FDA Approves Pembrolizumab for Adjuvant Treatment of Advanced Melanoma

The FDA approved pembrolizumab (Keytruda) for the adjuvant treatment of patients with resected, high-risk stage III melanoma.

The approval is based on data from the phase III EORTC 1325-MG/KEYNOTE-054 trial, that compared adjuvant pembrolizumab to placebo. Pembrolizumab, an immunotherapy agent that works by inhibiting the PD-1 protein, reduced the risk of death or recurrence by 43% for patients with resected, high-risk advanced melanoma.

“It is great to have another anti-PD1 immunotherapy option to consider for patients with resected melanoma who remain at risk of recurrence,” said Michael A. Postow, MD, medical oncologist, Memorial Sloan Kettering Cancer Center, in an interview with Oncology Nursing News^®.

In the study, patients randomized to the pembrolizumab arm received 200 mg of the drug intravenously on day 1 of each 21-day cycle. They underwent treatment for 18 cycles (about 1 year) or until disease recurrence or unacceptable toxicity. Patients randomized to the placebo arm who had recurrences were unblinded and able to cross over to the pembrolizumab arm, as long as they did not have brain metastases. Also, patients who started out on the pembrolizumab arm who had recurrences more than 6 months after the year of initial treatment could rechallenge with the checkpoint inhibitor.

Immunotherapy agents have a unique adverse event profile. Therefore, it is imperative that oncology nurses know what to look out for and the symptoms to educate their patients about.

Serious immune-related adverse events (irAEs) can occur with pembrolizumab, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, pembrolizumab should be withheld or discontinued and corticosteroids administered if appropriate. Pembrolizumab can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, pembrolizumab can cause fetal harm when administered to a pregnant woman.

“Although pembrolizumab is generally well tolerated in most patients, nurses need to be aware of the possibility that some side effects can be significant and permanent,” said Postow, who specializes in the care of patients who are receiving immunotherapy. “Nurses are often on the front-line managing side effects and establishing a close rapport and clear communication with patients will be critical to achieving optimal patient outcomes.”