Abstract
Primary results from a randomized (1:1), open-label phase II study of talimogene laherparepvec (T) and ipilimumab (I) vs I alone in unresected stage IIIB- IV melanoma
Journal of clinical oncology, Vol.35(15_suppl), pp.9509-9509
05/20/2017
DOI: 10.1200/JCO.2017.35.15_suppl.9509
Abstract
9509
Background: T is a HSV-1-based oncolytic virus designed to selectively replicate in tumors and produce GM-CSF to stimulate antitumor immune responses. I is an anti-CTLA-4 Ab that blocks inhibition of activated T cells. This is the first randomized study to evaluate the addition of an oncolytic virus to a checkpoint inhibitor. Methods: The 1
o
endpoint was ORR by immune-related response criteria. Key 2
o
endpoints: duration of response, disease control rate (DCR), PFS, OS, and safety. Prior treatment was allowed but not required. Pts had unresected stage IIIB-IV melanoma with measurable/injectable tumor(s) and no evidence of immunosuppression. T was given at approved dosing until no injectable tumors, disease progression (PD), or intolerance. I was started at w6 in T+I and at w1 in I at 3 mg/kg IV q3w x 4. Primary analysis occurred 6 m after last pt enrolled. Results: 198 pts were randomized: 98 T+I; 100 I. Characteristics were similar: 54% stage IIIB-IVM1a, 46% IVM1b/c. Median follow up time was 68 w (T+I) and 58 w (I). ORR was 38.8% (T+I) and 18.0% I, P = 0.002, Odds ratio (OR) 2.9. 89% T+I and 83% I pts remain in response. Unconfirmed visceral lesion response was 35.5% T+I vs 13.6% I. OS is immature. Of 190 pts (safety set: 95 T+I, 95 I), most common adverse events (AEs) for T+I, I (%) were fatigue (59, 42), chills (53, 3), and diarrhea (42, 35). 28% T+I and 18% I pts had gr ≥3 tx-related AE. There were 3 deaths (all unrelated) in T+I: 1 myocardial infarction and 2 PD. Conclusions: The study met the 1
o
endpoint. ORR was significantly higher for T+I vs I; responses were not limited to injected lesions. Toxicity of T+I combination was tolerable with no unexpected AEs. Clinical trial information: NCT01740297. [Table: see text]
Details
- Title: Subtitle
- Primary results from a randomized (1:1), open-label phase II study of talimogene laherparepvec (T) and ipilimumab (I) vs I alone in unresected stage IIIB- IV melanoma
- Creators
- Jason Alan Chesney - University of LouisvilleIgor Puzanov - Vanderbilt University Medical CenterMerrick I. Ross - The University of Texas MD Anderson Cancer CenterFrances A. Collichio - University of North Carolina at Chapel HillMohammed M. Milhem - University of IowaLisa Chen - AmgenJenny J. Kim - Johns Hopkins HospitalClaus Garbe - University of TübingenAxel Hauschild - University Hospital Schleswig-HolsteinRobert Hans Ingemar Andtbacka - Huntsman Cancer Institute
- Resource Type
- Abstract
- Publication Details
- Journal of clinical oncology, Vol.35(15_suppl), pp.9509-9509
- DOI
- 10.1200/JCO.2017.35.15_suppl.9509
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Language
- English
- Date published
- 05/20/2017
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984363167502771
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