By Julie Steenhuysen and Michael Erman
CHICAGO, Aug 19 (Reuters) - Moderna's personalized mRNA cancer therapy, developed with Merck, reduced the risk of recurrence and spread of skin cancer in a late-stage trial when combined with immunotherapy drug Keytruda, sending Moderna's shares up around 150% to multi-year highs.
Thousands of patients who have undergone surgery for high-risk melanoma could benefit as soon as next year, Moderna President Stephen Hoge said in an interview.
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 preventing 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 $160.25, while Merck climbed 11% in early trading.
Moderna's stock has suffered in recent years as it has struggled to prove to investors it can build its mRNA platform beyond its COVID-19 shot. Merck has been bracing for the looming patent loss of Keytruda, once the world's best-selling drug, later this decade.
Merck said the companies are already in talks with regulators about the treatment.
Hoge said given the vaccine's breakthrough therapy designation, it could be available as soon as next year.
He called the result a landmark.
"This is the first time that we've seen really clinically significant, statistically significant improvements over checkpoints like Keytruda in this population, and it is the first time we've done that with an individualized treatment," Hoge said.
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.
Last month, Barclays analysts said they expect the therapy could generate annual sales of 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, 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 in the manufacturing process, unlike some personalized cell therapies, which could allow manufacturing 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 Michael Erman; additional reporting by Christy Santhosh; Editing by Jamie Freed, Sriraj Kalluvila, Rod Nickel)
