Moderna's stock jumps 6% as its cancer vaccine could treat more than just melanoma

By Ciara Linnane

Data shows a better overall survival rate for head and neck cancer in combination with a key drug than the drug alone has shown

Moderna Inc.'s stock jumped 6% Tuesday to lead S&P 500 gainers, after the company shared cancer-vaccine data that suggests it may work in indications outside its target of melanoma.

In a presentation to the American Association for Cancer Research's annual meeting on Monday, Moderna (MRNA) said its cancer vaccine showed a greater overall survival rate in a trial of patients with HPV-negative head-and-neck squamous-cell cancer, or HNSCC, when it was combined with Merck's Keytruda, rather than Keytruda alone showed in earlier Phase 2/3 studies.

The data was based on a follow-up with patients about nine months after the trial was completed on May 4, 2023.

Read also: Moderna's new and improved COVID vaccine produced positive trial results

Of 28 people enrolled in the trial, 22 received MRNA-4157, the company's personalized cancer vaccine. Six discontinued the trial before they could receive the treatment due to death or disease progression and were not included in the analysis.

About 27% of those receiving the vaccine showed an overall response rate, or ORR, with 3.4 months of progression-free survival, or PFS, and 24.6 months of overall survival, or OS.

Jefferies analysts said the data compare favorably to the Keytruda monotherapy studies. One showed an 18% ORR, a 2.1-month PFS and 8.8-months of OS, while a second had a 15% ORR, 2.1-month PFS and 8.4-month OS.

"This is encouraging and could even support Moderna potentially going into 1L (first line) in combination with PD1 - where Keytruda is approved in combo with chemo with a 36% ORR, 4.9 mos PFS and 13 mos OS," analysts led by Michael J. Yee wrote in a note to clients.

Keytruda is a monoclonal antibody that belongs to a class of drugs that bind to either the PD-1, or the PD-L1, both of which are proteins that are found in T cells, blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response.

"Thus - it wouldn't be shocking to see Moderna move this forward into a larger Phase II or pivotal Phase III program in 1L directly," said Yee.

See also: Moderna, Merck combo cancer-vaccine treatment shows 'significant' promise

For now, Moderna is studying the vaccine as a treatment for melanoma and has not specified plans for HNSCC.

But HNSCC is a serious disease with a poor prognosis - most patients who are diagnosed are expected to survive for about five years.

The key debate for now is whether Moderna can file for accelerated approval for adjuvant melanoma as it continues to enroll patients in a Phase 3 confirmatory trial, said Yee.

Jefferies is expecting the company to talk to the Food and Drug Administration once enrollment is well under way, likely in the second half of this year.

Jefferies has a buy rating on Moderna's stock, which is up 13% in the year to date, while the S&P 500 SPX has gained 9%.

-Ciara Linnane

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04-10-24 0721ET

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