Biotech and oncology stocks surged on Monday after Phase 3 trial results demonstrated that an experimental mRNA cancer vaccine, when combined with Merck’s Keytruda, significantly improved survival outcomes in melanoma patients.
The trial, INTerpath-001, enrolled 1,137 melanoma patients and showed that the combination therapy outperformed Keytruda alone in both recurrence-free survival and distant metastasis-free survival. The data marks the first Phase 3 validation of the mRNA neoantigen platform, signaling broader implications for the oncology treatment landscape beyond the two involved companies.
Moderna’s shares jumped 101% to $126.55, while Merck & Co climbed 9.8% to $148.36. BioNTech, which is developing a pipeline of individualized cancer immunotherapies including BNT122/BIO1001, rose 18.8% to $110.22. Smaller players in the sector also saw gains, with Bristol-Myers Squibb up 3.2% to $68.13 and Regeneron Pharmaceuticals rising 3.1% to $835.19, both hitting 52-week highs.
Barclays analysts projected that the intismeran-Keytruda combination could generate up to $3 billion in melanoma-related revenue by 2035. The trial’s success is expected to reshape competitive dynamics in oncology, with PD-1/PD-L1 monotherapies—such as Bristol-Myers’ Opdivo and Regeneron’s Libtayo—potentially facing structural challenges in adjuvant melanoma settings. Smaller biotechs developing next-generation checkpoint inhibitors without vaccine combination strategies may also face headwinds over the next 12–24 months.
Summit Therapeutics was a notable outlier, rising just 1.2% to $12.98 despite a 49% decline over the past year. H.C. Wainwright raised concerns about the durability of progression-free survival data for the company’s bispecific drug ivonescimab, tempering its market reaction.
