Findings Show Durable Responses with KEYTRUDA after Treatment Concluded: 91 Percent of Patients Who Discontinued Treatment at Two Years Were Alive Without Progression of Disease after a Median Follow-Up of Nearly 10 Months
KENILWORTH, NJ, USA I June 2, 2017 I Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced updated longer-term overall survival (OS) data from KEYNOTE-006, the phase 3 study evaluating KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with unresectable or metastatic melanoma. The data showed sustained superior survival outcomes for patients receiving KEYTRUDA (monotherapy) compared to ipilimumab in patients who were treatment-naïve or received one prior line of therapy for the treatment of advanced melanoma. The survival benefit was sustained in patients who completed the planned two years of treatment with KEYTRUDA. These data will be presented in an oral session at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on Sunday, June 4, from 9:12 to 9:24 a.m. CDT (Location: Arie Crown Theater) (Abstract #9504).
In the longer-term findings to be presented, treatment with KEYTRUDA was associated with a 30 percent improvement in survival: 50 percent of patients in the KEYTRUDA group (based on a pooled analysis of the two doses studied: 10 mg/kg every two weeks or 10 mg/kg every three weeks; n=556) were alive nearly three years (33.9 months) after starting treatment with KEYTRUDA, compared to 39 percent of patients in the ipilimumab group (n=278) (HR: 0.70 [95% CI, 0.58-0.86]). In addition, KEYTRUDA nearly doubled the rate of progression-free survival (PFS) at 33.9 months: 31 percent of patients in the KEYTRUDA group were alive and their disease had not progressed, compared to 14 percent of patients in the ipilimumab group.
“KEYTRUDA continues to demonstrate improved overall survival compared to ipilimumab, and the findings to be presented at ASCO reinforce the benefit of KEYTRUDA in the treatment of advanced melanoma,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories.
The KEYTRUDA (pembrolizumab) clinical development program includes more than 30 tumor types in more than 500 clinical trials, including more than 300 trials that combine KEYTRUDA with other cancer treatments. Today, KEYTRUDA is approved for the treatment of advanced melanoma in more than 50 countries, including the United States and throughout Europe.
“With longer-term follow-up in this study, we are continuing to see superior survival with KEYTRUDA, including in patients whose treatment has concluded,” said Dr. Caroline Robert, head of dermatology at Gustave Roussy, Villejuif and Paris-Sud University Cancer Campus, Grand Paris. “Importantly, these findings also continue to reaffirm the established safety profile for KEYTRUDA.”
Key Findings from the KEYNOTE-006 Study
KEYNOTE-006 is a global, open-label, randomized, pivotal, phase 3 study evaluating KEYTRUDA compared to ipilimumab in patients with unresectable stage III or IV advanced melanoma who had either not been treated previously (first-line treatment setting) or who had received one prior therapy (in the KEYTRUDA arm 34% received prior therapy; in the ipilimumab arm, 35% received prior therapy). The study randomized 834 patients to receive KEYTRUDA 10 mg/kg every three weeks, KEYTRUDA 10 mg/kg every two weeks, or four cycles of ipilimumab 3 mg/kg every three weeks. Treatment continued until unacceptable toxicity or disease progression; patients without disease progression could be treated for up to 24 months. The co-primary endpoints were PFS and OS; secondary endpoints were overall response rate (ORR), duration of response and safety, with an exploratory analysis for health-related quality of life (QoL). Tumor response was assessed at week 12, then every 6 weeks until week 48, then every 12 weeks thereafter per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by independent, central, blinded radiographic review and investigator-assessed, immune-related response criteria.
The findings to be presented at ASCO were based on a pooled analysis of data from patients receiving the two doses of KEYTRUDA (10 mg/kg every two weeks or 10 mg/kg every three weeks; n=556). Analyses of these data continued to show superior OS, PFS and ORR compared to ipilimumab with follow-up of nearly three years (33.9 months). Specifically, long-term OS data showed 50 percent of patients in the KEYTRUDA (pembrolizumab) treatment arm (n=556) were alive at 33.9 months after starting treatment, compared to 39 percent of patients in the ipilimumab arm (n=278) (HR: 0.70 [95% CI, 0.58-0.86]). The PFS endpoint showed that 31 percent of patients in the KEYTRUDA arm were alive and were disease progression-free at 33.9 months, compared to 14 percent of patients receiving ipilimumab (HR: 0.56 [95% CI, 0.47-0.67]).
ORR, as assessed by investigator, was 42 percent for patients in the KEYTRUDA arm (range: 38-46), compared to 16 percent for patients receiving ipilimumab (range: 12-21). In patients in the KEYTRUDA arm, the complete response rate was 13 percent (95% CI, 11-16) and the partial response rate was 29 percent (95% CI, 25-33); in patients in the ipilimumab arm, the complete response rate was 3 percent (95% CI, 1-6) and the partial response rate was 14 percent (95% CI, 10-18). The responses achieved continue to be durable, as the median duration of response has not been reached.
Further analyses were conducted to assess the outcomes in patients who had completed 94 or more weeks of treatment with KEYTRUDA (n=104/556) and stopped treatment as planned per protocol. After a median follow-up of 9.7 months since stopping treatment, the estimated PFS was 91 percent (95% CI, 80-96). With longer follow-up, adverse events have remained consistent with previously reported safety data. There was one treatment-related death in the KEYTRUDA arm. In patients treated with KEYTRUDA, immune-mediated adverse events observed in more than 2 percent of patients were hypothyroidism (11%), hyperthyroidism (5%), colitis (3%), skin disorders (3%), and pneumonitis (2%).
About Melanoma
Melanoma, the most serious form of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells. The incidence of melanoma has been increasing over the past four decades – approximately 232,000 new cases were diagnosed worldwide in 2012. In the U.S., melanoma is one of the most common types of cancer diagnosed and is responsible for the vast majority of skin cancer deaths. In 2016, an estimated 76,380 people are expected to be diagnosed and an estimated 10,130 people are expected to die of the disease in the U.S. alone. The five-year survival rates for advanced or metastatic melanoma (Stage IV) are estimated to be 15 to 20 percent.
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 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 (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.
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 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 (pembrolizumab) 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 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: 144
Findings Show Durable Responses with KEYTRUDA after Treatment Concluded: 91 Percent of Patients Who Discontinued Treatment at Two Years Were Alive Without Progression of Disease after a Median Follow-Up of Nearly 10 Months
KENILWORTH, NJ, USA I June 2, 2017 I Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced updated longer-term overall survival (OS) data from KEYNOTE-006, the phase 3 study evaluating KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with unresectable or metastatic melanoma. The data showed sustained superior survival outcomes for patients receiving KEYTRUDA (monotherapy) compared to ipilimumab in patients who were treatment-naïve or received one prior line of therapy for the treatment of advanced melanoma. The survival benefit was sustained in patients who completed the planned two years of treatment with KEYTRUDA. These data will be presented in an oral session at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on Sunday, June 4, from 9:12 to 9:24 a.m. CDT (Location: Arie Crown Theater) (Abstract #9504).
In the longer-term findings to be presented, treatment with KEYTRUDA was associated with a 30 percent improvement in survival: 50 percent of patients in the KEYTRUDA group (based on a pooled analysis of the two doses studied: 10 mg/kg every two weeks or 10 mg/kg every three weeks; n=556) were alive nearly three years (33.9 months) after starting treatment with KEYTRUDA, compared to 39 percent of patients in the ipilimumab group (n=278) (HR: 0.70 [95% CI, 0.58-0.86]). In addition, KEYTRUDA nearly doubled the rate of progression-free survival (PFS) at 33.9 months: 31 percent of patients in the KEYTRUDA group were alive and their disease had not progressed, compared to 14 percent of patients in the ipilimumab group.
“KEYTRUDA continues to demonstrate improved overall survival compared to ipilimumab, and the findings to be presented at ASCO reinforce the benefit of KEYTRUDA in the treatment of advanced melanoma,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories.
The KEYTRUDA (pembrolizumab) clinical development program includes more than 30 tumor types in more than 500 clinical trials, including more than 300 trials that combine KEYTRUDA with other cancer treatments. Today, KEYTRUDA is approved for the treatment of advanced melanoma in more than 50 countries, including the United States and throughout Europe.
“With longer-term follow-up in this study, we are continuing to see superior survival with KEYTRUDA, including in patients whose treatment has concluded,” said Dr. Caroline Robert, head of dermatology at Gustave Roussy, Villejuif and Paris-Sud University Cancer Campus, Grand Paris. “Importantly, these findings also continue to reaffirm the established safety profile for KEYTRUDA.”
Key Findings from the KEYNOTE-006 Study
KEYNOTE-006 is a global, open-label, randomized, pivotal, phase 3 study evaluating KEYTRUDA compared to ipilimumab in patients with unresectable stage III or IV advanced melanoma who had either not been treated previously (first-line treatment setting) or who had received one prior therapy (in the KEYTRUDA arm 34% received prior therapy; in the ipilimumab arm, 35% received prior therapy). The study randomized 834 patients to receive KEYTRUDA 10 mg/kg every three weeks, KEYTRUDA 10 mg/kg every two weeks, or four cycles of ipilimumab 3 mg/kg every three weeks. Treatment continued until unacceptable toxicity or disease progression; patients without disease progression could be treated for up to 24 months. The co-primary endpoints were PFS and OS; secondary endpoints were overall response rate (ORR), duration of response and safety, with an exploratory analysis for health-related quality of life (QoL). Tumor response was assessed at week 12, then every 6 weeks until week 48, then every 12 weeks thereafter per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by independent, central, blinded radiographic review and investigator-assessed, immune-related response criteria.
The findings to be presented at ASCO were based on a pooled analysis of data from patients receiving the two doses of KEYTRUDA (10 mg/kg every two weeks or 10 mg/kg every three weeks; n=556). Analyses of these data continued to show superior OS, PFS and ORR compared to ipilimumab with follow-up of nearly three years (33.9 months). Specifically, long-term OS data showed 50 percent of patients in the KEYTRUDA (pembrolizumab) treatment arm (n=556) were alive at 33.9 months after starting treatment, compared to 39 percent of patients in the ipilimumab arm (n=278) (HR: 0.70 [95% CI, 0.58-0.86]). The PFS endpoint showed that 31 percent of patients in the KEYTRUDA arm were alive and were disease progression-free at 33.9 months, compared to 14 percent of patients receiving ipilimumab (HR: 0.56 [95% CI, 0.47-0.67]).
ORR, as assessed by investigator, was 42 percent for patients in the KEYTRUDA arm (range: 38-46), compared to 16 percent for patients receiving ipilimumab (range: 12-21). In patients in the KEYTRUDA arm, the complete response rate was 13 percent (95% CI, 11-16) and the partial response rate was 29 percent (95% CI, 25-33); in patients in the ipilimumab arm, the complete response rate was 3 percent (95% CI, 1-6) and the partial response rate was 14 percent (95% CI, 10-18). The responses achieved continue to be durable, as the median duration of response has not been reached.
Further analyses were conducted to assess the outcomes in patients who had completed 94 or more weeks of treatment with KEYTRUDA (n=104/556) and stopped treatment as planned per protocol. After a median follow-up of 9.7 months since stopping treatment, the estimated PFS was 91 percent (95% CI, 80-96). With longer follow-up, adverse events have remained consistent with previously reported safety data. There was one treatment-related death in the KEYTRUDA arm. In patients treated with KEYTRUDA, immune-mediated adverse events observed in more than 2 percent of patients were hypothyroidism (11%), hyperthyroidism (5%), colitis (3%), skin disorders (3%), and pneumonitis (2%).
About Melanoma
Melanoma, the most serious form of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells. The incidence of melanoma has been increasing over the past four decades – approximately 232,000 new cases were diagnosed worldwide in 2012. In the U.S., melanoma is one of the most common types of cancer diagnosed and is responsible for the vast majority of skin cancer deaths. In 2016, an estimated 76,380 people are expected to be diagnosed and an estimated 10,130 people are expected to die of the disease in the U.S. alone. The five-year survival rates for advanced or metastatic melanoma (Stage IV) are estimated to be 15 to 20 percent.
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 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 (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.
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 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 (pembrolizumab) 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 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: 144
