Daijiworld Media Network – New Delhi
New Delhi, Aug 20: Moderna and Merck have reported positive results from a Phase 3 trial of their personalised mRNA cancer vaccine, intismeran autogene, when used in combination with the immunotherapy Keytruda (pembrolizumab) for patients with melanoma.
The trial involved 1,137 patients with completely resected stage IIB to IV melanoma. Participants were given either the personalised mRNA therapy along with Keytruda or Keytruda alone. According to the companies, the combination met its primary goal of improving recurrence-free survival and also achieved a key secondary goal related to preventing the cancer from spreading to distant parts of the body.
In simple terms, patients receiving the combination remained free from the cancer returning for longer and had a lower risk of distant metastasis compared with those receiving Keytruda alone. The study will continue to assess other outcomes, including overall survival.
Intismeran autogene is designed to work differently from conventional vaccines that protect against infectious diseases. It is developed based on the individual genetic characteristics of a patient's tumour. After a tumour is removed, its mutations can be analysed to identify targets that may help the immune system recognise and attack remaining cancer cells.
The latest findings are significant because Keytruda is already an established immunotherapy for melanoma. The results suggest that adding a personalised treatment designed around tumour-specific mutations could potentially improve outcomes for patients with high-risk melanoma.
The companies said the safety profile of the combination remained consistent with earlier studies and that no new safety concerns were identified. However, detailed trial data have not yet been released, and the treatment remains investigational.
Moderna and Merck described the results as the first positive Phase 3 readout for an individualised neoantigen therapy and an mRNA-based cancer therapy. They plan to present detailed findings at an upcoming medical meeting and discuss potential regulatory submissions with authorities.
The latest results build on earlier findings from the KEYNOTE-942 study, which showed improved recurrence-free survival when the personalised mRNA therapy was combined with Keytruda. The companies are also studying intismeran autogene in other cancers, including non-small cell lung cancer, bladder cancer and renal cell carcinoma.
For melanoma patients who have undergone surgery, preventing the disease from returning is an important treatment goal. A personalised cancer vaccine could offer another way of helping the immune system identify cancer cells carrying mutations specific to an individual's tumour.
However, the latest Phase 3 findings alone do not establish whether the treatment can extend overall survival. Further follow-up, detailed clinical data and regulatory review will be needed to determine its long-term benefits and risks.