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Ref Type abstract
PMID
Authors J.W. Riess,E. Cohen,J. Spicer,P.H. Shaw,J. Rubio Perez,L. Medina Rodríguez,M.F. Chaney,S. O'Neill,A.W. Pedersen,D. McDowell,E. Ehrnrooth,P. Garrido Lopez
Title 1038P A phase II trial of the IO102-IO103 vaccine plus pembrolizumab: preliminary analysis for first-line (1L) treatment of non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN)
Journal Vol Issue Date Pages Journal Short Title
Annals of Oncology 34 Suppl_2 2023
URL https://www.annalsofoncology.org/article/S0923-7534(23)03014-4/fulltext#secsectitle0030
Abstract Text Background The IO102-IO103 vaccine is an investigational first-in-class, dual-antigen, immune-modulatory therapy that stimulates activation of T cells against IDO+ and/or PD-L1+ cells in cancer, resulting in potentially increased susceptibility to anti-PD-1 blockade. Treatment with IO102-IO103 plus nivolumab in anti-PD-1 naïve metastatic melanoma shows high clinical activity and is well tolerated ( Kjeldsen, Nat Med 2021). Thus, there is strong rationale for combining IO102-IO103 and anti-PD-1 therapy in 1L treatment of NSCLC and SCCHN. Methods This is a phase 2, non-comparative, open-label, multi-cohort trial (EudraCT No. 2021-003026-69; ClinicalTrials.gov No. NCT05077709). Patients (pts) with no prior treatment for metastatic disease are being enrolled: metastatic NSCLC, with PD-L1 tumor proportion Score ≥50% (Cohort A); recurrent or metastatic SCCHN with PD-L1 combined positive scores ≥20 (Cohort B). Pts receive 3-week cycles of subcutaneous IO102-IO103 (85-85 μg on Day [D] 1 and 8 of Cycle 1 and 2, then D1 only) plus intravenous pembrolizumab (200 mg on D1), for ≤2 years. Primary endpoint is overall response rate by RECIST 1.1., with secondary endpoints including safety. Results At data cut-off (April 12, 2023) 15/22 and 4/6 enrolled pts were efficacy evaluable (≥2 full cycles of treatment and ≥1 scan) in Cohorts A and B, respectively. Eleven and two patients had 2 or more scans in Cohort A and B. In Cohort A, 8 pts (53.3%) had a partial response (PR; 4 confirmed), while 5 had stable disease; 2 pts had progressive disease (PD). In Cohort B, 2 pts (50%) had a PR (1 confirmed) and 2 pts had PD. For the 28 treated pts, any grade treatment-related adverse events (TRAEs) occurred in 17 (60.7%) with 1 (3.6%) being serious. Most common TRAE reported was injection site reactions (n=8; 28.6%). Conclusions This preliminary analysis suggests combining IO102-IO103 and pembrolizumab in pts with metastatic NSCLC and recurrent/metastatic SCCHN is tolerable, with encouraging clinical activity, and supports further development. Enrollment is ongoing. Additional clinical and biomarker data from trial patients are planned to be presented at the meeting.

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