MRNA Stock Heads For Its Best Ever Day After Melanoma Therapy Meets Primary Goal

The Phase 3 trial tested Intismeran Autogene with Merck’s blockbuster immunotherapy Keytruda.

• The combination produced statistically significant and clinically meaningful improvements in recurrence-free survival and distant metastasis-free survival.
• The study enrolled 1,137 patients, with two-thirds receiving Intismeran plus Keytruda and the remainder receiving Keytruda alone.
• The trial will continue to assess overall survival.

Shares of Moderna (MRNA) nearly doubled in pre-market trading on Wednesday after its mRNA cancer treatment, developed with Merck (MRK), met the primary goal in a pivotal late-stage melanoma study.

MRNA shares are on track for their biggest ever single-day gains and could open at over two-year highs if the levels hold. MRK shares were up 9%.

Strong RFS And DMFS Data

The Phase 3 INTerpath-001 trial tested Intismeran Autogene alongside Merck’s blockbuster immunotherapy Keytruda in patients with high-risk stage IIB-IV melanoma whose tumors had been completely removed by surgery.

The combination produced statistically significant and clinically meaningful improvements in recurrence-free survival (RFS), meaning patients lived longer without their cancer returning. It also improved distant metastasis-free survival (DMFS), which measures how long patients lived without the cancer spreading to another part of the body, compared with Keytruda alone.

“These first Phase 3 findings for Intismeran in combination with Keytruda as adjuvant therapy reinforce the promise of a more personalized approach to cancer treatment. We believe individualized neoantigen therapies have the potential to redefine how patients with completely resected stage IIB-IV melanoma are treated,” said Dean Y. Li, President at Merck Research Laboratories.

A First For mRNA Cancer Therapy

The result marks the first positive Phase 3 trial for both a personalized neoantigen therapy, a type of cancer immunotherapy, and Moderna’s mRNA-based cancer treatment, according to the release.

Intismeran is created using a sample of the patient’s tumor. The goal is to train the immune system to recognize and attack cancer cells bearing those mutations.

The study enrolled 1,137 patients, with two-thirds receiving Intismeran plus Keytruda and the remainder receiving Keytruda alone. No new safety concerns emerged.

The trial will continue to assess overall survival, while the companies plan to present detailed results at an international medical meeting and discuss regulatory submissions.

The Phase 3 success supports encouraging results from the smaller Phase 2b Keynote-942 study. At five years, the combination reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 59% compared with Keytruda alone, according to data presented at ASCO earlier this year.

The companies are now exploring the approach in nine Phase 2 and Phase 3 trials covering melanoma, lung, bladder, kidney, pancreatic and gastric cancers.

Retail Says First Real Step To Curing Cancer

Retail sentiment surrounding MRNA on Stocktwits turned ‘bullish’ from ‘neutral’ over the past 24 hours, amid ‘high’ message volumes.

One user called the results a “Real Catalyst.”

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Another user called it a “first real step” to curing cancer.

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The stock has surged nearly 320% so far this year

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