Merck’s KEYTRUDA (pembrolizumab) Significantly Reduces Risk of Distant Metastasis as Adjuvant Therapy in Resected Stage IIB/IIC/III Melanoma
Mar 16, 2022 02:15
CST Updated
02:15
MSD
Pharmaceutical R&D and Manufacturer
Melanoma(Image Source: healthjade.com)
News on March 15, 2022 /BioValleyBIOON/ -- MSD (Merck & Co) recently announced new analysis data from the Phase 3 KEYNOTE-716 trial (NCT03553836). The trial is evaluating the anti-PD-1 therapy Keytruda (generic name: pembrolizumab) as an adjuvant treatment for patients with completely resected stage IIB and IIC melanoma.MelanomaPatient.
In a pre-specified interim analysis, the trial met the key secondary endpoint of distant metastasis-free survival (DMFS):Compared with the placebo group, the Keytruda treatment group showed a statistically significant improvement in DMFS.。No new safety signals were observed in the trial.
In this interim analysis, compared with the placebo group,Keytruda Treatment Group Continues to Show Improvement in Recurrence-Free Survival (RFS)As previously reported, the KEYNOTE-716 trial met its primary endpoint of RFS (HR=0.65 [95% CI: 0.46 to 0.92]; P=0.00658) at the first interim analysis, which supported the U.S. Food and Drug Administration (FDA) approved this indication in December 2021. The full results of the KEYNOTE-716 trial analysis will be presented at an upcoming medicalConferencePublished on.
To date, compared with placebo, Keytruda in resected stage IIB and IIC (KEYNOTE-716) as well as stage IIIMelanoma(EORTC132/KEYNOTE-054: RFS HR=0.57 [95% CI, 0.46, 0.70] p<0.001; DMFS HR=0.60 [95% CI, 0.49-0.73]; p<0.001) both showed significant improvements in RFS and DMFS.
In December 2021, the U.S. FDA approved Keytruda for adjuvant treatment of adult and pediatric (≥12 years) patients with stage IIB or IIC melanoma who have undergone complete surgical resection. Additionally,FDAExpanded the use of Keytruda for adjuvant treatment in patients with stage III cancer who have undergone surgical resection.MelanomaIndications, including pediatric patients (≥12 years old).
Now,Keytruda can be used as an adjuvant treatment for patients (≥12 years old) with stage IIB, IIC, and III melanoma who have undergone complete surgical resection.Notably, Keytruda is the first in adjuvant treatment for stages IIB and IIC.MelanomaAspects showing relapse-free survival benefits of anti-PD-1/PD-L1 therapy.
Melanoma is the most serious type of skin cancer, characterized by uncontrolled growth of pigment-producing cells. In the past few decades, the incidence of melanoma has been on the rise, with nearly 325,000 new confirmed cases worldwide in 2020. In the United States, skin cancer is one of the most commonly diagnosed cancers, and melanoma accounts for the majority of skin cancer deaths. It is estimated that in 2021, there will be more than 106,000 new cases in the United States.DiagnosisTheMelanomaCase: More than 7,000 people will die from the disease.
It is estimated that stage IIB and stage IICMelanomaThe recurrence rate after surgery is 32-46% for patients, and 39-74% for stage III patients. The estimated 5-year survival rates (AJCC 8th edition) are as follows: 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.
Keytruda belongs to the anti-PD-(L)1 tumor immunotherapy class, which helps detect and combat tumor cells by enhancing the ability of the human immune system. Keytruda is an anti-PD-1 therapy that activates potentially impactful responses by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2.TumorT lymphocytes of cancer cells and healthy cells. Currently, Keytruda has become a foundational therapy for various types of cancer.
In the treatment of melanoma, based on the results of the EORTC132/KEYNOTE-054 trial, Keytruda has been approved in more than 90 countries worldwide and is recognized as a crucial adjuvant treatment option for patients with resected high-risk stage III melanoma. Additionally, Keytruda is also approved for the treatment of unresectable or metastatic melanoma.MelanomaPatient. (Bioon.com)