An experimental personalised cancer vaccine developed by Moderna and Merck has lowered the risk of the disease returning or death by 42% in patients with high-risk melanoma, the most dangerous form of skin cancer. Despite the strength of the late-stage data, the announcement was followed by a steep fall in Moderna’s share price on Wall Street.
Phase 3 trial results
According to the results of the Phase 3 clinical trial, combining the experimental vaccine with Merck’s immunotherapy Keytruda reduced the risk of recurrence or death compared with Keytruda alone.
The study involved more than 1,100 patients with high-risk melanoma, all of whom had previously undergone surgery to remove their tumour. The key findings were:
- 42% lower risk of recurrence or death with the combination, compared with Keytruda alone
- 38% lower risk of distant metastases or death
- 82.2% of patients receiving the combination remained recurrence-free two years after treatment, compared with 70% of those receiving Keytruda alone
How the personalised vaccine works
The vaccine, named intismeran autogene, is based on messenger RNA (mRNA) technology and is designed individually for each patient according to the genetic mutations of their tumour.
Its aim is to activate the immune system so that it recognises and attacks cancer cells that may remain in the body after surgery.
Regulatory status and limitations of the data
The two companies are in contact with regulators about potential approval of the treatment, which remains experimental.
The data available so far do not yet demonstrate a corresponding improvement in overall survival.
Moderna shares fall despite positive results
On Thursday 22 October, Moderna’s shares fell by more than 17%, and continued to decline on Friday, losing around 4% in morning trading.
According to Reuters, the drop during Thursday’s session at one point exceeded 25%, wiping out around $24 billion from the company’s market value.
Analysts attribute the reaction to the particularly high expectations that had built up in previous months, during which the stock had risen sharply. Although the results have been described as positive, some investors had expected even greater efficacy and moved to take profits.
Merck recorded considerably smaller losses, as it has a broader portfolio of medicines. For Moderna, the development of cancer therapies is a central pillar of its future growth.
Full data at ESMO in Madrid
The next key milestone is the detailed presentation of the results at the congress of the European Society for Medical Oncology (ESMO) in Madrid on Saturday 24 October.
With information from LiFO, Reuters, 24/7 Wall St, KSL and Yahoo! Finance
