Aulos Bioscience’s Imneskibart With Avelumab Delivers Exceptional Progression-Free Survival in Checkpoint Inhibitor-Refractory Adenocarcinoma Non-Small Cell Lung Cancer
Median progression-free survival of 5.8 months, confirmed objective response rate of 21% and 86% disease control rate observed following progression on prior checkpoint inhibitor therapy
Median overall survival not reached at 10.6 months median follow-up
Imneskibart continues to demonstrate tolerable and easily managed safety profile, with strong evidence that higher Teff/Treg ratio correlates with longer PFS and OS for patients
LARKSPUR, Calif., October 26, 2026--Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through development of its lead immune-activating antibody therapeutic imneskibart (AU-007), today presented positive Phase 2 data for imneskibart with avelumab in checkpoint inhibitor (CPI)-refractory adenocarcinoma non-small cell lung cancer (NSCLC). The data were shared in a poster session at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain.
The Phase 2 results demonstrate promising clinical activity with imneskibart plus low-dose, subcutaneous aldesleukin and avelumab in heavily pre-treated patients with CPI-refractory advanced adenocarcinoma NSCLC. Median progression-free survival (PFS) was 5.8 months, confirmed objective response rate (ORR) was 21% and disease control rate was 86% among 14 response-evaluable patients. Patients in this study were on average heavily pre-treated and had received a mean of 2.6 prior lines of therapy. For context, historical studies in less pre-treated patients reported with the standard-of-care treatment, docetaxel, demonstrated ORRs of approximately 4% to 15% and median PFS of 2.8 to 3.9 months in adenocarcinoma populations following only one prior line of therapy.
"These clinical results show remarkable progression-free survival in patients whose lung cancers have progressed despite multiple lines of prior therapies, including checkpoint inhibition, and who have very limited treatment options," said Aron Knickerbocker, President and Chief Executive Officer of Aulos Bioscience. "A median PFS of 5.8 months, durable and confirmed responses, and prolonged disease control in such heavily pre-treated patients exceed what would be expected with standard-of-care docetaxel therapy, and provide a strong rationale for advancing this immunotherapy triplet into randomized clinical trial evaluation in lung cancer. The accompanying safety profile and immune changes also reinforce our confidence in imneskibart's differentiated mechanism and its potential to address an important unmet medical need."