Quavonlimab - Merck Sharp & Dohme
Alternative Names: AK-107; MK-1308Latest Information Update: 10 Oct 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; Malignant melanoma; Non-small cell lung cancer
- Phase I/II Solid tumours
Most Recent Events
- 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)
- 08 Apr 2024 Merck Sharp & Dohme completes the Phase-I/II clinical trials in Solid tumours (Combination therapy, Metastatic disease, Late-stage disease) in USA, Australia, Canada, Chile, France, Greece, Israel, Italy, Japan, New Zealand, Poland, South Korea, Spain, Sweden, South Africa (IV) (NCT03179436)