Five Months of Additional Data from KEYNOTE-021, Cohort G, Including Updated Overall Survival, to be Presented at ESMO 2017 Congress
KENILWORTH, NJ, USA I September 8, 2017 I Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced updated results from Cohort G of the phase 2 KEYNOTE-021 trial investigating KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in combination with pemetrexed and carboplatin (pem/carbo) in patients with previously untreated advanced nonsquamous non-small cell lung cancer (NSCLC), with or without PD-L1 expression. With an additional five months of follow-up, significant improvements observed in prior analyses were maintained, including improvements in overall response rate (ORR) and progression-free survival (PFS) for KEYTRUDA + pem/carbo compared to pem/carbo alone. With a median of 18.7 months of follow-up, more than half of patients in the KEYTRUDA combination arm responded to treatment compared to approximately one-third in the pem/carbo arm (ORR of 56.7% vs. 31.7% [95% CI, 7.2-40.9], p=0.0029). The risk of progression or death continued to be reduced by nearly half with KEYTRUDA + pem/carbo compared to pem/carbo alone (HR 0.54 [95% CI, 0.33-0.88, p=0.0067]). In addition, despite the crossover design, a trend in improvement in overall survival continues to be seen for KEYTRUDA + pem/carbo compared to pem/carbo alone (HR, 0.59 [95% CI, 0.34-1.05, p=0.03]). Findings are being presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, in an oral presentation on Friday, Sept. 8 from 5:03 – 5:15 p.m. CEST (Location: Madrid Auditorium) (Abstract #LBA49).
“The continued benefit observed with KEYTRUDA plus pem/carbo in overall response rate and progression-free survival reinforce the importance of this combination therapy for the treatment of patients with advanced nonsquamous non-small cell lung cancer, with or without PD-L1 expression,” said Dr. Hossein Borghaei, chief of the division of thoracic medical oncology, Fox Chase Cancer Center.
“Lung cancer is one of the most common and devastating cancers, and these additional data confirm that KEYTRUDA in combination with pemetrexed and carboplatin has the potential to have a meaningful impact in the lives of many of these patients,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories.
Merck is currently advancing multiple registration-enabling studies in NSCLC with KEYTRUDA (pembrolizumab) as monotherapy and in combination, including the combination of KEYTRUDA plus a platinum/pemetrexed-based chemotherapy regimen in patients with previously untreated nonsquamous NSCLC in the ongoing phase 3 KEYNOTE-189 trial.
Data from KEYNOTE-021, Cohort G (Abstract #LBA49)
KEYNOTE-021, Cohort G, evaluated the efficacy and safety of KEYTRUDA + pem/carbo compared to pem/carbo in 123 patients with metastatic, nonsquamous, EGFR- and ALK-negative NSCLC in the first-line treatment setting. In patients randomized to the pem/carbo arm, 63 percent (n=40/63) went on to receive subsequent anti-PD-1 or PD-L1 therapy, including 25 who received KEYTRUDA as part of study crossover (additional details on the trial design are provided below).
Data to be presented at ESMO include five months of additional follow-up from prior presentations, for a median follow-up of 18.7 months (range: 0.8-29.0). In this analysis, the KEYTRUDA + pem/carbo combination group (n=60) continued to show improvement over the group receiving pem/carbo alone (n=63) in overall response rate, duration of response and PFS.
ORR was 56.7 percent in the KEYTRUDA + pem/carbo combination group compared to 31.7 percent in the pem/carbo group (95% CI, 7.2-40.9; p=0.0029). The median duration of response had not been reached in either arm (range: 1.4+ to 22.7+ with KEYTRUDA + pem/carbo and 2.8 to 23.7+ in the pem/carbo group). At the time of analysis, 50 percent of responses were ongoing in the KEYTRUDA + pem/carbo combination group compared to 40 percent in the pem/carbo group.
The patients in the KEYTRUDA + pem/carbo arm had a 46 percent reduction in progression or death risk compared with pem/carbo alone (HR 0.54 [95% CI, 0.33-0.88, p=0.0067]). The median PFS was twice as long in the group receiving KEYTRUDA, with 19.0 months (95% CI, 8.5-not reached) for KEYTRUDA plus pem/carbo compared to 8.9 months in the pem/carbo group (95% CI, 6.2-11.8). At 12 and 18 months, PFS in the KEYTRUDA + pem/carbo combination group was 57 percent and 52 percent, respectively, compared to 37 percent and 29 percent in the pem/carbo group.
A trend toward improvement in OS was observed in the KEYTRUDA (pembrolizumab) + pem/carbo arm: the combination was associated with a 41 percent reduction in the risk of death (HR, 0.59 [95% CI, 0.34-1.05, p=0.03]). The median OS was not reached (range: 22.8-not reached) in the KEYTRUDA + pem/carbo combination group compared to 20.9 months (range: 14.9-not reached) in the pem/carbo group.
The safety findings were consistent with previously presented results from this study. Grade 3-5 treatment-related adverse events (TRAEs) occurred in 41 percent of patients in the KEYTRUDA + pem/carbo group. TRAEs of any grade with an incidence of 15 percent or more in the KEYTRUDA + pem/carbo group were fatigue (68%), nausea (59%), anemia (34%), vomiting (31%), rash (27%), diarrhea (24%), decreased appetite (22%), AST increased (19%), constipation (19%), dysgeusia (19%), ALT increased (17%), blood creatinine increased (17%), decreased neutrophils (17%) and lacrimation increased (15%). The most common immune-mediated adverse events of any grade in patients receiving KEYTRUDA + pem/carbo were hypothyroidism (14%), hyperthyroidism (8%), pneumonitis (7%), infusion reactions (2%), severe skin toxicity (2%) and colitis (2%). There was one treatment-related death in a patient receiving KEYTRUDA + pem/carbo and two in patients receiving pem/carbo alone.
About KEYNOTE-021, Cohort G
Cohort G1 of the multicenter, open-label, phase 1/2 multi-cohort KEYNOTE-021 study evaluated the efficacy and safety of KEYTRUDA in combination with pemetrexed and carboplatin (KEYTRUDA + pem/carbo) compared with pemetrexed and carboplatin (pem/carbo) in 123 patients with metastatic, nonsquamous, EGFR- and ALK-negative NSCLC in the first-line treatment setting. The KEYNOTE-021G1 trial was conducted in collaboration with Eli Lilly and Company, the maker of pemetrexed. Patients were randomized to receive KEYTRUDA + pem/carbo (n=60) or pem/carbo alone (n=63). Patients in the KEYTRUDA + pem/carbo combination group received KEYTRUDA (200 mg), pemetrexed (500 mg/m2) and carboplatin (AUC 5 mg/mL/min) every three weeks for four cycles followed by KEYTRUDA every three weeks. In the pem/carbo group, patients received pemetrexed (500 mg/m2) and carboplatin (AUC 5 mg/mL/min) alone for four cycles. At the investigator’s discretion, maintenance pemetrexed (500 mg/m2) every three weeks was permitted in both treatment groups. The major efficacy outcome measure was ORR as assessed by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Additional efficacy outcome measures were PFS as assessed by BICR using RECIST 1.1, duration of response and OS.
About Lung Cancer
Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. Each year, more people die of lung cancer than die of colon, breast and prostate cancers combined. The two main types of lung cancer are non-small cell and small cell. NSCLC is the most common type of lung cancer, accounting for about 85 percent of all cases. The five-year survival rate for patients suffering from highly advanced, metastatic (Stage IV) lung cancers is estimated to be two percent.
About KEYTRUDA® (pembrolizumab) Injection 100 mg
KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Studies of KEYTRUDA – from the largest immuno-oncology program in the industry with more than 550 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 (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 (pembrolizumab).
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 (pembrolizumab) 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 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 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.comand connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
SOURCE: Merck
Post Views: 88
Five Months of Additional Data from KEYNOTE-021, Cohort G, Including Updated Overall Survival, to be Presented at ESMO 2017 Congress
KENILWORTH, NJ, USA I September 8, 2017 I Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced updated results from Cohort G of the phase 2 KEYNOTE-021 trial investigating KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in combination with pemetrexed and carboplatin (pem/carbo) in patients with previously untreated advanced nonsquamous non-small cell lung cancer (NSCLC), with or without PD-L1 expression. With an additional five months of follow-up, significant improvements observed in prior analyses were maintained, including improvements in overall response rate (ORR) and progression-free survival (PFS) for KEYTRUDA + pem/carbo compared to pem/carbo alone. With a median of 18.7 months of follow-up, more than half of patients in the KEYTRUDA combination arm responded to treatment compared to approximately one-third in the pem/carbo arm (ORR of 56.7% vs. 31.7% [95% CI, 7.2-40.9], p=0.0029). The risk of progression or death continued to be reduced by nearly half with KEYTRUDA + pem/carbo compared to pem/carbo alone (HR 0.54 [95% CI, 0.33-0.88, p=0.0067]). In addition, despite the crossover design, a trend in improvement in overall survival continues to be seen for KEYTRUDA + pem/carbo compared to pem/carbo alone (HR, 0.59 [95% CI, 0.34-1.05, p=0.03]). Findings are being presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, in an oral presentation on Friday, Sept. 8 from 5:03 – 5:15 p.m. CEST (Location: Madrid Auditorium) (Abstract #LBA49).
“The continued benefit observed with KEYTRUDA plus pem/carbo in overall response rate and progression-free survival reinforce the importance of this combination therapy for the treatment of patients with advanced nonsquamous non-small cell lung cancer, with or without PD-L1 expression,” said Dr. Hossein Borghaei, chief of the division of thoracic medical oncology, Fox Chase Cancer Center.
“Lung cancer is one of the most common and devastating cancers, and these additional data confirm that KEYTRUDA in combination with pemetrexed and carboplatin has the potential to have a meaningful impact in the lives of many of these patients,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories.
Merck is currently advancing multiple registration-enabling studies in NSCLC with KEYTRUDA (pembrolizumab) as monotherapy and in combination, including the combination of KEYTRUDA plus a platinum/pemetrexed-based chemotherapy regimen in patients with previously untreated nonsquamous NSCLC in the ongoing phase 3 KEYNOTE-189 trial.
Data from KEYNOTE-021, Cohort G (Abstract #LBA49)
KEYNOTE-021, Cohort G, evaluated the efficacy and safety of KEYTRUDA + pem/carbo compared to pem/carbo in 123 patients with metastatic, nonsquamous, EGFR- and ALK-negative NSCLC in the first-line treatment setting. In patients randomized to the pem/carbo arm, 63 percent (n=40/63) went on to receive subsequent anti-PD-1 or PD-L1 therapy, including 25 who received KEYTRUDA as part of study crossover (additional details on the trial design are provided below).
Data to be presented at ESMO include five months of additional follow-up from prior presentations, for a median follow-up of 18.7 months (range: 0.8-29.0). In this analysis, the KEYTRUDA + pem/carbo combination group (n=60) continued to show improvement over the group receiving pem/carbo alone (n=63) in overall response rate, duration of response and PFS.
ORR was 56.7 percent in the KEYTRUDA + pem/carbo combination group compared to 31.7 percent in the pem/carbo group (95% CI, 7.2-40.9; p=0.0029). The median duration of response had not been reached in either arm (range: 1.4+ to 22.7+ with KEYTRUDA + pem/carbo and 2.8 to 23.7+ in the pem/carbo group). At the time of analysis, 50 percent of responses were ongoing in the KEYTRUDA + pem/carbo combination group compared to 40 percent in the pem/carbo group.
The patients in the KEYTRUDA + pem/carbo arm had a 46 percent reduction in progression or death risk compared with pem/carbo alone (HR 0.54 [95% CI, 0.33-0.88, p=0.0067]). The median PFS was twice as long in the group receiving KEYTRUDA, with 19.0 months (95% CI, 8.5-not reached) for KEYTRUDA plus pem/carbo compared to 8.9 months in the pem/carbo group (95% CI, 6.2-11.8). At 12 and 18 months, PFS in the KEYTRUDA + pem/carbo combination group was 57 percent and 52 percent, respectively, compared to 37 percent and 29 percent in the pem/carbo group.
A trend toward improvement in OS was observed in the KEYTRUDA (pembrolizumab) + pem/carbo arm: the combination was associated with a 41 percent reduction in the risk of death (HR, 0.59 [95% CI, 0.34-1.05, p=0.03]). The median OS was not reached (range: 22.8-not reached) in the KEYTRUDA + pem/carbo combination group compared to 20.9 months (range: 14.9-not reached) in the pem/carbo group.
The safety findings were consistent with previously presented results from this study. Grade 3-5 treatment-related adverse events (TRAEs) occurred in 41 percent of patients in the KEYTRUDA + pem/carbo group. TRAEs of any grade with an incidence of 15 percent or more in the KEYTRUDA + pem/carbo group were fatigue (68%), nausea (59%), anemia (34%), vomiting (31%), rash (27%), diarrhea (24%), decreased appetite (22%), AST increased (19%), constipation (19%), dysgeusia (19%), ALT increased (17%), blood creatinine increased (17%), decreased neutrophils (17%) and lacrimation increased (15%). The most common immune-mediated adverse events of any grade in patients receiving KEYTRUDA + pem/carbo were hypothyroidism (14%), hyperthyroidism (8%), pneumonitis (7%), infusion reactions (2%), severe skin toxicity (2%) and colitis (2%). There was one treatment-related death in a patient receiving KEYTRUDA + pem/carbo and two in patients receiving pem/carbo alone.
About KEYNOTE-021, Cohort G
Cohort G1 of the multicenter, open-label, phase 1/2 multi-cohort KEYNOTE-021 study evaluated the efficacy and safety of KEYTRUDA in combination with pemetrexed and carboplatin (KEYTRUDA + pem/carbo) compared with pemetrexed and carboplatin (pem/carbo) in 123 patients with metastatic, nonsquamous, EGFR- and ALK-negative NSCLC in the first-line treatment setting. The KEYNOTE-021G1 trial was conducted in collaboration with Eli Lilly and Company, the maker of pemetrexed. Patients were randomized to receive KEYTRUDA + pem/carbo (n=60) or pem/carbo alone (n=63). Patients in the KEYTRUDA + pem/carbo combination group received KEYTRUDA (200 mg), pemetrexed (500 mg/m2) and carboplatin (AUC 5 mg/mL/min) every three weeks for four cycles followed by KEYTRUDA every three weeks. In the pem/carbo group, patients received pemetrexed (500 mg/m2) and carboplatin (AUC 5 mg/mL/min) alone for four cycles. At the investigator’s discretion, maintenance pemetrexed (500 mg/m2) every three weeks was permitted in both treatment groups. The major efficacy outcome measure was ORR as assessed by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Additional efficacy outcome measures were PFS as assessed by BICR using RECIST 1.1, duration of response and OS.
About Lung Cancer
Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. Each year, more people die of lung cancer than die of colon, breast and prostate cancers combined. The two main types of lung cancer are non-small cell and small cell. NSCLC is the most common type of lung cancer, accounting for about 85 percent of all cases. The five-year survival rate for patients suffering from highly advanced, metastatic (Stage IV) lung cancers is estimated to be two percent.
About KEYTRUDA® (pembrolizumab) Injection 100 mg
KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Studies of KEYTRUDA – from the largest immuno-oncology program in the industry with more than 550 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 (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 (pembrolizumab).
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 (pembrolizumab) 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 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 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.comand connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
SOURCE: Merck
Post Views: 88
