Data from Phase 3 MANEUVER study demonstrating significant improvements in physical function and symptoms in patients with tenosynovial giant cell tumor (TGCT) treated with pimicotinib, to be featured in oral presentation
Latest results for potential first-in-class anti-CEACAM5 ADC precemtabart tocentecan (M9140) highlight strong rationale for further development in colorectal cancer (CRC)
Not intended for Canada-, UK- or US-based media
DARMSTADT, Germany--(BUSINESS WIRE)--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. CDT. 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.
Select Merck-related abstracts accepted for the ASCO 2025 Annual Meeting include (all times in CDT):
|
Title |
Lead Author |
Abstract |
Session Information |
|
Pimicotinib |
|
|
|
|
Pimicotinib in tenosynovial giant cell tumor (TGCT): Efficacy, safety and patient-reported outcomes of Phase 3 MANEUVER study |
Niu X |
11500 |
Session Title: Sarcoma Date: Sunday, June 1, 2025 Session Time: 9:45 AM – 12:45 PM Presentation Time: 9:45 AM – 9:57 AM Location: S100a |
|
Precemtabart tocentecan (M9140) |
|
|
|
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Precemtabart tocentecan (M9140), an anti-CEACAM5 ADC with exatecan payload, in patients with metastatic colorectal cancer (mCRC): Results from the dose optimization of the phase 1 PROCEADE CRC-01 study |
Kopetz S |
3038 |
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Date: Monday, June 2, 2025 Session Time: 1:30 PM – 4:30 PM Location: Hall A |
|
BAVENCIO® (avelumab) |
|||
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Avelumab + sacituzumab govitecan (SG) vs avelumab monotherapy as first-line (1L) maintenance treatment in patients (pts) with advanced urothelial carcinoma (aUC): Interim analysis from the JAVELIN Bladder Medley phase 2 trial |
Hoffman-Censit J |
4501 |
Session Title: Genitourinary Cancer—Kidney and Bladder Date: Sunday, June 1, 2025 Session Time: 9:45 AM – 12:45 PM Presentation Time: 9:57 AM – 10:09 AM Location: Hall D2 |
|
Differences in patient (pt) characteristics and therapy choice across treatment (tx) groups in locally advanced or metastatic urothelial cancer (la/mUC) in the US: A survey on unmet patient needs |
Milloy N |
e16561 |
Session Title: Publication Only: Genitourinary Cancer—Kidney and Bladder
|
|
Management and outcomes of rash, peripheral neuropathy (PN), and hyperglycemia (HG) during first-line (1L) treatment (tx) of locally advanced/metastatic urothelial cancer (la/mUC) in a real-world setting |
Nizam A |
e23275 |
Session Title: Publication Only: Quality Care/Health Services Research |
|
Real-world safety and effectiveness of avelumab in immune-compromised (IC) and non-IC patients with Merkel cell carcinoma (MCC): Results from a prospective German registry (MCC-TRIM)
|
Becker J |
9543
|
Session Title: Publication Only: Genitourinary Cancer—Kidney and Bladder |
|
ERBITUX® (cetuximab) |
|
|
|
|
FIRE-4 (AIO KRK-0114): Randomized study evaluating the efficacy of cetuximab re-challenge in patients with metastatic RAS wild-type colorectal cancer responding to first-line treatment with FOLFIRI plus cetuximab |
Weiss L |
3513 |
Session Title: Gastrointestinal Cancer—Colorectal and Anal Date: Sunday, June 1, 2025 Session Time: 11:30 AM – 1:00 PM Presentation Time: 11:36 AM – 11:42 AM Location: Hall D1 |
|
First-line encorafenib + cetuximab + mFOLFOX6 in BRAF V600E-mutant metastatic colorectal cancer (BREAKWATER): Progression-free survival and updated overall survival analyses |
Elez E |
LBA3500 |
Session Title: Oral Abstract Session C: Cancers of the Colon, Rectum, and Anus Date: Friday, May 30, 2025 Session Time: 2:45 PM – 5:45 PM Presentation Time: 2:45 PM – 2:57 PM Location: Arie Crown Theater |
Advancing the Future of Cancer Care
At Merck, we strive every day to improve the futures of people living with cancer. Building on our 350-year global heritage as pharma pioneers, we are focusing our most promising science to target cancer’s deepest vulnerabilities, pursuing differentiated molecules to strike cancer at its core. By developing new therapies that can help advance cancer care, we are determined to create a world where more cancer patients will become cancer survivors. Learn more at www.merckgroup.com.
About Pimicotinib (ABSK021)
Pimicotinib (ABSK021), which is being developed by Abbisko Therapeutics, is a novel, orally administered, highly selective and potent small-molecule inhibitor of CSF-1R. Pimicotinib has been granted breakthrough therapy designation (BTD) for the treatment of inoperable TGCT by China National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA), and priority medicine (PRIME) designation from the European Medicines Agency (EMA). Merck holds worldwide commercialization rights for pimicotinib.
About precemtabart tocentecan (M9140)
Precemtabart tocentecan (previously known as M9140) is an investigational anti-CEACAM5 antibody-drug conjugate (ADC). Leveraging the company’s novel linker-payload technology, precemtabart tocentecan is the first CEACAM5 ADC with an exatecan payload, a potent topoisomerase inhibitor (TOP1i), which has been rationally designed for stability in circulation and superior cancer cell killing activity. Beyond the direct effect on the target cell, precemtabart tocentecan has been shown in preclinical research to induce tumor cell death through a bystander effect permeating the cell membrane to neighboring cells, inducing apoptosis (cell death). This bystander effect within the tumor microenvironment may enhance efficacy, particularly in tumors with heterogenous CEACAM5 expression. Precemtabart tocentecan is currently being evaluated across tumor types with CEACAM5 expression and a high unmet need, including metastatic colorectal cancer (mCRC), gastric cancer (GC), non-small cell lung cancer (NSCLC), and pancreatic ductal adenocarcinoma (PDAC).
About BAVENCIO® (avelumab)
BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.
BAVENCIO Approved Indications
BAVENCIO® (avelumab) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
BAVENCIO in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
In the US, BAVENCIO is indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC).
BAVENCIO is currently approved for at least one indication for patients in more than 50 countries.
BAVENCIO Safety Profile from the EU Summary of Product Characteristics (SmPC)
The special warnings and precautions for use for BAVENCIO monotherapy include infusion-related reactions, as well as immune-related adverse reactions that include pneumonitis and hepatitis (including fatal cases), colitis, pancreatitis (including fatal cases), myocarditis (including fatal cases), endocrinopathies, nephritis and renal dysfunction, and other immune-related adverse reactions. The special warnings and precautions for use for BAVENCIO in combination with axitinib include hepatotoxicity.
The SmPC list of the most common adverse reactions with BAVENCIO monotherapy in patients with solid tumors includes fatigue, nausea, diarrhea, decreased appetite, constipation, infusion-related reactions, weight decreased and vomiting. The list of most common adverse reactions with BAVENCIO in combination with axitinib includes diarrhea, hypertension, fatigue, nausea, dysphonia, decreased appetite, hypothyroidism, cough, headache, dyspnea, and arthralgia.
About ERBITUX® (cetuximab)
ERBITUX® is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX® is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Based on in vitro evidence, ERBITUX® also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells (antibody-dependent cell-mediated cytotoxicity [ADCC]).
ERBITUX® has already obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck licensed the right to market ERBITUX®, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company, in 1998.
About Merck
Merck, a leading science and technology company, operates across life science, healthcare and electronics. More than 62,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2024, Merck, generated sales of € 21.2 billion in 65 countries.
The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.
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