- Moderna and Merck announced positive phase 3 trial results for their personalized mRNA cancer vaccine combined with Keytruda, showing significant improvement in recurrence-free survival and distant metastasis-free survival in melanoma patients.
- Moderna's stock surged 176% on Wednesday, more than doubling its value to above $174, making co-founder Thomas Langer a billionaire again.
- On Thursday, Moderna's stock plunged more than 25% to around $129, cutting more than $18 billion from its market valuation, as investors appeared to take profits.
- Bank of America analyst Alec Stranahan quadrupled his price target to $170, calling the results a 'watershed moment' for the firm.
- Merck and Moderna announced plans to engage with regulatory authorities worldwide, including the FDA, about potential filings.
- The results mark the first positive phase 3 trial of an mRNA-based personalized cancer vaccine, according to the companies.
- Known as INTerpath-001, the study evaluated 1,137 patients globally who had surgery to remove high-risk (Stage IIB through Stage IV) melanoma.
- Patients were randomly assigned to receive either KEYTRUDA plus the personalized vaccine or KEYTRUDA plus placebo.
- Patients who received the personalized vaccine experienced significantly better recurrence-free survival, meaning their cancer was less likely to return than in those who received KEYTRUDA alone.
- The combination also significantly improved distant metastasis-free survival, a measure of how long patients remained alive without the cancer spreading to distant parts of the body.
Moderna and Merck's personalized mRNA cancer vaccine has shown promising results in a phase 3 trial, significantly reducing melanoma recurrence. The study, known as INTerpath-001, involved 1,137 patients and demonstrated improved recurrence-free survival and distant metastasis-free survival compared to Keytruda alone.178910
The combination therapy, which includes Merck's Keytruda and a custom-tailored mRNA vaccine, is designed to target cancer cells specifically, minimizing damage to normal cells. According to a company spokesperson, “It doesn't hit normal cells, and it hits the cancer cells very effectively because it's not just a generic vaccine.” The results mark the first positive phase 3 trial for an mRNA-based personalized cancer vaccine, prompting plans for regulatory discussions with authorities, including the U.S. Food and Drug Administration.6
Despite the positive trial results, Moderna's stock fell over 25% after a record surge, losing more than $18 billion in market valuation. Analysts noted that the decline reflects investors taking profits after a 176% increase in stock value, which had more than doubled to above $174 before the drop. Bank of America analyst Alec Stranahan described the trial results as a “watershed moment” for Moderna, although he cautioned that further testing is needed to determine the treatment's long-term efficacy.234
The phase 3 results, while significant, did not clarify how long patients remained cancer-free or whether the treatment ultimately extends survival, as the findings were based on investigator assessments rather than an independent review.
“The trial, known as INTerpath-001, evaluated 1,137 patients with high-risk melanoma, and the combination significantly improved recurrence-free survival. Bank of America's Alec Stranahan quadrupled his price target to $170, calling the results a 'watershed moment' for Moderna, though he noted more testing is needed.”
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