Abstract
HB-200 arenavirus-based immunotherapy plus pembrolizumab as first-line treatment of patients with recurrent/metastatic HPV16-positive head and neck cancer: Updated results
Journal of clinical oncology, Vol.42(16_suppl), pp.6005-6005
06/01/2024
DOI: 10.1200/JCO.2024.42.16_suppl.6005
Abstract
6005 Background: Treatment options are limited for patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) with no approved treatment specifically targeting human papillomavirus (HPV) 16-positive tumors. In the first-line (1L) R/M setting, only a minority of patients (~20%) respond to pembrolizumab monotherapy, including those with high programmed death ligand 1 (PD-L1) expression in the tumor. HB-200 comprises an alternating sequence of two replicating attenuated arenavirus vectors derived from LCMV (HB-201) and Pichinde virus (HB-202), respectively. HB-200 vectors express a non-oncogenic HPV16 E7E6 fusion protein and induce E6 and E7-specific CD8 T-cell responses. Previously, we reported promising preliminary clinical activity of HB-200 in combination with pembrolizumab as 1L treatment for patients with HPV16+ PD-L1+ R/M HNSCC. Here, we report updated results with a focus on PD-L1 status. Methods: In this non-randomized Phase 2 part of the study, participants with HPV16+ PD-L1 combined positive score (CPS) ≥1 R/M HNSCC were treated with HB-200 intravenously (every 3 weeks [Q3W] then Q6W) in combination with pembrolizumab (200 mg Q3W or 400 mg Q6W). Safety, T cell response, and preliminary antitumor activity were assessed. Results: As of 12 January 2024, 42 patients with HPV16+ PD-L1+ R/M HNSCC (41 of oropharynx as primary cancer site) were treated with HB-200 plus pembrolizumab in the 1L setting. Median follow-up time was 5.6 months. Characteristics of this cohort included: median age 66 years (range 50-77), 41 (98%) male, 37 (88%) White, 14 (33%) with ≥ 10 pack/year smoking history, 40 (95%) check point inhibitor (CPI) naïve (2 received CPI in the adjuvant setting), and 21 (50%) with PD-L1 CPS ≥ 20. HB-200 + pembrolizumab were generally well tolerated. Grade ≥3 treatment-related adverse events (TRAEs) were reported in 6 (14%) patients, serious TRAEs in 3 (7%) patients, and TRAEs leading to treatment discontinuation in 2 (5%) patients. No treatment-related death were reported. Among 35 evaluable patients (those with ≥ 1 tumor response assessments), the overall response rate (ORR) was 43% (3 complete response [CR], 9 partial response [PR], 3 unconfirmed PR) and the disease control rate (DCR) was 71%. Notably, among patients with PD-L1 CPS ≥20 (N = 17), ORR was 59% (3 CR, 6 PR, 1 unconfirmed PR) and DCR was 88%. Conclusions: Updated data of HB-200 arenavirus-based immunotherapy plus pembrolizumab continued to demonstrate a favorable safety profile and promising clinical activity as 1L treatment in patients with HPV16+ PD-L1+ R/M HNSCC and confirms previously reported data. The results suggest that the subgroup of patients with PD-L1 CPS ≥20 may benefit more from this treatment, which warrants further development in a randomized pivotal study. Clinical trial# NCT04180215. Clinical trial information: NCT04180215 .
Details
- Title: Subtitle
- HB-200 arenavirus-based immunotherapy plus pembrolizumab as first-line treatment of patients with recurrent/metastatic HPV16-positive head and neck cancer: Updated results
- Creators
- Alan Loh Ho - Memorial Sloan Kettering Cancer CenterLisle Nabell - University of Alabama at BirminghamPrakash C. Neupane - University of Kansas Medical CenterMarshall R. Posner - Icahn School of Medicine at Mount SinaiEmrullah Yilmaz - Cleveland ClinicJiaxin Niu - The University of Texas MD Anderson Cancer CenterAbdul Rafeh Naqash - University of Oklahoma Health Sciences CenterAlexander T. Pearson - University of ChicagoStuart J. Wong - Medical College of WisconsinJorge J. Nieva - University of Southern CaliforniaDouglas Earl Laux - University of IowaDeborah J.L. Wong - Los Angeles Medical CenterZujun Li - NYU Langone HealthAri Joseph Rosenberg - University of ChicagoWinston Wong - Memorial Sloan Kettering Cancer CenterXiaoping Qing - HOOKIPA Pharma Inc., New York, NYCorinne Iacobucci - Hookipa Pharma Inc., New York, NYHenning Lauterbach - HOOKIPA Pharma Inc., New York, NYIlian Tchakov - HOOKIPA Pharma Inc., New York, NYDavid G. Pfister - Memorial Sloan Kettering Cancer Center
- Resource Type
- Abstract
- Publication Details
- Journal of clinical oncology, Vol.42(16_suppl), pp.6005-6005
- DOI
- 10.1200/JCO.2024.42.16_suppl.6005
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Language
- English
- Date published
- 06/01/2024
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984649059202771
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