- Merck and Moderna announced that the trial of a personalized mRNA cancer vaccine found that when combined with Keytruda delayed melanoma recurrence.
- This is the first phase 3 randomized trial to show a neoantigen vaccine can reduce cancer recurrence.
- The companies did not release specific efficacy numbers but said those will be shared at an upcoming medical meeting and with regulators.
Merck and Moderna announced a phase 3 trial using an mRNA-based experimental vaccine delayed recurrence of melanoma in a study involving 1,137 high-risk patients.
The interim study results were revealed in a news release Wednesday, but have not been published in a peer-reviewed journal yet. The companies have plans to share the data with pharmaceutical regulators and share findings at a medical meeting.
The vaccine is a personalized mRNA drug that uses the mutations in a person’s melanoma tumor and is used along with an existing treatment. As Stat reported, “So-called ‘neoantigen’ vaccines have long been seen as having potential as cancer treatments, but this is the first randomized Phase 3 clinical trial aimed at definitively proving their benefit. In this case the personalized vaccine, intismeran, was combined with Merck’s Keytruda ...”
Participants in the study received as many as nine doses of Keytruda alongside the mRNA vaccine, or they received Keytruda alone for a year.
The vaccine was part of a trial involving patients who’d had surgery to remove melanoma, which can be deadly. The National Cancer Institute estimated more than 1.5 million people in the U.S. live with melanoma, the most deadly common form of skin cancer.
The vaccine’s premarketing name is intismeran.
The companies didn’t say how long recurrence was delayed, but said the clinical trial found the combination of vaccine and drug seemed to delay recurrence.
Potential game changer for deadly tumor?
“Today’s results represent a landmark moment for adjuvant melanoma treatment. This is the first phase 3 study to show that intismeran, a treatment designed based on the unique mutational ‘fingerprint’ of a patient’s own tumor, given in combination with pembrolizumab can reduce the risk of recurrence or death in patients with completely resected stage IIB-IV melanoma compared to Keytruda alone,” said Georgina Long, the study’s principal investigator and medical director of the Melanoma Institute Australia and also chair of Melanoma Medical Oncology and Translational Research at the University of Sydney.
“Intismeran in combination with pembrolizumab has the potential to establish a new treatment paradigm in the adjuvant melanoma setting, helping patients remain cancer-free for longer.”
NBC News reported that in June, “Merck and Moderna presented research on the experimental melanoma vaccine at the American Society of Clinical Oncology’s annual meeting, saying at the time that it halved the risk of melanoma returning after five years in a group of 157 patients. Side effects of the vaccine-drug combo were mostly mild or moderate, though some patients had to discontinue or delay the treatment due to adverse reactions. Those findings were published in the Journal of Clinical Oncology.”
That trial was a phase 2b trial where risk was reduced by 49%. Two-thirds of the patients in that trial received the combination drugs, while the other third received only Keytruda.
The results are “as big a day for humanity as Nov. 16, 2020,” when Moderna released late-stage clinical trial results showing that its Covid-19 vaccine worked, the company’s chief executive, Stephane Bancel, told CNN on Wednesday. “This is a new chapter in cancer care.”
Not everyone keen on mRNA
As CNN noted, mRNA technology has been controversial since it was used to create the Covid vaccine in the early days of the pandemic. “Experts say major safety concerns are unfounded, but government funding for mRNA, particularly for its use against respiratory viruses, has been slashed during President Donald Trump’s second administration, driving concerns that mRNA innovation would stall,” CNN reported.
The federal government has canceled some contracts to develop mRNA-based vaccines, as Deseret News reported. Health and Human Services Secretary Robert F. Kennedy Jr. has been an outspoken critic of the technology that underpins mRNA-based vaccines.