeran Autogene Plus KEYTRUDA and Sacituzumab Tirumotecan

The MSD oncology pipeline will take center stage in Madrid, Spain, from Oct. 23-27, 2026, as Merck (MSD) (NYSE: MRK), known as MSD outside the United States and Canada, prepares to present first-time results from three pivotal clinical trials at the European Society for Medical Oncology Congress 2026. The company announced the plan on October 13, 2026, through a Business Wire release datelined Rahway, N.J.

Each of the three trials has secured a late-breaking Presidential Symposium slot. They are INTerpath-001, evaluating intismeran autogene plus KEYTRUDA (pembrolizumab) in melanoma; TroFuse-005, evaluating sacituzumab tirumotecan (sac-TMT) in endometrial cancer; and KEYNOTE-C93, evaluating first-line KEYTRUDA monotherapy in a biomarker-defined endometrial cancer population. More than 90 additional abstracts across more than 20 tumor types will also be presented across the Merck oncology pipeline and portfolio.

Dr. Marjorie Green, senior vice president and head of oncology global clinical development at Merck Research Laboratories, said the data reflect an “industry-leading oncology portfolio and pipeline.” She added that Merck is proud to share Phase 3 data for the first time from intismeran and sac-TMT, alongside new research across a range of cancer types. The announcement does not disclose numerical efficacy results, which are expected to be shared at the presentations.

MSD Oncology Pipeline Leads With Intismeran Autogene Plus KEYTRUDA in Melanoma

The headline melanoma presentation is INTerpath-001, a Phase 3 study of intismeran autogene (V940/mRNA-4157) combined with KEYTRUDA as adjuvant treatment for patients with completely resected stage IIB-IV melanoma. It is scheduled as Presentation #LBA1 in Presidential Symposium I, with G. V. Long listed as presenter. According to Merck, the study demonstrates improvements in recurrence-free survival and distant metastasis-free survival versus KEYTRUDA alone. Hazard ratios, confidence intervals and event counts were not disclosed.

Intismeran is a novel, investigational mRNA-based individualized neoantigen therapy jointly developed by Merck and Moderna. Each therapy is designed and produced from a patient’s own tumor sample, which is used to identify the unique mutational signature of that cancer. The synthetic mRNA codes for up to 34 neoantigens, and the encoded sequences are translated in the body and presented to the immune system to support specific T-cell responses against cancer cells.

Merck and Moderna are advancing the INTerpath clinical development program to evaluate intismeran with KEYTRUDA and other anti-cancer therapies, and as a monotherapy. A separate Phase I poster, Presentation #3151P with D. J. Pinato, will report adjuvant intismeran plus FOLFIRINOX in resectable pancreatic ductal adenocarcinoma, extending the Merck oncology pipeline beyond melanoma.

KEYTRUDA, Merck’s anti-PD-1 therapy, is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. The company reports that more than 2,800 trials are studying KEYTRUDA across cancers and treatment settings. In the United States, KEYTRUDA is already indicated for adjuvant treatment of stage IIB, IIC or III melanoma following complete resection in adult and pediatric patients aged 12 years and older.

Merck Oncology Pipeline Expands Its TROP2 Strategy With Sacituzumab Tirumotecan

TroFuse-005 is the second Presidential Symposium study, scheduled as Presentation #LBA11 in Presidential Symposium III with D. Lorusso listed as presenter. The Phase 3 trial evaluates sac-TMT, an investigational TROP2-directed antibody-drug conjugate, in patients with advanced or recurrent endometrial cancer who progressed after platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. Merck describes it as 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 this disease.

Sac-TMT carries a belotecan-derived topoisomerase I inhibitor payload and a bifunctional linker intended to maximize payload delivery to tumor cells while limiting payload loss in circulation. Through the TroFuse development program, Merck is evaluating the molecule in 18 ongoing global Phase 3 trials, which the company says is the broadest range of disease and treatment settings of any TROP2-directed antibody-drug conjugate to date. The program spans more than nine disease areas and more than 15,000 patients worldwide.

Lung cancer data come from studies led by Kelun-Biotech and conducted in China. OptiTROP-Lung06 tests sac-TMT plus pembrolizumab against chemotherapy plus pembrolizumab in first-line PD-L1-negative advanced non-squamous non-small cell lung cancer. OptiTROP-Lung04 reports final overall survival in EGFR-mutated disease after progression on EGFR tyrosine kinase inhibitors. A final overall survival analysis from OptiTROP-Breast01 in triple-negative breast cancer is also on the Merck oncology pipeline schedule.

Merck Oncology Pipeline Reinforces Endometrial, Kidney and KRAS Research

KEYNOTE-C93 is the third Presidential Symposium study, scheduled as Presentation #LBA12 with B. M. Slomovitz listed as presenter. The Phase 3, randomized, open-label trial compares first-line KEYTRUDA with carboplatin plus paclitaxel in mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma. Merck says the data suggest an important role for first-line KEYTRUDA monotherapy in certain patients. The study is run in collaboration with the ENGOT groups and the GOG Foundation, adding endometrial depth to the Merck oncology pipeline.

In renal cell carcinoma, the final analysis of the Phase 3 LITESPARK-011 study will be presented as Presentation #3587O by D. Y. Heng. It evaluates WELIREG (belzutifan), Merck’s first-in-class oral HIF-2 alpha inhibitor, plus LENVIMA (lenvatinib) versus cabozantinib in advanced clear cell renal cell carcinoma after a PD-1 or PD-L1 inhibitor. LENVIMA was discovered by Eisai, which collaborates on the study. The final KEYNOTE-564 analysis of adjuvant KEYTRUDA in clear cell disease will also be shown.

The wider Merck oncology pipeline includes calderasib (MK-1084), an investigational next-generation KRAS G12C covalent inhibitor. Presentation #2680RO covers metastatic non-small cell lung cancer, and Presentation #1039P covers the Phase 1 KANDLELIT-001 study in KRAS G12C-mutated advanced solid tumors. Merck notes that KRAS G12C occurs in approximately 14% of patients with non-small cell lung cancer adenocarcinoma. Additional partnered work includes Daiichi Sankyo antibody-drug conjugates and Astellas/Pfizer urothelial studies.

Three Presidential Symposium Trials