Accelerated approval incoming? Moderna 'hopeful' for...

Accelerated approval incoming? Moderna 'hopeful' for personalized cancer vaccine

Moderna will look to use the FDA’s accelerated approval pathway for its personalized cancer vaccine, president Stephen Hoge said at Cowen’s annual conference on healthcare.

The company read out Phase IIb results in December suggesting the mRNA-based therapy reduced melanoma patients’ risk of cancer recurrence or death by 44% in combination with Keytruda, with a p-value of 0.0266 and a hazard ratio of 0.56. The trial was designed with a one-side p-value, meaning these results may not be enough to meet the FDA’s bar for efficacy. However, Hoge said on Monday that investigators are curious whether that hazard ratio may improve over time.

They’re also analyzing translational biomarker data that could show “not only is the picture robust and strong, but there may be populations that are already really strong,” Hoge said.

“At some point, this randomized 150-person Phase IIb study that we ran might — might — be able to become the basis of accelerated approval,” he added. “It’s too early to say but we are hopeful that the data will mature that way.”

Updated: Moderna claims cancer vaccine success in trial of mRNA shot with Merck

Last month, Moderna announced plans to launch a Phase III study in adjuvant melanoma this year and “rapidly expand” into other tumor types such as non-small cell lung cancer.

“The first chapter is going to be: go after places where Keytruda works,” CEO Stéphane Bancel said on Monday at the WSJ Health Forum in Boston. “But also the scientific and clinical teams are working to figure out other places where Keytruda did not work, that maybe there’s a scientific rationale where you combine Keytruda and the Moderna vaccine to potentially get over the hump of the immune system to get to clinical impact.”

Accelerated approval incoming? Moderna 'hopeful' for personalized cancer vaccine

Accelerated approval incoming? Moderna 'hopeful' for personalized cancer... Moderna will look to use the FDA’s accelerated approval pathway for its personalized cancer vaccine, president S...