Adjuvant Pembrolizumab Approved by European Commission for Resected Stage IIB/C Melanoma


Patients with fully resected stage IIB or IIC melanoma can now receive treatment with pembrolizumab in the adjuvant setting following its approval by the European Commission.

Pembrolizumab (Keytruda) used in the adjuvant setting for the treatment of adult and adolescent patients 12 years or older with completely resected stage IIB or IIC melanoma was approved by the European Commission, according to a press release from Merck.1

The regulatory organization also expanded the approval of pembrolizumab in settings of advanced melanoma and as adjuvant therapy for stage III disease after complete resection in those who are 12 years or older.

The newly approved indication was based on findings from the phase 3 KEYNOTE-716 study (NCT03553836), which compared the use of pembrolizumab with placebo in resected high-risk stage II melanoma. Data from the trial indicated that those treated with adjuvant pembrolizumab experienced a prolonged recurrence-free survival interval and reduced the risk of recurrence or death by 39% (HR, 0.61; 95% CI, 0.45-0.82; P = .00046). Moreover, a significant improvement in distant metastases-free survival was observed that translated to a 36% reduction in risk of distant metastases (HR, 0.64; 95% CI, 0.47-0.88; P = .00292).

“When melanoma recurs, patients often have a significantly worse long-term prognosis, especially if the cancer returns or spreads to distant sites,” Alexander Eggermont, MD, PhD, chief scientific officer at Princess Máxima Center for Pediatric Oncology, the Netherlands, said in a press release. “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.”

Adjuvant pembrolizumab for the treatment of fully resected stage IIB or IIC melanoma was approved by the FDA in the United States in December 2021.2


  1. European Commission approves Keytruda (pembrolizumab) as adjuvant treatment for adult and adolescent patients (≥12 years of age) with stage IIB or IIC melanoma following complete resection. News release. Merck. June 24, 2022. Accessed June 26, 2022.
  2. FDA approves pembrolizumab for adjuvant treatment of Stage IIB or IIC melanoma. News release. FDA. December 3, 2021. Accessed June 26, 2022.
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