Early Leak of INTerpath-001 Phase 3 Data Splits Views on mRNA Cancer Vaccine Market

The mRNA tumor vaccine field is at a critical validation juncture. Registry records show that the phase 3 study V940-001 (i.e., INTerpath-001) of V940 (intismeran autogene) plus pembrolizumab in high-risk melanoma adjuvant therapy was sponsored by Merck Sharp & Dohme, with recurrence-free survival (RFS) as the primary endpoint ; industry media reported that topline results showed significant improvement in both RFS and DMFS . The same pipeline is also advancing the phase 2 INTerpath-012 study in melanoma, evaluating intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab with PFS as primary endpoint . As a benchmark, the subcutaneous pembrolizumab formulation KEYTRUDA QLEX was approved as a new molecular entity in September 2025 and has since received multiple efficacy supplements, covering unresectable or metastatic melanoma and adjuvant treatment of completely resected Stage IIB, IIC, and III melanoma (needs verification).

The core facts of this news: the INTerpath-001 results, originally slated for oral presentation at the 2026 ESMO congress, were leaked ahead of schedule. Per the material, the study enrolled 1137 patients with completely resected Stage IIB–IV high-risk melanoma; at a median follow-up of 24.6 months, the two-year RFS was 82.2% in the combination arm versus 70.0% in the control arm, HR 0.58, a relative 42% reduction in risk of recurrence or death; 24-month DMFS was 88.5% versus 80.2%, HR 0.62. Compared with phase 2, however, the DMFS HR moved from 0.35 (65% risk reduction) to 0.62 (38% risk reduction), weakening the phase 2 highlight (these phase 2 comparison figures are media-exclusive). Another market concern is cost-effectiveness: industry estimates put V940's price at about $500,000 with roughly a six-week waiting period (media-exclusive), while Merck's own SWOG S1801 study showed that simply moving 3 cycles of pembrolizumab before surgery yielded two-year EFS of 72% versus 49% at a median follow-up of 14.7 months, with the same HR of 0.58; that study was peer-reviewed and confirmed improved EFS for neoadjuvant-adjuvant versus adjuvant-only . After the news, Moderna's stock fell more than 20% at one point, erasing over $20 billion in market value (needs verification).

This news crystallizes the divergence in the field. On one hand, Moderna has shown a personalized mRNA vaccine can be delivered, and is expanding the pipeline into lung cancer, bladder cancer, renal cell carcinoma and other tumor types, with additional assets including the off-the-shelf therapy mRNA-4359, preventive vaccine mRNA-4194, and multiple myeloma T-cell engager mRNA-2808 (media-exclusive). On the other hand, BioNTech's BNT113 failed to significantly improve PFS in first-line combination with pembrolizumab in unresectable recurrent or metastatic HPV16-positive head and neck cancer; industry media reported the trial enrolled 285 patients . BNT113 had previously received FDA fast track designation , and an earlier study confirmed the RP2D with good tolerability . In short, whether a program can be delivered, and whether it can do better once delivered, have become two sequential thresholds (needs verification).

Information yet to be disclosed includes the full INTerpath-001 data at ESMO (overall survival, subgroups, safety details), and the regulatory filing pathway and timeline, none of which has been disclosed; the phase 3 registry lists primary completion in October 2029, and its relationship to this disclosure should await formal publication . Subsequent milestones include readouts from INTerpath-012 and progress in broader tumor-type expansion (needs verification).