KENILWORTH, NJ, USA I June 4, 2017 I Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced findings from Cohort 1 of the phase 2 registrational KEYNOTE-059 trial investigating KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, as monotherapy in previously-treated patients with advanced gastric or gastroesophageal junction adenocarcinoma. Results showed an overall response rate (ORR) of 11.6 percent (95% CI, 8.0-16.1) in patients treated with KEYTRUDA who had received two or more prior lines of treatment, with higher response rates among patients with PD-L1 positive tumors. The results will be presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago in an oral presentation on Sunday, June 4 from 9:00 – 9:12 a.m. CDT (Location: Hall D2) (Abstract #4003).
Data from this Cohort support Merck’s supplemental Biologics License Application (sBLA) for KEYTRUDA – currently under Priority Review with the U.S. Food and Drug Administration (FDA) – seeking approval for the treatment of patients with recurrent or advanced gastric or gastroesophageal junction adenocarcinoma who have already received two or more lines of chemotherapy.
“Advanced gastric cancer is difficult to treat and there is a significant need to identify new treatment options for these patients,” said Charles S. Fuchs, M.D., MPH, lead investigator and director of Yale Cancer Center. “The findings from this study showed meaningful response rates for KEYTRUDA in heavily pre-treated patients, who have historically faced poor outcomes.”
“The data we are observing from this trial are encouraging as they demonstrate the potential for KEYTRUDA to address the serious unmet need that currently exists for patients with advanced gastric cancer,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories.
Merck is committed to investigating new approaches across the spectrum of cancers with more than 500 clinical trials evaluating KEYTRUDA (pembrolizumab) in more than 30 tumor types – including multiple gastrointestinal disorders, such as gastric or gastroesophageal cancers and MSI-H colorectal cancer, among others. Specific to gastric cancer, Merck’s broad clinical development program encompasses all stages of advanced disease and is investigating KEYTRUDA as monotherapy and in combination with other cancer treatments across multiple lines of therapy. To date, the program includes four gastric cancer registration-enabling studies and numerous other gastrointestinal cancer studies are underway.
Key Findings from KEYNOTE-059 Cohort 1
KEYNOTE-059 is a registrational, phase 2 non-randomized, multi-cohort study investigating KEYTRUDA in patients with advanced gastric or gastroesophageal junction adenocarcinoma. In patients who received at least two prior chemotherapies (Cohort 1), KEYTRUDA is being investigated as a monotherapy (200 mg every three weeks for up to 24 months). The primary endpoints are ORR as assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and safety; secondary endpoints include duration of response and overall survival. Data were further assessed based on PD-L1 expression; tumors were considered to have positive PD-L1 expression if the combined positive score (CPS) – as examined by tumor and immune cells – was equal to or greater than one.
The efficacy analysis in all patients (n=259) showed an ORR of 11.6 percent (95% CI, 8.0- 16.1) – with a complete response rate of 2.3 percent (95% CI, 0.9-5.0) and a partial response rate of 9.3 percent (95% CI, 6.0-13.5). Data were further analyzed based on PD-L1 expression. In patients whose tumors expressed PD-L1 (CPS ≥1%) (n=148), the ORR was 15.5 percent (95% CI, 10.1-22.4) – with a complete response rate of two percent (95% CI, 0.4-5.8) and a partial response rate of 13.5 percent (95% CI, 8.5-20.1). In PD-L1 negative patients (n=109), the ORR was 6.4 percent (95% CI, 2.6-12.8) – with a complete response rate of 2.8 percent (95% CI, 0.6-7.8) and a partial response rate of 3.7 percent (95% CI, 1.0-9.1).
Analyses based on prior lines of therapy showed that in patients who received two lines of prior chemotherapy (third-line treatment setting; n=134), the ORR was 16.4 percent (95% CI, 10.6-23.8) – with a complete response rate of 3.0 percent (95% CI, 0.8-7.5) and a partial response rate of 13.4 percent (95% CI, 8.2-20.4). In patients who had received three lines of prior chemotherapy (fourth-line treatment setting; n=125), the ORR was 6.4 percent (95% CI, 2.8-12.2) – with a complete response rate of 1.6 percent (95% CI, 0.2-5.7) and a partial response rate of 4.8 percent (95% CI, 1.8-10.2).
The safety profile of KEYTRUDA (pembrolizumab) was consistent with that observed in previously reported studies. The treatment-related adverse events (any grade occurring in 5% or more of patients) were fatigue (18.9%), pruritus (8.9%), rash (8.5%), hypothyriodism (7.7%), decreased appetite (7.3%), anemia (6.9%), nausea (6.9%), diarrhea (6.6%), and arthralgia (5.8%). Grade 3-4 treatment-related adverse events observed (in all patients) were anemia (2.7%), fatigue (2.3%), diarrhea (1.2%), rash (0.8%), nausea (0.8%), hypothyroidism (0.4%), and arthralgia (0.4%). Two patients discontinued treatment due to treatment-related adverse events (abnormal hepatic function and bile duct stenosis); Grade 5 treatment-related adverse events occurred in two patients (acute kidney injury and pleural effusion). Immune-mediated adverse events of Grade 3-4 occurred in 4.6 percent or less of patients and included: colitis, pneumonitis, thyroiditis, hypothyroidism, and severe skin reactions.
About Gastric Cancer
Gastric cancer, also called stomach cancer, is a type of cancer that begins in the stomach and tends to develop slowly over many years. Most gastric cancers are adenocarcinomas, which develop from the cells of the innermost lining (mucosa) of the stomach. Risk factors for gastric cancer include gender, age, ethnicity, geography and infection with Helicobacter pylori. Worldwide, gastric cancer is the fifth most common type of cancer and the third leading cause of cancer death. Each year there are approximately 952,000 newly diagnosed cases of gastric cancer resulting in approximately 723,000 deaths worldwide. It is estimated that in 2017, more than 10,000 people will die from gastric cancer in the U.S. alone.
About KEYTRUDA ® (pembrolizumab) Injection
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.
Studies of KEYTRUDA – from the largest immuno-oncology program in the industry with more than 500 trials – include a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand factors that predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including the exploration of several different biomarkers across a broad range of tumors.
KEYTRUDA is administered as an intravenous infusion over 30 minutes every three weeks for the approved indications. KEYTRUDA (pembrolizumab) for injection is supplied in a 100 mg single-dose vial.
KEYTRUDA (pembrolizumab) Indications and Dosing
Melanoma
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity.
Lung Cancer
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [tumor proportion score (TPS) ≥50%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA, as a single agent, is also indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
KEYTRUDA, in combination with pemetrexed and carboplatin, is indicated for the first-line treatment of patients with metastatic nonsquamous NSCLC. This indication is approved under accelerated approval based on tumor response rate and progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
In metastatic NSCLC, KEYTRUDA is administered at a fixed dose of 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
When administering KEYTRUDA in combination with chemotherapy, KEYTRUDA should be administered prior to chemotherapy when given on the same day. See also the Prescribing Information for pemetrexed and carboplatin.
Head and Neck Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. In HNSCC, KEYTRUDA (pembrolizumab) is administered at a fixed dose of 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
Classical Hodgkin Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after three or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. In adults with cHL, KEYTRUDA is administered at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression. In pediatric patients with cHL, KEYTRUDA is administered at a dose of 2 mg/kg (up to a maximum of 200 mg) every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.
Urothelial Carcinoma
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
KEYTRUDA is also indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
In locally advanced or metastatic urothelial carcinoma, KEYTRUDA is administered at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.
Microsatellite Instability-High (MSI-H) Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
- solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
- colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA (pembrolizumab) in pediatric patients with MSI-H central nervous system cancers have not been established.
In adult patients with MSI-H cancer, KEYTRUDA is administered at a fixed dose of 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. In pediatric patients with MSI-H cancer, KEYTRUDA is administered at a dose of 2 mg/kg (up to a maximum of 200 mg) every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.
Our Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, helping people fight cancer is our passion and supporting accessibility to our cancer medicines is our commitment. Our focus is on pursuing research in immuno-oncology and we are accelerating every step in the journey – from lab to clinic – to potentially bring new hope to people with cancer.
As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the fastest-growing development programs in the industry. We are currently executing an expansive research program that includes more than 500 clinical trials evaluating our anti-PD-1 therapy across more than 30 tumor types. We also continue to strengthen our immuno-oncology portfolio through strategic acquisitions and are prioritizing the development of several promising immunotherapeutic candidates with the potential to improve the treatment of advanced cancers.
For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.
About Merck
For more than a century, Merck, a leading global biopharmaceutical company 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. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
SOURCE: Merck
Post Views: 66
KENILWORTH, NJ, USA I June 4, 2017 I Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced findings from Cohort 1 of the phase 2 registrational KEYNOTE-059 trial investigating KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, as monotherapy in previously-treated patients with advanced gastric or gastroesophageal junction adenocarcinoma. Results showed an overall response rate (ORR) of 11.6 percent (95% CI, 8.0-16.1) in patients treated with KEYTRUDA who had received two or more prior lines of treatment, with higher response rates among patients with PD-L1 positive tumors. The results will be presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago in an oral presentation on Sunday, June 4 from 9:00 – 9:12 a.m. CDT (Location: Hall D2) (Abstract #4003).
Data from this Cohort support Merck’s supplemental Biologics License Application (sBLA) for KEYTRUDA – currently under Priority Review with the U.S. Food and Drug Administration (FDA) – seeking approval for the treatment of patients with recurrent or advanced gastric or gastroesophageal junction adenocarcinoma who have already received two or more lines of chemotherapy.
“Advanced gastric cancer is difficult to treat and there is a significant need to identify new treatment options for these patients,” said Charles S. Fuchs, M.D., MPH, lead investigator and director of Yale Cancer Center. “The findings from this study showed meaningful response rates for KEYTRUDA in heavily pre-treated patients, who have historically faced poor outcomes.”
“The data we are observing from this trial are encouraging as they demonstrate the potential for KEYTRUDA to address the serious unmet need that currently exists for patients with advanced gastric cancer,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories.
Merck is committed to investigating new approaches across the spectrum of cancers with more than 500 clinical trials evaluating KEYTRUDA (pembrolizumab) in more than 30 tumor types – including multiple gastrointestinal disorders, such as gastric or gastroesophageal cancers and MSI-H colorectal cancer, among others. Specific to gastric cancer, Merck’s broad clinical development program encompasses all stages of advanced disease and is investigating KEYTRUDA as monotherapy and in combination with other cancer treatments across multiple lines of therapy. To date, the program includes four gastric cancer registration-enabling studies and numerous other gastrointestinal cancer studies are underway.
Key Findings from KEYNOTE-059 Cohort 1
KEYNOTE-059 is a registrational, phase 2 non-randomized, multi-cohort study investigating KEYTRUDA in patients with advanced gastric or gastroesophageal junction adenocarcinoma. In patients who received at least two prior chemotherapies (Cohort 1), KEYTRUDA is being investigated as a monotherapy (200 mg every three weeks for up to 24 months). The primary endpoints are ORR as assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and safety; secondary endpoints include duration of response and overall survival. Data were further assessed based on PD-L1 expression; tumors were considered to have positive PD-L1 expression if the combined positive score (CPS) – as examined by tumor and immune cells – was equal to or greater than one.
The efficacy analysis in all patients (n=259) showed an ORR of 11.6 percent (95% CI, 8.0- 16.1) – with a complete response rate of 2.3 percent (95% CI, 0.9-5.0) and a partial response rate of 9.3 percent (95% CI, 6.0-13.5). Data were further analyzed based on PD-L1 expression. In patients whose tumors expressed PD-L1 (CPS ≥1%) (n=148), the ORR was 15.5 percent (95% CI, 10.1-22.4) – with a complete response rate of two percent (95% CI, 0.4-5.8) and a partial response rate of 13.5 percent (95% CI, 8.5-20.1). In PD-L1 negative patients (n=109), the ORR was 6.4 percent (95% CI, 2.6-12.8) – with a complete response rate of 2.8 percent (95% CI, 0.6-7.8) and a partial response rate of 3.7 percent (95% CI, 1.0-9.1).
Analyses based on prior lines of therapy showed that in patients who received two lines of prior chemotherapy (third-line treatment setting; n=134), the ORR was 16.4 percent (95% CI, 10.6-23.8) – with a complete response rate of 3.0 percent (95% CI, 0.8-7.5) and a partial response rate of 13.4 percent (95% CI, 8.2-20.4). In patients who had received three lines of prior chemotherapy (fourth-line treatment setting; n=125), the ORR was 6.4 percent (95% CI, 2.8-12.2) – with a complete response rate of 1.6 percent (95% CI, 0.2-5.7) and a partial response rate of 4.8 percent (95% CI, 1.8-10.2).
The safety profile of KEYTRUDA (pembrolizumab) was consistent with that observed in previously reported studies. The treatment-related adverse events (any grade occurring in 5% or more of patients) were fatigue (18.9%), pruritus (8.9%), rash (8.5%), hypothyriodism (7.7%), decreased appetite (7.3%), anemia (6.9%), nausea (6.9%), diarrhea (6.6%), and arthralgia (5.8%). Grade 3-4 treatment-related adverse events observed (in all patients) were anemia (2.7%), fatigue (2.3%), diarrhea (1.2%), rash (0.8%), nausea (0.8%), hypothyroidism (0.4%), and arthralgia (0.4%). Two patients discontinued treatment due to treatment-related adverse events (abnormal hepatic function and bile duct stenosis); Grade 5 treatment-related adverse events occurred in two patients (acute kidney injury and pleural effusion). Immune-mediated adverse events of Grade 3-4 occurred in 4.6 percent or less of patients and included: colitis, pneumonitis, thyroiditis, hypothyroidism, and severe skin reactions.
About Gastric Cancer
Gastric cancer, also called stomach cancer, is a type of cancer that begins in the stomach and tends to develop slowly over many years. Most gastric cancers are adenocarcinomas, which develop from the cells of the innermost lining (mucosa) of the stomach. Risk factors for gastric cancer include gender, age, ethnicity, geography and infection with Helicobacter pylori. Worldwide, gastric cancer is the fifth most common type of cancer and the third leading cause of cancer death. Each year there are approximately 952,000 newly diagnosed cases of gastric cancer resulting in approximately 723,000 deaths worldwide. It is estimated that in 2017, more than 10,000 people will die from gastric cancer in the U.S. alone.
About KEYTRUDA ® (pembrolizumab) Injection
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.
Studies of KEYTRUDA – from the largest immuno-oncology program in the industry with more than 500 trials – include a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand factors that predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including the exploration of several different biomarkers across a broad range of tumors.
KEYTRUDA is administered as an intravenous infusion over 30 minutes every three weeks for the approved indications. KEYTRUDA (pembrolizumab) for injection is supplied in a 100 mg single-dose vial.
KEYTRUDA (pembrolizumab) Indications and Dosing
Melanoma
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity.
Lung Cancer
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [tumor proportion score (TPS) ≥50%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA, as a single agent, is also indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
KEYTRUDA, in combination with pemetrexed and carboplatin, is indicated for the first-line treatment of patients with metastatic nonsquamous NSCLC. This indication is approved under accelerated approval based on tumor response rate and progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
In metastatic NSCLC, KEYTRUDA is administered at a fixed dose of 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
When administering KEYTRUDA in combination with chemotherapy, KEYTRUDA should be administered prior to chemotherapy when given on the same day. See also the Prescribing Information for pemetrexed and carboplatin.
Head and Neck Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. In HNSCC, KEYTRUDA (pembrolizumab) is administered at a fixed dose of 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
Classical Hodgkin Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after three or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. In adults with cHL, KEYTRUDA is administered at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression. In pediatric patients with cHL, KEYTRUDA is administered at a dose of 2 mg/kg (up to a maximum of 200 mg) every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.
Urothelial Carcinoma
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
KEYTRUDA is also indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
In locally advanced or metastatic urothelial carcinoma, KEYTRUDA is administered at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.
Microsatellite Instability-High (MSI-H) Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
- solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
- colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA (pembrolizumab) in pediatric patients with MSI-H central nervous system cancers have not been established.
In adult patients with MSI-H cancer, KEYTRUDA is administered at a fixed dose of 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. In pediatric patients with MSI-H cancer, KEYTRUDA is administered at a dose of 2 mg/kg (up to a maximum of 200 mg) every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.
Our Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, helping people fight cancer is our passion and supporting accessibility to our cancer medicines is our commitment. Our focus is on pursuing research in immuno-oncology and we are accelerating every step in the journey – from lab to clinic – to potentially bring new hope to people with cancer.
As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the fastest-growing development programs in the industry. We are currently executing an expansive research program that includes more than 500 clinical trials evaluating our anti-PD-1 therapy across more than 30 tumor types. We also continue to strengthen our immuno-oncology portfolio through strategic acquisitions and are prioritizing the development of several promising immunotherapeutic candidates with the potential to improve the treatment of advanced cancers.
For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.
About Merck
For more than a century, Merck, a leading global biopharmaceutical company 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. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
SOURCE: Merck
Post Views: 66
