Moderna Inc.’s stock soared 14% early Thursday after the biotech company and partner Merck & Co. announced positive data from a trial of Moderna’s mRNA-4157 in combination with Merck’s blockbuster cancer drug Keytruda in patients with resected high-risk melanoma (stage III/IV).
The stock
MRNA,
was on track for its biggest one-day percentage gain since Aug. 3, 2022. Volume of 8.4 million shares traded was more than double the daily average over the last 65 days.
The companies said that after about three years, the combination reduced the risk of recurrence or death by 49% in a Phase 2 trial and the risk of distant metastasis or death by 62%, as compared with Keytruda alone.
“As we continue to follow participants in the Keynote-942/mRNA-4157-P201 study, we are excited to see such a robust clinical benefit with mRNA-4157 (V940) as adjuvant treatment in combination with Keytruda in people with resected high-risk melanoma,” said Kyle Holen, senior vice president and head of development in therapeutics and oncology at Moderna.
“These data add another positive analysis to the multiple endpoints and subgroups previously assessed in this study,” he said.
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Adverse events were consistent with previous trials and were primarily fatigue, injection-site pain and chills.
The companies have started Phase 3 trials of mRNA-4157 in combination with Keytruda, which has been granted breakthrough designation by the U.S. Food and Drug Administration and by the European Medicines Agency, the European regulator.
Moderna and Merck presented data on the primary endpoint in April at the annual meeting of the American Association for Cancer Research. In June, they presented data on the study’s secondary endpoint at the annual meeting of the American Society of Clinical Oncology. Data from the primary analysis has been submitted for publication in a peer-reviewed journal, they said in a statement.
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Merck’s stock
MRK,
was down 1.4% in Thursday morning trading and is down 5% to date in 2023. Moderna’s stock has fallen 50% year to date, while the S&P 500
SPX,
has gained 22.6%.
