Key Moments
- Moderna Inc shares climbed more than 90% in pre-market trading after a successful Phase 3 melanoma study with Merck.
- The INTerpath-001 trial met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival.
- The study delivered the first positive Phase 3 result for both an individualized neoantigen therapy and an mRNA-based cancer therapy.
Phase 3 Melanoma Trial Drives Major Rally in Moderna Shares
Investing.com — Moderna Inc shares soared more than 90% in pre-market trading on Wednesday after the company and Merck reported that their investigational melanoma drug combination outperformed Keytruda alone in a Phase 3 study.
The trial, known as INTerpath-001, evaluated intismeran autogene – an investigational, mRNA-based individualized neoantigen therapy – in combination with Merck’s Keytruda. The study enrolled patients with completely resected stage IIB-IV melanoma.
Study Design and Efficacy Outcomes
INTerpath-001 was designed to compare the combination of intismeran autogene plus Keytruda against Keytruda monotherapy. The trial achieved its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival.
The combination regimen delivered statistically significant improvements in both endpoints compared with Keytruda alone in patients with completely resected stage IIB, IIC, III or IV cutaneous melanoma who had not received prior systemic therapy.
| Parameter | Details |
|---|---|
| Trial name | INTerpath-001 |
| Investigational agent | Intismeran autogene (mRNA-based individualized neoantigen therapy) |
| Combination | Intismeran autogene + Keytruda |
| Comparator | Keytruda alone |
| Patient population | Completely resected stage IIB-IV cutaneous melanoma, no prior systemic therapy |
| Primary endpoint | Recurrence-free survival |
| Key secondary endpoint | Distant metastasis-free survival |
Analyst Reaction and Revenue Diversification
The positive data prompted a bullish reaction from at least one Wall Street analyst. William Blair’s Myles Minter wrote in a note,
“who are upgrading shares to Outperform from Market Perform given that we believe Moderna has a clear line of sight to revenue diversification from the COVID business now,” William Blair analyst Myles Minter said in a note.
First-of-Its-Kind Phase 3 Milestones
The results represent several notable firsts in oncology and mRNA therapeutics. According to the announcement, this is the first positive Phase 3 readout for an individualized neoantigen therapy and for an mRNA-based cancer therapy.
In addition, INTerpath-001 is described as the first Phase 3 study to demonstrate clinically meaningful improvement over Keytruda alone in the adjuvant setting for patients with resected melanoma.
Safety Profile and Ongoing Evaluation
Safety data from the trial showed that the profiles of intismeran and Keytruda were consistent with previously reported studies, with no new safety signals identified.
The trial remains ongoing and will continue to assess additional key secondary endpoints, including overall survival.
Next Steps and Broader Oncology Pipeline
Moderna and Merck intend to present the INTerpath-001 data at an upcoming international medical conference and to submit the results to regulatory authorities.
Beyond this trial, Merck and Moderna are conducting nine Phase 2 and Phase 3 clinical studies across a range of tumor types. These include melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma.
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