Based on data, 1.75 mg/kg dose established
as recommended dose for Phase 3 trial of this investigational
antibody-drug conjugate
Merck (NYSE: MRK), known as MSD outside of the United States and
Canada, today announced the first presentation of data from the
Phase 2 waveLINE-007 trial evaluating zilovertamab vedotin, Merck’s
investigational antibody drug conjugate (ADC) that targets receptor
tyrosine kinase-like orphan receptor 1 (ROR1), in combination with
cyclophosphamide, doxorubicin and prednisone plus rituximab (R-CHP)
for the treatment of patients with previously untreated diffuse
large B-cell lymphoma (DLBCL). At a pre-planned analysis,
zilovertamab vedotin in combination with R-CHP achieved a 100%
(n=15) complete response (CR) rate in patients treated with
zilovertamab vedotin at 1.75 mg/kg. Based on the data, the study
has established 1.75 mg/kg as the recommended Phase 3 dose of
zilovertamab vedotin. These data are being presented for the first
time today in an oral presentation (Abstract #578) at the 66th
American Society of Hematology (ASH) Annual Meeting and
Exposition.
“There is a need for additional first-line treatment options to
help patients with diffuse large B-cell lymphoma, since,
unfortunately, approximately 40% still experience relapsed or
refractory disease after initial treatment with the current
standard of care,” said Dr. Muhit Ozcan, the study’s principal
investigator, Ankara University School of Medicine. “These data
from the Phase 2 waveLINE-007 trial are promising and support
further research in the first-line setting in a larger patient
population to help address this significant unmet need for
patients.”
“We are pleased to see these early positive results from the
Phase 2 waveLINE-007 trial, in which zilovertamab vedotin
demonstrated a highly promising response rate and a manageable
safety profile in combination with standard of care,” said Dr.
Gregory Lubiniecki, vice president, oncology clinical research,
Merck Research Laboratories. “We look forward to advancing our
research of this investigational ROR1-directed antibody drug
conjugate, which we believe has strong potential in multiple
hematologic malignancies.”
As announced, data from more than 20 abstracts are being
presented from across a broad range of hematologic malignancies
from Merck’s hematology pipeline, which includes a diverse range of
investigational assets with novel modalities, at the 66th ASH
Annual Meeting and Exposition.
Study design and additional data from waveLINE-007
WaveLINE-007 is a non-randomized, open-label Phase 2 trial
(ClinicalTrials.gov, NCT05406401) evaluating zilovertamab vedotin
(MK-2140) in combination with R-CHP in patients with previously
untreated DLBCL. The primary endpoints are safety (number of
patients with dose limiting toxicity, adverse events and
discontinuation due to adverse events) and CR rate based on
investigator review per Lugano Response Criteria. Secondary
endpoints include objective response rate (ORR) and duration of
response (DOR) per Lugano Response Criteria. As of data cut-off, 36
patients were enrolled in the study to receive zilovertamab vedotin
plus R-CHP intravenously on day 1 of each 21-day cycle (Q3W) for up
to eight cycles. The treatment arms of the study included:
- 1.75 mg/kg (n=15); all 15 patients in this arm completed the
trial (none discontinued)
- 2.0 mg/kg (n=15); 14 patients in this arm completed treatment
and one patient discontinued after cycle 1 due to physician
decision and was entered to safety follow-up, or
- 2.25 mg/kg (n=6); 5 patients in this arm completed treatment
and one patient discontinued due to physician decision
The efficacy results showed a CR was achieved in combination
with R-CHP in 100% (n=15) of patients receiving the 1.75 mg/kg dose
of zilovertamab vedotin (CI: 95%, 78.2-100.0), 93.3% (n=14) of
patients receiving the 2.0 mg/kg dose (CI: 95%, 68.1-99.8) and 100%
(n=6) of patients receiving the 2.25 mg/kg dose (CI: 95%,
54.1-100.0). The total CR rate at the end of treatment was 97.2%
(CI: 95%, 85.5-99.9). The median follow-up for all patients was
17.6 months (range, 7.1-24.6). The ORR was 100% (CI: 95%,
78.2-100.0) for patients receiving the 1.75 mg/kg dose, 93.3% (CI:
95%, 68.1-99.8) for patients receiving the 2.0 mg/kg dose, and 100%
(CI: 95%, 54.1-100.0) for patients receiving the 2.25 mg/kg dose,
all in combination with R-CHP. The median DOR has not been reached
for all patients, and the total 12-month DOR was 93.5%. Based on
the data, the recommended zilovertamab vedotin dose was determined
to be 1.75 mg/kg.
Serious treatment-related adverse events (TRAEs) occurred in 11%
(n=4) of all patients (1.75 mg/kg [n=1], 2.0 mg/kg [n=1], 2.25
mg/kg [n=2]). Grade 3-4 TRAEs occurred in 58% (n=21) of all
patients. The most common of these events were neutropenia, nausea,
anemia and diarrhea.
About diffuse large B-cell lymphoma
Lymphoma is cancer beginning in the lymphatic system – the
network of organs, vessels and tissues that protects the body from
infection. There are many subtypes of lymphoma, which are often
categorized into two main types – Hodgkin lymphoma and non-Hodgkin
lymphoma (NHL). DLBCL, the most common form of NHL, is derived from
white blood cells that grow rapidly and uncontrollably, enlarging
the lymph nodes and often migrating to other parts of the body.
DLBCL accounts for approximately 25-30% of all non-Hodgkin
lymphomas worldwide. In the U.S., it is estimated that
approximately 25,000 patients are diagnosed with DLBCL each year.
The five-year relative survival rate for DLBCL is 60-70%.
About zilovertamab vedotin (MK-2140)
Zilovertamab vedotin is an investigational ADC that targets
ROR1. ROR1 is a transmembrane protein that is overexpressed in
multiple hematologic malignancies. Merck is committed to research
with zilovertamab vedotin across B-cell malignancies and is
establishing a robust program of clinical trials under the name
waveLINE. The waveLINE program includes a Phase 2/3 study in
patients with relapsed or refractory DLBCL (waveLINE-003,
NCT05139017) and a Phase 3 study in treatment naïve patients with
DLBCL (waveLINE-010, NCT06717347).
About Merck in hematology
Merck is committed to advancing innovation and care for people
with hematologic neoplasms and malignancies. Building on its
leadership in oncology, the company has a broad clinical
development program that evaluates novel mechanisms of action to
address longstanding unmet needs for patients with hematologic
disorders. Among Merck’s research efforts are studies evaluating
multiple investigational medicines as monotherapy or in combination
with other therapies across a range of hematologic neoplasms and
malignancies.
Merck’s focus on cancer
Every day, we follow the science as we work to discover
innovations that can help patients, no matter what stage of cancer
they have. As a leading oncology company, we are pursuing research
where scientific opportunity and medical need converge, underpinned
by our diverse pipeline of more than 25 novel mechanisms. With one
of the largest clinical development programs across more than 30
tumor types, we strive to advance breakthrough science that will
shape the future of oncology. By addressing barriers to clinical
trial participation, screening and treatment, we work with urgency
to reduce disparities and help ensure patients have access to
high-quality cancer care. Our unwavering commitment is what will
bring us closer to our goal of bringing life to more patients with
cancer. For more information, visit
https://www.merck.com/research/oncology.
About Merck
At Merck, known as MSD outside of the United States and Canada,
we are unified around our purpose: We use the power of leading-edge
science to save and improve lives around the world. For more than
130 years, we have brought hope to humanity through the development
of important medicines and vaccines. We aspire to be the premier
research-intensive biopharmaceutical company in the world – and
today, we are at the forefront of research to deliver innovative
health solutions that advance the prevention and treatment of
diseases in people and animals. We foster a diverse and inclusive
global workforce and operate responsibly every day to enable a
safe, sustainable and healthy future for all people and
communities. For more information, visit www.merck.com and connect
with us on X (formerly Twitter), Facebook, Instagram, YouTube and
LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Rahway,
N.J., USA
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the candidates will receive the necessary regulatory approvals or
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Media: Julie Cunningham, (617) 519-6264 Sienna Choi, (908)
873-4311 Investor: Peter Dannenbaum, (732) 594-1579 Steven
Graziano, (732) 594-1583
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