NextCure announces presentation of Phase 2 data on NC318

NextCure 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 monoclonal antibody, and pembrolizumab, an anti-PD-1 antibody. 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. Key findings from the trial include: Efficacy data demonstrate that the combination of NC318 and pembrolizumab is active in advanced PD-1 axis inhibitor refractory NSCLC: 28% of patients had durable clinical benefit with three of these being confirmed responses. To date, both monotherapy and combination arms have been well tolerated, with six Grade 3 treatment-related adverse events and four Grade 2 TRAEs between both arms. NC318 infusion reactions were seen in seven patients, six receiving the combination and one NC318 alone. No additional infusion reactions occurred once NC318 infusion time was increased from 30 to 60 minutes. All confirmed responses were in patients with PD-L1 negative tumors, and benefits were seen in patients with both PD-L1 positive and negative tumors. Additional biomarker and pharmacodynamic studies are ongoing.