A Phase 2 Study of Anti-Siglec-15 Antibody, NC318, in Combination with Pembrolizumab (NCT04699123) Demonstrates Clinical Activity in Patients with Advanced PD-1 Axis Inhibitor Refractory NSCLC
BELTSVILLE, Md., Sept. 12, 2023 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today announced the presentation of Phase 2 clinical data by collaborators at the Yale Cancer Center demonstrating clinical benefit in patients with advanced, PD-1 axis inhibitor refractory non-small cell lung cancer (NSCLC) treated with a combination regimen of NC318, a Siglec-15 (S15) monoclonal antibody (mAb), and pembrolizumab, an anti-PD-1 antibody.
- In an earlier monotherapy study from NextCure, NC318 demonstrated single agent activity in a Phase 1/2 dose escalation trial (NCT03665285) for patients with advanced solid tumors (Tolcher et al, SITC 2019).
- The ongoing NCT04699123 study is a randomized trial designed to assess the safety and efficacy of NC318 alone or in combination with pembrolizumab.
- The combination portion of the study is assessing efficacy in NSCLC subjects who have experienced disease progression on, or after, PD-1 axis inhibitor therapy.
- NC318 infusion reactions were seen in seven patients (three Grade 3, four Grade 2), six receiving the combination and one NC318 alone.