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Mini Oral - Melanoma and other skin tumours

1083MO - Final results from ILLUMINATE-204, a phase I/II trial of intratumoral tilsotolimod in combination with ipilimumab in PD-1 inhibitor refractory advanced melanoma


18 Sep 2020


Mini Oral - Melanoma and other skin tumours


Clinical Research;  Immunotherapy

Tumour Site



Cara Haymaker


Annals of Oncology (2020) 31 (suppl_4): S672-S710. 10.1016/annonc/annonc280


C. Haymaker1, R.H.I. Andtbacka2, D.B. Johnson3, M.F. Shaheen4, S. Rahimian5, S. Chunduru6, N. Gabrail7, G. Doolittle8, I. Puzanov9, J. Markowitz10, C. Bernatchez1, A. Diab11

Author affiliations

  • 1 Investigational Cancer Therapeutics, The University of Texas M. D. Anderson Cancer Center, 77030 - Houston/US
  • 2 Surgical Oncology Department, University of Utah Health - Huntsman Cancer Institute, 84112 - Salt Lake City/US
  • 3 Medical Oncology, Vanderbilt University Medical Center, Nashville/US
  • 4 Medicine, University of Arizona Cancer Center, Tucson/US
  • 5 Oncology Department, Idera pharmaceuticals, 19341 - Exton/US
  • 6 Translational Biology Department, Idera pharmaceuticals, 19341 - Exton/US
  • 7 Medical Oncology, Gabrail Cancer Center Research, LLC, 44718 - Canton/US
  • 8 Medical Oncology, University of Kansas Medical Center, Westwood/US
  • 9 Department Of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo/US
  • 10 Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa/US
  • 11 Melanoma Medical Oncology Dept, The University of Texas M. D. Anderson Cancer Center, 77030 - Houston/US


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Abstract 1083MO


Tilsotolimod (IMO-2125), an investigational Toll-like receptor 9 agonist, activates innate and adaptive immune responses and rapidly upregulates Type I IFN and dendritic cell activation following intratumoral injection. ILLUMINATE-204 was a phase 1/2 study of tilsotolimod with ipilimumab in patients with advanced melanoma following progression on or after anti-PD-1 therapy.


Adults with unresectable or metastatic melanoma that progressed on or after a PD-1 inhibitor, an accessible tumor for intratumoral administration of tilsotolimod, and ≤ 2 lines of prior therapy (≤ 3 if BRAF-mutant) were eligible. Prior ipilimumab was allowed. Tilsotolimod was administered to a single tumor during weeks 1, 2, 3, 5, 8, and 11; ipilimumab was administered per the product label. The primary objective of the phase II portion was to assess preliminary clinical activity at the recommended phase II dose (RP2D).


A total of 62 patients were treated with tilsotolimod in combination with ipilimumab. Of these, 52 received the RP2D of 8 mg, and 49 were evaluable for efficacy. The median OS was 21.0 months (95% confidence interval (CI): 9.8 - not reached [NR]), and the overall response rate per RECIST v1.1 was 22.4% (95% CI: 11.8 - 36.6), including 2 complete responses. Median duration of response was 11.4 months (95% CI: 3.3 - NR) with 7/11 responses lasting ≥ 6 months. The disease control rate was 71.4% (95% CI: 56.7 - 83.4). Tumor reduction was observed in injected and non-injected lesions. Analysis of biopsies showed rapid local IFNα gene expression, dendritic cell maturation, and expansion of shared CD8+ T cell clones in injected and non-injected tumors. Grade ≥ 3 AEs were observed in 48% (30/62) of patients, most commonly increased ALT and AST and colitis, and 26% experienced immune-related AEs. No AEs led to treatment discontinuation or death.


Tilsotolimod with ipilimumab was generally well-tolerated and demonstrated efficacy in anti-PD-1-refractory advanced melanoma. Activity was observed in injected and non-injected lesions. A phase III study of this combination compared with ipilimumab alone (ILLUMINATE-301; NCT03445533) is ongoing.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

Idera Pharmaceuticals.


Idera Pharmaceuticals.


C. Haymaker, C. Bernatchez: Advisory/Consultancy: Idera Pharmaceuticals. R.H.I. Andtbacka: Advisory/Consultancy: Aduro; Advisory/Consultancy: Merck and Co; Advisory/Consultancy: Novartis; Advisory/Consultancy: OncoSec; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Takara. D.B. Johnson: Advisory/Consultancy, Research grant/Funding (self): Bristol-Myers Squibb; Research grant/Funding (self): Incyte; Advisory/Consultancy: Array Biopharma; Advisory/Consultancy: Merck and Co; Advisory/Consultancy: Novartis; Advisory/Consultancy: Janssen. S. Rahimian, S. Chunduru: Shareholder/Stockholder/Stock options, Full/Part-time employment: Idera Pharmaceuticals. I. Puzanov: Advisory/Consultancy: Amgen. J. Markowitz: Research grant/Funding (institution): Morphogenesis; Research grant/Funding (institution): Jackson Labs; Advisory/Consultancy: Newlink Genetics; Advisory/Consultancy: Array Biopharma. A. Diab: Advisory/Consultancy, Research grant/Funding (self): Idera Pharmaceuticals; Advisory/Consultancy, Research grant/Funding (self): Nektar Therapeutics; Advisory/Consultancy, Research grant/Funding (self): Bristol-Myers Squibb; Advisory/Consultancy: Jounce Therapeutics; Advisory/Consultancy: Novartis; Advisory/Consultancy: Array BioPharma. All other authors have declared no conflicts of interest.

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