In a nutshell
This study investigated the effectiveness of pembrolizumab (Keytruda) in the treatment of patients with stage 3 melanoma who underwent surgery. Researchers suggested that this drug is associated with longer recurrence-free survival with no new side effects.
The use of PD-1 antibodies, such as pembrolizumab, in patients with high risk melanoma is rapidly increasing. This type of treatment has been shown to be associated with longer progression-free survival and overall survival in advanced melanoma patients. However, the effectiveness of pembrolizumab in patients with high risk of recurrence (when the cancer comes back) such as stage 3 melanoma patients.
Methods & findings
This study investigated the effectiveness of pembrolizumab in treating stage 3 melanoma patients.
Melanoma patients were randomly assigned to receive pembrolizumab (514 patients) or placebo (drug with no effect on the body; 505 patients) every 3 weeks for 1 year or until recurrence or significant side effects.
After an average follow-up of 15 months, 75.4% of patients treated with pembrolizumab were recurrence-free. This was compared to 61% of those treated with placebo. Patients treated with pembrolizumab had a 43% increase in the odds of a better recurrence-free survival when compared to the placebo group.
Severe negative side effects were seen in 14.7% of the patients treated with pembrolizumab and 3.4% in patients from the placebo group. These included fatigue, diarrhea, and joint pain. There was one death caused by myositis (loss of muscle function).
The bottom line
This study suggests that pembrolizumab improves recurrence-free survival in patients with stage 3 melanoma.
The fine print
This study was supported by Merck, the producer of pembrolizumab.
Published By :
The New England Journal of Medicine
Apr 15, 2018