First-Time KEYTRUDA Monotherapy Data in Clear Cell RCC to be Presented at 2018 ASCO Annual Meeting
KENILWORTH, NJ, USA I June 03, 2018 I Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced interim results from Cohort A of KEYNOTE-427, a Phase 2 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as first-line treatment for advanced clear cell renal cell carcinoma (RCC). Interim data showed an overall response rate (ORR) of 38.2 percent (95% CI, 29.1-47.9) in patients who received KEYTRUDA monotherapy as first-line therapy, the primary endpoint of the study. In a pre-specified, exploratory sub-group analysis based on PD-L1 status, ORR was 50.0 percent (95% CI, 34.9-65.1) in patients whose tumors expressed PD-L1 (CPS ≥1). In a pre-specified exploratory sub-group analysis based on the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk model, ORR was 42.0 percent (95% CI, 30.2-54.5) in patients with intermediate/poor prognostic risk. This is the first presentation of Phase 2 data for an anti-PD-1 monotherapy as first-line treatment for advanced clear cell RCC. These results, as well as other study findings, are being presented today in an oral session at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #4500).
“Until now, there have been limited data evaluating anti-PD-1 monotherapy in the first-line treatment of advanced clear cell renal cell cancer,” said Dr. David F. McDermott, lead study investigator, director, Biologic Therapy and Cutaneous Oncology Programs, Beth Israel Deaconess Medical Center, leader, Dana Farber/Harvard Cancer Center, Kidney Cancer Program, professor of medicine, Harvard Medical School. “With an overall response rate of nearly 40 percent as monotherapy, these data from KEYNOTE-427 are encouraging for clinicians and for patients living with this difficult-to-treat cancer.”
“We are pleased by the promising results for KEYTRUDA from KEYNOTE-427 – the first Phase 2 study to evaluate an anti-PD-1 therapy as first-line monotherapy for patients with advanced clear cell renal cell cancer,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “These findings support the continued evaluation of KEYTRUDA in the first-line setting, and we look forward to progressing ongoing studies in renal cell cancer investigating KEYTRUDA as both monotherapy and in combination with other therapies.”
Merck has an extensive clinical development program across RCC and is advancing multiple potential registration-enabling studies with KEYTRUDA, as monotherapy and in combination with other treatments, including KEYNOTE-564, KEYNOTE-426 and KEYNOTE-581.
Additional Data from KEYNOTE-427 (Abstract #4500)
KEYNOTE-427 is a single-arm, open-label, non-randomized, multi-cohort, Phase 2 study evaluating the safety and efficacy of KEYTRUDA as monotherapy in patients with advanced RCC who have not received prior systemic therapy. Data being presented at ASCO are from Cohort A, which includes patients with advanced clear cell RCC (n=110). The primary endpoint is ORR, according to RECIST v1.1, as assessed by independent central review. Secondary endpoints include duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety and tolerability.
With a median follow-up of 12.1 months (range, 2.5 to 16.8), KEYTRUDA demonstrated an ORR of 38.2 percent (95% CI, 29.1-47.9), with a complete response rate of 2.7 percent and a partial response rate of 35.5 percent. Additionally, the DCR was 59.1 percent (95% CI, 49.3-68.4) and 67.2 percent of patients experienced a reduction in tumor burden. The median time to response was 2.8 months (range, 2.5 to 10.3) and, at the time of analysis, median DOR was not yet reached (range, 1.4+ to 12.5). Responses lasting for six months or more were observed in 74.8 percent of patients. In an analysis of PFS and OS endpoints, the median PFS was 8.7 months (95% CI, 6.7-12.2) and the six-month PFS rate was 60.2 percent; OS was not reached (95% CI, not reached) and the six-month OS rate was 92.7 percent.
ORR was also assessed in several pre-specified, exploratory subgroups. In an analysis based on PD-L1 status, patients whose tumors expressed PD-L1 (CPS ≥1) (n=46) had an ORR of 50.0 percent (95% CI, 34.9-65.1), with a complete response rate of 6.5 percent and a partial response rate of 43.5 percent. In patients whose tumors did not express PD-L1 (CPS <1) (n=53), ORR was 26.4 percent (95% CI, 15.3-40.3) (all responses were partial responses). Additionally, data were analyzed based on IMDC risk groups. In patients with favorable IMDC risk (n=41), ORR was 31.7 percent (95% CI, 18.1-48.1). In patients with intermediate/poor IMDC risk (n=69), ORR was 42.0 percent (95% CI, 30.2-54.5).
The safety of KEYTRUDA was consistent with what has been seen in previous trials among patients treated with KEYTRUDA monotherapy. Treatment-related grade 3-5 adverse events were reported in 30.2 percent of patients. The most common treatment-related adverse events (TRAEs) with an incidence of 10 percent or more were pruritus (27.3%), fatigue (24.5%), diarrhea (19.1%), rash (15.5%), arthralgia (12.7%) and hypothyroidism (10%). The most common immune-mediated adverse events of any grade were hypothyroidism (10.9%), hyperthyroidism (4.5%), pneumonitis (4.5%), colitis (2.7%), hepatitis (1.8%), severe skin reaction (1.8%) and myositis (1.8%). Twelve patients discontinued treatment due to TRAEs. There was one treatment-related death due to pneumonitis.
About KEYNOTE-427
KEYNOTE-427 (ClinicalTrials.gov, NCT02853344) enrolled 275 patients with advanced RCC across two cohorts: patients with clear cell RCC (Cohort A) or patients with non-clear cell RCC (Cohort B). Patients in both cohorts received KEYTRUDA (200 mg fixed dose intravenously every three weeks) until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
About Renal Cell Carcinoma
Renal cell carcinoma (RCC) is the most common type of kidney cancer in the U.S. The rate of kidney cancer has been rising nationwide since the 1990s, and it is estimated that there will be approximately 63,340 new cases of the disease diagnosed this year alone. About 9 out of 10 kidney cancers are RCCs. There are several subtypes of RCC, including clear cell RCC, which accounts for approximately 70 percent of all RCC diagnoses. Kidney cancer is more common among older people; the average age of diagnosis is 64 years.
Merck Investor Webcast
Merck will hold an investor event in conjunction with the 2018 ASCO Annual Meeting on Monday, June 4 at 5:45 p.m. CT. Those unable to attend in person will be able to listen to a live audio webcast of the presentation. Those interested in participating can register and join here.
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.
Merck has the industry’s largest immuno-oncology clinical research program, which currently involves more than 750 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.
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 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 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 children 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.
Gastric Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted 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. The recommended dose of KEYTRUDA is 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
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.
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: 108
First-Time KEYTRUDA Monotherapy Data in Clear Cell RCC to be Presented at 2018 ASCO Annual Meeting
KENILWORTH, NJ, USA I June 03, 2018 I Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced interim results from Cohort A of KEYNOTE-427, a Phase 2 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as first-line treatment for advanced clear cell renal cell carcinoma (RCC). Interim data showed an overall response rate (ORR) of 38.2 percent (95% CI, 29.1-47.9) in patients who received KEYTRUDA monotherapy as first-line therapy, the primary endpoint of the study. In a pre-specified, exploratory sub-group analysis based on PD-L1 status, ORR was 50.0 percent (95% CI, 34.9-65.1) in patients whose tumors expressed PD-L1 (CPS ≥1). In a pre-specified exploratory sub-group analysis based on the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk model, ORR was 42.0 percent (95% CI, 30.2-54.5) in patients with intermediate/poor prognostic risk. This is the first presentation of Phase 2 data for an anti-PD-1 monotherapy as first-line treatment for advanced clear cell RCC. These results, as well as other study findings, are being presented today in an oral session at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #4500).
“Until now, there have been limited data evaluating anti-PD-1 monotherapy in the first-line treatment of advanced clear cell renal cell cancer,” said Dr. David F. McDermott, lead study investigator, director, Biologic Therapy and Cutaneous Oncology Programs, Beth Israel Deaconess Medical Center, leader, Dana Farber/Harvard Cancer Center, Kidney Cancer Program, professor of medicine, Harvard Medical School. “With an overall response rate of nearly 40 percent as monotherapy, these data from KEYNOTE-427 are encouraging for clinicians and for patients living with this difficult-to-treat cancer.”
“We are pleased by the promising results for KEYTRUDA from KEYNOTE-427 – the first Phase 2 study to evaluate an anti-PD-1 therapy as first-line monotherapy for patients with advanced clear cell renal cell cancer,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “These findings support the continued evaluation of KEYTRUDA in the first-line setting, and we look forward to progressing ongoing studies in renal cell cancer investigating KEYTRUDA as both monotherapy and in combination with other therapies.”
Merck has an extensive clinical development program across RCC and is advancing multiple potential registration-enabling studies with KEYTRUDA, as monotherapy and in combination with other treatments, including KEYNOTE-564, KEYNOTE-426 and KEYNOTE-581.
Additional Data from KEYNOTE-427 (Abstract #4500)
KEYNOTE-427 is a single-arm, open-label, non-randomized, multi-cohort, Phase 2 study evaluating the safety and efficacy of KEYTRUDA as monotherapy in patients with advanced RCC who have not received prior systemic therapy. Data being presented at ASCO are from Cohort A, which includes patients with advanced clear cell RCC (n=110). The primary endpoint is ORR, according to RECIST v1.1, as assessed by independent central review. Secondary endpoints include duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety and tolerability.
With a median follow-up of 12.1 months (range, 2.5 to 16.8), KEYTRUDA demonstrated an ORR of 38.2 percent (95% CI, 29.1-47.9), with a complete response rate of 2.7 percent and a partial response rate of 35.5 percent. Additionally, the DCR was 59.1 percent (95% CI, 49.3-68.4) and 67.2 percent of patients experienced a reduction in tumor burden. The median time to response was 2.8 months (range, 2.5 to 10.3) and, at the time of analysis, median DOR was not yet reached (range, 1.4+ to 12.5). Responses lasting for six months or more were observed in 74.8 percent of patients. In an analysis of PFS and OS endpoints, the median PFS was 8.7 months (95% CI, 6.7-12.2) and the six-month PFS rate was 60.2 percent; OS was not reached (95% CI, not reached) and the six-month OS rate was 92.7 percent.
ORR was also assessed in several pre-specified, exploratory subgroups. In an analysis based on PD-L1 status, patients whose tumors expressed PD-L1 (CPS ≥1) (n=46) had an ORR of 50.0 percent (95% CI, 34.9-65.1), with a complete response rate of 6.5 percent and a partial response rate of 43.5 percent. In patients whose tumors did not express PD-L1 (CPS <1) (n=53), ORR was 26.4 percent (95% CI, 15.3-40.3) (all responses were partial responses). Additionally, data were analyzed based on IMDC risk groups. In patients with favorable IMDC risk (n=41), ORR was 31.7 percent (95% CI, 18.1-48.1). In patients with intermediate/poor IMDC risk (n=69), ORR was 42.0 percent (95% CI, 30.2-54.5).
The safety of KEYTRUDA was consistent with what has been seen in previous trials among patients treated with KEYTRUDA monotherapy. Treatment-related grade 3-5 adverse events were reported in 30.2 percent of patients. The most common treatment-related adverse events (TRAEs) with an incidence of 10 percent or more were pruritus (27.3%), fatigue (24.5%), diarrhea (19.1%), rash (15.5%), arthralgia (12.7%) and hypothyroidism (10%). The most common immune-mediated adverse events of any grade were hypothyroidism (10.9%), hyperthyroidism (4.5%), pneumonitis (4.5%), colitis (2.7%), hepatitis (1.8%), severe skin reaction (1.8%) and myositis (1.8%). Twelve patients discontinued treatment due to TRAEs. There was one treatment-related death due to pneumonitis.
About KEYNOTE-427
KEYNOTE-427 (ClinicalTrials.gov, NCT02853344) enrolled 275 patients with advanced RCC across two cohorts: patients with clear cell RCC (Cohort A) or patients with non-clear cell RCC (Cohort B). Patients in both cohorts received KEYTRUDA (200 mg fixed dose intravenously every three weeks) until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
About Renal Cell Carcinoma
Renal cell carcinoma (RCC) is the most common type of kidney cancer in the U.S. The rate of kidney cancer has been rising nationwide since the 1990s, and it is estimated that there will be approximately 63,340 new cases of the disease diagnosed this year alone. About 9 out of 10 kidney cancers are RCCs. There are several subtypes of RCC, including clear cell RCC, which accounts for approximately 70 percent of all RCC diagnoses. Kidney cancer is more common among older people; the average age of diagnosis is 64 years.
Merck Investor Webcast
Merck will hold an investor event in conjunction with the 2018 ASCO Annual Meeting on Monday, June 4 at 5:45 p.m. CT. Those unable to attend in person will be able to listen to a live audio webcast of the presentation. Those interested in participating can register and join here.
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.
Merck has the industry’s largest immuno-oncology clinical research program, which currently involves more than 750 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.
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 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 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 children 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.
Gastric Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted 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. The recommended dose of KEYTRUDA is 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
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.
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: 108
