Merck (known as MSD outside the US and Canada) and Moderna have announced positive results from the Phase 3 trial evaluating an investigational personalised mRNA cancer vaccine.
The vaccine, called Intismeran, was given in combination with Keytruda, an immunotherapy drug already used in cancer treatment.
The readout represents the first successful Phase 3 trial for an individualised neoantigen therapy (INT) and an mRNA-based oncology vaccine.
Researchers will continue to track the same 1,137 patients over several years to measure overall survival (OS) - confirming whether the treatment actually extends life span.
Melanoma is one of the most aggressive forms of skin cancer. Despite surgical removal of primary tumours, patients with stage IIB–IV disease face high rates of recurrence, with the majority of relapses spreading to distant organs.
The randomised trial enrolled 1,137 patients who received either intismeran autogene every three weeks for up to nine doses alongside Keytruda every six weeks for approximately one year, or Keytruda monotherapy.
Merck and Moderna confirmed they will present detailed findings at an upcoming medical congress and begin formal discussions with international regulatory bodies regarding marketing authorisation submissions.
The partners are currently evaluating the INT platform across nine Phase 2 and Phase 3 trials spanning non-small cell lung cancer, bladder cancer, and renal cell carcinoma.
