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Poster Discussion session - Head and neck cancers

3560 - 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)


20 Oct 2018


Poster Discussion session - Head and neck cancers


Clinical Research;  Immunotherapy

Tumour Site

Head and Neck Cancers


Ezra Cohen


Annals of Oncology (2018) 29 (suppl_8): viii372-viii399. 10.1093/annonc/mdy287


E.E..W. Cohen1, A. Algazi2, D. Laux3, D.J. Wong4, A. Amin5, L. Nabell6, M. Chisamore7, E. Gamelin8, R. Janssen9, S. Bishnoi10

Author affiliations

  • 1 Moores Cancer Center, University of California, San Diego, 92093 - San Diego/US
  • 2 Medicine: Hematology / Oncology, UCSF Medical Center at Mount Zion, 94115 - San Francisco/US
  • 3 Medicine, University of Iowa, 52242 - Iowa City/US
  • 4 Medicine, Hematology/oncology, UCLA - School of Medicine, 90095 - Los Angeles/US
  • 5 Medical Oncology, Levine Cancer Institute, NC 28204 - Charlotte/US
  • 6 Hematology And Oncology, University of Alabama at Birmingham, Birmingham/US
  • 7 Clinical research, Oncology, Merck & Co, Kenilworth/US
  • 8 Clinical Development, Dynavax Technologies Corporation, 94618 - Berkeley/US
  • 9 Clinical Development, Dynavax Technologies Corporation, 94710 - Berkeley/US
  • 10 Oncololgy, Adelaide Cancer Center, Kurralta Park/AU


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Abstract 3560


SD-101 is a synthetic CpG-ODN agonist of TLR9 that stimulates dendritic cells to release IFN-alpha and mature into antigen presenting cells to activate T cell anti-tumor responses. Pembrolizumab is a PD-1 inhibitor with demonstrated activity in HNSCC with an ORR of 14%. Study DV3-MEL-01 (SYNERGY-001) assesses safety and preliminary efficacy of SD-101 in combination with pembrolizumab in patients with recurrent or metastatic HNSCC.


In a phase 2 expansion cohort for anti-PD-1/PD-L1 treatment naïve recurrent and/or metastatic HNSCC patients, SD-101 was injected in a single tumor lesion (Weekly x 4 doses then Q3W x 7 doses) at 8 mg and pembrolizumab was administered IV (200 mg Q3W). Responses are assessed per investigator using RECIST v1.1/irRECIST and reported for the modified ITT (mITT) population that excludes patients on study who have not yet reached the first CT scan.


26 patients are enrolled to date: median age 65 y/o; male 91%; ECOG PS 0-1 (23%/73%); median prior lines of therapy in metastatic setting 1 (0 to 2); median treatment duration is 9 weeks (1 to 45). 15 patients interrupted treatment: 10 PD, 2 AEs, 1 withdrew consent, 1 death not treatment related, 1 other. SD-101 safety profile with a median of 5 doses (1.0 to 16.0) consists of flu-like symptoms and injection-site reactions. 28% Grade≥3 SD-101 treatment-related AEs including influenza-like symptoms, myalgia, headache, injection site pain and swelling, and fatigue. No increase in frequency of known pembrolizumab immune-related AEs (16%) and no new safety signal. ORR in mITT (n = 23) was 30.4% (7 PR; 3 SD, 10 PD, 3 discontinued due to clinical progression before first scan). Tumor shrinkage > 30% was seen in injected (8/18: 44.4%) and non-injected lesions (8/14: 57.1%). Five of the 7 PR are ongoing, (1 to 27 weeks).


In anti-PD-1 treatment naïve recurrent and/or metastatic HNSCC patients, SD-101 in combination with pembrolizumab showed a promising response rate and has been well tolerated. SD-101 appears to enhance the systemic effect of anti-PD-1 blockade.

Clinical trial identification


Legal entity responsible for the study

Dynavax Technologies Corporation.


Dynavax Technologies Corporation.

Editorial Acknowledgement


E.E.W. Cohen: Consulting or advisory role: Eisai, Pfizer, Merck, AstraZeneca, Bristol-Myers Squibb. A. Algazi: Research funding to institution: BMS, Merck, AstraZeneca, Medimmune, Acerta, Oncosec, Idera, Incyte, and Genentech; Unpaid advisor: Oncosec, Valitor. A. Amin: Honoraria from speaker’s bureau: Merck & Co. M. Chisamore: Employee: Merck & Co. E. Gamelin: Employee: Dynavax Technologies. R. Janssen: Employee: Dynavax Technologies; Stock holder: Dynavax Technologies, Merck. All other authors have declared no conflicts of interest.

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