Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Melanoma

1802 - Final Results of Phase I Trial of HF10, Oncolytic Virus Immunotherapy, in Japanese Patients with Refractory Superficial Cancers (382O)

Date

17 Nov 2017

Session

Melanoma

Presenters

Naoya Yamazaki

Citation

Annals of Oncology (2017) 28 (suppl_10): x113-x116. 10.1093/annonc/mdx667

Authors

N. Yamazaki1, A. Takahashi1, A. Tsutsumida1, M. Tanaka2, K. Namikawa1

Author affiliations

  • 1 Dermatologic Oncology, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 2 -, Takara Bio Inc., Shiga/JP
More

Resources

Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 1802

Background

HF10, an attenuated, replication-competent mutant strain of Herpes Simplex Virus type 1 (HSV-1), is a promising new oncolytic viral immunotherapy. HF10 (intratumoral injection) showed activity in injected lesions and uninjected lesions in the preclinical and the clinical. To assess the safety and tolerability of HF10, we conducted a Phase I trial in the Japanese patients with refractory solid tumors with cutaneous and/or superficial lesions.

Methods

The study was an open label, non-randomized, dose escalation study evaluating 2 dose levels of HF10 (1 x 106, 1 x 107 TCID50/dose). Dose escalation proceeded according to a “3 + 3” design. HF10 injected into single lesion up to 4 injections (≥ 2 weeks apart). Adverse events (AEs) were evaluated according to NCI CTCAE v4.0. Evaluation criteria at sequential timepoints included overall and injected tumor response per mWHO criteria; safety; viral detection by qPCR.

Results

Six patients (pts) with melanoma or other skin cancers were enrolled and treated. Of 6 safety evaluable pts, no DLTs were reported. HF10-related AEs occurred in 3 pts (Grade 1 Malaise in 2pts, Gr 1 Headache and Gr 1 Abdominal pain lower in 1 pt). These AEs were easily managed, and no HF10-related serious AEs were reported. Of 6 efficacy evaluable pts, 4 pts showed SD and 2 pts showed PD. One pt with vaginal melanoma had pigmented-lesion faded during the HF10 treatment, and showed SD (16.7% decrease) at the end of study. Moreover, the pt started PD-1 treatment soon after HF10, and finally reached CR.

Conclusions

Multiple intratumoral injections of HF10 in superficial tumors was well-tolerated and appeared to be safe. Also, HF10 injection resulted in stabilization of the injected tumor. Comparing the results from the Phase I in the US, it was considered that there was no significant difference in the safety profile between the US and Japanese pts.

Clinical trial identification

NCT02428036.

Legal entity responsible for the study

Takara Bio, Inc.

Funding

Takara Bio, Inc.

Disclosure

N. Yamazaki: Receipt of honorarium from Takara Bio, Inc.

All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings