New Research for KEYTRUDA? (pembrolizumab) at Society for Melanoma Research (SMR) 2021 Congress Reinforces Merck?s Commitment to Patients With Melanoma Across Stages of Disease
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced new data from studies evaluating KEYTRUDA, Merck?s anti-PD-1 therapy, at the Society for Melanoma Research (SMR) 2021 Congress. Presentations demonstrate the company?s scientific expertise and continuing commitment to delivering meaningful advances for patients with melanoma. Key data include exploratory 7-year follow-up from KEYNOTE-006, the pivotal trial that supported the indication for KEYTRUDA in advanced melanoma, and updated findings from the KEYNOTE-716 trial that is evaluating KEYTRUDA as an adjuvant treatment for patients with resected stage IIB or IIC melanoma. These data were both selected for inclusion in plenary sessions at the SMR 2021 Congress.
?The seven-year data for KEYTRUDA in advanced melanoma is a significant milestone for the field of melanoma research and for patients,? said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. ?Just ten years ago, the median survival for patients with metastatic melanoma was less than a year and only 10% of patients could expect to survive more than five years. We are incredibly honored to present these new long-term survival data in advanced disease at this year?s SMR 2021 Congress, as well as updated findings in stage IIB and stage IIC melanoma.?
Data from KEYOTE-587: Exploratory 7-Year Follow-up of KEYNOTE-006 Patients (Plenary Session 11)
KEYNOTE-006 (ClinicalTrials.gov,?NCT01866319) was an open-label, randomized Phase 3 study comparing the efficacy and safety of KEYTRUDA versus ipilimumab in participants with advanced melanoma. After KEYNOTE-006 concluded, participants were eligible to transition to KEYNOTE-587 for extended follow-up. 210 former participants of KEYNOTE-006 (158 patients treated with KEYTRUDA and 52 patients treated with ipilimumab) were assessed for 7-year follow-up. Findings from this long-term follow-up showed that median OS was 32.7 months for KEYTRUDA and 15.9 months for ipilimumab (HR=0.70; [95% CI, 0.58-0.83]). The 7-year OS rates were 37.8% for KEYTRUDA and 25.3% for ipilimumab. Findings from this exploratory analysis showed that KEYTRUDA was associated with improved clinical outcomes regardless of BRAF status, prior BRAFi therapy, and poor prognostic characteristics such as high LDH level, larger tumor size, or presence of brain metastases. These results represent the longest follow-up from a Phase 3 trial of anti-PD-1/L1 therapy for advanced melanoma available to date. No formal statistical testing was planned. Selected safety information from KEYNOTE-006 can be found below.
Data from KEYNOTE-716 (Plenary Session 11)
KEYNOTE-716 (ClinicalTrials.gov,?NCT03553836) is a multicenter, randomized, double-blind Phase 3 trial evaluating adjuvant treatment with KEYTRUDA compared to placebo in adult and pediatric (12 years or older) patients with resected stage IIB or IIC melanoma. The trial?s primary endpoint is recurrence-free survival (RFS). At the protocol-specified second interim analysis (IA2), treatment with KEYTRUDA continued to show a clinically meaningful improvement in RFS compared to placebo as adjuvant therapy for these patients, with a reduction in the risk of disease recurrence or death of 39% (HR=0.61 [95% CI, 0.45-0.82]). As previously announced, KEYNOTE-716 met the primary endpoint of RFS at the first interim analysis (HR=0.65 [95% CI, 0.46-0.92]; p=0.00658), and therefore, statistical testing was not performed at IA2. No new safety signals were observed.
At IA2, 14.8% (n=72/487) of patients who received KEYTRUDA had recurrence or died compared to 23.5% (n=115/489) of patients on placebo. Median RFS continued to not be reached for either group at the time of this analysis. Twice as many patients on placebo (12.3% [n=60/489]) experienced distant recurrence compared to patients on KEYTRUDA (6.4% [n=31/487]).
The safety profile of KEYTRUDA at IA2 was consistent with previous reports. Treatment-related adverse events (TRAEs) occurred in 82.8% (n=400/483) of patients who received KEYTRUDA versus 63.4% (n=308/486) of patients who received placebo, while Grades 3-4 TRAEs were observed in 17.0% (n=82/483) versus 4.3% (n=21/486) of patients, respectively. Grades 3-4 immune-mediated adverse events and infusion reactions occurred in 10.1% (n=49/483) of patients and 1.2% (n=6/486) of patients in the KEYTRUDA and placebo arms, respectively.
About Merck 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 diagnosed worldwide in 2020.
Merck?s clinical research program is uniquely positioned to address evolving patient populations in melanoma, with research directed at earlier stages of disease and novel combinations in PD-1-na?ve and PD-1-experienced populations. Key studies include KEYNOTE-716, LEAP-003, KEYMAKER-U02 and LEAP-004.
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 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.
- 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.
- 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.