Merck and Moderna have reported positive results from a Phase 3 trial evaluating intismeran autogene, an individualized mRNA-based cancer therapy, in combination with pembrolizumab for patients with completely resected high-risk melanoma.
The INTerpath-001 trial met its primary endpoint of recurrence-free survival (RFS) and a key secondary endpoint of distant metastasis-free survival (DMFS). The combination demonstrated statistically significant and clinically meaningful improvements compared with pembrolizumab alone in patients with stage IIB-IV melanoma.
“By intervening earlier in the course of disease, when many cancers are considered most treatable, the goal of adjuvant therapy given after surgery is to increase the possibility of cure for more patients,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “These first Phase 3 findings for intismeran in combination with KEYTRUDA as adjuvant therapy reinforce the promise of a more personalized approach to cancer treatment. We believe individualized neoantigen therapies have the potential to redefine how patients with completely resected stage IIB-IV melanoma are treated.”
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The global trial enrolled 1,137 patients following complete surgical removal of their tumors. Intismeran is designed using the unique mutations identified in an individual patient’s tumor, with the aim of training the immune system to recognize and target cancer cells.
Professor Georgina Long, the study’s principal investigator and medical director of Melanoma Institute Australia, Chair of Melanoma Medical Oncology and Translational Research at the University of Sydney said, “Intismeran in combination with pembrolizumab has the potential to establish a new treatment paradigm in the adjuvant melanoma setting, helping patients remain cancer-free for longer.”
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Detailed findings will be presented at an upcoming international medical meeting, while the companies plan to engage with regulators regarding potential filings.
The treatment is also being studied across other cancer types, including lung, bladder and kidney cancers.
