Moderna and Merck Announce Success in Phase 3 Trial of Personalized mRNA Cancer Treatment

US pharmaceutical companies Moderna and Merck announced on the 19th local time that their jointly developed, patient-personalized mRNA cancer vaccine has met its primary endpoint of suppressing cancer recurrence and metastasis in a late-stage (Phase 3) clinical trial involving high-risk melanoma patients.

This marks the first time that a personalized cancer treatment based on messenger RNA (mRNA) technology—the same technology used in COVID-19 vaccines—has achieved positive results in a large-scale Phase 3 clinical trial.

The developed treatment is "intismeran autogene" (development names V940 and mRNA-4157), which is designed to target up to 34 neoantigens expressed in each patient's individual tumor.

The two companies conducted the clinical trial on approximately 1,100 high-risk patients who underwent surgery to remove melanoma.

As a result, the group of patients administered the personalized vaccine "intismeran" combined with Merck's immunotherapy drug "Keytruda" showed a significant extension in the time to cancer recurrence compared to the group treated with Keytruda alone.

They also met the secondary endpoint of lowering the risk of cancer metastasizing to other organs.

The treatment is custom-designed for each patient by analyzing their tumor tissue and blood samples to identify unique mutations present in the tumor and induce an immune response targeting them.

The research team explained that these results could serve as a new paradigm for precision immunotherapy, tailoring treatments to the individual characteristics of each patient's tumor.

The US daily Wall Street Journal evaluated that this paves the way for developing a new treatment capable of preventing recurrence and extending survival in patients with melanoma, a deadly form of skin cancer.

Previously, Moderna applied for accelerated approval of this treatment with the US Food and Drug Administration (FDA) in 2024, but the application was rejected.

Stephan Hoge, President of Moderna, said during an earnings conference call last month, "If we get positive interim results like this, it will provide the basis to apply for accelerated review."

The two companies are discussing application procedures with regulatory authorities with the goal of obtaining marketing approval in 2027.

Following the news of the clinical success on this day, Moderna's stock price skyrocketed 177% on the New York Stock Exchange, closing at 174.38 dollars.

Trading volume reached approximately 18 times the 3-month average.

The daily surge was the largest single-day gain for any S&P 500 component stock in the past 25 years.

Moderna's stock continued to show strength, rising an additional 1.50% in after-hours trading.

Evaluations indicate that Moderna, which had experienced a slump following the COVID-19 vaccine, has laid the groundwork to enter the 240 billion dollar oncology market.

In particular, the market is anticipating the potential success of nine ongoing follow-up clinical trials spanning a total of six cancer types beyond melanoma, including lung, bladder, kidney, pancreatic, and stomach cancers.

Merck's stock also rose 12.6% to close at 152.20 dollars, setting a record high.

(Photo: AP, Yonhap News)
※ Please note: This article was translated by AI and may contain errors.