A messenger RNA (mRNA)-based therapy designed for cancer has delivered positive Phase 3 results in patients with resected, advanced myeloma representing a first of its kind treatment in oncology. Announced on 19 August, the trial, INTerpath-001, delivered recurrence-free survival and distant metastasis-free survival for patients who had tumours removed but were still at risk of disease. The trial enrolled 1,137 patients who were randomised to receive intismeran, the mRNA therapy, and Keytruda (pembrolizumab) or Keytruda alone.
Intismeran is a neoantigen mRNA therapy based on tumour samples from patients which bear unique mutational signatures. Each treatment consists of a synthetic mRNA coding for up to 34 neoantigen sequences. Upon administration, the sequences are translated in the body and presented to the immune system which then attacks the cancer. The therapy was developed by Moderna Inc and Merck & Co Inc, which is also developer of Keytruda. The therapy is being positioned as a standard-of-care immunotherapy in an adjuvant setting for patients whose tumours have been surgically removed.
In a statement, Moderna’s chief executive Stéphane Bancel, said that before the trial was launched, the idea of creating an mRNA treatment for cancer was ‘aspirational.’ This is now becoming a reality. The two companies are evaluating intismeran in combination with Keytruda and other cancer therapies, and as a monotherapy. Nine Phase 2 and Phase 3 trials are underway across multiple tumour types, including in melanoma, non-small cell lung cancer, bladder cancer, and renal cell carcinoma.
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