KENILWORTH - Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-177 trial evaluating first-line treatment of KEYTRUDA, Merck's anti-PD-1 therapy, in patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer met one of its dual primary endpoints of progression-free survival (PFS).
Based on an interim analysis conducted by an independent Data Monitoring Committee (DMC), KEYTRUDA monotherapy demonstrated a statistically significant and clinically meaningful improvement in PFS compared with chemotherapy (investigator's choice of mFOLFOX6 or FOLFIRI, with or without bevacizumab or cetuximab). Based on the recommendation of the DMC, the study will continue without changes to evaluate overall survival (OS), the other dual primary endpoint. The safety profile of KEYTRUDA in this trial was consistent with previously reported studies, and no new safety signals were identified.
'These head-to-head data with KEYTRUDA are the first time a single-agent, anti-cancer therapy, and particularly an anti-PD-1 monotherapy, achieved a statistically significant improvement in progression-free survival over chemotherapy, including the current standard of care regimen of mFOLFOX6 plus bevacizumab, in patients with MSI-H colorectal cancer,' said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. 'These data in the first-line treatment setting provide further evidence of the benefits of KEYTRUDA monotherapy in patients whose tumors are MSI-H or dMMR. We look forward to sharing these data as quickly as possible with the medical community and regulatory authorities.'
In May 2017, KEYTRUDA became the first cancer therapy approved by the U.S. Food & Drug Administration for use based on a biomarker, regardless of tumor type, in previously treated patients with MSI-H or dMMR solid tumors.
Microsatellite instability (or MSI) is defined by the National Cancer Institute as a change that occurs in the DNA of certain cells (such as tumor cells) in which the number of repeats of microsatellites (short, repeated sequences of DNA) is different from the number of repeats that was in the DNA when it was inherited. The cause of microsatellite instability may be a defect in the ability to repair mistakes made when DNA is copied in the cell. This defect is also referred to as mismatch repair deficient (dMMR). It is estimated that approximately 10-15% of colorectal cancer patients have tumors that score as either MSI-H or dMMR when testing is performed.
About KEYNOTE-177
KEYNOTE-177 (ClinicalTrials.gov, NCT02563002) is a randomized, open-label, Phase 3 trial evaluating KEYTRUDA monotherapy versus standard of care chemotherapy for the first-line treatment of patients with MSI-H or dMMR advanced colorectal cancer. The dual primary endpoints are PFS and OS, and the secondary endpoint is ORR. The study enrolled 308 patients who were randomized to receive either: KEYTRUDA (200 mg fixed dose every three weeks for up to 35 cycles of treatment [up to approximately two years]); or Investigator's choice of one of the following chemotherapy-based regimens: mFOLFOX6; mFOLFOX6 plus bevacizumab (5 mg/kg IV on Day 1 of each two-week cycle); mFOLFOX6 plus cetuximab (400 mg/m2 IV, then 250 mg/m2 weekly in each two-week cycle); FOLFIRI; FOLFIRI plus bevacizumab (5 mg/kg IV on Day 1 of each two-week cycle); or FOLFIRI plus cetuximab (400 mg/m2 IV, then 250 mg/m2 weekly in each two-week cycle).
About Colorectal Cancer
Colorectal cancer starts in the colon or the rectum, and these cancers are referred to as colon cancer and rectal cancer depending on where the cancer starts. Colorectal cancer often begins with growths on the inner lining of the colon or rectum called polyps, which can change into cancer over time. Colorectal cancer is the third most commonly diagnosed cancer and the second most common cause of cancer-related death worldwide. It is estimated there were nearly 850,000 new cases of colorectal cancer and more than 880,000 deaths from the disease globally in 2018. In the United States, it is estimated there will be nearly 105,000 new cases of colon cancer and more than 43,000 new cases of rectal cancer, resulting in more than 53,000 deaths from colorectal cancer in 2020. The five-year survival rates for advanced/metastatic colon cancer and rectal cancer (stage IV) are estimated to be 14% and 15%, respectively.
About KEYTRUDA (pembrolizumab) Injection, 100 mg
KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Merck has the industry's largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.
Merck's Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers.
About Merck
For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases as we aspire to be the premier research-intensive biopharmaceutical company in the world.
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
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