Moderna's stock price jumped more than 145% on Wednesday, at around 2:05pm Brasília time, after the company's personalized mRNA cancer therapy, developed in partnership with MSD, reduced the risk of skin cancer recurrence and spread in a final-stage clinical trial when combined with the immunotherapy drug Keytruda.
Thousands of patients who have undergone surgery for high-risk melanoma could benefit as early as next year, according to Moderna's president, Stephen Hoge, in an interview.
Preliminary results of the ongoing study, released on Wednesday, showed that treatment with Intismeran met both the trial's main goal of reducing cancer recurrence and its secondary goal of preventing tumors from spreading to other parts of the body, compared with Keytruda alone.
It is the first positive result from a final-phase clinical trial for an mRNA cancer vaccine, and the first study of its kind to show that adding a treatment to Keytruda worked better than the standalone therapy in people whose melanoma had been surgically removed.
Stock Struggles and Patent Pressure
Moderna's shares have suffered in recent years as the company has struggled to prove to investors that it can expand its mRNA platform beyond its Covid-19 vaccine, the product that made it a household name during the pandemic. MSD, for its part, has been preparing for the looming loss of its patent on Keytruda, a drug that has been the world's best-selling this decade. Keytruda, known generically as pembrolizumab, is a checkpoint inhibitor that works by helping the immune system identify and attack cancer cells.
MSD said the companies are already in talks with regulators about the treatment. Hoge said that given the vaccine's breakthrough therapy designation, it could be available as early as next year. He described the result as a historic milestone.
Hoge said this was the first time clinically significant and statistically relevant improvements had been observed compared with checkpoint inhibitors like Keytruda in this patient population, and the first time this had been achieved with an individualized treatment.
William Blair analyst Myles Minter said the interim results position both companies well to pursue regulatory approval, and are a positive signal 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 melanoma treatment by 2035.
Price Still Undecided
JPMorgan analysts said the launch of the Intismeran vaccine for adjuvant melanoma treatment will be key to Moderna returning to profitability.
The cancer treatment combines MSD's Keytruda with a personalized mRNA vaccine from Moderna, built from an analysis of the mutations found in each patient's own tumors.
Trial Details
The clinical trial included 1,137 high-risk patients with stage IIB-IV melanoma who had undergone surgical removal of the cancer. Volunteers were randomly assigned to receive up to nine doses of Keytruda plus the personalized vaccine, or Keytruda alone, over about a year. The companies said no new safety warning signs emerged during the trial.
In January, the companies announced results from a mid-phase trial of the treatment, showing that it reduced the risk of recurrence or death by 49% after five years.
Pricing and Manufacturing
Moderna's chief executive, Stephane Bancel, said in an interview with CNBC that the companies have not yet set prices, noting that the data had only become available a few days earlier.
He said the treatment does not use patients' own cells in its manufacturing process, unlike some personalized cell therapies, which he said could allow for increased production and lower prices.
About Melanoma
Melanoma is the most lethal form of skin cancer. In 2023, more than 1.5 million people in the United States were living with melanoma, according to the National Cancer Institute.
