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.

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 1o endpoint was ORR by immune-related response criteria. Key 2o 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 1o 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]

Evaluation of Arteriosclerosis Using the Brachial-Ankle Pulse Wave Velocity in Patients with Visceral Lesion-Free Systemic Lupus Erythematosus Characterized by Skin Lesions

Recently, the cardio-/cerebrovascular lesion-related mortality rate has been high in patients with systemic lupus erythematosus (SLE). In these patients, the risk of cardio-/cerebrovascular lesions is also higher than in the general population. Cardio-/cerebrovascular lesions may occur during long-term follow-up. In this study, we evaluated arteriosclerosis using the brachial-ankle pulse wave velocity (baPWV) in visceral lesion-free SLE patients with skin lesions. In these patients, baPWV was higher than in healthy adults even at a young age. This suggests that baPWV is a possible tool to evaluate the patient’s vascular function, which was difficult to evaluate using a conventional sera arteriosclerosis index. Even when conditions are characterized by skin lesions, it may be important to consider the influence on the cardio-/cerebrovascular systems, as indicated for patients with systemic symptoms.

Isolation of Acinetobacter calcoaceticus from the gastrointestinal tracts of SCID mice

Acinetobacter calcoaceticus colonization was observed in the gastrointestinal tracts of C.B17- scid/seid (SCID) mice, while it was not observed in C.B17- scid/+ and C.B17-+/+ mice with normal immunity housed under the same conditions. A. calcoaceticus and other viable enteric bacteria were not isolated from any organs other than gastrointestinal tract in SCID mice. The mice colonized with this organism were apparently healthy and no significant visceral lesion was observed.