KENILWORTH - Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the first presentation of results from KEYNOTE-204, a Phase 3 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
In this pivotal study, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), one of the dual primary endpoints. KEYTRUDA reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.48-0.88; p=0.00271]) and showed a median PFS of 13.2 months compared with 8.3 months for patients treated with brentuximab vedotin (BV), a current standard of care in this patient population. As previously announced, KEYNOTE-204 serves as the confirmatory trial for the KEYTRUDA accelerated approval hematology indications and the company plans to submit these data to global regulatory authorities this year.
'In this head-to-head study, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in progression-free survival when compared with brentuximab vedotin, reinforcing the benefit of KEYTRUDA in classical Hodgkin lymphoma,' said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. 'Merck is committed to researching innovative approaches for the treatment of blood cancers through our broad clinical program evaluating KEYTRUDA across multiple hematologic malignancies and our investigational Bruton's tyrosine kinase inhibitor MK-1026, which we recently added to our pipeline through our acquisition of ArQule.'
'These data are particularly meaningful since approximately 15 to 20% of patients with classical Hodgkin lymphoma, the most common type of Hodgkin lymphoma, generally do not achieve remission following first-line treatment,' said Dr. John Kuruvilla, hematologist and associate professor of medicine at the Princess Margaret Cancer Centre and University of Toronto, Toronto, Ontario, Canada. 'Data from KEYNOTE-204 show that KEYTRUDA monotherapy has the potential to change the current treatment paradigm for these patients who are generally young and face a poor prognosis when they do not achieve remission.'
These results are being presented in an oral abstract session of the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #8005). As announced, more than 80 abstracts in nearly 20 types of solid tumors and blood cancers will be presented from Merck's broad oncology portfolio and investigational pipeline. Follow Merck on Twitter via @Merck and keep up to date with ASCO news and updates by using the hashtag #ASCO20.
KEYNOTE-204 Study Design and Additional Data (Abstract #8005)
KEYNOTE-204 is a randomized, open-label, Phase 3 trial evaluating KEYTRUDA monotherapy versus BV for the treatment of patients with relapsed or refractory cHL (ClinicalTrials.gov, NCT02684292). The dual primary endpoints are PFS and overall survival (OS). Key secondary endpoints include objective response rate (ORR), complete response rate and safety. The study enrolled 304 patients, aged 18 years and older, who were randomized to receive either KEYTRUDA (200 mg intravenously on Day 1 of each three-week cycle for up to 35 cycles) or BV (1.8 mg/kg [maximum 180 mg per dose] intravenously on Day 1 of each three-week cycle for up to 35 cycles). Per the pre-specified analysis plan, the other dual primary endpoint of OS was not formally tested at this interim analysis. The study will continue to evaluate OS.
In this study, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in PFS (HR=0.65 [95% CI, 0.48-0.88; p=0.00271]) and showed a median PFS of 13.2 months compared with 8.3 months for patients treated with BV. The one-year PFS rate was 53.9% with KEYTRUDA versus 35.6% with BV. Additionally, the ORR was 65.6% with KEYTRUDA versus 54.2% with BV, with a complete response observed in 24.5% and 24.2% of patients, respectively; partial responses were observed in 41.1% and 30.1% of patients, respectively. Median duration of response was 20.7 months (range, 0.0+ to 33.2+) with KEYTRUDA versus 13.8 months with BV (range, 0.0+ to 33.9+).
The incidence of treatment-related adverse events (TRAEs) was similar with KEYTRUDA (74.3%) compared with BV (77.0%). Grade 3-5 TRAEs were lower in patients treated with KEYTRUDA (19.6%) compared with BV (25.0%). There was one treatment-related death with KEYTRUDA (pneumonia).
Merck Investor Event
Merck will hold a virtual investor event in conjunction with the ASCO Annual Meeting on Tuesday, June 2 at 2 p.m. ET.
Merck's Blood Cancer Research Program
Merck is studying KEYTRUDA across hematologic malignancies through a broad clinical program, including three registrational trials in cHL and primary mediastinal large B-cell lymphoma (PMBCL), and more than 60 investigator-initiated studies across 15 tumors. In addition to KEYTRUDA, Merck is evaluating the oral Bruton's tyrosine kinase inhibitor MK-1026 (formerly ARQ 531), which the company acquired in the recent acquisition of ArQule. MK-1026 is currently in a Phase 2 dose expansion study for the treatment of B-cell malignancies.
About Hodgkin Lymphoma
Hodgkin lymphoma is a type of lymphoma that develops in the white blood cells, called lymphocytes, which are part of the immune system. Hodgkin lymphoma can start almost anywhere - most often in lymph nodes in the upper part of the body, with the most common sites being in the chest, neck or under the arms. Worldwide, there were approximately 80,000 new cases of Hodgkin lymphoma and more than 26,000 people died from the disease in 2018. In 2020, it is estimated that nearly 8,500 people will be diagnosed with Hodgkin lymphoma in the U.S. Classical Hodgkin lymphoma accounts for more than nine in 10 cases of Hodgkin lymphoma in developed countries.
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.
Merck has the industry's largest immuno-oncology clinical research program. There are currently more than 1,200 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.
For more than 125 years, Merck, 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 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.
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