Merck, a leading science and technology company, today announced the presentation of new oncology data across more than 12 tumor types at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, May 31 to June 4 in Chicago. The presentations include the Phase 3 MANEUVER data for potentially best-in-class pimicotinib in the treatment of the rare tumor TGCT, as well as data from both company- and investigator-sponsored studies highlighting the company’s focus on advancing differentiated molecules to tackle some of the most challenging cancers.
“The new clinical data we are presenting at ASCO showcase our dedication to advancing innovative therapies for a wide range of diseases—spanning from common cancers to rare non-malignant neoplasms,” said Victoria Zazulina, M.D., Head of Development Unit, Oncology, for the Healthcare business of Merck. “From encouraging early data for our lead antibody-drug conjugate, precemtabart tocentecan, in patients with advanced CRC, to new Phase 2 findings and real-world evidence that reinforce the value of BAVENCIO first-line maintenance as a treatment option for advanced bladder cancer, to detailed Phase 3 results for pimicotinib in tenosynovial giant cell tumor, we are working to advance treatments that provide hope to patients and their families.”
Highlights of the company’s data include:
First presentation of Phase 3 MANEUVER data for pimicotinib in the treatment of TGCT (Abstract 11500)
Detailed results from Part 1 of the Phase 3 MANEUVER study of pimicotinib in the treatment of patients with TGCT, conducted by Abbisko Therapeutics Co., Ltd., will be presented for the first time during the Sarcoma Oral Abstract Session on June 1, at 9:57 a.m. CST. In the trial, pimicotinib significantly improved objective response rate versus placebo, the primary endpoint, as well as all key secondary endpoints, and was well-tolerated. Pimicotinib is being developed by Abbisko Therapeutics; Merck holds the rights to commercialize pimicotinib worldwide.
Latest data for potentially first-in-class precemtabart tocentecan (Abstracts 3038 & TPS3165)
The company continues to progress the clinical investigation of its lead antibody-drug conjugate (ADC), precemtabart tocentecan. New findings from the Phase 1 PROCEADE-CRC 01 study include data from the dose-optimization part in 60 irinotecan-refractory metastatic CRC patients (3L+) demonstrating encouraging efficacy at doses of 2.4mg/kg and 2.8mg/kg every 3 weeks (Q3W) and a predictable and manageable safety profile. These data, which showed a higher ORR and similar safety at the 2.8 mg/kg dose, support the rationale for selecting this as the recommended dose for further development in CRC and other solid tumors, including those cancer types being investigated in the ongoing Phase 1b/2 PROCEADE-PanTumor study (NCT06710132). More mature data for PROCEADE-CRC-01 and details on the design for the PROCEADE-PanTumor study investigating precemtabart tocentecan in patients with locally advanced/metastatic non-small cell lung, gastric, gastroesophageal junction or pancreatic cancer will be presented at the congress.
New findings further building on the benefit from BAVENCIO® (avelumab) in the first-line maintenance setting in advanced bladder cancer (Abstracts 4501, e16561, e23275, 9543)
Interim results from the Phase 2 JAVELIN Bladder Medley trial will be presented, focusing on the efficacy of BAVENCIO in combination with the anti-Trop-2 ADC sacituzumab govitecan (Trodelvy®, Gilead Sciences) for patients with advanced urothelial carcinoma (UC) who are progression-free after first-line platinum-containing chemotherapy. When used in the maintenance setting, the combination therapy significantly improved progression-free survival (PFS) versus BAVENCIO alone (HR 0.49 [95% CI, 0.31-0.76]); median PFS was 11.17 months versus 3.75 months, respectively. Overall survival (OS) data were immature at the time of analysis. Treatment-related adverse events were more frequent in the combination group (97.3%) compared with BAVENCIO monotherapy (63.9%).
The company also will present real-world evidence that reinforces the clinical trial findings from the Phase 3 JAVELIN Bladder 100 study of BAVENCIO as a first-line maintenance therapy in patients with locally advanced/metastatic UC. The data highlight the effectiveness and safety of BAVENCIO in routine clinical practice and heterogenous populations as well as the importance of personalized treatment decision-making.
New research reinforcing the role of ERBITUX® (cetuximab) in colorectal cancer (Abstracts 3513, LBA3500)
Investigator-sponsored research continues to reinforce ERBITUX as the backbone of treatment in CRC, including a rapid oral presentation on the final analysis of the FIRE-4 study evaluating the efficacy of cetuximab re-challenge in patients with RASwt mCRC. The study demonstrated greater overall response rate (ORR) in the ERBITUX-containing experimental arm versus physicians’ choice of treatment (11.9% vs 28.9%) and numerically higher OS and PFS. Additional data from Pfizer’s Phase 3 BREAKWATER trial, evaluating the clinical efficacy of the combination of mFOLFOX6, encorafenib and ERBITUX in metastatic BRAF V600E-mutant CRC, will be featured in the Cancers of the Colon, Rectum, and Anus session. Merck holds the marketing rights to Erbitux globally, outside of the US and Canada.
