Vaccinex announces interim results of pepinemab with avelumab study at ASCO
Vaccinex announced that updated interim results of the Phase 1b/2 study of pepinemab in combination with avelumab in non-small cell lung cancer, or NSCLC, subjects were reported during a poster session at the American Society of Clinical Oncology, or ASCO. This ongoing Phase 1b/2, open label, single arm, first-in-human combination study is designed to evaluate the safety, tolerability and efficacy of pepinemab in combination with avelumab in 62 subjects with advanced NSCLC. The trial is split into dose escalation and dose expansion phases. The dose escalation phase, in which 12 subjects were enrolled, is complete and the recommended Phase 2 dose of the combination was selected as 10mg/kg pepinemab in combination with 10mg/kg avelumab, both administered intravenously once every two weeks. The dose expansion phase of the study is ongoing and includes two cohorts: 17 subjects who are immunotherapy naive and up to 33 subjects whose tumors will have progressed during or following prior immunotherapy. The combination of pepinemab and avelumab has been well-tolerated and no concerning safety signals have been identified to date. One DLT, a grade 3 pulmonary embolism, occurred in the 10mg/kg pepinemab + 10mg/kg avelumab escalation cohort, resolved and did not recur in that same subject or additional subjects in any cohort. In addition, there have been no drop-outs or discontinuations due to toxicity. Among the 16 evaluable subjects to date who received prior immunotherapy, five had been treated with pembrolizumab or nivolumab for six to 18 months before progression, of whom 2 had partial responses and 2 had stable disease after receiving combination therapy with pepinemab and avelumab. An additional 9 subjects had prior immunotherapy for three to six months before progression, of whom five had stable disease and four continued progressing after receiving the combination of pepinemab and avelumab. Exploratory biomarker immunohistochemical analysis demonstrated increased CD8+ T cell influx into tumors and increased T effector / T regulatory ratio following combination therapy, suggesting a favorable immuno-phenotype in the tumor micro-environment. Tumor was absent or reduced in biopsies from the 2 subjects who had partial responses, and no tumor was evident in biopsies from 3 of 4 subjects with stable disease, as defined by RECIST criteria.