Patients with high-risk melanoma who received the immunotherapy drug pembrolizumab both before and after surgery to remove cancerous tissue had a significantly lower risk of their cancer recurring than similar patients who received the drug only after surgery.
To test this hypothesis, S1801 investigators enrolled 345 participants with stage IIIB through stage IV melanoma that was deemed operable. Participants ages 18-90 were randomized to receive either upfront surgery followed by 200 mg of pembrolizumab every three weeks for a total of 18 doses, or to 200 mg of pembrolizumab every three weeks for three doses leading up to surgery , then an additional 15 doses following surgery.
The primary endpoint measured was the duration of event-free survival, defined as the time from randomization to the occurrence of one of the following:or toxicity that resulted in not receiving surgery, failure to begin adjuvant therapy within 84 days of surgery, melanoma recurrence after surgery, or death from any cause.
With a median follow-up of 14.7 months, event-free survival was significantly longer in the neoadjuvant therapy arm, with a hazard ratio of 0.58 when compared to the adjuvant therapy arm, which corresponds to a 42% lower event rate in the patients receiving the neoadjuvant regimen. "Our study noted a significant improvement in event-free survival in the neoadjuvant regimen compared to the adjuvant regimen," Patel said."Importantly, a similar number of patients in both arms experienced events before initiating adjuvant pembrolizumab, but the rate of eventsThe researchers found that the benefit from neoadjuvantwas consistent across a range of factors including patient age, sex, performance status, and stage of disease.
"Based on the findings from S1801, patients with high-risk melanoma should start immunotherapy prior to surgery to generate an
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