Safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy from a first-in-human study of volrustomig, a novel PD-1/CTLA-4 bispecific antibody - PubMed
4 days ago
- #immunotherapy
- #clinical trial
- #bispecific antibody
- Volrustomig is a novel PD-1/CTLA-4 bispecific antibody designed to target CTLA-4 on PD-1-positive T cells while providing durable PD-1 inhibition.
- The phase I study (NCT03530397) evaluated safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy in advanced cancer patients.
- Patients received volrustomig doses ranging from 2.25-2500 mg intravenously every 3 weeks until disease progression or unacceptable toxicity.
- Common treatment-related adverse events included pruritus (30.2%), hypothyroidism (26.7%), hyperthyroidism (24.4%), and rash (24.4%).
- TRAEs led to treatment discontinuation in 33.7% of patients, with one death reported.
- At doses ≥500 mg, volrustomig showed robust peripheral and intra-tumoral T cell activation and proliferation, exceeding approved PD-1/CTLA-4 regimens.
- Objective responses were observed in 19.8% of patients, including 2.3% complete responses, with a median response duration of 17.5 months.
- Results support further development of volrustomig as monotherapy and in combination regimens, with phase 3 trials ongoing.