Personalised mRNA shot from Moderna and Merck cuts melanoma relapse
· BehindLines newsroom
A messenger RNA vaccine designed individually for each patient lowered the risk of melanoma coming back in a phase 3 trial, the last stage of testing before a drug can be submitted for approval. The full results of the INTerpath-001 study were presented on Saturday, October 24, at the congress of the European Society for Medical Oncology (ESMO) in Madrid by the Australian oncologist Georgina Long.
The trial enrolled 1,137 people who had undergone surgery for stage IIB to IV melanoma, meaning a high chance of recurrence. Two thirds received intismeran autogene, Moderna's product, on top of Merck's pembrolizumab (Keytruda); the rest received pembrolizumab with a placebo. According to Merck, the combination reduced the risk of relapse or death by 42% after a median follow-up of about two years. At 24 months, 82.2% of vaccinated patients were still free of recurrence, against 70.0% in the comparison group. The risk of distant spread or death fell by 38%. Overall survival data are not yet mature enough to draw a conclusion, and the vaccine did not add notable immune-related side effects.
The two groups only began to diverge after roughly six months, once the vaccination course was over. The timetable was also upended: after a leak, the companies released the data on Thursday, ahead of schedule, Fierce Biotech reported. The findings have been accepted for publication in the New England Journal of Medicine.
How it works: the tumour removed during surgery is sequenced to find the mutations specific to it, then an RNA is made that teaches the immune system to recognise those targets. The immunotherapy drug, for its part, releases the brakes that stop immune cells from attacking.
Why it matters: according to STAT, this is the first phase 3 success for a personalised therapeutic cancer vaccine and for an mRNA-based cancer treatment. Drugmakers now want to extend the approach to other tumours. Investors were more cautious: shares of both companies fell, as some analysts found the secondary measure weaker than hoped, BioPharma Dive reported.
For patients, nothing changes yet: the product is not approved anywhere, and the companies still have to submit the data to regulators. Because each dose is made for one person, there are also open questions about turnaround time and cost, which the trial does not settle.