378O - Subgroup Analysis of a Phase II Multicenter Trial of HF10, Oncolytic Virus Immunotherapy, and Ipilimumab Combination Treatment in Unresectable or M...

Date 18 November 2017
Event ESMO Asia 2017 Congress
Session Proffered paper session 2
Topics Immunotherapy
Skin cancers
Presenter Robert Andtbacka
Citation Annals of Oncology (2017) 28 (suppl_10): x113-x116. 10.1093/annonc/mdx667
Authors R.H.I. Andtbacka1, M. Ross2, S.S. Agarwala3, M. Taylor4, J. Vetto4, R.I. Neves5, A. Daud6, H.T. Khong1, R.S. Ungerleider7, M. Tanaka8, K.F. Grossmann1
  • 1-, Huntsman Cancer Institute, University of Utah, 84103 - Salt Lake City/US
  • 2-, The University of Texas, MD Anderson Cancer Center, Houston/US
  • 3-, St. Luke's University Hospital and Temple University, Easton/US
  • 4-, Knight Cancer Institute, Oregon Health and Science University, Portland/US
  • 5-, Penn State Hershey Cancer Institute, Hershey/US
  • 6-, University of California San Francisco UCSF, 94143 - San Francisco/US
  • 7-, Theradex Oncology, 08540 - Princeton/US
  • 8-, TAKARA BIO INC, Shiga/JP



HF10 is a bioselected replication-competent oncolytic virus derived from HSV-1. Herein, we report the safety and efficacy data of HF10+ipilimumab (ipi) combination treatment in a Phase II trial in melanoma.


Ipi naïve patients (pts) with Stage IIIB-IV unresectable melanoma received HF10 injections (inj) into single or multiple dermal, subcutaneous or lymph node tumors (1x107 TCID50/mL, up to 5mL/dose); 4 inj qwk; then up to 15 inj q3wk. Ipi was administered IV (3 mg/kg), q3wk for 4 doses. Tumor responses assessed per irRC at 12, 18, 24, 36 and 48wks. Primary endpoint was Best Overall Response Rate (BORR) at 24wks.


Of 46 pts enrolled and treated: 59% men, median age 67 yrs (range 28 to 91); disease stage 20% IIIB, 43% IIIC & 37% IV; therapy (tx) naïve: 57% and ≥ 1 prior cancer tx: 43% (2 pts received prior immune checkpoint inhibitors). Most HF10-related AEs were ≤G2, similar to HF10 monotherapy. 37% had ≥G3 AEs, the majority due to ipi. HF10-related ≥G3 AEs (n = 3) were embolism, lymphedema, diarrhea, hypoglycemia, and groin pain. Of 44 efficacy evaluable pts per irRC, BORR at 24wks was 41% (18% irCR, 23% irPR); disease control rate was 68% (27% irSD). BORR at 48wks was 45% (18% irCR, 27% irPR). BORR at 24wks in tx naïve pts was 50% (17% irCR, 33% irPR) and pts with ≥1 prior therapies was 30% (20% irCR, 10% irPR). BORR in pts with stages IIIB/IIIC/IVM1a (n = 34) and IVM1b/IVM1c (n = 10) were 47% (21% irCR, 26% irPR) and 20% (10% irCR, 10% irPR), respectively. Median PFS was 19mos and 1-year overall survival rate was 85%. Median PFS in tx naïve and pts with ≥1 prior therapies were 19mos and 22mos, respectively; 1-year overall survival rates in tx naïve and pts with ≥1 prior therapies 87% and 82%, respectively. HF10+ipi treatment resulted in a decrease in lesion size by ≥ 50% in 57% of injected lesions (N = 148), 39% of never injected non-visceral lesions (N = 41) and 14% of never injected visceral lesions (N = 22). Complete resolution of lesions occurred in 30% of injected lesions and 20% of never injected non-visceral lesions.


The combination HF10 and ipi treatment demonstrated a favorable benefit/risk profile and encouraging antitumor activity in unresectable or metastatic melanoma pts.

Clinical trial identification


Legal entity responsible for the study





R.H.I. Andtbacka: Receipt of grants/research supports: from Takara, Amgen, Viralytics Receipt of honoraria: from Merck, Novartis, M. Ross: Receipt of honoraria or consultation fees: AMGEN, MERCK, PROVECTUS Participation in a company sponsored speaker’s bureau: AMGEN, M. Taylor: Receipt of honoraria or consultation fees: Bristol Myers Squibb, Eisai Inc, Trillium Pharma, Blue Print Medicines. Participation in a company sponsored speaker’s bureau: Bristol Myers Squibb, Eisai Inc. J. Vetto: Receipt of grants/research supports: none Receipt of honoraria or consultation fees: Castle Biosciences, Novartis Participation in a company sponsored speaker’s bureau: Castle Biosciences, Amgen Stock shareholder (Yes/No): No Spouse/Partner (Yes/No): Yes; salary and stock (Roche)

All other authors have declared no conflicts of interest.