WCLC 2023 - P2.08Metastatic Non-small Cell Lung Cancer ?...

WCLC 2023 - P2.08Metastatic Non-small Cell Lung Cancer ? Immunotherapy - TIPs (abstractsonline.com)

For those interested it's worth a look, IMU stacks up pretty well when compared to others in the session today, check out the Bio's of the speakers as well Michael Boyer looks like he might have some pull at the conference.


Introduction: Immune checkpoint inhibitors (ICI) are a part of standard of care treatment alone or in combination with chemotherapy in first-line advanced NSCLC. Only a subset of patients benefit from this treatment while others develop primary or acquired resistance due to lack of T-cell response, exhaustion, or other mechanisms (Yost, 2019). Resistance may be overcome by combining PD-1 + PD-L1 blockade to increase tumor-specific T-cells and generate memory T-cells (Burrack, 2019). IMU-201 is a B-cell peptide vaccine which stimulates polyclonal antibodies against PD-1 leading to active immunization and induction of memory B- and T-cells. IMU-201 significantly reduced tumor growth with no toxicity or autoimmunity in pre-clinical models (Bekaii-Saab, T 2019, Kaumaya, 2019). Atezolizumab is an approved monoclonal antibody that targets PD-L1. IMPrinter seeks to evaluate the clinical benefit of adding IMU-201 to atezolizumab with and without chemotherapy in NSCLC.
Methods: IMPrinter is an ongoing, open-label, dose escalation study of IMU-201 conducted in 2 phases. Phase 1 (monotherapy) includes patients who progressed on/after ICI with TPS/TC ≥ 50% or IC ≥ 10%. The primary objective is to evaluate safety and tolerability of IMU-201 and identify the optimal biological dose and recommended Phase 2 Dose. IMU-201 is administered by intramuscular (IM) injection on Day 1 of study weeks 1, 3, 5, 9, and every 9 weeks thereafter. The Phase 1b study comprise 3 arms: Arms 1 and 2 will receive IMU-201 + atezolizumab combination in patients with TPS/TC ≥ 50% or IC ≥ 10% for those who have progressed (Arm 1) or are naïve (Arm 2) to ICIs. Patients in Arm 3 are naïve to ICI and will receive IMU-201 + atezolizumab + chemotherapy combination irrespective of PD-L1 status. The primary objective in Phase 1b is to evaluate the efficacy. Immunogenicity data will be evaluated, including IMU-201 and PD-1 specific antibodies (IgG, IgM), vaccine-specific cytokine levels, and regulatory and effector T and B cells. For combination cohorts, IMU-201 will be administered on Day 1 of weeks 1, 3, 5, 8, and every 8 (28-day cycles) or 9 (21-Day cycles) weeks depending on combination therapy. Atezolizumab 840mg will be administered IV every 2 weeks starting on Day 15. Standard of care chemotherapy will be administered per investigators choice. Key inclusions criteria include: confirmed NSCLC tumor stage IIIB not eligible for definitive treatment or IV, ECOG 0-1, and measurable disease. Dose-limiting toxicity (DLT) assessment is completed after 29 days on treatment. Tumor progression is evaluated according to RECIST 1.1 every 6 weeks for 54 weeks followed by every 12 weeks until progression. This study is currently enrolling patients in Australia and US. NCT04432207

Michael Boyer is amedical oncologist at Chris O’Brien Lifehouse, where he holds the position ofChief Clinical Officer. He is also a Conjoint Professor of Medical Oncology(Thoracic Oncology) at the University of Sydney. Professor Boyer has over 25years of experience in the management of thoracic malignancies and head andneck cancers. His major research interest is in clinical trials of new agentsin the management of lung cancer, mesothelioma and head and neck cancers. He isthe author of over 180 publications, has given numerous national andinternational presentations, both invited and selected from abstractsubmission, and is actively involved in the lung cancer community. He is aBoard member of the Thoracic Oncology Group of Australasia. Previously, hewas on the Board of the International Association for the Study of Lung Cancerfrom 2015 – 2019, and was the Conference Co-President for the 15th WorldConference on Lung Cancer in 2013.