Keytruda Approved for Treatment of Stage III Melanoma

The U.S. Food and Drug Administration (FDA) has approved Keytruda for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete surgical resection.

Adjuvant Therapy in Melanoma

Melanoma is separated into five staging categories (stages 0-4).  Stage 3 melanoma is a cancer that has spread to the regional lymph nodes but has not yet spread to distant lymph nodes or to other parts of the body (metastasized).  Current standard treatment of stage 3 melanoma is surgical resection of the primary tumor as well as the involved lymph nodes followed by adjuvant therapy. Despite surgical removal of the cancer however, most patients experience disease recurrence and progress to metastatic disease. By five years, the majority of stage IIIb and IIIc patients (68% and 89%, respectively) experience disease recurrence however this has been improved with the use of adjuvant immunotherapy and Keytruda represents a new adjuvant treatment option.

About KEYNOTE-054

The KEYNOTE-054 clinical trial is a multicenter, randomized, double-blind, placebo-controlled phase 3 trial which included patients with completely resected stage IIIA (>1 mm lymph node metastasis), IIIB or IIIC melanoma.  Overall 1,019 patients were treated with either Keytruda or a placebo following surgery every three weeks for up to one year or until disease recurrence or unacceptable toxicity and directly compared.

Sixteen percent had stage IIIA; 46 percent had stage IIIB; 18 percent had stage IIIC (1-3 positive lymph nodes) and 20 percent had stage IIIC (≥4 positive lymph nodes); 50 percent were BRAF V600 mutation positive, and 44 percent were BRAF wild-type; and 84 percent had PD-L1.

The FDA approval was based on results from the KEYNOTE-054 trial phase 3 clinical trial, which demonstrated that Keytruda improved recurrence-free survival by reducing the risk of disease recurrence by 43 percent in individuals with resected, high-risk stage III melanoma.


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