RAHWAY, N.J. - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that the European Commission (EC) has approved KEYTRUDA, Merck's anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection. Additionally, the EC approved expanding the indications for KEYTRUDA in advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) to include adolescent patients aged 12 years and older.
The approval of KEYTRUDA for the adjuvant treatment of patients with resected stage IIB or IIC melanoma was based on results from the Phase 3 KEYNOTE-716 trial, in which KEYTRUDA significantly prolonged recurrence-free survival (RFS), reducingthe risk of disease recurrence or death by 39% (HR=0.61 [95% CI, 0.45-0.82]; p=0.00046) compared to placebo in this patient population at a median follow-up of 20.5 months. KEYTRUDA in this adjuvant setting also significantly prolonged distant metastasis-free survival (DMFS), reducing the risk of distant metastasis by 36% (HR=0.64 [95% CI, 0.47-0.88]; p=0.00292) compared to placebo in this patient population at a median follow-up of 26.9 months.
'When melanoma recurs, patients often have a significantly worse long-term prognosis, especially if the cancer returns or spreads to distant sites,' said Dr. Alexander Eggermont, chief scientific officer, Princess Maxima Center for Pediatric Oncology, the Netherlands. 'This approval further reinforces the important role of adjuvant therapy for patients 12 years and older with completely resected stage IIB and IIC melanoma who now have a treatment option that has demonstrated the potential to significantly reduce the risk of their cancer returning.'
The safety of KEYTRUDA monotherapy has been evaluated in 7,631 patients across tumor types. The incidences of immune-related adverse reactions were 36.1% for all Grades and 8.9% for Grades 3-5 for KEYTRUDA monotherapy in the adjuvant setting (n=1,480). No new immune-related adverse reactions were identified for KEYTRUDA monotherapy in the adjuvant setting.
'Melanoma continues to be a public health burden in Europe, claiming more than 26,000 lives in 2020, with rates rising annually,' said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. 'KEYTRUDA has become the first anti-PD-1 adjuvant treatment option approved in the EU for patients 12 years and older across stage IIB, IIC and III melanoma following complete resection, based on data that show the potential of KEYTRUDA to help reduce the risk of recurrence, including as distant metastases, in these patients. This approval furthers our commitment to finding new effective options for even more patients with melanoma.'
This approval allows marketing of KEYTRUDA for this indication in all 27 European Union (EU) member states plus Iceland, Lichtenstein, Norway and Northern Ireland. In the EU, KEYTRUDA was previously approved for the treatment of adult patients with advanced (unresectable or metastatic) melanoma and for the adjuvant treatment of adult patients with stage III melanoma and lymph node involvement who have undergone complete resection.
About KEYNOTE-716
The approval was based on data from KEYNOTE-716 (ClinicalTrials.gov, NCT03553836), a randomized, double-blind Phase 3 trial that enrolled 976 adult and pediatric patients (12 years and older) with resected stage IIB or IIC melanoma. Following complete surgical resection, patients were randomized to KEYTRUDA (200 mg for adult patients and 2 mg/kg for pediatric patients [up to 200 mg]) or placebo every three weeks for approximately one year until disease recurrence or unacceptable toxicity. The primary endpoint is RFS, and secondary endpoints include DMFS and overall survival.
About Merck's research in melanoma
Melanoma, the most serious form of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells. The rates of melanoma have been rising over the past few decades, with nearly 325,000 new cases of melanoma diagnosed worldwide in 2020, and melanoma is the leading cause of skin cancer deaths, with more than 57,000 deaths from the disease worldwide in 2020. In Europe, it is estimated there were more than 150,000 new cases of melanoma diagnosed and more than 26,000 deaths from the disease in 2020.
The recurrence rates for resected melanoma are estimated to be 32-46% for patients with stage IIB and IIC disease and 39-74% for patients with stage III disease. The five-year survival rates are estimated to be 87% for stage IIB, 82% for stage IIC, 93% for stage IIIA, 83% for stage IIIB, 69% for stage IIIC and 32% for stage IIID.
Merck is committed to delivering meaningful advances for patients with melanoma with KEYTRUDA and to continuing research in skin cancers through a broad clinical development program across investigational and approved medicines. KEYTRUDA has been established as an important treatment option for the adjuvant treatment of patients with resected stage III melanoma and is approved in over 90 countries based on the results from EORTC1325/KEYNOTE-054. KEYTRUDA is also approved worldwide for the treatment of patients with unresectable or metastatic melanoma.
About Merck's early-stage cancer clinical program
Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is studying KEYTRUDA in earlier disease states, with approximately 20 ongoing registrational studies across multiple types of cancer.
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 1,700 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.
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
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world - and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
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