Moderna
on Thursday unveiled new data from a continuing early-stage trial of the personalized cancer treatment it is testing with Merck, saying that the updated results help build the case that the drug works.
The new data follows up on results Merck and Moderna first announced last December, and presented in full at a scientific conference in April. At the time, the companies said that after two years, late-stage melanoma patients who received the Moderna treatment in combination with Merck’s Keytruda immunotherapy drug had a lower risk of disease recurrence or death compared with those who received Keytruda alone.
In the new announcement Thursday morning, Moderna said that updated results after three years show that the combination regimen of the Moderna treatment and Keytruda continued to offer improvements in survival rates over Keytruda alone.
Investors have been enthusiastic about the Moderna treatment, called mRNA-4157, and Moderna shares climbed 19.6% on the day the company first released the results last December.
The stock up 12% in premarket trading Thursday.
The treatment is tailored for each individual recipient based on the genetic makeup of his or her tumor, but is otherwise identical in its design to the Moderna Covid-19 vaccine. The aim is that mRNA-4157 guides the patients’ own T-cells to attack their cancerous tumors, while Keytruda ramps up patients’ immune system.
The treatment is an important part of Moderna’s postpandemic vision. Shares are down 56.6% so far this year, as Covid-19 vaccine sales have virtually evaporated. The cancer treatment opens the door to applications of Moderna’s messenger RNA-based technology that go far beyond the respiratory virus vaccines that fill its near-term pipeline.
Moderna says that the new data show that the shot is working. “The p value keeps improving,” Moderna CEO Stéphane Bancel told Barron’s, referring to a statistical calculation that indicates how likely it is that the result is due to random chance. “This is not a random fluke. This is real.”
Moderna said that after three years, mRNA-4157 in combination with Keytruda reduced the risk of recurrence or death by 49% compared with Keytruda alone. The combination reduced the risk of developing distant metastasis or death by 62% compared with Keytruda alone.
Moderna didn’t say how many patients the trial was tracking. Analysts have in the past complained that the study was too small to get excited about.
Merck and Moderna have already begun Phase 3 trials of mRNA-4157 in combination with Keytruda. Bancel said that the company is also working to prepare its new manufacturing plant in Marlborough, Mass., which will be fully dedicated to making commercial doses of its cancer shot.
Bancel said that the new data increases the odds that the company will be able to get conditional approval of mRNA-4157 ahead of the completion of the continuing Phase 3 trials. “These data improvement should make more regulators comfortable…to give us conditional approval,” he said.
He said he expects the Phase 3 melanoma trial to be fully enrolled in the second half of next year. The company has said that accelerated launch of the drug could come as early as 2025.
Write to Josh Nathan-Kazis at [email protected]
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