V940

Merck Sharp & Dohme LLC · Phase 2 active Biologic

V940 is a Biologic drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 2 development. Also known as: mRNA-4157, Intismeran Autogene.

Likelihood of approval

18.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

• Baseline phase 2 → approval rate +15.3pp
  Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
• Big-pharma sponsor +3.0pp
  Merck Sharp & Dohme LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	V940
Also known as	mRNA-4157, Intismeran Autogene
Sponsor	Merck Sharp & Dohme LLC
Modality	Biologic
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• A Study of (Neo)Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007) (PHASE2, PHASE3)
• A Study of V940/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013) (PHASE2)
• A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011) (PHASE2)
• A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002) (PHASE3)
• A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009) (PHASE3)
• A Clinical Study of V940 and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012) (PHASE2)
• A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005) (PHASE1, PHASE2)
• A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001) (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• V940 CI brief — competitive landscape report
• V940 updates RSS · CI watch RSS
• Merck Sharp & Dohme LLC portfolio CI

Frequently asked questions about V940

What is V940?

V940 is a Biologic drug developed by Merck Sharp & Dohme LLC.

Who makes V940?

V940 is developed by Merck Sharp & Dohme LLC (see full Merck Sharp & Dohme LLC pipeline at /company/merck).

Is V940 also known as anything else?

V940 is also known as mRNA-4157, Intismeran Autogene.

What development phase is V940 in?

V940 is in Phase 2.

Related

• Manufacturer: Merck Sharp & Dohme LLC — full pipeline
• Also known as: mRNA-4157, Intismeran Autogene