Anti-TIGIT Monoclonal Antibody Plus Pembrolizumab Focus of Phase II Study in NSCLC
Posted: Wednesday, January 5, 2022
Solange Peters, MD, PhD, of the University of Lausanne, Centre Hospitalier Universitaire Vaudois, Switzerland, and colleagues presented their ongoing phase II study evaluating the safety and efficacy of MK-7684A, a co-formulation of vibostolimab—an anti–T-cell immunoreceptor with immunoglobulin and ITIM domains (TIGIT) monoclonal antibody—plus the PD-1 inhibitor pembrolizumab with or without docetaxel in patients with non–small cell lung cancer (NSCLC). During the 2021 Society for Immunotherapy of Cancer (SITC) Annual Meeting (Abstract 463), they presented the methods of this trial.
In previous studies, vibostolimab (MK-7684) demonstrated manageable toxicity and antitumor activity in patients who were heavily treated across various tumor types, especially when combined with pembrolizumab. Although pembrolizumab has shown significant improvement in overall survival over chemotherapy in PD-L1–positive NSCLC, many individuals have the potential to be resistant to immunotherapy.
This multicenter trial is currently enrolling adults with histologically or cytologically confirmed metastatic NSCLC with progressive disease who received prior chemotherapy and anti–PD-L1 therapy. Participants must have measurable disease, an Eastern Cooperative Oncology Group performance score of 0 or 1, and no known central nervous system metastases.
Approximately 240 patients will be randomly assigned 1:1:1 to receive intravenous vibostolimab plus pembrolizumab, vibostolimab plus pembrolizumab plus docetaxel, or docetaxel plus placebo. Treatment will continue for up to 35 cycles or until disease progression, intercurrent illness, unacceptable adverse events, or investigator discretion. Additionally, patients achieving a complete response, a partial response, or stable disease will be allowed to receive 17 additional cycles of vibostolimab plus pembrolizumab.
The primary endpoint is progression-free survival, and secondary endpoints include objective response rate, duration of response, overall survival, and safety. Radiographic imaging will occur at baseline; every 6 weeks through week 36; every 9 weeks until week 54; and every 12 weeks until the start of new treatment, disease progression, consent withdrawal, or death.
Disclosure: No disclosure information was provided.
