First-Time Data for Merck’s KEYTRUDA® (pembrolizumab) in Patients with Previously Treated Advanced Hepatocellular Carcinoma (HCC) to be Presented at 2018 ASCO GI Symposium
KENILWORTH, N.J.--(BUSINESS WIRE)--Jan. 19, 2018-- Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced findings from the registrational phase 2 KEYNOTE-224 trial investigating the use of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with advanced hepatocellular carcinoma (HCC), the most common type of liver cancer, who were previously treated with systemic therapy (sorafenib). Results showed an overall response rate (ORR) of 16.3 percent (95% CI, 9.8-24.9) (n=17/104) with KEYTRUDA as monotherapy. Data also include six-month overall survival (OS) and progression-free survival (PFS) rates. The findings will be presented at the 2018 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium in San Francisco in an oral presentation on Friday, Jan. 19, from 1:10-1:15 p.m. PT (Location: Level 3 – Room 3014) (Abstract #209).
“There continues to be a significant need for new options in the treatment of advanced hepatocellular carcinoma,” said Andrew Zhu, M.D., Ph.D., lead investigator and director of liver cancer research at Massachusetts General Hospital Cancer Center. “The durable responses observed with KEYTRUDA monotherapy in this difficult-to-treat cancer are encouraging.”
“Merck is committed to understanding the clinical benefit of KEYTRUDA monotherapy across a range of gastrointestinal cancers, including advanced liver cancer,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “The findings from this study demonstrate the potential of KEYTRUDA in patients with advanced HCC following prior systemic therapy and support the advancement of our clinical development program in this cancer type.”
Merck has the industry’s largest immuno-oncology clinical research program, which currently involves more than 650 trials studying KEYTRUDA (pembrolizumab) across a wide variety of cancers and treatment settings, including multiple gastrointestinal disorders such as HCC and gastroesophageal cancer.
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.
Data in Previously Treated Advanced HCC, KEYNOTE-224 (Abstract #209)
KEYNOTE-224 is a registrational, open-label phase 2 trial investigating KEYTRUDA monotherapy in patients with advanced HCC who had previously received systemic therapy with sorafenib. The primary endpoint is ORR; secondary endpoints include duration of response, disease control rate, time to progression, PFS and OS.
Findings presented at ASCO GI were based on data from 104 evaluable patients, previously treated with sorafenib, who received one or more doses of KEYTRUDA (200 mg intravenous infusion on day 1 of each 3-week cycle for up to 35 administrations). Data showed an ORR of 16.3 percent (95% CI, 9.8-24.9) (n=17/104) with a complete response rate of one percent (95% CI, 0.0-5.2) and a partial response rate of 15.4 percent (95% CI, 9.1-23.8). ORR was similar across subgroups with different etiology, including Hepatitis B and Hepatitis C positive patients. At the time of analysis, the median duration of response was 8.2 months (range: 2.3+ to 8.3+) with 94 percent of responses ongoing for six months or longer (calculated per Kaplan-Meier method). The disease control rate was 61.5 percent (95% CI, 51.5-70.9) (n=64/104). The median PFS was 4.8 months (95% CI, 3.4-6.6) with a six-month PFS rate of 43.1 percent. The median OS had not been reached at the time of analysis (95% CI, 9.4-not reached) with a six-month OS rate of 77.9 percent.
The safety profile of KEYTRUDA was consistent with that observed in previously reported studies. The treatment-related adverse events (any grade occurring in 10% or more of patients) were fatigue (12.5%), increased aspartate aminotransferase (9.6%), diarrhea (9.6%) and pruritus (21.2%). Grade 3-5 treatment-related adverse events occurred in 26 (25%) patients and there was one treatment-related death. Immune-mediated adverse events occurred in 2.9 percent of patients. Seven patients discontinued treatment due to treatment-related adverse events.
About Hepatocellular Carcinoma (HCC)
Hepatocellular carcinoma (HCC) is the most common type of liver cancer in adults. Worldwide, more than 782,000 new cases of liver cancer were diagnosed in 2012. In the U.S., the incidence of liver cancer has more than tripled since 1980 and it is estimated that 42,220 new cases will be diagnosed in this year. In Europe, around 63,500 new cases were diagnosed in 2012. Risk factors for liver cancer include gender, ethnicity, chronic viral hepatitis (Hep-B or Hep-C) infection, cirrhosis, heavy alcohol abuse and obesity. HCC – which is frequently diagnosed at an advanced stage – has one of the highest mortality rates of solid cancers, with a 5-year survival rate of less than 15 percent.
About KEYTRUDA ® (pembrolizumab) Injection 100mg
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.
KEYTRUDA (pembrolizumab) Indications and Dosing
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KENILWORTH, N.J.--(BUSINESS WIRE)--Jan. 19, 2018-- Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced findings from the registrational phase 2 KEYNOTE-224 trial investigating the use of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with advanced hepatocellular carcinoma (HCC), the most common type of liver cancer, who were previously treated with systemic therapy (sorafenib). Results showed an overall response rate (ORR) of 16.3 percent (95% CI, 9.8-24.9) (n=17/104) with KEYTRUDA as monotherapy. Data also include six-month overall survival (OS) and progression-free survival (PFS) rates. The findings will be presented at the 2018 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium in San Francisco in an oral presentation on Friday, Jan. 19, from 1:10-1:15 p.m. PT (Location: Level 3 – Room 3014) (Abstract #209).
“There continues to be a significant need for new options in the treatment of advanced hepatocellular carcinoma,” said Andrew Zhu, M.D., Ph.D., lead investigator and director of liver cancer research at Massachusetts General Hospital Cancer Center. “The durable responses observed with KEYTRUDA monotherapy in this difficult-to-treat cancer are encouraging.”
“Merck is committed to understanding the clinical benefit of KEYTRUDA monotherapy across a range of gastrointestinal cancers, including advanced liver cancer,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “The findings from this study demonstrate the potential of KEYTRUDA in patients with advanced HCC following prior systemic therapy and support the advancement of our clinical development program in this cancer type.”
Merck has the industry’s largest immuno-oncology clinical research program, which currently involves more than 650 trials studying KEYTRUDA (pembrolizumab) across a wide variety of cancers and treatment settings, including multiple gastrointestinal disorders such as HCC and gastroesophageal cancer.
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.
Data in Previously Treated Advanced HCC, KEYNOTE-224 (Abstract #209)
KEYNOTE-224 is a registrational, open-label phase 2 trial investigating KEYTRUDA monotherapy in patients with advanced HCC who had previously received systemic therapy with sorafenib. The primary endpoint is ORR; secondary endpoints include duration of response, disease control rate, time to progression, PFS and OS.
Findings presented at ASCO GI were based on data from 104 evaluable patients, previously treated with sorafenib, who received one or more doses of KEYTRUDA (200 mg intravenous infusion on day 1 of each 3-week cycle for up to 35 administrations). Data showed an ORR of 16.3 percent (95% CI, 9.8-24.9) (n=17/104) with a complete response rate of one percent (95% CI, 0.0-5.2) and a partial response rate of 15.4 percent (95% CI, 9.1-23.8). ORR was similar across subgroups with different etiology, including Hepatitis B and Hepatitis C positive patients. At the time of analysis, the median duration of response was 8.2 months (range: 2.3+ to 8.3+) with 94 percent of responses ongoing for six months or longer (calculated per Kaplan-Meier method). The disease control rate was 61.5 percent (95% CI, 51.5-70.9) (n=64/104). The median PFS was 4.8 months (95% CI, 3.4-6.6) with a six-month PFS rate of 43.1 percent. The median OS had not been reached at the time of analysis (95% CI, 9.4-not reached) with a six-month OS rate of 77.9 percent.
The safety profile of KEYTRUDA was consistent with that observed in previously reported studies. The treatment-related adverse events (any grade occurring in 10% or more of patients) were fatigue (12.5%), increased aspartate aminotransferase (9.6%), diarrhea (9.6%) and pruritus (21.2%). Grade 3-5 treatment-related adverse events occurred in 26 (25%) patients and there was one treatment-related death. Immune-mediated adverse events occurred in 2.9 percent of patients. Seven patients discontinued treatment due to treatment-related adverse events.
About Hepatocellular Carcinoma (HCC)
Hepatocellular carcinoma (HCC) is the most common type of liver cancer in adults. Worldwide, more than 782,000 new cases of liver cancer were diagnosed in 2012. In the U.S., the incidence of liver cancer has more than tripled since 1980 and it is estimated that 42,220 new cases will be diagnosed in this year. In Europe, around 63,500 new cases were diagnosed in 2012. Risk factors for liver cancer include gender, ethnicity, chronic viral hepatitis (Hep-B or Hep-C) infection, cirrhosis, heavy alcohol abuse and obesity. HCC – which is frequently diagnosed at an advanced stage – has one of the highest mortality rates of solid cancers, with a 5-year survival rate of less than 15 percent.
About KEYTRUDA ® (pembrolizumab) Injection 100mg
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.
KEYTRUDA (pembrolizumab) Indications and Dosing
Continue reading:
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