Merck’s KEYTRUDA® (pembrolizumab) Superior to Brentuximab Vedotin (BV), a Standard of Care, in Patients With Classical Hodgkin Lymphoma (cHL) in Head-to-Head Phase 3 Trial

KEYNOTE-204 is the First Positive Phase 3 Trial of an Anti-PD-1 Therapy in Patients with Relapsed or Refractory cHL

Data Show KEYTRUDA Monotherapy Significantly Reduced the Risk of Disease Progression or Death by 35% Compared with BV

KENILWORTH, NJ, USA I May 13, 2020 I 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. Details will be provided at a date closer to the event at http://investors.merck.com/home/default.aspx.

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.

Selected KEYTRUDA® (pembrolizumab) Indications

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.

Small Cell Lung Cancer
KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line 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 confirmatory trials.

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 head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

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 3 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.

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. 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 confirmatory trials. 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 cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) ≥10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. 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 confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) 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 (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

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.

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 (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.

Esophageal Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

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 patients with advanced renal cell carcinoma (RCC).

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 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. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

SOURCE: Merck

La Merie Biologics

FREE Weekly News Bulletin

Sign Up

2019 Sales ofAntibodies & Proteins

New Product Alert

For La Merie Publishing

Sign Up

Top