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ARQ 197 plus erlotinib

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) · Phase 2 active Small molecule

ARQ 197 plus erlotinib is a c-MET inhibitor, EGFR inhibitor Small molecule drug developed by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA). It is currently in Phase 2 development for Non-small cell lung cancer, Other cancers with EGFR and c-MET overexpression. Also known as: Tivantinib.

ARQ 197 is a small molecule inhibitor of c-MET, and when combined with erlotinib, targets the EGFR and c-MET pathways.

ARQ 197 is a small molecule inhibitor of c-MET, and when combined with erlotinib, targets the EGFR and c-MET pathways. Used for Non-small cell lung cancer, Other cancers with EGFR and c-MET overexpression.

Likelihood of approval
16.3% 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).
  • Oncology Phase 2 attrition -2.0pp
    Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
  • Big-pharma sponsor +3.0pp
    ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) 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 nameARQ 197 plus erlotinib
Also known asTivantinib
SponsorArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Drug classc-MET inhibitor, EGFR inhibitor
Targetc-MET, EGFR
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 2

Mechanism of action

The combination of ARQ 197 and erlotinib targets the EGFR and c-MET pathways, which are involved in the growth and spread of cancer cells. This dual inhibition can potentially lead to a more effective treatment of certain types of cancer.

Approved indications

Common side effects

Key clinical trials

Primary sources

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

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about ARQ 197 plus erlotinib

What is ARQ 197 plus erlotinib?

ARQ 197 plus erlotinib is a c-MET inhibitor, EGFR inhibitor drug developed by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA), indicated for Non-small cell lung cancer, Other cancers with EGFR and c-MET overexpression.

How does ARQ 197 plus erlotinib work?

ARQ 197 is a small molecule inhibitor of c-MET, and when combined with erlotinib, targets the EGFR and c-MET pathways.

What is ARQ 197 plus erlotinib used for?

ARQ 197 plus erlotinib is indicated for Non-small cell lung cancer, Other cancers with EGFR and c-MET overexpression.

Who makes ARQ 197 plus erlotinib?

ARQ 197 plus erlotinib is developed by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) (see full ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) pipeline at /company/arqule-inc-a-subsidiary-of-merck-sharp-dohme-llc-a-subsidiary-of-merck-co-inc-ra).

Is ARQ 197 plus erlotinib also known as anything else?

ARQ 197 plus erlotinib is also known as Tivantinib.

What drug class is ARQ 197 plus erlotinib in?

ARQ 197 plus erlotinib belongs to the c-MET inhibitor, EGFR inhibitor class. See all c-MET inhibitor, EGFR inhibitor drugs at /class/c-met-inhibitor-egfr-inhibitor.

What development phase is ARQ 197 plus erlotinib in?

ARQ 197 plus erlotinib is in Phase 2.

What are the side effects of ARQ 197 plus erlotinib?

Common side effects of ARQ 197 plus erlotinib include Diarrhea, Rash, Fatigue, Nausea, Vomiting.

What does ARQ 197 plus erlotinib target?

ARQ 197 plus erlotinib targets c-MET, EGFR and is a c-MET inhibitor, EGFR inhibitor.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing