Phase 3: personalized mRNA vaccine intismeran plus pembrolizumab lowers melanoma recurrence risk
In a phase 3 trial of 1,137 patients with resected stage IIB to IV melanoma, 24-month recurrence-free survival was 82.2 percent with the vaccine versus 70.0 percent with placebo.
The addition of a personalized mRNA-based cancer vaccine, intismeran autogene, to pembrolizumab was associated with a reduced risk of recurrence or death in patients with surgically resected stage IIB to IV cutaneous melanoma, oncologynurseadvisor.com reports. The results were presented at the annual meeting of the European Society for Medical Oncology, held from Oct. 23 to 27 in Madrid. oncologynurseadvisor.com
oncologynurseadvisor.comoncologynurseadvisor.comOpen source ↗
Trial design
Georgina Long and colleagues from Melanoma Institute Australia in Wollstonecraft randomly assigned 1,137 adults with surgically resected stage IIB/IIC or III/IV cutaneous melanoma. All received pembrolizumab 400 mg; 757 patients also received intismeran 1 mg and 380 received placebo. Patients were followed for a median of 24.6 months.
According to Long, the tumor is sequenced to read its individual "fingerprint," and an mRNA "wanted poster" of the cancer is made to show the immune system what to look for and attack.
Results and safety
Adding intismeran gave a significant improvement in recurrence-free survival (hazard ratio, 0.58). At 24 months, recurrence-free survival was 82.2 percent with intismeran versus 70.0 percent with placebo. oncologynurseadvisor.com
oncologynurseadvisor.comoncologynurseadvisor.comOpen source ↗ Distant metastasis-free survival also improved significantly (hazard ratio, 0.62), and similar benefits were seen in stage IIB/IIC and stage III/IV.
Grade 3 or higher adverse events occurred in 23.6 percent of patients receiving intismeran and 20.3 percent of those receiving placebo. The most common were pyrexia, injection site pain and fatigue. Long described the work as the first phase 3 study to show that a treatment built from a patient's own tumor can reduce the risk of recurrence or death from cancer.
