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Quavonlimab - Merck Sharp & Dohme

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Drug Profile

Quavonlimab - Merck Sharp & Dohme

Alternative Names: AK-107; MK-1308

Latest Information Update: 06 Nov 2025

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At a glance

  • Originator Akeso Biopharma
  • Developer Merck Sharp & Dohme
  • Class Antineoplastics; Biological factors; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Cytotoxic T-lymphocyte antigen 4 inhibitors; T lymphocyte stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Liver cancer; Non-small cell lung cancer
  • Phase I/II Malignant melanoma; Solid tumours

Most Recent Events

  • 17 Oct 2025 Merck Sharp & Dohme completes a phase I/II clinical trials in Malignant melanoma (Metastatic disease, Second-line therapy or greater, Late-stage disease, Inoperable/Unresectable, Combination therapy) in Switzerland, Spain, South Africa, Italy, Israel, Australia, USA and France (IV) (NCT04700072)
  • 25 Aug 2025 Merck Sharp & Dohme Corp completes the phase I/II KEYNOTE-U02 trial for Malignant melanoma (Combination therapy, Second-line therapy or greater, Late-stage disease, Inoperable/Unresectable) in USA, Switzerland, Australia, France, Germany, Israel, Italy, South Africa (IV) (NCT04305041) (EudraCT2019-003956-35)
  • 31 May 2024 Efficacy and adverse events data from a phase I/II KEYMAKER-U02A trial in Malignant melanoma presented at the 60th Annual Meeting of the American Society of Clinical Oncology (ASCO-2024)

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