Merck Unveils Comprehensive Oncology Advances at ASCO 2025, Targeting Advanced Cancers and Rare Tumors
Merck, a global leader in science and technology innovation, today announced the presentation of a broad spectrum of new clinical data across more than a dozen tumor types at the prestigious 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held from May 31 to June 4 in Chicago. These presentations reflect Merck’s unwavering commitment to advancing next-generation cancer therapies and highlight progress in both company-sponsored and investigator-initiated studies. The data emphasize Merck’s strategic focus on differentiated molecules designed to tackle some of the most complex and challenging cancers, including rare tumors and hard-to-treat advanced malignancies.
Broad Portfolio Advancements Across Multiple Tumor Types
The breadth of data Merck is showcasing underscores the company’s multi-faceted approach to oncology drug development, which spans common cancers like colorectal and bladder cancer, as well as rare and non-malignant neoplasms such as tenosynovial giant cell tumor (TGCT). By investing in cutting-edge therapies including antibody-drug conjugates (ADCs), targeted kinase inhibitors, and immunotherapies, Merck aims to provide novel treatment options that improve patient outcomes and offer hope to families affected by these devastating diseases.
Victoria Zazulina, M.D., Head of the Oncology Development Unit at Merck’s Healthcare business, emphasized the company’s commitment: “The new clinical data we are presenting at ASCO reflect our dedication to pioneering innovative therapies that span from common cancers to rare non-malignant tumors. We are excited to share encouraging early results for our lead ADC, precemtabart tocentecan, in patients with advanced colorectal cancer, as well as new Phase 2 findings and real-world evidence that reinforce the clinical value of BAVENCIO as a first-line maintenance therapy for advanced bladder cancer. Additionally, our detailed Phase 3 results for pimicotinib in TGCT highlight our work to address rare diseases with significant unmet medical need.”
Pimicotinib Phase 3 MANEUVER Data: A Potential Breakthrough for TGCT
One of the most highly anticipated presentations at ASCO 2025 is the first public disclosure of detailed Phase 3 data from the MANEUVER study, evaluating pimicotinib in patients with tenosynovial giant cell tumor (TGCT), a rare, locally aggressive tumor that affects joints and tendons. Pimicotinib is a novel small molecule being developed by Abbisko Therapeutics Co., Ltd., with Merck holding worldwide commercialization rights.
The MANEUVER trial, which compares pimicotinib to placebo, demonstrated a statistically significant improvement in the objective response rate (ORR), which was the study’s primary endpoint. In addition to ORR, pimicotinib showed meaningful benefits across all key secondary endpoints, including progression-free survival and symptom improvement. Importantly, pimicotinib was well-tolerated by patients, with a manageable safety profile.
This presentation will take place during the Sarcoma Oral Abstract Session on June 1 at 9:57 a.m. CST (Abstract 11500). The results signal a potential best-in-class treatment for TGCT, addressing an unmet clinical need for therapies beyond surgical intervention, which is often associated with high recurrence rates.
Precemtabart Tocentecan: Promising Advances in Antibody-Drug Conjugate Therapy for Colorectal and Solid Tumors
Merck is advancing its lead antibody-drug conjugate, precemtabart tocentecan, designed to selectively deliver cytotoxic agents to tumor cells while sparing healthy tissue. The company presented new data from the Phase 1 PROCEADE-CRC 01 study, which investigated precemtabart in patients with irinotecan-refractory metastatic colorectal cancer (mCRC), who have exhausted multiple lines of therapy (3L+).
Dose-optimization results from 60 patients showed encouraging efficacy at two dosing levels—2.4 mg/kg and 2.8 mg/kg every three weeks—with a favorable and predictable safety profile. Notably, the higher dose of 2.8 mg/kg demonstrated a greater objective response rate without compromising safety, supporting its selection as the recommended dose for further clinical development in colorectal cancer and other solid tumors.
Merck will also present early data from the ongoing Phase 1b/2 PROCEADE-PanTumor study (NCT06710132), evaluating precemtabart in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), gastric cancer, gastroesophageal junction cancer, and pancreatic cancer. These results further underscore Merck’s commitment to expanding ADC therapy across multiple tumor types with high unmet needs (Abstracts 3038 & TPS3165).
BAVENCIO® (Avelumab) Reinforces Its Role in Advanced Bladder Cancer Treatment
Merck continues to build on the clinical foundation of BAVENCIO®, its PD-L1 checkpoint inhibitor, in advanced bladder cancer through new data presentations. The Phase 2 JAVELIN Bladder Medley trial results reveal promising efficacy when BAVENCIO is combined with sacituzumab govitecan (Trodelvy®, marketed by Gilead Sciences), an anti-Trop-2 ADC, as maintenance therapy for patients with advanced urothelial carcinoma (UC) who are progression-free following first-line platinum-based chemotherapy.
In this trial, the combination significantly improved progression-free survival (PFS) compared to BAVENCIO monotherapy, with median PFS of 11.17 months versus 3.75 months (Hazard Ratio [HR] 0.49; 95% CI, 0.31-0.76). While overall survival (OS) data remain immature, the observed PFS benefit suggests the combination may offer a valuable new maintenance option for this patient population. However, treatment-related adverse events were higher in the combination arm (97.3%) compared to monotherapy (63.9%), highlighting the need for careful patient monitoring (Abstracts 4501, e16561, e23275, 9543).
In addition to clinical trial data, Merck will present real-world evidence that mirrors the findings of the pivotal Phase 3 JAVELIN Bladder 100 study, which established BAVENCIO as a first-line maintenance therapy standard in locally advanced or metastatic UC. These real-world analyses confirm the drug’s effectiveness and safety in broader patient populations encountered in everyday clinical practice, reinforcing the importance of individualized treatment strategies.
ERBITUX® (Cetuximab) Strengthens Its Position in Colorectal Cancer Therapy
Merck’s commitment to colorectal cancer treatment is further exemplified by new investigator-sponsored data supporting the continued use of ERBITUX® (cetuximab) in managing this disease. The final analysis of the FIRE-4 study, presented in a rapid oral session, evaluated the efficacy of cetuximab re-challenge in patients with RAS wild-type metastatic colorectal cancer (mCRC).
The study revealed a higher overall response rate (ORR) for patients receiving cetuximab re-challenge (28.9%) compared to physician’s choice of other therapies (11.9%), alongside numerically improved overall survival (OS) and progression-free survival (PFS). These findings suggest that retreatment with ERBITUX may offer clinical benefits for selected patients, providing an additional line of therapy in the complex mCRC treatment landscape (Abstracts 3513, LBA3500).
Furthermore, data from Pfizer’s Phase 3 BREAKWATER trial, examining the combination of mFOLFOX6 chemotherapy, encorafenib (a BRAF inhibitor), and ERBITUX in patients with metastatic BRAF V600E-mutant colorectal cancer, will also be featured. This regimen is poised to address a particularly aggressive CRC subset with poor prognosis, marking a crucial step in precision oncology for colorectal cancer.
Merck holds global marketing rights to ERBITUX outside the United States and Canada, reinforcing its role as a key player in colorectal cancer treatment worldwide.
Commitment to Transformative Oncology Care
The data presented by Merck at ASCO 2025 showcase the company’s holistic strategy to develop and commercialize innovative therapies that address diverse and challenging cancers, ranging from rare tumors to advanced solid malignancies. By integrating cutting-edge science, robust clinical research, and real-world evidence, Merck aims to improve patient outcomes and advance the standard of care in oncology.
Dr. Zazulina concludes, “Our portfolio exemplifies Merck’s dedication to scientific innovation and patient-centric development. We are driven by the goal of delivering therapies that not only extend lives but also enhance quality of life for patients and their families. ASCO 2025 offers a platform to share our progress and vision as we continue our journey toward transforming cancer care.”
