By Julie Steenhuysen and Christy Santhosh
CHICAGO, Aug 19 (Reuters) – Moderna’s personalized mRNA cancer therapy, developed with Merck, reduced the risk of melanoma recurrence and spread in a late-stage trial when combined with Keytruda, sending the biotech’s shares surging 90% in premarket trading.
Interim results of the ongoing study, released on Wednesday, found the treatment, Intismeran, met both its primary target of reducing cancer recurrence and its secondary goal of keeping the tumors from spreading to other parts of the body, compared with Keytruda alone.
This is the first positive late-stage trial result for an mRNA cancer vaccine and the first such study to show that adding a treatment to Keytruda worked better than the therapy alone in people whose melanoma had been removed by surgery.
Shares of Moderna were trading at $118.61, while Merck climbed 7.5% before the bell. Moderna was the No. 1 trending stock on retail-investor forum Stocktwits, according to the platform.
The data will likely ease investor worries over the companies’ long-term growth drivers. Moderna has been looking for growth beyond its COVID-19 shot while Merck is bracing for the looming patent loss for Keytruda, its blockbuster therapy, later this decade.
William Blair analyst Myles Minter said the interim results position both companies well to seek regulatory approval, while also reading positively for the vaccine’s ongoing studies in other types of cancer.
Merck’s R&D head Dean Li, in an appearance on CNBC, said the companies expect to begin talks with regulators in the next few months.
Last month, Barclays analysts said they expect the therapy could generate about $3 billion for treating melanoma by 2035.
NO PRICING DECISION YET
J.P. Morgan analysts said the launch of the vaccine, Intismeran, in adjuvant melanoma will be key to Moderna returning to profitability.
The cancer treatment combines Merck’s Keytruda with a made-to-order mRNA vaccine from Moderna that is based on an analysis of mutations found in the patients’ own tumors.
The trial enrolled 1,137 high-risk patients with stage IIB-IV melanoma that had been surgically removed.
Volunteers were randomized to receive up to nine doses of Keytruda plus the personalized vaccine or Keytruda alone for about one year. The companies said no new safety signals have emerged in the trial.
In January, the companies announced results of a mid-stage trial of the treatment showing that it reduced the risk of recurrence or death by 49% after five years.
Moderna CEO Stephane Bancel, appearing on CNBC alongside Dean Li, said the companies have not decided on pricing, saying the data had only become available “a couple days ago”.
He said the treatment does not use patients’ own cells, unlike some personalized cell therapies, which could allow the manufacturing process to be scaled and the price reduced.
Melanoma is the deadliest form of skin cancer. In 2023, there were more than 1.5 million people in the U.S. living with melanoma, according to the National Cancer Institute.
(Reporting by Julie Steenhuysen and Christy Santhosh; Editing by Jamie Freed and Sriraj Kalluvila)
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