Moderna eyes accelerated approval for mRNA cancer vaccine
Published: Mar 07, 2023
By Tristan Manalac
Moderna may seek the FDA’s accelerated approval for its personalized cancer vaccine, the company’s president, Stephen Hoge, said Monday at Cowen’s 43rd Annual Healthcare Conference in Boston.
The announcement follows data from the Phase IIb KEYNOTE-942 trial, published in December 2022, which showed the investigational mRNA vaccine in combination with Merck’s Keytruda (pembrolizumab) significantly improved recurrence-free survival in stage III/IV melanoma.
Compared with Keytruda alone, the combination regimen had a hazard ratio of 0.56, indicating that it cut the risk of recurrence or death by 44%.
Moderna’s shot was also safe, with a profile consistent with what had been previously published. Treatment-related serious adverse events arose in 14.4% and 10% of patients treated with the combination regimen and Keytruda alone, respectively.
“We hope that at some point, this randomized 150-person Phase IIb study that we ran might be able to become the basis of accelerated approval,” Hoge said. “We have to follow it. It’s too early to say, but we are hopeful the data will mature that way.”
The FDA has granted the cancer vaccine candidate its Breakthrough Therapy designation. Merck has also exercised its option to jointly develop and commercialize the investigational shot.
Designed to be a personalized cancer vaccine, Moderna’s candidate can code for up to 34 neoantigens based on the unique genetic sequence of a patient’s tumor. In turn, the shot enables the body to effectively target and eliminate tumor cells.
The Path Forward
Also on Monday, during the WSJ Health Conference in Boston, Stéphane Bancel, CEO, said the company will first try its investigational vaccine against cancers that Keytruda works against.
Moving forward, however, Moderna will also push the vaccine into therapeutic areas where the blockbuster drug has failed to establish a foothold, Bancel said.
At the Cowen’s conference, Hoge likewise revealed the company is conducting additional analyses on its Phase IIb data. While topline data already show promising efficacy for the cancer vaccine, Hoge said Moderna is still studying “the evolution of that hazard ratio over time.”
The company is also looking at the candidate’s translational biomarker data to see if it can predict treatment response and select patients that might be more likely to respond to the shot.
These analyses are ongoing and Moderna hopes to present findings at upcoming medical conferences.