Abstract
Phase 1b/2, open label, multicenter study of intratumoral SD-101 in combination with pembrolizumab in anti-PD-1 treatment naïve patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
Journal of clinical oncology, Vol.37(15_suppl), pp.6039-6039
05/20/2019
DOI: 10.1200/JCO.2019.37.15_suppl.6039
Abstract
6039
Background: SD-101, a synthetic CpG-ODN agonist of TLR9, stimulates dendritic cells to release IFN-alpha and mature into antigen presenting cells - activating T cell anti-tumor responses. Pembrolizumab has demonstrated activity in HNSCC. Study DV3-MEL-01 (NCT02521870) assesses safety and efficacy of SD-101 in combination with pembrolizumab in patients with recurrent/metastatic HNSCC. We have previously reported a 27.3% ORR in 22 patients receiving 8 mg SD-101/injection in the modified ITT after at least 2 CT scans due to late responses (Abstract 3560, ESMO 2018). Higher efficacy at a lower SD-101 dose, 2 mg/injection, has been reported in advanced melanoma patients (LBA 45, ESMO 2018). Consequently, this dose is now being assessed in HNSCC. We report preliminary data with the 2 mg/injection dose in 23 patients in mITT at the first CT scan. Methods: Anti-PD-1/PD-L1 naïve patients received 2 mg SD-101 intratumorally in 1 - 4 lesions (weekly x 4 doses then Q3W x 7 doses). Pembrolizumab is was administered IV at 200 mg Q3W. Responses were assessed per RECIST v1.1. Results: 28 patients enrolled: median age 63 y/o, male 68%; ECOG PS 0-1 (18%/82%); mean prior lines of systemic therapy 1 (0-3); mean treatment duration 70 days (1-253). Primary tumors: 19 (68%) oropharyngeal; 3 (10%) laryngeal; 2 (7%) hypopharyngeal; 4 (14%) unknown. Mean number of target lesions: 1.82 (1 to 5). HPV status: 7 (25%) +, 9 (32%) -, 12 (43%) unknown. 18 (64 %) discontinued treatment: 12 (42%) due to PD, 4 (16%) deaths, 1 (3%) consent withdrawn, 1 (3%) went to hospice. Mean follow up 2.70 months. Safety: 16 non-treatment-related SAEs in 9 patients. 2 treatment-related Grade ≥3 AEs: sepsis (4%) and lymphopenia (4% ). No treatment-related deaths. Efficacy: 23 patients in the mITT population with first CT scan at day 64: ORR: CR: 2, PR: 3 (22%); SD: 6 (26%), PD: 7 (30%), non-evaluable: 5 (22%). Disease control rate (48%). 5 patients on study have not had a CT scan. Conclusions: SD-101 with Pembrolizumab shows early promising data and is well tolerated. Additional follow-up scans from both dose cohorts are being evaluated and will be presented. Clinical trial information: NCT02521870.
Details
- Title: Subtitle
- Phase 1b/2, open label, multicenter study of intratumoral SD-101 in combination with pembrolizumab in anti-PD-1 treatment naïve patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
- Creators
- Ezra E.W. Cohen - University of California, San DiegoLisle Nabell - University of Alabama at BirminghamDeborah J.L. Wong - University of California, Los AngelesTerry A Day - Medical University of South CarolinaGregory A. Daniels - University of California, San DiegoMohammed M. Milhem - University of IowaSanjeev Deva - Auckland City HospitalMichael B. Jameson - Waikato HospitalOrlando Guntinas-Lichius - Jena University HospitalMohammed Almubarak - West Virginia UniversityRobert Matthew Strother - Canterbury District Health BoardEric D. Whitman - Atlantic Health SystemMichael Jon Chisamore - MSDCynthia Chinedu Obiozor - Dynavax TechnologiesTeresa Bagulho - Dynavax TechnologiesAlbert Candia - Dynavax TechnologiesErick Gamelin - Dynavax TechnologiesRobert Janssen - Dynavax TechnologiesAlain Patrick Algazi - University of California, San Francisco
- Resource Type
- Abstract
- Publication Details
- Journal of clinical oncology, Vol.37(15_suppl), pp.6039-6039
- DOI
- 10.1200/JCO.2019.37.15_suppl.6039
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Language
- English
- Date published
- 05/20/2019
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984363297402771
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