Quavonlimab - Merck Sharp & Dohme
Alternative Names: AK-107; MK-1308Latest Information Update: 06 Nov 2025
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
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Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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)
- 13 Jun 2025 Merck completes a phase II trial in Non-small cell lung cancer (Combination therapy, Late-stage disease) in United Kingdom, Taiwan, Switzerland, Spain, South Africa, Singapore, Russia, Poland, Poland, South Korea, Japan, Japan, Italy, Italy, Ireland, Hong Kong, Canada, Australia, Australia, USA (IV) (NCT03516981)