The stock jumped more than 90% in premarket trading, reaching around $120, compared with Tuesday’s close of $62.96.
Earlier today, Moderna Inc and Merck & Co announced positive topline results from the Phase 3 INTerpath-001 trial of intismeran autogene, an investigational mRNA-based individualised neoantigen therapy, in combination with KEYTRUDA for patients with completely resected stage IIB-IV melanoma.
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The trial met its primary endpoint of recurrence-free survival (RFS) and a key secondary endpoint of distant metastasis-free survival (DMFS). The companies said the combination demonstrated statistically significant and clinically meaningful improvements in both RFS and DMFS compared with KEYTRUDA alone.
Moderna shares surged following the announcement. The stock rose sharply in premarket trading on Wednesday after the companies reported the positive Phase 3 results.
The companies said the trial marks the first positive Phase 3 readout for an individualised neoantigen therapy and an mRNA-based cancer therapy. It is also the first Phase 3 study to demonstrate a clinically meaningful improvement over KEYTRUDA alone in the adjuvant setting for patients with resected melanoma, according to the companies.
At a pre-specified interim analysis, intismeran autogene in combination with KEYTRUDA showed improvements in RFS and DMFS in patients with completely resected stage IIB, IIC, III or IV cutaneous melanoma who had not received prior systemic therapy.
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The study will continue as planned to evaluate other key secondary endpoints, including overall survival (OS). The safety profiles of intismeran autogene and KEYTRUDA in the trial were consistent with those observed in previously reported studies for the combination, with no new safety signals observed.
The companies plan to present the data at an upcoming international medical meeting and share the results with regulatory authorities. They also plan to engage with regulators on filing submissions for intismeran autogene in combination with KEYTRUDA.
What is intismeran autogene?
Intismeran autogene, also known as V940 or mRNA-4157, is an investigational mRNA-based individualised neoantigen therapy being jointly developed by Merck and Moderna. The therapy is designed specifically for each patient based on the unique set of mutations within their tumour. It is intended to train and activate the immune system to recognise and fight cancer.
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“Today’s results represent a landmark moment for adjuvant melanoma treatment. This is the first Phase 3 study to show that intismeran, a treatment designed based on the unique mutational ‘fingerprint’ of a patient’s own tumor, given in combination with pembrolizumab can reduce the risk of recurrence or death in patients with completely resected stage IIB-IV melanoma compared to KEYTRUDA alone,” said Professor Georgina Long, the study’s principal investigator and medical director of Melanoma Institute Australia, Chair of Melanoma Medical Oncology and Translational Research at the University of Sydney.
First Published: Aug 19, 2026 7:01 PM IST
