- 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
(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) |
|
|
|
|
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) |
|||
|
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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