Shares of Moderna Inc. soared 14% early Thursday after the biotechnology company and its partner Merck & Co. announced positive data from a trial of Moderna’s mRNA-4157 in combination with the anticancer drug success of Merck, 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 August 3, 2022. The volume of 8.4 million shares traded was more than double the daily average over the past 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 metastases or death by 62%, compared to Keytruda alone.
“As we continue to follow participants in the Keynote-942/mRNA-4157-P201 study, we are pleased to see such robust clinical benefit with mRNA-4157 (V940) as adjuvant therapy in combination with Keytruda in people with high resection. melanoma risk,” said Kyle Holen, senior vice president and head of therapeutics and oncology development at Moderna.
“These data add another positive analysis to the multiple endpoints and subgroups previously evaluated 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 initiated Phase 3 trials of mRNA-4157 in combination with Keytruda, which has received breakthrough designation from the U.S. Food and Drug Administration and the European Medicines Agency, the European regulator.
Moderna and Merck presented data on the primary endpoint in April at the American Association for Cancer Research annual meeting. In June, they presented data on the study’s secondary endpoint at the American Society of Clinical Oncology annual meeting. Data from the primary analysis have been submitted for publication in a peer-reviewed journal, they said in a statement.
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Merck shares
MRK,
was down 1.4% as of Thursday morning and 5% so far in 2023. Moderna’s stock has fallen 50% year to date, while the S&P 500
SPX,
gained 22.6%.
