FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy for Resected Stage IIB, IIC, and III Melanoma in Patients Aged ≥12

December 17, 2021 /BioValleyBIOON/ -- MSD (Merck & Co) recently announced that the U.S. Food and Drug Administration (FDA) has approved the anti-PD-1 therapy Keytruda (generic name: pembrolizumab) 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 after complete surgical resection in Stage IIIMelanomaIndications, including pediatric patients (≥12 years old).

In other words,Keytruda is now approved for adjuvant treatment of patients (≥12 years old) with stage IIB, IIC, and III melanoma who have undergone complete surgical resection.. It is worth mentioning that,Keytruda is the first in adjuvant treatment for Stage IIB and IICMelanomaAspects showing recurrence-free survival benefits of anti-PD-1/PD-L1 therapy.

FDAApproval of Keytruda for Stage IIB and IICMelanoma, based on the first interim analysis data from the Phase 3 KEYNOTE-716 trial (NCT03553836). The trial involved 954 patients aged 12 years and older, evaluating the efficacy and safety of Keytruda as a monotherapy for adjuvant treatment. The results showed that, at the time of interim analysis, the trial had already met the primary endpoint of recurrence-free survival (RFS): Keytruda treatment demonstrated a statistically significant improvement in RFS.Compared with the placebo group, the risk of disease recurrence or death in the Keytruda treatment group was reduced by 35% (HR=0.65; 95% CI: 0.46-0.92; p=0.0132).The median RFS was not reached in either group. After a median follow-up of 14.4 months, 11% (n=54/487) of patients in the Keytruda treatment group had disease recurrence or died, compared to 17% (n=82/489) in the placebo group.

Given the similar biology, pharmacology of drug effects, as well as similar efficacy and safety exposure responses, for Stage IIB, IIC, and IIIMelanomaThe efficacy in pediatric patients (≥12 years) is supported by extrapolation from adult efficacy data.

Many patients with Stage II melanoma have a high risk of recurrence after surgery. The results of the KEYNOTE-716 trial represent an important milestone, as it is the first Phase 3 study specifically designed to evaluate adjuvant therapy for Stage IIB and IIC melanoma, an area with significant unmet medical need. By advancing Keytruda immunotherapy intoMelanomaIn the early stages, after complete surgical resection, adjuvant treatment with Keytruda effectively reduces the risk of recurrence in high-risk stage II patients compared to observation alone.

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%, and the recurrence rate for stage III patients is 39-74%. 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 affected pathways 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)

Source of Original Text:FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adult and Pediatric (≥12 Years of Age) Patients With Stage IIB or IIC Melanoma Following Complete Resection