‘s experimental messenger RNA-based cancer vaccine to a standard regimen of
‘s Keytruda in high-risk melanoma patients meaningfully reduced the risk of death or recurrence of cancer in a Phase 2 trial, the company said early Tuesday.
The results represents a significant vindication for
(ticker: MRNA), and a step in its ambitions to extend beyond its current profile as a Covid-19 vaccine company.
If the results hold up in a planned Phase 3 trial in the same category of patients, and in similar tests expected in other indications, it could represent the start of a significant shift in cancer treatment, where mRNA-based personalized cancer vaccines are given in combination with established checkpoint inhibitors like Keytruda.
“I think this is as big a step for patients as Keytruda was,” Moderna’s CEO, Stephane Bancel, told Barron’s on Monday, shortly before the trial results were announced.
The trail enrolled 157 high-risk melanoma patients who had had a tumor surgically removed. The trial andomized participants into two groups, one that received only
‘s (MRK) Keytruda, the immuno-oncology drug that revolutionized cancer therapy when it was first introduced in 2014, and another group that received Keytruda plus Moderna’s personalized cancer vaccine known as mRNA-4157.
Patients who received both mRNA-4157 plus Keytruda had a 44% lower risk of death or recurrence than those who received Keytruda alone. The result was statistically significant.
“The personalized cancer vaccine decreased your risk of relapse by almost half,” Bancel said.
Moderna and Merck will run a Phase 3 trial of the combination in the same indication. Bancel said that the companies are in discussions with regulators about next steps.
Merck and Moderna have collaborated on personalized cancer vaccines since 2016. In October, Merck said that it had exercised an option to jointly develop mRNA-4157, and announced the companies would report the results of the melanoma trial in the fourth quarter.
Moderna shares traded up 8.3% on the day of the October announcement, which suggests that investors may already have priced in a positive trial result, and that any reaction on Tuesday could be muted.
MRNA-4157 is tailored to target each patient’s individual tumor in a process that Moderna says takes just weeks. The basic concept behind pairing the two drugs is that Keytruda will amp up the immune response mounted by the patient’s T-cells, while MRNA-4157 will help guide the T-cells to the tumor.
If the approach works in melanoma, it’s possible it could work in other indications, as well. “The belief that we have…is all the tumor types where Keytruda has a positive impact on patients, we believe this approach should have the same,” Bancel said.
Aside from the specific proteins in the personalized cancer vaccine, mRNA-4157 is identical to the Moderna Covid-19 vaccine that has been administered hundreds millions of times around the globe. “Same mRNA chemistry,” Bancel said. “Same lipid. Same route, intramuscular. Same manufacturing process.”
Moderna has been making personalized cancer vaccines for its clinical trial program in Norwood, Mass., but Bancel said that the company is now scaling up to be able to make enough vaccines for its Phase 3 trials. He said that the company is also currently investing to scale up for an eventual commercial launch.
Moderna shares are down 35.2% this year. While the company has an extensive pipeline, its Covid-19 vaccine remains its only approved product, and the share price has stumbled as global demand for the vaccine plummets. Bancel said that the results of the personalized cancer vaccine trial demonstrate the breadth of the company’s pipeline.
“A lot of people think we are a Covid-19 company, but I think the power of this very broad platform that we spent the last 10 years building is starting to come to light,” he said.
Write to Josh Nathan-Kazis at firstname.lastname@example.org