Guangzhou,
China -- Bio-Thera Solutions, announced the initiation of a Phase III
clinical trial evaluating the efficacy and safety of its investigational
HER2 Antibody-Drug Conjugate (ADC), BAT8001, in patients with HER-2
positive metastatic breast cancer who previously received trastuzumab
separately or in combination with taxanes. The trial is designed to
compare BAT8001 versus lapatinib combined with capecitabine which is 2nd-line standard of care for metastatic breast cancer patients in China.
This Phase
III, multicenter, randomized, open-label, controlled trial will recruit
approximately 410 patients in China. The primary efficacy outcome of the
trial is progression-free survival (PFS). Other pre-specified outcome
measures include overall survival (OS), and objective response rate
(ORR). The safety and immunogenicity of BAT8001 will also be evaluated
in the trial.
More information on the trial is available at http://www.chinadrugtrials.org.cn/ (CTR20180157).
About BAT8001
About Antibody-Drug Conjugates
Antibody-drug
Conjugates or ADCs are designed to harness the targeting ability of
monoclonal antibodies (mAbs) to deliver cytotoxic agents selectively to
tumor cells by linking the monoclonal antibody and cytotoxic agent
through a chemical linker. An ideal ADC consists of: 1) a highly
selective mAb for a tumor-associated antigen that has little or no
expression on normal cells, 2) a potent cytotoxic agent designed to
induce target cell death after being internalized in the tumor cell and
released and 3) a chemical linker that is stable in circulation but
releases the cytotoxic agent in target cells. By selectively delivering
a cytotoxic agent directly inside a tumor cell, ADCs increase the
safety and tolerability of the cytotoxic agent relative to giving the
cytotoxic agent systemically to the patient.
About Metastatic Breast Cancer
"Metastatic
breast cancer is a difficult to treat cancer that impacts hundreds of
thousands of patients around the world. Patients with metastatic breast
cancer need more treatment options that provide an improved survival
benefit," said Shengfeng Li, CEO of Bio-Thera Solutions. "This Phase III
trial is an important step in the development of BAT8001, potentially
providing patients with metastatic breast cancer a new treatment
option."
BAT8001 is
an investigational HER2-ADC being evaluated in multiple tumor types.
HER2 is a naturally occurring receptor that is overexpressed in many
types of cancer, including breast cancer and gastric cancer. BAT8001 is
being developed for use as a single agent and in combination with other
agents for the treatment of multiple cancers. The BAT8001 clinical
study program will be expanded beyond metastatic cancer to other
HER2-positive cancers, including gastric cancer, over the next 12
months.
Metastatic
breast cancer is not a specific type of breast cancer, it is breast
cancer that has spread beyond the breast to other organs in the body.
Metastatic breast cancer is most often found in the bones, lungs, liver
or brain but can be found in other locations in the body. Although
metastatic breast cancer has spread to another part of the body, it is
still considered and treated as breast cancer. Typically, metastatic
breast cancer arises months or years after a person has completed
treatment for early or locally advanced breast cancer. This is sometimes
called a distant recurrence. Some patients are first diagnosed with
metastatic breast cancer. This is called de novo metastatic breast
cancer. The risk of metastasis after breast cancer treatment varies
from person to person and depends greatly on the biology of the tumor,
the stage at the time of the original diagnosis and the treatments for
the original cancer.
