Merck MRK, known as MSD outside the United States and Canada, today
announced that the U.S. Food and Drug Administration (FDA) has granted
Breakthrough Therapy Designation to KEYTRUDA(R) (pembrolizumab), the
company's anti-PD-1 therapy, for the treatment of patients with
microsatellite instability high (MSI-H) metastatic colorectal cancer. This
is the third Breakthrough Therapy Designation granted for KEYTRUDA.
"We are committed to understanding the full potential of KEYTRUDA to help
patients with a broad range of difficult-to-treat cancers," said Dr. Roger
M. Perlmutter, president, Merck Research Laboratories. "The data
investigating the use of KEYTRUDA in patients with advanced colorectal
cancer whose tumors have substantial evidence of mismatch DNA repair defects
have been encouraging, and we appreciate the opportunity that this FDA
Breakthrough Therapy Designation provides us to accelerate our effort to
bring KEYTRUDA to these patients."
The FDA's Breakthrough Therapy Designation is intended to expedite the
development and review of a candidate that is planned for use, alone or in
combination, to treat a serious or life-threatening disease or condition
when preliminary clinical evidence indicates that the drug may demonstrate
substantial improvement over existing therapies on one or more clinically
significant endpoints. KEYTRUDA was previously granted breakthrough status
for advanced melanoma and advanced non-small cell lung cancer (NSCLC).
The Breakthrough Therapy Designation in advanced colorectal cancer is based
on data from a Phase 2 study evaluating the activity of KEYTRUDA in cancers
with microsatellite instability, a well-established feature seen in cells
with certain types of DNA repair defects. Findings from the study, led by
researchers from Johns Hopkins Kimmel Cancer Center, were presented at the
2015 American Society of Clinical Oncology (ASCO) annual meeting and were
published simultaneously in the New England Journal of Medicine.
Testing tumors for microsatellite instability can identify patients with
defective DNA mismatch repair (MMR) systems. DNA MMR is a process that
permits cells to recognize and repair genetic mismatches generated during
DNA replication. A defective MMR system allows mismatch mutations to
persist. The average tumor has dozens of mutations; however tumors with DNA
MMR deficiency may harbor thousands, especially in regions of repetitive DNA
known as microsatellites. Tumors that are found to have mutations in select
microsatellite sequences, called microsatellite instability (MSI), are
considered DNA MMR-deficient. These tumors are referred to as being "MSI
high." Overall, DNA MMR-deficiency is present in approximately 15-20 percent
in Stage II disease, 10 percent in Stage III disease and approximately 5
percent or less in Stage IV disease. In colorectal cancers, MMR-deficiency
is seen in approximately 15-20 percent of non-hereditary colorectal cancers
and in most hereditary colorectal cancers associated with Lynch Syndrome.
Merck is conducting a Phase 2 registration study (KEYNOTE-164) to evaluate
the efficacy and safety of KEYTRUDA based on microsatellite instability
status in patients with previously treated advanced colorectal cancers, and
is also planning a Phase 3 study (KEYNOTE-177) in a treatment naïve
patient population.
The KEYTRUDA clinical development program includes patients with more than
30 tumor types in more than 160 clinical trials, including more than 80
trials that combine KEYTRUDA with other cancer treatments.
Registration-enabling trials of KEYTRUDA are currently enrolling patients in
melanoma, NSCLC, head and neck cancer, bladder cancer, gastric cancer,
colorectal cancer, esophageal cancer, breast cancer, Hodgkin lymphoma,
multiple myeloma and other tumors, with further trials in planning for other
cancers.
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