KEYTRUDA Is First Anti-PD-1/PD-L1 Therapy to Show Overall Survival Improvement in Combination With Chemotherapy With or Without Bevacizumab in These Patients
Results From Phase 3 KEYNOTE-826 Trial Selected for Official Press Program and Presentation During Presidential Symposium at ESMO Congress 2021 and Simultaneously Published in New England Journal of Medicine
KENILWORTH, NJ, USA I September 18, 2021 I Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of the full results from the pivotal Phase 3 KEYNOTE-826 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy with or without bevacizumab for the first-line treatment of persistent, recurrent or metastatic cervical cancer at the European Society for Medical Oncology (ESMO) Congress 2021 (Abstract #LBA2). These data were also simultaneously published in the New England Journal of Medicine. This is the first combination regimen with an anti-PD-1/PD-L1 therapy to improve overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to chemotherapy with or without bevacizumab as a first-line treatment of persistent, recurrent or metastatic cervical cancer.
KEYTRUDA plus chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin) with or without bevacizumab (KEYTRUDA plus chemo ± bev) reduced the risk of death by one-third, or 33% (HR=0.67 [95% CI, 0.54-0.84]; p<0.001), versus chemotherapy with or without bevacizumab (chemo ± bev). Median OS for KEYTRUDA plus chemo ± bev was 24.4 months (95% CI, 19.2-not reached [NR]) compared to 16.5 months (95% CI, 14.5-19.4) for chemo ± bev. For the dual primary endpoint of PFS, median PFS (HR=0.65 [95% CI, 0.53-0.79]; p<0.001) was 10.4 months (95% CI, 9.1-12.1) in those treated with KEYTRUDA plus chemo ± bev and 8.2 months (95% CI, 6.4-8.4) among those treated with chemo ± bev. In the trial, KEYTRUDA plus chemo ± bev showed an ORR of 65.9% (95% CI, 60.3-71.2), and chemo ± bev showed an ORR of 50.8% (95% CI, 45.1-56.5). Median duration of response (DOR) was 18.0 months (range, 1.3+ to 24.2+) in the KEYTRUDA plus chemo ± bev arm and 10.4 months (range, 1.5+ to 22.0+) in the chemo ± bev arm. The results were consistent with or without bevacizumab use.
“Cervical cancer continues to be the second leading cause of cancer-related death in young women between 15 and 44 years of age, and historically women have faced a poor prognosis when diagnosed at later stages,” said Dr. Nicoletta Colombo, associate professor, University of Milan-Bicocca, and director, European Institute of Oncology in Milan, Italy. “These important survival results support KEYTRUDA plus chemotherapy with or without bevacizumab as a potential new treatment option in the first-line setting for patients with persistent, recurrent or metastatic cervical cancer.”
Treatment-related adverse events (TRAEs) Grade ≥3 occurred in 68.4% of patients in the KEYTRUDA plus chemo ± bev arm and 64.1% of patients in the chemo ± bev arm. Patients in the KEYTRUDA plus chemo ± bev arm had a longer duration of treatment than those in the chemo ± bev arm. In the KEYTRUDA plus chemo ± bev arm, TRAEs led to discontinuation of any treatment in 31.3% of patients and of all treatment in 3.3% of patients. In the chemo ± bev arm, TRAEs led to discontinuation of any treatment in 22.3% of patients and of all treatment in 1.9% of patients.
“KEYTRUDA, in combination with chemotherapy with or without bevacizumab, is the first anti-PD-1/PD-L1-based regimen to demonstrate statistically significant improvement in overall survival for the first-line treatment of patients with persistent, recurrent or metastatic cervical cancer,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “These results highlight the critical role KEYTRUDA can play in improving outcomes for certain women with persistent, recurrent or metastatic cervical cancer. We continue to prioritize research into how we can extend the lives of patients facing deadly cancers, such as cervical cancer, through innovative combination approaches.”
Merck is dedicated to advancing research in women’s cancers. The company is rapidly advancing an extensive clinical development program for KEYTRUDA and several other investigational and approved medicines across gynecologic cancers, including evaluating KEYTRUDA for the treatment of locally advanced cervical cancer.
A compendium of presentations and posters of Merck-led studies is available here. Follow Merck on Twitter via @Merck, and keep up to date with ESMO news and updates by using the hashtag #ESMO21.
About KEYNOTE-826
KEYNOTE-826 is a randomized, double-blind, Phase 3 trial (ClinicalTrials.gov, NCT03635567) evaluating KEYTRUDA in combination with platinum-based chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin) with or without bevacizumab compared with placebo in combination with the same platinum-based chemotherapy regimens with or without bevacizumab for the first-line treatment of adult patients with persistent, recurrent or metastatic cervical cancer who had not been treated with chemotherapy except when used concurrently as a radio-sensitizing agent. The primary endpoints are OS and PFS. The secondary endpoints include ORR, DOR and safety.
The study enrolled 617 patients. The study population characteristics were: median age of 51 years (range, 22 to 82), 16% age 65 or older; 58% white and 42% all other races; 56% and 43% ECOG PS of 0 or 1, respectively; 89% with PD-L1 (CPS ≥1); 63% received bevacizumab as study treatment; 23% with adenocarcinoma and 5% with adenosquamous histology; for patients with persistent or recurrent disease with or without distant metastases, 39% had received prior chemoradiation only, and 17% had received prior chemoradiation plus surgery.
Patients in the KEYTRUDA arm received KEYTRUDA 200 mg intravenously every three weeks (Q3W) for up to 35 cycles plus investigator’s choice of paclitaxel plus cisplatin or paclitaxel plus carboplatin Q3W for up to six cycles with or without bevacizumab Q3W. Patients in the placebo arm received placebo plus investigator’s choice of paclitaxel plus cisplatin or paclitaxel plus carboplatin Q3W for up to six cycles with or without bevacizumab Q3W.
Immune-mediated adverse events and infusion reactions of any grade occurred in 33.9% of patients in the KEYTRUDA plus chemo ± bev arm and 15.2% of patients in the chemo ± bev arm. Treatment-related deaths occurred in two patients in the KEYTRUDA plus chemo ± bev arm (encephalitis autoimmune [also immune-mediated] and intestinal perforation [n=1 each]), and four patients in the chemo ± bev arm (embolism, female genital tract fistula, large intestine perforation and pulmonary sepsis [n=1 each]).
About Cervical Cancer
Cervical cancer forms in the cells lining the cervix, which is the lower part of the uterus. While screenings and prevention have resulted in declining cervical cancer rates, the disease continues to affect many people in the U.S. and around the world. Cervical cancer is the fourth most commonly diagnosed cancer in women and the fourth leading cause of cancer-related death in women globally. Worldwide, it is estimated there were more than 604,000 new cases of cervical cancer diagnosed and nearly 342,000 deaths resulting from the disease in 2020. In the U.S., it is estimated there will be nearly 14,500 new cases of invasive cervical cancer diagnosed and almost 4,300 deaths resulting from the disease in 2021. For patients in the U.S. who are diagnosed with cervical cancer that has spread to nearby organs or distant parts of the body, the five-year survival rate is estimated to be 17%.
About KEYTRUDA® (pembrolizumab) Injection, 100 mg
KEYTRUDA is an anti-programmed death receptor-1 (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. There are currently more than 1,600 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.
Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.
Melanoma
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.
KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
Non-Small Cell Lung Cancer
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is
- stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
- metastatic.
KEYTRUDA, as a single agent, is 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.
Head and Neck Squamous Cell Cancer
KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1)] as determined by an FDA-approved test.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
Classical Hodgkin Lymphoma
KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
Primary Mediastinal Large B-Cell Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.
Urothelial Carcinoma
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC):
- who are not eligible for any platinum-containing chemotherapy, or
- who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Microsatellite Instability-High or Mismatch Repair Deficient 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.
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.
Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).
Gastric Cancer
KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. 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.
Esophageal Cancer
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or GEJ (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:
- in combination with platinum- and fluoropyrimidine-based chemotherapy, or
- as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test.
Cervical Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. 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.
Hepatocellular Carcinoma
KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. 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.
Merkel Cell Carcinoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). 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.
Renal Cell Carcinoma
KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
Tumor Mutational Burden-High Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. 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 TMB-H central nervous system cancers have not been established.
Cutaneous Squamous Cell Carcinoma
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.
Triple-Negative Breast Cancer
KEYTRUDA is indicated for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test.
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 over 130 years, Merck, known as MSD outside the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
SOURCE: Merck
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KEYTRUDA Is First Anti-PD-1/PD-L1 Therapy to Show Overall Survival Improvement in Combination With Chemotherapy With or Without Bevacizumab in These Patients
Results From Phase 3 KEYNOTE-826 Trial Selected for Official Press Program and Presentation During Presidential Symposium at ESMO Congress 2021 and Simultaneously Published in New England Journal of Medicine
KENILWORTH, NJ, USA I September 18, 2021 I Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of the full results from the pivotal Phase 3 KEYNOTE-826 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy with or without bevacizumab for the first-line treatment of persistent, recurrent or metastatic cervical cancer at the European Society for Medical Oncology (ESMO) Congress 2021 (Abstract #LBA2). These data were also simultaneously published in the New England Journal of Medicine. This is the first combination regimen with an anti-PD-1/PD-L1 therapy to improve overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to chemotherapy with or without bevacizumab as a first-line treatment of persistent, recurrent or metastatic cervical cancer.
KEYTRUDA plus chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin) with or without bevacizumab (KEYTRUDA plus chemo ± bev) reduced the risk of death by one-third, or 33% (HR=0.67 [95% CI, 0.54-0.84]; p<0.001), versus chemotherapy with or without bevacizumab (chemo ± bev). Median OS for KEYTRUDA plus chemo ± bev was 24.4 months (95% CI, 19.2-not reached [NR]) compared to 16.5 months (95% CI, 14.5-19.4) for chemo ± bev. For the dual primary endpoint of PFS, median PFS (HR=0.65 [95% CI, 0.53-0.79]; p<0.001) was 10.4 months (95% CI, 9.1-12.1) in those treated with KEYTRUDA plus chemo ± bev and 8.2 months (95% CI, 6.4-8.4) among those treated with chemo ± bev. In the trial, KEYTRUDA plus chemo ± bev showed an ORR of 65.9% (95% CI, 60.3-71.2), and chemo ± bev showed an ORR of 50.8% (95% CI, 45.1-56.5). Median duration of response (DOR) was 18.0 months (range, 1.3+ to 24.2+) in the KEYTRUDA plus chemo ± bev arm and 10.4 months (range, 1.5+ to 22.0+) in the chemo ± bev arm. The results were consistent with or without bevacizumab use.
“Cervical cancer continues to be the second leading cause of cancer-related death in young women between 15 and 44 years of age, and historically women have faced a poor prognosis when diagnosed at later stages,” said Dr. Nicoletta Colombo, associate professor, University of Milan-Bicocca, and director, European Institute of Oncology in Milan, Italy. “These important survival results support KEYTRUDA plus chemotherapy with or without bevacizumab as a potential new treatment option in the first-line setting for patients with persistent, recurrent or metastatic cervical cancer.”
Treatment-related adverse events (TRAEs) Grade ≥3 occurred in 68.4% of patients in the KEYTRUDA plus chemo ± bev arm and 64.1% of patients in the chemo ± bev arm. Patients in the KEYTRUDA plus chemo ± bev arm had a longer duration of treatment than those in the chemo ± bev arm. In the KEYTRUDA plus chemo ± bev arm, TRAEs led to discontinuation of any treatment in 31.3% of patients and of all treatment in 3.3% of patients. In the chemo ± bev arm, TRAEs led to discontinuation of any treatment in 22.3% of patients and of all treatment in 1.9% of patients.
“KEYTRUDA, in combination with chemotherapy with or without bevacizumab, is the first anti-PD-1/PD-L1-based regimen to demonstrate statistically significant improvement in overall survival for the first-line treatment of patients with persistent, recurrent or metastatic cervical cancer,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “These results highlight the critical role KEYTRUDA can play in improving outcomes for certain women with persistent, recurrent or metastatic cervical cancer. We continue to prioritize research into how we can extend the lives of patients facing deadly cancers, such as cervical cancer, through innovative combination approaches.”
Merck is dedicated to advancing research in women’s cancers. The company is rapidly advancing an extensive clinical development program for KEYTRUDA and several other investigational and approved medicines across gynecologic cancers, including evaluating KEYTRUDA for the treatment of locally advanced cervical cancer.
A compendium of presentations and posters of Merck-led studies is available here. Follow Merck on Twitter via @Merck, and keep up to date with ESMO news and updates by using the hashtag #ESMO21.
About KEYNOTE-826
KEYNOTE-826 is a randomized, double-blind, Phase 3 trial (ClinicalTrials.gov, NCT03635567) evaluating KEYTRUDA in combination with platinum-based chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin) with or without bevacizumab compared with placebo in combination with the same platinum-based chemotherapy regimens with or without bevacizumab for the first-line treatment of adult patients with persistent, recurrent or metastatic cervical cancer who had not been treated with chemotherapy except when used concurrently as a radio-sensitizing agent. The primary endpoints are OS and PFS. The secondary endpoints include ORR, DOR and safety.
The study enrolled 617 patients. The study population characteristics were: median age of 51 years (range, 22 to 82), 16% age 65 or older; 58% white and 42% all other races; 56% and 43% ECOG PS of 0 or 1, respectively; 89% with PD-L1 (CPS ≥1); 63% received bevacizumab as study treatment; 23% with adenocarcinoma and 5% with adenosquamous histology; for patients with persistent or recurrent disease with or without distant metastases, 39% had received prior chemoradiation only, and 17% had received prior chemoradiation plus surgery.
Patients in the KEYTRUDA arm received KEYTRUDA 200 mg intravenously every three weeks (Q3W) for up to 35 cycles plus investigator’s choice of paclitaxel plus cisplatin or paclitaxel plus carboplatin Q3W for up to six cycles with or without bevacizumab Q3W. Patients in the placebo arm received placebo plus investigator’s choice of paclitaxel plus cisplatin or paclitaxel plus carboplatin Q3W for up to six cycles with or without bevacizumab Q3W.
Immune-mediated adverse events and infusion reactions of any grade occurred in 33.9% of patients in the KEYTRUDA plus chemo ± bev arm and 15.2% of patients in the chemo ± bev arm. Treatment-related deaths occurred in two patients in the KEYTRUDA plus chemo ± bev arm (encephalitis autoimmune [also immune-mediated] and intestinal perforation [n=1 each]), and four patients in the chemo ± bev arm (embolism, female genital tract fistula, large intestine perforation and pulmonary sepsis [n=1 each]).
About Cervical Cancer
Cervical cancer forms in the cells lining the cervix, which is the lower part of the uterus. While screenings and prevention have resulted in declining cervical cancer rates, the disease continues to affect many people in the U.S. and around the world. Cervical cancer is the fourth most commonly diagnosed cancer in women and the fourth leading cause of cancer-related death in women globally. Worldwide, it is estimated there were more than 604,000 new cases of cervical cancer diagnosed and nearly 342,000 deaths resulting from the disease in 2020. In the U.S., it is estimated there will be nearly 14,500 new cases of invasive cervical cancer diagnosed and almost 4,300 deaths resulting from the disease in 2021. For patients in the U.S. who are diagnosed with cervical cancer that has spread to nearby organs or distant parts of the body, the five-year survival rate is estimated to be 17%.
About KEYTRUDA® (pembrolizumab) Injection, 100 mg
KEYTRUDA is an anti-programmed death receptor-1 (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. There are currently more than 1,600 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.
Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.
Melanoma
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.
KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
Non-Small Cell Lung Cancer
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is
- stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
- metastatic.
KEYTRUDA, as a single agent, is 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.
Head and Neck Squamous Cell Cancer
KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1)] as determined by an FDA-approved test.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
Classical Hodgkin Lymphoma
KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
Primary Mediastinal Large B-Cell Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.
Urothelial Carcinoma
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC):
- who are not eligible for any platinum-containing chemotherapy, or
- who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Microsatellite Instability-High or Mismatch Repair Deficient 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.
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.
Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).
Gastric Cancer
KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. 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.
Esophageal Cancer
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or GEJ (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:
- in combination with platinum- and fluoropyrimidine-based chemotherapy, or
- as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test.
Cervical Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. 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.
Hepatocellular Carcinoma
KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. 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.
Merkel Cell Carcinoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). 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.
Renal Cell Carcinoma
KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
Tumor Mutational Burden-High Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. 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 TMB-H central nervous system cancers have not been established.
Cutaneous Squamous Cell Carcinoma
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.
Triple-Negative Breast Cancer
KEYTRUDA is indicated for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test.
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 over 130 years, Merck, known as MSD outside the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
SOURCE: Merck
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