Reference Detail

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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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
CD274 positive	head and neck squamous cell carcinoma	predicted - sensitive	IO102-IO103 + Pembrolizumab	Case Reports/Case Series	Actionable	In a Phase II trial, treatment with the combination of IO102-IO103 and Keytruda (pembrolizumab) demonstrated safety and resulted in a partial response in 50% (2/4, 1 confirmed partial response) in patients with squamous cell carcinoma of the head and neck with CD274 (PD-L1) expression (combined positive scores >/=20) (Ann Oncol (2023) 34 (suppl_2): S630; NCT05077709).	detail...
CD274 over exp	lung non-small cell carcinoma	predicted - sensitive	IO102-IO103 + Pembrolizumab	Phase II	Actionable	In a Phase II trial, treatment with the combination of IO102-IO103 and Keytruda (pembrolizumab) demonstrated safety and resulted in a partial response in 53.3% (8/15, 4 confirmed partial responses) and 5 with stable disease in non-small cell lung cancer patients with CD274 (PD-L1) expression (tumor proportion score >/=50%) (Ann Oncol (2023) 34 (suppl_2): S630; NCT05077709).	detail...