Moderna’s mRNA cancer vaccine shows promise in preliminary study
Summary
The shot combined with a Merck immunotherapy reduced the risk of relapse in people with skin cancer in a study, Moderna saidA customized Moderna Inc. vaccine combined with a Merck & Co. cancer drug helped ward off the recurrence of the skin cancer melanoma after surgery in patients in a mid-stage clinical trial, the companies said.
The companies said Tuesday the combination of Moderna’s personalized cancer vaccine and Merck’s Keytruda cancer immunotherapy reduced patients’ risk of relapse or death by about 44%, versus Keytruda alone, in the 150-volunteer study.
The results, which the companies said were statistically significant but haven’t been reviewed by independent scientists, suggest promise for an emerging but unproven class of vaccines that aim to treat diseases rather than prevent infections like typical shots.
If the combination proves successful in further testing, the results could broaden the applications for Moderna’s messenger RNA platform beyond the Covid-19 vaccine that was the first use for the gene-based technology.
The companies said they plan to run a larger study to confirm the combination’s safety and efficacy next year. Positive results of that study could clear the way for potential regulatory approval of Moderna’s experimental cancer vaccine.
Moderna and Merck also plan to test the combination in other types of cancers. “We don’t want to waste time. Given the data is so strong, for me it’s a Covid-like moment," Moderna Chief Executive Stephane Bancel said.
Moderna has been eyeing new uses for its mRNA technology since it was validated with the company’s widely used Covid-19 vaccine. Researchers have long probed giving vaccines to patients with cancer, one of the pharmaceutical industry’s biggest markets.
Moderna makes its vaccine in a complex way because the shot is unique to each patient.
The Cambridge, Mass., company starts with a biopsy of the patient’s tumor. Then it analyzes the tumor sample and identifies mutations in the cancer cells known as neoepitopes.
Moderna selects up to 34 neoepitopes that it believes would elicit the strongest immune response from a patient, and incorporates the genetic codes for these neoepitopes into a vaccine.
Once injected into a patient, the vaccine instructs the patient’s cells to make the neoepitopes. This in turn is supposed to trigger an immune response that can better target and destroy cancer cells.
The companies have said they believe the immune response would complement the effect of Keytruda, which works by releasing the brakes on the body’s immune system to fight tumors.
It takes about four to eight weeks between biopsy and the first injection of the cancer vaccine.
Small, early stage studies of the personalized cancer vaccine in people with various tumor types showed promise.
In 2019, Moderna and Merck started a Phase 2 trial of the personalized cancer vaccine with Keytruda in people whose melanoma had been removed by surgery but were deemed to be at high risk of cancer recurrence.
After their surgeries, some patients received up to nine doses of the personalized cancer vaccine, given every three weeks, while also receiving Keytruda every three weeks for up to 18 cycles. Others received Keytruda alone.
Keytruda alone is approved for postsurgical treatment of melanoma patients, among its many uses.
“This is the first time we see a really strong signal with a cancer vaccine," Eliav Barr, Merck’s head of global clinical development and chief medical officer, said in an interview. “This is the first time we can actually show that with the removal of the brakes on immune responsiveness that Keytruda provides, plus an extraordinarily good vaccine, we engender a really great immune response."
Study volunteers receiving the combination experienced adverse events that were consistent with Keytruda, such as fatigue and gastrointestinal effects, and those associated with mRNA vaccines, such as arm pain and aches.
Moderna’s development of the personalized cancer vaccine was delayed by the Covid-19 pandemic because patient enrollment was paused temporarily, and Moderna repurposed some of the cancer vaccine manufacturing equipment to make early batches of its Covid-19 shots, Mr. Bancel said.
The companies released top-line data from the study in a press release, and it hasn’t been vetted by peer review. They plan to publish full details in a peer-reviewed medical journal.