演題抄録

FACO International Workshop

開催概要
開催回
第53回・2015年・京都
 

Delayed tumor response and safety profile in patients (pts) with refractory superficial cancers treated with intratumoral injections of HF10, an oncolytic HSV-1

演題番号 : FWS3-6

[筆頭演者]
Andtbacka Robert H.:1 
[共同演者]
Grossmann Kenneth F.:2、Khong Hung T.:2、Tanaka Maki:3、Ungerleider Richard S.:4、Ferris Robert L.:5

1:Surgical Oncology, Surgery, Huntsman Cancer Institute, University of Utah、2:Medical Oncology, Internal Medicine, Huntsman Cancer Institute, University of Utah、3:Takara Bio Inc.、4:Theradex、5:Otolaryngology, University of Pittsburgh

 

Background: HF10, a HSV-1 derived intratumoral injectable oncolytic immunotherapy, infects and lyses cancer cells resulting in antitumor immune activation. Here we report on a US Phase I dose escalation trial in patients with refractory superficial cancers.
Methods: In Stage 1, a single HF10 injection was administered to a superficial/cutaneous lesion; in Stage 2, up to 4 injections (at least 2 weeks apart) were given. Safety and responses (RECIST 1.0) were assessed.
Results: Of 26 patients treated, 24 pts had adverse events (AEs). 9 pts had HF10-related AEs including injection site reaction, chills and fatigue. There were no grade 3 or greater HF10-related AEs. HF10 was rapidly cleared from blood, saliva and urine. HSV-1 sero-positive and sero-negative pts did not differ in AE profile or HF10 clearance. 1 x 107 TCID50/mL was the recommended dose for repeated HF10 injections. Of 24 evaluable pts at end of study (EOS - per protocol at least 10 wks after initiating therapy), none had a complete (CR) or partial response; 7 and 8 pts had local and overall stable disease (SD), respectively. Six of 9 melanoma pts had overall SD. One melanoma pt had a 45% decrease in injected tumor size, but was not a partial responder. Interestingly, in long-term follow-up after EOS, 3 other melanoma pts had delayed responses in their HF10-injected lesions: one patient with an injected thigh tumor had a pathological CR on resection and remains disease free 1.5 yrs later; one pt with an injected submandibular lymph node had a CR and remains disease free; and one pt had a CR in an injected neck lymph node, but has slowly progressed in a lung metastasis.
Conclusions:HF10 serial injections are safe. In pts with metastatic melanoma, HF10 treatment can result in delayed CRs. HF10 is a potential new treatment option for melanoma pts, and a Phase II study of intratumoral HF10 combined with systemic immunotherapy (ipilimumab) in unresectable metastatic melanoma pts is underway.

キーワード

臓器別:Skin

手法別:Clinical Trial

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