Merck Highlights Breakthrough Innovations in Advanced Cancers and Rare Tumors at ASCO 2025
Merck, a global leader in science and technology, has once again showcased its commitment to transforming cancer care through the presentation of groundbreaking clinical data across a broad spectrum of oncology indications at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The conference, held from May 31 to June 4 in Chicago, provided Merck with a prominent platform to reveal new findings from more than 12 tumor types, underscoring the company’s ongoing dedication to pioneering therapies that address both common and rare cancers.
Among the most notable presentations is the Phase 3 MANEUVER trial data for pimicotinib, a potentially best-in-class therapy targeting tenosynovial giant cell tumor (TGCT), a rare but debilitating neoplasm. This pivotal trial not only highlights the promise of pimicotinib as a novel treatment option but also exemplifies Merck’s strategic focus on advancing differentiated molecules with the potential to make significant clinical impacts in challenging oncologic conditions.
Victoria Zazulina, M.D., Head of Development Unit, Oncology, for Merck’s Healthcare business, emphasized the significance of these developments: “The new clinical data we are presenting at ASCO demonstrate our steadfast commitment to advancing innovative therapies that span a wide array of diseases—from prevalent cancers to rare, non-malignant tumors. We are encouraged by early data for our lead antibody-drug conjugate, precemtabart tocentecan, in patients with advanced colorectal cancer (CRC), and by compelling Phase 2 results and real-world evidence supporting BAVENCIO® (avelumab) as a first-line maintenance therapy in advanced bladder cancer. Additionally, the detailed Phase 3 results for pimicotinib in TGCT further validate our mission to develop treatments that offer hope and improved outcomes to patients and their families.”
Groundbreaking Phase 3 MANEUVER Trial Data for Pimicotinib in TGCT
One of the standout highlights from Merck’s presentations is the first public disclosure of the Phase 3 MANEUVER trial data assessing pimicotinib in patients with tenosynovial giant cell tumor (TGCT). The study, conducted by Abbisko Therapeutics Co., Ltd., a Merck collaborator, evaluated the efficacy and safety of pimicotinib compared to placebo in patients afflicted with this rare tumor type.
Presented during the Sarcoma Oral Abstract Session on June 1, the data revealed a statistically significant improvement in the objective response rate (ORR), which was the primary endpoint of the study. Pimicotinib not only met this key measure but also demonstrated superiority across all major secondary endpoints, including progression-free survival and symptom relief. Importantly, the therapy exhibited a favorable tolerability profile, an encouraging factor for patients living with TGCT, a disease often marked by painful joint swelling and limited treatment options.
While pimicotinib is developed by Abbisko Therapeutics, Merck holds global commercialization rights, positioning the company to bring this innovative therapy to patients worldwide upon approval.
Advancing Antibody-Drug Conjugates: Precemtabart Tocentecan Shows Promise in Colorectal and Solid Tumors
Merck continues to advance its cutting-edge portfolio through precemtabart tocentecan, a novel antibody-drug conjugate (ADC) that targets tumors with precision to deliver cytotoxic agents directly to cancer cells while sparing healthy tissue. The latest clinical findings were presented from the Phase 1 PROCEADE-CRC 01 trial, which focused on patients with metastatic colorectal cancer who had failed prior lines of therapy, specifically those refractory to irinotecan.
The dose-optimization cohort included 60 patients treated at two dosing levels—2.4 mg/kg and 2.8 mg/kg administered every three weeks. Data showcased an encouraging efficacy signal, with a higher objective response rate observed at the 2.8 mg/kg dose without a corresponding increase in adverse events. This balance of enhanced efficacy and manageable safety supports the selection of the higher dose for ongoing and future trials.
Beyond colorectal cancer, Merck is exploring the potential of precemtabart tocentecan in a variety of solid tumors through the Phase 1b/2 PROCEADE-PanTumor study. This broader investigation includes patients with locally advanced or metastatic non-small cell lung cancer, gastric cancer, gastroesophageal junction cancer, and pancreatic cancer. The evolving data from these trials are anticipated to further define the therapeutic versatility and clinical utility of this promising ADC platform.
Expanding the Role of BAVENCIO in Advanced Bladder Cancer Through Combination and Real-World Data
Merck also unveiled compelling new data regarding BAVENCIO (avelumab), its anti-PD-L1 immunotherapy, reinforcing its pivotal role in the management of advanced urothelial carcinoma (UC), commonly known as bladder cancer.
Interim results from the Phase 2 JAVELIN Bladder Medley trial examined the efficacy of BAVENCIO in combination with sacituzumab govitecan (Trodelvy®, an anti-Trop-2 ADC developed by Gilead Sciences) as maintenance therapy in patients whose disease remained stable after first-line platinum-based chemotherapy. The combination regimen significantly improved progression-free survival (PFS), with a median PFS of 11.17 months compared to 3.75 months for BAVENCIO monotherapy—a substantial enhancement in disease control.
While the overall survival data were immature at the time of analysis, these findings offer an exciting potential new approach to prolonging disease stability and delaying progression in advanced bladder cancer. Notably, combination treatment was associated with a higher rate of treatment-related adverse events, underscoring the need for vigilant management of side effects in clinical practice.
Complementing these clinical trial findings, Merck presented real-world evidence underscoring BAVENCIO’s effectiveness and safety as a first-line maintenance therapy in diverse patient populations outside the controlled setting of clinical trials. This real-world data affirms the generalizability of the Phase 3 JAVELIN Bladder 100 study results, demonstrating that BAVENCIO delivers meaningful clinical benefit in routine oncology practice. These insights also highlight the importance of personalized treatment strategies tailored to individual patient profiles.
Reinforcing ERBITUX as a Foundation in Colorectal Cancer Therapy
Merck’s oncology portfolio also includes ERBITUX® (cetuximab), a well-established monoclonal antibody targeting the epidermal growth factor receptor (EGFR), used extensively in colorectal cancer (CRC) treatment. New investigator-sponsored research presented at ASCO further validates ERBITUX’s continued relevance in the treatment landscape.
The final analysis of the FIRE-4 study was delivered as a rapid oral presentation. This trial evaluated the strategy of cetuximab rechallenge in patients with RAS wild-type metastatic colorectal cancer (mCRC), a population where limited treatment options exist after disease progression. The study showed a higher overall response rate (28.9%) in patients re-exposed to ERBITUX-containing regimens compared to 11.9% in those receiving physicians’ choice of other treatments. Additionally, numerical improvements in overall survival and progression-free survival were noted, supporting the clinical benefit of this rechallenge approach.
Furthermore, data from Pfizer’s Phase 3 BREAKWATER trial, in which Merck holds marketing rights to ERBITUX outside the U.S. and Canada, were also highlighted. This trial investigates the efficacy of a combination regimen involving mFOLFOX6 chemotherapy, encorafenib, and ERBITUX in patients with metastatic BRAF V600E-mutant CRC, a subset of colorectal cancer characterized by poor prognosis. These results reinforce the importance of molecularly targeted therapies in tailoring treatment to genetic tumor profiles and improving patient outcomes.
Merck’s Vision for Oncology Innovation
Through these presentations, Merck reinforces its position as a trailblazer in oncology research and development. The company’s strategic investment in novel agents like pimicotinib and precemtabart tocentecan, alongside the continuous refinement of established therapies such as BAVENCIO and ERBITUX, highlights its multi-faceted approach to addressing unmet needs across the cancer care continuum.
Dr. Zazulina summarized this vision: “Our goal is to deliver therapies that not only extend survival but also enhance quality of life for patients facing some of the most difficult-to-treat cancers. By leveraging innovative science and collaborating closely with the oncology community, we aim to bring forth solutions that change the standard of care and offer new hope.”
As ASCO 2025 concludes, Merck’s comprehensive oncology data package stands as a testament to its unwavering commitment to advancing cancer treatment worldwide, with a pipeline poised to deliver transformative therapies for patients battling both common and rare cancers.
