Moderna wants an accelerated approval for its cancer vaccine — but it’s waiting on three things

Merck and Moderna made news in December 2022 when they unveiled Phase II data suggesting their individualized neoantigen therapy, or INT, reduced the risk of cancer recurrence or death in melanoma patients when used with Merck’s Keytruda. The data reinvigorated a field that has frustrated scientists for years. The therapy is now in two Phase III trials in adjuvant melanoma and non-small cell lung cancer.

But Moderna said Thursday that it wants to see more progress on enrollment before it considers filing for an accelerated approval.

“We have to substantially enroll the confirmatory Phase III study,” the company’s president Stephen Hoge said on a fourth-quarter earnings call Thursday. “For an accelerated approval in this space, we do believe we have to show we’ve really already done the diligence to allow that confirmatory data to come in.”

Moderna plans on launching additional clinical studies for INT this year, including “additional Phase III and confirmatory studies,” Hoge said. That also includes “some potential metastatic indications,” though Moderna declined to comment on the new tumor types it plans to pursue.

Hoge also said the company wants proof of durability, something it saw signs of in Phase IIb results released in December. At a three-year analysis, patients who took INT and Keytruda saw a 49% reduction in the risk of recurrence or death compared to patients on Keytruda alone. Hoge said the company is “incredibly encouraged by that.”

But the final box he wants to tick is going to take a bit more time. Hoge’s third criteria for approaching regulators will be an established manufacturing facility. Without that, he added, “There isn’t really a product here to talk about.”

Moderna is currently building an estimated $322 million site in Marlborough, MA for that purpose, roughly 30 miles west of its Cambridge headquarters. A spokesperson said the site is slated for completion this year.

“We’re making progress on all three,” Hoge said. “The durability of the benefit we’ve been seeing really causes us to lean into working hard to complete the enrollment of that confirmatory study, criteria two, and finish the build-out of that Marlborough facility.”

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